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Archives of Psychiatric Nursing 30 (2016) 322–328
Contents lists available at ScienceDirect
Archives of Psychiatric Nursing
journal homepage: www.elsevier.com/locate/apnu
The Effect of a Drug Adherence Enhancement Program on the Drug
Adherence Behaviors of Patients With Major Depressive Disorder in Thailand: A Randomized Clinical Trial
Usa Vannachavee a, Acharaporn Seeherunwong b,⁎, Prapa Yuttatri b, Sudsabuy Chulakadabba a a Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand b Faculty of Nursing, Mahidol University, Bangkok, Thailand
a b s t r a c t
This study aimed to compare drug adherence behaviors during the sixth week between patients with first diagnosed major depressive disorder who received the Drug Adherence Enhancement Program and those who received only the usual care. A randomized clinical trial, post-test only design was conducted in the outpatient-unit of a medical school hospital in Bangkok, Thailand. The experimental and control groups consisted of 30 and 26 participants respectively. Participants in the experimental group exhibited significantly higher drug adherence behaviors than the control group. This is important for nurses in promoting adherence to antidepressant drugs for patients with first diagnosed major depressive disorder.
© 2015 Elsevier Inc. All rights reserved.
Patients with major depressive disorder (MDD) can have their depressive symptoms relieved by taking antidepressant drugs continu- ously according to a treatment protocol. Clinical practice guidelines strongly recommend using antidepressant medication as an initial modality for at least 6–12 weeks to induce remission of symptoms during the acute phase of treatment (American Psychiatric Association, 2010). However, patients with MDD tend to be uncooperative regarding medication intake when antidepressant drugs are first prescribed. Study findings have revealed that the lack of cooperation of patients with MDD is commonly found within the first three months of treatment (Nemeroff, 2003), and about 70% of patients with MDD discontinue their medications by themselves during the course of treatment (Demyttenaere et al., 2008; Haynes, Ackloo, Sahota, McDonald, & Yao, 2008; Pampallona, Bollini, Tibaldi, Kupelnick, & Munizza, 2002). Of Thai patients with MDD who sought treatment at a medical school hospital as many as 64% did not follow up on treatment within the first month (Vannachavee, Pakdeejit, & Seeherunwong, 2008). On the other hand, approximately four out of 10 US patients (42.4%) who initiated antidepressant treatment for depression discontinued their antidepressant medication during the first 30 days of treatment.
⁎ Corresponding Author: Acharaporn Seeherunwong, DNS, RN, Associate Professor, Faculty of Nursing, Mahidol University, 2 Phannok road, Bangkoknoi, Bangkok, Thailand 10700.
E-mail addresses: [email protected] (U. Vannachavee), [email protected] (A. Seeherunwong), [email protected] (P. Yuttatri), [email protected] (S. Chulakadabba).
http://dx.doi.org/10.1016/j.apnu.2015.12.001 0883-9417/© 2015 Elsevier Inc. All rights reserved.
BACKGROUND
There are many reasons for drug non-adherence during the first diagnosis of MDD. The major reasons are erroneous beliefs about the disease and its pharmacological treatment. The other reasons are physical and mental suffering from the adverse drug effect occurring after their use (Bollini, Pampallona, Kupelnick, Tibaldi, & Munizza, 2006; Chakraborty, Avasthi, Kumar, & Grover, 2008; Demyttenaere, 2001; Nabeel, 2008). People who have been diagnosed with MDD have perceived that they were insane and could not accept their abilities as a normal person (Seeherunwong, Boontong, Sindthu, & Nilchaikovit, 2002). As a result, they refused and neglected taking medication because it is a symbol of having mental illness (Sirey et al., 2001). Regarding the treatment, patients believed that medication cannot solve their mental sufferings, and assume that continuous medication intake will make them become dependent on antidepressant drugs for the rest of their lives (Aikens, Nease, & Klinkman, 2008). Patients also incorrectly think that antidepressant drugs are like symptomatic treatment that should be discontinued when the symptoms are lessened or should be taken only when they have the symptoms (Chakraborty et al., 2008). Regarding drug adverse reactions, patients were unable to tolerate the undesirable reactions of the drugs such as dizziness and drowsiness, which are most likely to occur in the early course of treatment (Lin, Korff, & Katon, 1995; Maddox, Levi, & Thompson, 1994). Furthermore, during delivery services in an outpatient clinic, health care providers did not have enough time to create a relationship and provide individualized information to the patients, which led to the patients' continued misunderstanding and erroneous beliefs. All of these reasons cause patients to terminate their medication in the early days of treatment.
