Community re-entry program on global functioning and medication adherence among bipolar affective disorder patients- A randomized controlled trial pilot study

Abstract

BACKGROUND:

The Community re-entry program aims to train participants with the skills and information and help to move efficiently through the mental health in-patient setting to more independent living in the community. This quantitative study to explores the effectiveness of community re-entry program on global functioning and medication adherence for patients with bipolar affective disorder.

MATERIAL AND METHODS:

The study was a randomized controlled clinical trial and conducted by the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines. The present study was done at the in-patient department of the tertiary care academic institute, Jodhpur. Samples N = 50 (25 + 25) were selected through consecutive sampling techniques and randomly assigned to intervention and control groups. The baseline data was collected with sample characteristics for both groups by using World Health Organisation Disability Assessment Schedule 2.0 to assess global functioning, the Medication Adherence Rating Scale for medication adherence. The community re-entry program group received 8 sessions of intervention each session is 45 minutes, and every day one session after post-intervention assessment and follow-up done at 1 month with the same scales. Statistical Package for Social Sciences (SPSS) version 20.0 was used. The data were analyzed using descriptive statistics (frequency, percentage, mean, and standard deviation) and inferential statistics Chi-square, fisher’s exact test and Yate’s correction used as applicable. Repeated measures-ANOVA mixed design (Two-way) is used for post-intervention comparison of outcome variables.

RESULTS:

Post-intervention comparison of medication adherence, found that there was a significant time effect F = 566.406 and np² = 0.922, group effect F = 24.495 and np² = 0.338, interaction effect with large effect size F = 21.052 and np² = 0.305. Whereas in global functioning there was a time effect with a large effect size of F = 65.783 and np² = 0.578 but no group or interaction effect.

CONCLUSION:

CREP is effective in enhancing medication adherence in patients with bipolar affective disorder and consequently, useful for the treatment and prevention of symptoms recurrence.

Introduction

Bipolar affective disorder is a chronic mental illness that causes unusual shifts in the mood, ranging from extreme highs to lows.[1] Around the world, 46 million people including U.S. 2.8% have bipolar affective disorder.[2] One out of 150 or 0.3% suffer from bipolar affective disorder in India, and 70% are left untreated though it is treatable.[3] An alarming situation if left unchecked.[4]

Unfortunately, despite the availability of effective treatment, patients with bipolar affective disorder continue to be an illness that is underdiagnosed, misdiagnosed, or diagnosed after a substantial delay.[5] In a country like India, patients have limited resources, poor knowledge and superstition about the disorder and treatment, and inadequate access to healthcare facilities, which makes treatment of bipolar affective disorder a challenge.[6] The National Institute for Health and Care Excellence (NICE) 2015 report suggests that one in every four individuals with BPAD does not receive the required treatment.[7] People with bipolar disorder spend around half their time with symptoms and, when compared with healthy individuals, people with bipolar disorder reported significantly less satisfaction with their quality of life.[8]

Bipolar affective disorder patients have common problems such as global functioning impairment, medication non-adherence, and higher relapse rates.[9] In the present study global functioning indicates an overall judgment about patient’s current level of functioning. It integrates three different dimensions psychosocial, social, and occupational on a hypothetical continuum of mental health-illness.[10] In a prospective study conducted by Tohen et al. the symptomatic recovery rate was 72%, while the functional recovery rate was 43% at 2 years after the first episode of mania.[11] This is an indication that patients with bipolar affective disorder suffer from significant functional impairment even during inter-episode intervals and after recovery from an acute episode of illness.[2]

Medication non-adherence is a major concern in bipolar affective disorder patients. Nearly half of the patients diagnosed with bipolar affective disorder become non-adherent during long-term treatment.[12,13] One of the influences of chronic conditions is that patients may stop taking medication contrary to the advice of mental health professionals, and present with relapse.[14] Relapse is challenging treatment in patients with mental illness, especially in patients with bipolar affective disorder, which causes high economic and social burdens.[15]

When conceptualizing the current study, a review of global and Indian studies on community re-entry care for bipolar affective disorder shows most of the literature studies are epidemiological, descriptive, cross-sectional studies, narrative and systemic reviews on Bipolar affective disorder. Globally, the majority of the published studies on community re-entry program have been conducted on schizophrenia. Only very few evidence-based research supports that the Community re-entry program will benefit clients suffering from bipolar affective disorder.[16] A study on the efficacy of the Community Re-Entry Module for patients with schizophrenia and bipolar affective disorder (Xiang YT et al),[17] shows CRM group significantly improved in terms of social functioning, insight, medication adherence, reduced relapse rate, and re-hospitalization rates.