Table 1 Topic and Implementation of Each Session of the DAEP.
Session Implementation
#1 Motivation to comply with the treatment plans
Build the nurse–patient relationship and conduct comprehensive assessment for understanding the patient's problems and care needs Find out the participant's goal for visiting psychiatry clinic Explore patient's attitude, perceptions, and feelings toward depressive disorder and its impact Find out the patient's erroneous attitudes toward becoming a patient with depressive disorder and its treatment Provide information about MDD and its treatment Encourage participants to present their concerns and intention to adhere to the regime Use trigger questioning to make the patients aware of their problems, provide information or useful options for making decisions regarding self-care and to perceive the situation as manageable, leading them to have hope, set goals, and make plans for their mental health
Assign homework to record drug taking on worksheet every day #2 Enhancement of confidence and strengthening the commitment to take medication
Explore the experience of medication taking, its benefit, and barriers to adhering to drug taking Search for feelings of ambivalence toward drug use Elicit attitudes, perceptions, and feelings about drug taking that made the patients have ambivalence concerning adherence Modify erroneous automatic thought toward drug taking, symptoms of adverse effects, and their illness Provide information tailored to the patient regarding the illness, reasons for using antidepressant drugs, and how to manage adverse effects Modify their behaviors that did not facilitate drug taking or recovery Record a plan to change specific behavior Assign homework to make them have a sense of success
#3 Monitoring and evaluation of the actual situation
Help the patients manage problems related to adverse effects of drugs and other problems Anchor drug adherence Assign homework to record change in perceptions and feelings in the worksheet
#4 Planning for continuing adherence
Prepare for solutions to drug taking problems for a long time Rehearse alternative options when forgetting to take drugs Provide information related to problems in discontinuing the regimen Encourage continuous medication intake after the end of the program Revision and summarization
323U. Vannachavee et al. / Archives of Psychiatric Nursing 30 (2016) 322–328
A program that can enhance patients' cooperation in the treatment of MDD, increase their medication adherence, and reduce their depres- sive symptoms has been developed based on the concept of motivational interviewing of Miller and Rollnick (2002), together with the strategies of the cognitive therapy of Beck, Rush, Shaw, and Emery (1979). It has been reported that such a program is effective in adjusting patients' attitudes toward medication intake (Tay, 2007) and their motivation to continue drug taking to 12 weeks is 2.7 times that of those who received the usual care (OR 2.7, 95% CI 1.6–4.8), resulting in significantly improvement in depressive symptoms during the follow-ups at 12 weeks (Peveler, George, Kinmonth, Campbell, & Thompson, 1999) and six months after the medication treatment (Sirey et al., 2001). In Thai psychiatric clinics, there is no nursing inter- vention to improve the drug adherence of patients with MDD. There- fore, the researcher developed the Drug Adherence Enhancement Program (DAEP) based on the concept of motivational interviewing (MI) proposed by Miller and Rollnick (2002), implemented together with the concept of cognitive therapy of Beck et al. (1979). The DAEP was utilized for patients with first episodes of MDD who were still receiving pharmacological treatment for the first time. According to MI, the program provides counseling which emphasizes to the patients the problems caused to them by non-adherence and manages their hes- itation in becoming motivated to take antidepressant drugs. Regarding the cognitive approach, the program placed its emphasis on negative automatic thinking and erroneous beliefs associated with the disease and its treatment, which directly affected patients' motivation and hesitation in appropriately adhering to the treatment plan and taking antidepressant drugs. In addition, the DAEP emphasized the establishment of a good relationship between nurses and patients, encouraged patients to accept their illness and treatment with medica- tions, reduced their anxiety and concern about the undesirable side effects of the prescribed antidepressant drugs, and provided informa- tion regarding the benefits of antidepressant drugs. Therefore, the specific aim of the current study was to determine the effect of the DAEP on the drug adherence behaviors of patients with MDD. The secondary aim was to explore the lessons learned from the clinical implementation. We hypothesized that patients with MDD who received the DAEP together with usual care would exhibit better drug adherence behaviors during the sixth week after the initial treatment than those who received only the usual care.
METHODS
Design
A randomized controlled trial with two parallel-group posttest-only designs was used in this study. As a result of the patients visiting the clinic for the first time, there was no pre-test score for drug adherence behavior. The study was carried out from October 2009 to January 2010. The experimental group received the DAEP for four weeks plus the usual care, while the control group only received the usual care.
Sample and Setting
The target population was outpatients first diagnosed with MDD at the psychiatric unit of a medical school hospital, in Bangkok, Thailand. The patients were recruited based on the inclusion criteria as follows: 1) male or female patients aged 18 or over, 2) receiving a first diagnosis of MDD based on the DSM-IV TR criteria by psychiatrist, 3) starting treatment with antidepressant drugs, 4) Thai language ability and 5) no psychosis. The participants who met the inclusion criteria and who were willing to participate in the study were randomly assigned into the experimental group and the control group, with 30 participants in each group, using block randomization performed using a statistical computer program. Participants were excluded if they had any addi- tional psychotic symptoms and/or had attempted suicide.
Sample sizes were calculated on the basis of medium effect size (ES = 0.5) of the intervention on the outcome of the drug adherence (Cohen, 1988), using a one-sided 5% significance level. The sample sizes are sufficient to have about 90% power to detect a difference between experimental and control groups of 30 in t-test analysis.
The hospital where this study took place is a leading medical school. The hospital provides general tertiary health care services having 1200 beds for inpatients. Bangkok is the capital of Thailand, and a major commercial city, with a population of 10,000,000 and an estimated MDD prevalence of 3.2% in males and 4.8 in females aged over 15 (data from national survey of Department of Mental Health, Ministry of Public Health, Thailand 2008). From the monthly record of the psychiatric unit, the number of new patients with first episode MDD averages 29 per month.
324 U. Vannachavee et al. / Archives of Psychiatric Nursing 30 (2016) 322–328
Drug Adherence Enhancement Program
The DAEP was developed by the researchers and comprises four individual face-to-face sessions that take place over a 4-week period. The program integrated three main components: an educational component imparting information about depressive disorders and their treatment; (2) a motivational component; and (3) a cognitive compo- nent. The contents of the program covered the initiation of motivation to adhere to the treatment plan, solving the patients' problems, negative automatic thoughts, and erroneous beliefs, and overcoming obstacles during medication intake to strengthen the patients' motivation to adhere continuously to medication intake. The topics and implementation of the four sessions are shown in Table 1. The first session took 1 hour, and the second through fourth sessions were approximately 30–45 minutes in length.
During the implementation of the program, worksheets designed by the researchers were used to record the participants' information, which was provided in response to trigger questions for the creation of motivation, such as the reasons for coming to see the doctor, the levels of motivation regarding medication intake, problems and obstacles with medication intake, the reasons for medication intake, etc. The level of motivation was arranged on a ruler scale, which is a simple form of measurement. The participants were asked to evaluate their motivation and encouraged to talk about drug taking “How strong do you feel about wanting to take drugs?” on a scale from 1 to 10, where 1 was “not at all” and 10 was “very much.” The patient was asked, “Where would you place yourself now?” For instance, the patient was asked why he or she gave a particular number, say 5, and not a lower number. This conversation was explored in some detail. During sessions 1–4 the researcher provided written tasks for that session, and in the follow-up session the researcher kept a record of all of the patient contacts.
In addition to the worksheets, the participants received a booklet comprising knowledge on dealing with the adverse effects of medication and a self-reported medication intake form created by the researchers.