There is a severe lacuna in the studies published on the efficacy of community re-entry program intervention on schizophrenia and bipolar affective disorder in-patients in home/community settings. The present study was a preliminary attempt to include all the above issues which have not been addressed in prior research involving the Indian population. Therefore, the researcher felt that the community re-entry program teaches skills and information to improve global functioning, and medication adherence.[18] It also helps ease the transition of BPAD patients from psychiatric hospitalization setting to community-based care.[19]

Materials and Methods

Study design and setting: A randomized controlled trial (RCT) design is used to see the effectiveness of a community re-entry program, for patients with bipolar affective disorder. Global functioning and medication adherence were assessed at baseline, post-intervention, and the 1 month. The study was conducted in the inpatient psychiatry department.

Study participants and sampling: The patients with bipolar affective disorder were assessed and enrolled based on inclusion criteria of being admitted more than two times in the inpatient department with a history of nonadherence (medication adherence questionnaire with score 2 and above) and admitted along with their caregivers. After calculating sample size, N = 50 (25 + 25) samples were selected using a consecutive sampling technique, sequentially numbered, opaque, sealed envelopes, containing computer-generated sequence numbers were used to allocate intervention to ensure allocation concealment.

Data collection tool and technique

Socio-demographic datasheet: The items included in the socio-demographic data sheet were divided into two parts of a structured questionnaire:- Patients’ basic information and clinical characteristics such as age at onset of illness, duration of present illness, number of relapses, number of medications prescribed, number of previous admissions, duration of treatment, family history of psychiatric illness, family history of BPAD.

World Health Organization Disability Assessment Schedule (WHODAS 2.0): The WHO-DAS 2.0- 36 item self-administered tool, it takes around 5 minutes to assess global functioning. This tool captures the level of functioning in six domains of life such as cognition, mobility, self-care, getting along, life activities, and participation. The scores assigned to each of the items—“none” (1), “mild” (2), “moderate” (3), “severe” (4), and “extreme” (5)—are summed. The total score is 180, 0 = no disability, 180 = full disability. WHO-DAS 2.0 scale test-retest reliability had an intra-class coefficient of 0.69–0.89 at the item level, 0.93– 0.96 at the domain level, and 0.98 at the overall level.

Medication Adherence Rating Scale (MARS) - MARS is used to assess medication adherence among BPAD. The scale has 10 items of self-reported questionnaires with “yes” or “no” responses. MARS each item was scored as “0” for a non-adherent attitude and behavior or “1” for an adherent attitude and behavior. The MARS total scores range from 0 to 10. Low values (0–7) on the scale show low adherence and the high values (8–10) show high adherence levels. Higher scores indicate better medication adherence. The reliability MARS was calculated with Cronbach’s alpha at 0.87 and the test-retest reliability coefficient was 0.91.

Development of community re-entry program- The community re-entry program trainer manual, which is used in the present study was acquired from the University of California, Los Angeles, it included 10 workbooks, 1 videocassette recorder compact disc of CREP, and 1 Trainer manual. Videocassette recorder compact disc and CREP Trainer manual were used with modifications according to the study setting. The principal investigator obtained permission from the author for modification from the University of California, Los Angeles. The community re-entry program was translated by the principal investigator and then back-translated by another experienced bilingual psychiatrist, following which the ambiguities in language were discussed and corrected. Specific modifications are done in the present CREP, combining 16 sessions into 8 sessions [Table 1], adding information regarding accessing telepsychiatric consultation from the institute, getting medication with less cost in the community, and financial and transportation benefits available in western Rajasthan, scheduling their daily activities especially soon after discharge from the hospital at home, maintain the stress-free environment at the community, benefits of medications and solving problems of medication side effects after discharge from the hospital. After modification of the module video recording was done in a hospital setting, short recorded video recordings were merged according to the session (8 sessions, each video maximum 10 minutes, between 3 and 4 minutes of video have question and answer round) and video is edited with subtitle Hindi for better understanding. After completion, Videos are validated by 5 experts modified videos according to expert advice including more graphics, and implemented.

Table 1.

Focus on the session of the Community re-entry program

Sessions	Title of sessions
Session: 1	Introduction to the CREP and symptoms of disabling mental disorders
Session: 2	Determining discharge readiness and community re-entry planning
Session: 3	Connecting with the community and coping with stress in the community
Session: 4	Planning daily schedules and making and keeping appointments
Session: 5	How medications work to prevent relapse and evaluating the effects of medication
Session: 6	Solving medication problems and medication side effect problems
Session: 7	Identifying warning signs of relapse and keeping track of warning signs
Session: 8	Developing an emergency relapse prevention plan and bringing your emergency plan to the community

After intervention oral feedback was taken from patients and patients reported that the videos and information given on CREP were understandable and they were interested especially, the question and answer round between the videos was more interesting because patients got more time to clarify their doubts. The workbook was a reminder for the patient to do activities explained in each session, with the help of the workbook patients can schedule daily activities at a hospital as well as at home, track their warning signs at home, and keep emergency plans with them in the experimental group.