A candidate master degree researcher conducted the intervention using a comprehensive program manual developed by the researchers. The program manual was examined by a panel of five experts, including two psychiatrists, two psychiatric nursing instructors, and one highly- experienced professional nurse, to ensure content validity and language appropriateness.
Measurement
The General Information Questionnaire was designed to collect the demographic data and clinical information, including gender, age, marital status, educational background, occupation, and antidepressant drugs prescribed.
Montgomery–Asberg Depression Rating Scale (MADRS) The MADRS is a ten-item observer-rated scale (1979) and was
translated into Thai by Thitakawee Kaewpornsawan (Sathapisit, Posya-anuwat, Sasalaksananon, Kaewpornsawan, & Singhakan, 2007). The MADRS was used to assess the severity of depressive symptoms on a 0–6 severity scale, resulting in a total score range of 0–60. The va- lidity and reliability of the MADRS Thai-version were at a high level, with the inter-rater reliability and intra-rater reliability equal to .99 and .99, respectively (Sathapisit et al., 2007). MADRS provides informa- tion on depression, internal tension, reduced sleeping, reduced appetite, difficulty concentrating, fatigue, inability to have feelings, negative thinking, and suicidal thoughts. Scores equal to or higher than 21 points meant that the patients were depressed.
Self-Medication Intake Record Form (SMIR) Drug adherence behaviors were measured using the SMIR devel-
oped by the researchers based on the concept that drug adherence
behaviors can be assessed according to the number of days that the patients correctly take medication, with the right dose and at the right time (Demyttenaere, 1997). This should be followed up continuously for more than one month. In this study, a self-report daily medication intake form was designed with three response choices: complete as pre- scribed by the doctor, score = 1; incomplete medication intake, score = 0; and no medication intake at all, score = 0. The total scores were calculated from the patients' self-report lasting six weeks (42 days) to determine their drug adherence behaviors. The record form was determined to be valid in previous research, and it yields sim- ilar results to the medication event monitor system (MEMS) (Ludman et al., 2003; Peveler et al., 1999). The self-reported number of days that the patients took medication in one month was highly correlated with the data from the MEMS with 86.7% agreement and K = 0.66 (Ludman et al., 2003). The record form was submitted to a panel of ex- perts to ensure its content validity and was revised based on their sug- gestions. The record form was tried out with five participants whose demographic characteristics were similar to those of the participants in the main study to ensure clarity and ease of understanding.
Ethical Considerations
This study was approved by the Medical School's Ethical Committee for the protection of human subjects, code number Si476/2009. A com- plete description of the study was provided to the patients and written informed consent was obtained from each one. The participants were informed that they could withdraw at any time without effect on their health service from the clinic. They were also informed that all of the in- formation gathered in the study would be treated as confidential.
Data Collection
The evaluation of the program took place two weeks after the last session. The program was used with newly-diagnosed patients when they were first admitted to treatment. The participants of the control group received the usual care from the nurses. When the participants finished their first visit to a psychiatrist in the outpatient clinic, nurses provided them with health education on MDD, offered advice on keep- ing up with their follow-up appointments, and made telephone follow- ups if the participants did not show up on the appointment day. In gen- eral, the psychiatrist made an appointment for a follow-up examination every one or two weeks, for a total of four appointments. When the pa- tients' symptoms had improved, the intervals between the follow-ups were extended. In this study, one of the researchers met each partici- pant in the control group twice, at six-week intervals. During the first session, the researcher collected information on patients' demographic characteristics and severity of depressive symptoms from their first di- agnosis with MDD and pharmacological treatment via interviewing. The researcher also gave them a manual for patients with MDD which included the SMIR for keeping a daily record of their medication intake at home for a period of six weeks. During the second session, at the sixth week of treatment, the researcher assessed their depressive symptoms and collected the SMIR during the follow-up appointment. At the end of the research procedure, it was found that there were four participants who did not show up on the appointment days and these participants could not be reached. Therefore, they were excluded from the study, and the total number of participants in the control group was then re- duced to 26.
The participants in the experimental group received routine nursing care similar to that of the participants in the control group. However, they also received the DAEP for a total of four sessions, each lasting 30–60 minutes. The first session was conducted when the participants first attended the clinic with the initial received antidepressant treatment, and the second to fourth sessions were conducted when the participants came to visit the psychiatrist on the days of the appointment. The researcher conducted the intervention after the
Randomly assigned
approached
60 participants received
baseline assessment
Experimental group:
n=30 Control group: n=30
7 re-arranged their
appointment
2 re-arranged their appointment
4 lost to follow-up
30 participants
completed the study
Post-test Post-test
2 wks 2 wks
DAEP 4 wks
4 wks
26 participants completed the study
60 potential participants were
Fig. 1. Recruitment and retention patterns of participants.
325U. Vannachavee et al. / Archives of Psychiatric Nursing 30 (2016) 322–328
psychiatrists had finished the examination of the participants. The researcher asked the participants if it was convenient for them to participate in the rest of the sessions on the day that was planned or if they would rather choose the days on which they were available, which could be the days of the follow-up appointment. The researcher offered the participants 200 baht (35 THB = 1 $US) for their traveling expenses. After the research ended, it was found that all of the experiment's participants cooperated with the research procedure and all 30 participants remained in the program until the end (Fig. 1).
Data Analysis
Chi-square or Fisher's exact test was used to compare the character- istics of the experimental and control groups and an independent t-test was utilized to compare age and depressive symptoms. The indepen- dent t-test was employed to examine the mean difference in drug adherence behaviors after the intervention with both groups. The significance level was set at 0.05. Data analysis was carried out using IBM SPSS Statistics, version 17. Moreover, the written statements on the experimental group worksheets from the second and third sessions of the intervention were analyzed using content analysis.
RESULTS
Participants
The participants in the experimental and control groups were not different in terms of statistical significance, except for occupation. A further analysis revealed that most of the participants in the control group were unemployed, while the largest group of participants in the experimental group consisted of government officials. The mean scores on the depressive symptoms at baseline were not different but a difference was found between both groups at two weeks after the intervention (Table 2).
Effect of Intervention on Drug Adherence Behaviors
The participants in the experimental group who received the usual care together with the DAEP had a higher mean score on drug adher- ence behaviors during the sixth week than that of the participants in the control group, who received only the usual care, with statistical sig- nificance (Table 3). In addition, the three highest barriers to taking anti- depressant drugs during the second week of participations in the experimental group included drug adverse effects (33%), the beliefs that drugs cannot relieve mental distress (21%), and concern about the danger of taking drugs (10%) (Table 4). After participating in the sec- ond session of the intervention, during the third week they reported their reasons for continuing to take drugs, including getting better after taking them (40%), no longer suffering from the side effects of the drugs (20%), and making the decision to complete the treatment plan (20%) (Table 5).
DISCUSSION
The participants in the experimental group had more correct drug adherence behaviors in terms of the dosage and timing when compared to those in the control group with statistical significance. Thus, the study hypothesis was accepted. This evidenced that a multi-facetted compo- nents program based on the integration of the strategies of motivational interviewing and cognitive therapy tailored to meet the needs of Thai patients with MDD can improve drug adherence behaviors. It reinforced a finding from a recent systematic review (Nieuwlaat et al., 2014). As a result, patients' needs were met as soon as they first came to seek treat- ment, which continued all through the subsequent follow-ups at the outpatient-clinic. The finding was consistent with previous studies that reported that collaborative intervention between health care providers and patients tailoring the information and the methods of communication, in response to the problems reported by the patient at the initial time of treatment could enhance drug adherence and attendance at subsequent appointments. A study of Olfson, Marcus, Tedeschi, and Wan (2006) found that patients who received
Table 2 Group Differences on Demographic Characteristics and Clinical Symptoms of Participants.
Variables Experimental (n = 30)
Control (n = 26)
p-value
n (%) n (%)
Gendera .815ns
Male 4 13 5 19 Female 26 87 21 81
Agea .619ns
b25 years 3 10 4 15 25–44 years 12 40 7 27 45–59 years 11 37 9 35 N60 years 4 13 6 23
Ageb 44.07 14.15 45.92 17.47 .439ns
Marital statusa .062ns
Single 9 30 10 39 Married 17 57 13 50 Separated/divorced/widowed 4 13 3 11
Education levela .637ns
No formal education 1 3 2 8 Primary education 8 27 5 19 Secondary education 2 7 5 19 Certificate of vocational Education 3 10 1 4 Under graduate education 13 43 11 42 Graduate education 3 10 2 8
Occupationa .035 Housework/unemployed 7 23 16 62 Government official 10 33 1 4 Agriculture 2 7 2 8 Own business 2 7 2 8 Employed 8 27 4 14 Student 1 3 1 4
Antidepressant drugs receiveda .904ns
MAOI – – – – TCA 3 10 2 8 SSRI 24 80 22 84 Others 3 10 2 8
Depressive symptoms [Mean (SD)]b
Pre-test 28.01 6.82 25.73 6.83 1.29ns
Post-test 11.53 6.59 19.90 11.07 .004⁎
ns = no statistical significance, p N .05 ⁎ p-value ≤0.05 level was considered statistically significant. a Chi-square or Fisher's exact test was used. b Independent sample t-test was used.
326 U. Vannachavee et al. / Archives of Psychiatric Nursing 30 (2016) 322–328
psychotherapy or mental health counseling during the initial period of antidepressant treatment were significantly more likely to continue antidepressants beyond 30 days than those who did not receive psycho- therapy (64.8% versus 43.7%). A study by Peveler et al. (1999) revealed that drug counseling by a nurse at weeks 2 and 8 according to a written protocol had a significant effect on adherence self-reported at 6 weeks and 12 weeks than receiving a leaflet. Regarding the counseling, the nurses assessed the patients' attitudes toward treatment, under- standing of medication intake and provided knowledge about depressive illness and related problems, the importance of medication intake, and side effects and their management. Similarly, Hunkeler, Mersman, Hargreaves, and Fireman (2000) found that when nurses showed compassion and understanding and offered to help solve the patients' problems with medication intake and psychosocial problems through consistent telephone calls during the first six weeks of the
Table 3 Effect of the DAEP on Drug Adherence Behaviors During the Sixth Week.
Drug adherence behaviors Experimental group (n = 30)
Con (n =
Mean SD Mea
Total drug adherence scores at six weeks (42 days) 41.17 2.87 22.5
⁎ Significance at p b .05 † Significance at p b .05
treatment, the patients with MDD had more satisfaction with the treatment. Also, 10 minutes of drug-related counseling by a pharmacist for the patients increased attendance at scheduled follow up clinics 6 weeks after initial treatment (66%) more than the group receiving leaflets (58%) and the 34% of the control group, which is a statistically significant difference (p = 0.004). After adjusting for age, sex and education, counseling was significantly associated with a much higher incidence of using medication correctly (OR 31.3, p = 0.009), leaflet use was less strongly associated (OR 8.4, p = 0.009) (Nabeel, 2008). On the other hand, it was supported by previous studies that found that information alone provided by leaflet (Peveler et al., 1999) or repeated mailings (Mundt, Clarke, Burroughs, Brenneman, & Griest, 2001) were not enough to enhance medication adherence.
Regarding clinical benefits, the findings showed that the patients who received the DAEP had better depression scores after the interven- tion than those who received only the usual care at a significant level, as shown in Table 1. This information supported the finding that the DAEP could enhance patients' drug adherence behaviors. As the antidepres- sant drugs adjusted the balance of the biochemical substances in the brain, patients' depressive symptoms improved. However, the depres- sion scores of the participants in the control group also reduced during the sixth week of the intervention, but to a lesser extent when com- pared to the scores of the participants in the intervention group. One plausible explanation is that the participants in the control group did not have correct or consistent medication intake. According to the interviews, some participants indicated that they took only sleeping pills but did not take the antidepressant drugs. Others took antidepres- sant drugs only on the days when there were events that caused depres- sion or when they felt extremely depressed. Furthermore, some only took half of the medications prescribed by the doctor, while others did not take any medication at all. Therefore, the participants who received the DAEP were able to increase their drug adherence behaviors more than the participants who received the usual care to a statistically significant extent.
Lessons Learned About Clinical Implementation
As stated, the DAEP has four sessions, and in each session the researcher recorded the conversation between the researcher and the participants during the delivery interventions and collected the worksheets from the participants. According to the first interviewing session, it was found that most of the participants were still at the deter- mination stage of behavior change. Their motivation for taking medica- tion was generally low, and some of them never even thought of medication intake at all and as a result they had no idea about the dis- ease or its treatment. They decided to see the doctor for information and some help for their suffering. Consistent with the findings of Aikens et al. (2008) the first-episode patients had an unclear understanding of depression and attributed their symptoms to random factors. The responses to the participants at this stage were to show them under- standing and compassion. The researcher also gave them information and options that would benefit the patients in their decision to perform self-care. This implementation was supported by previous studies, which found that the patients' lack of knowledge and understanding
trol group 26)
Levene's test for equality of variances t-test
n SD F t df
8 17.07 130.976 † 5.486⁎ 26
Table 4 Barriers to Taking Antidepressant Drugs During the Second Week of Participation in Ex- perimental Group (n = 30).a
Barrier factors Frequency (n) Percentage (%)
No barrier 7 14 Adverse effects of drugs 16 33
Drowsiness (12) (25) Nausea (4) (8)
Beliefs that drugs cannot relieve mental distress 10 21 Concern about danger from taking drugs 5 10 Concern about drug addiction 4 8 Total 49 100
a Data from the worksheet from the experimental group in the second week. The par- ticipant can have more than one answer.
327U. Vannachavee et al. / Archives of Psychiatric Nursing 30 (2016) 322–328
about their illness and treatment was one of the barriers to drug adherence (Gellad, Jerry, Grenard, & Marcum, 2011) and that the patient–provider relationship was able to improve drug adherence (World Health Organization, 2003). Thus, it was possible that if, at an early stage, patients received information about their illness and its problems and learned that their problems could be solved, it would give them more motivation, and they could set their goals and plan self-care practices.
During the second and third sessions, it became apparent that the adverse side effects of the antidepressants were important problems and obstacles that prevented the participants from adhering to the prescribed medication intake. The findings showed that 33% of the experimental participants suffered from various side effects of medica- tion intake, including extreme drowsiness during the day, at 25%, and nausea and loss of appetite, at 8%. Likewise, Demyttenaere (2003) found that undesirable side effects of antidepressants, including daytime drowsiness, were major causes of the discontinuation of the medication intake from the initial period of the treatment. Regarding Thai patients, Vannachavee et al. (2008) found that the main reason why most patients with MDD discontinued their medication intake during the first four weeks of treatment was the discomfort caused by the medication. Moreover, when investigating the patients' hesitation, it was found that the side effects made patients scared and they devel- oped incorrect ideas and beliefs about medication intake. In the present study, the findings indicated that 10% of the subjects thought that the drugs were dangerous, and 8% were concerned with addiction. Also, 21% of the subjects believed that the medications could not relieve their mental suffering. These results are similar to those of another study, in which it was seen that the patients' first experiences of taking antidepressants were fear of addiction or stigma, and reluctance to take their medications (Schofield et al., 2011). For these reasons, the re- searcher responded to the participants by listening attentively to them in order to identify their problems, reasons for hesitation, and negative beliefs and attitudes about their medication intake. After the ideas that affected the patients' hesitation to adhere to the treatment plan became known, the researcher helped the patients by modifying their thoughts. The findings showed that at the third week after the participants
Table 5 Reasons for Taking Antidepressants Drugs of the Participants in the Experimental Group During the Third Week (n = 30).a
Reasons for continuing to take antidepressant drugs Frequency (n)
Percentage (%)
Get better after taking drugs 12 40 No longer suffered from side effects of the drugs 6 20 Decided to complete the treatment plan 6 20 Wanted to see if the drugs could actually improve symptoms
3 10
Better than doing nothing; if not, the symptoms will increase
3 10
Total 30 100
a Data from the worksheet from the experimental group in the third week. The partic- ipant can have more than one answer.
received the DAEP, they developed positive motivation to adhere to medication intake, as shown in Table 4. About 40% of them indicated that they adhered to the drugs because they could improve their symp- toms and 20% felt that they no longer suffered from side effects of the drugs. A similar percentage also indicated that they had decided to com- plete the treatment plan as prescribed by the psychiatrist. The patients further explained to the nurses that even though their symptoms may not have improved, the explanation they received from the psychiatrist and nurses confirmed that they needed to complete the medication in- take as prescribed in order to realize the outcomes. Thus, they decided to continue taking their medication. Other subjects reasoned that they wanted to see if the drugs could actually improve their symptoms, so they adhered to medication intake. It is worth noting that some of the participants informed the nurses that they did not see any improve- ment after they took the medications, but the nurses explained that the medications had different effects and patients had different responses to the medications, so the participants decided to continue their drug adherence.
On the other hand, the control group received advice and pamphlets on self-care practices for patients with MDD from nurses in the psychi- atric unit, which was one-way communication. The participants did not have any chance to ask nurses to clarify their doubts, and they had a chance to meet the nurses only very briefly as there were a large num- ber of patients in the unit. Therefore, the control group may not have received comprehensive or individualized advice and they may have developed misunderstandings about the disease and treatment. It could be stated that their needs were not satisfied when they first came to seek treatment at the hospital. For these reasons, some of the participants in the control group lacked understanding of the signifi- cance of medication intake and lost the chance to exchange their experiences or share ideas about MDD and medication intake with the nurses. More importantly, their negative ideas and attitudes toward drug adherence were not adjusted, so their drug adherence behaviors were lower when compared to those of the participants in the experimental group with a statistical significance.
Limitations
The results of the current study might have been affected by the fact that the drug adherence behaviors were assessed only via self-reported medication intake because it was easy to use and saved costs. However, it is possible that the subjects may have given inaccurate information in order to please the researcher. In addition, the subjects in the experi- mental group met the researcher on a weekly basis, so they were followed-up closely during the acute phase. In contrast, the subjects in the control group were not as closely monitored. Thus, it is possible that the outcomes of the experimental subjects did not result from their participation in the DAEP alone, but also from the fact that they received close attention from the researcher. Another limitation was that this study had no pre-test scores to compare the difference in drug adherence behaviors between the experimental and control groups because the participants were receiving antidepressant drugs for the first time. However, the depressive symptoms and other characteristics of the participants between the groups were not significantly different.
CONCLUSION
The findings of the present study suggest that the DAEP, which is a multi-faceted component program based on the collaboration between nurses and patients to tailor interventions to respond to the patients experiencing the first episode of MDD during their initial drug treat- ment, can improve drug adherence behaviors. The program encouraged the patients to be motivated in adhering to their medication and modi- fied their misunderstanding, attitudes, and beliefs about the disease and the drugs used to ensure better remission.
328 U. Vannachavee et al. / Archives of Psychiatric Nursing 30 (2016) 322–328
Acknowledgment
The researchers would like to extend their sincerest gratitude to the Thai Nursing Council for the financial support in completing the study. Their profound thanks also go to all of the study participants for their participation in the study.
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- The Effect of a Drug Adherence Enhancement Program on the Drug Adherence Behaviors of Patients With Major Depressive Disorder in Thailand: A Randomized Clinical Trial
- Background
- Methods
- Design
- Sample and Setting
- Drug Adherence Enhancement Program
- Measurement
- Montgomery–Asberg Depression Rating Scale (MADRS)
- Self-Medication Intake Record Form (SMIR)
- Ethical Considerations
- Data Collection
- Data Analysis
- Results
- Participants
- Effect of Intervention on Drug Adherence Behaviors
- Discussion
- Lessons Learned About Clinical Implementation
- Limitations
- Conclusion
- Acknowledgment
- References