Intervention: The experimental group receives 8 sessions of CREP intervention (each session is 45 minutes) everyday one session, and all sessions are predetermined with specific topics mentioned in Table 1. In each session introduction about the session, playing video on predetermined specific topics, each video 10 minutes after every 2-3 minutes break in the video, during that time asking questions on the video, clarifying doubts and completing the workbook, and assigning homework.

Procedure and data collection

At the time of data collection clinical status of patients was assessed with the Young Mania Rating Scale and selected with a cut-off score of less than 36 and depression patients were assessed with the Hamilton Depression Rating Scale and selected with a cut-off score of less than 24. The data were collected through self-reported questionnaires and interview methods. Pre-intervention assessment completed on bipolar affective disorder patients with WHODAS 2.0 scale for global functioning, MARS scale for medication adherence. After CREP intervention, the post-intervention assessment was done on bipolar affective disorder patients, and follow-up was done at 1 month with the same scales [Figure 1].

Figure 1.

CONSORT flow diagram of the progress through the phases of a parallel randomized controlled trial of two groups (that is, enrolment, intervention allocation, follow-up, and data analysis)

Treatment as usual/post-discharge follow-up

Participants in the control group received routine care and one session of psycho-education. Follow-up assessment was scheduled for both groups at 1 month.

Ethical consideration: The study was approved by the institutional ethical committee, AIIMS/IEC/2018/, and CTRI registration was done with Search Result, Clinical Trials Registry - India (CTRI) No- CTRI/2022/04/042166 [Registered on: 26/04/2022]. Informed consent was obtained from the participants. The purpose of carrying out the research project was explained, a participant information sheet was provided with detailed information regarding participation, and confidentiality was assured to the participants. The study was carried out according to the guidelines laid out by the Indian Council of Medical Research (2017).

Results

Table 2 depicts the baseline comparison between experimental and control group participants about socio-demographic variables. The results revealed that all the demographic variables were found to be homogenous and comparable at the baseline between the groups as the calculated statistics were non-significant at 0.05 level of significance.

Table 2.

Baseline comparison of Socio-demographic variables between experimental and control group participants (n=50)

Variables	Mean±SD		t/χ2	df	P
	Experimental (n=25)	Control (n=25)
Age in Years	33.16±7.967	35.64±8.703	-1.054t	48	0.299NS
Frequency (%)		Frequency (%)
Gender
Male	12 (48.0)	15 (60.0)	0.725^	1	0.395NS
Female	13 (52.0)	10 (40.0)
Religion
Hindu	25 (100.0)	25 (100.0)	-	-	-
Educational Status
Primary education	12 (48.0)	13 (52.0)	0.529￥	-	0.848NS
Secondary education	11 (44.0)	9 (36.0)
Higher Secondary	2 (8.0)	3 (12.0)
Marital Status
Unmarried	12 (48.0)	15 (60.0)	0.725^	1	0.395NS
Married	13 (52.0)	10 (40.0)
Occupation
Government	2 (8.0)	3 (12.0)	0.850￥	-	0.711NS
Self-employed	10 (40.0)	12 (48.0)
Others	13 (52.0)	10 (40.0)
Income
Upto 10000	12 (48.0)	15 (60.0)	1.471￥	-	0.586NS
10001-20000	2 (8.0)	3 (12.0)
20001-30000	11 (44.0)	7 (28.0)
Socio-economic status
Low	11 (44.0)	15 (60.0)	1.282^	1	0.258NS
Medium	14 (56.0)	10 (40.0)
Type of family
Joint family	25 (100.0)	25 (100.0)	-	-	-
Place of residence
Rural	6 (24.0)	9 (36.0)	0.857^	1	0.355NS
Urban	19 (76.0)	16 (44.0)

*P- Significant at 0.05 level; NS=Non-significant; ^{^}Chi square; ^￥Fisher’s test; t=t-test t (48)=2.01

Table 3 depicts the baseline comparison between experimental and control group participants about clinical variables. The results revealed that all the clinical variables were found to be homogenous and comparable at the baseline between the groups as the calculated statistics were non-significant at 0.05 level of significance.

Table 3.

Baseline comparison of Clinical variables between experimental and control group participants n=50

Variables	Mean±SD		t/χ2	df	P
	Experimental (n=25)	Control (n=25)
Number of depressive episodes	1.60±0.645	1.52±0.714	0.416t	48	0.680NS
Number of manic episodes	1.24±0.597	1.36±0.700	-0.652t	48	0.517NS
Number of mixed episodes	-	-	-	-	-
Frequency (%)		Frequency (%)
Age of onset
18-28	19 (76.0)	16 (64.0)	0.934￥	-	0.668NS
29-38	4 (16.0)	6 (24.0)
39-48	2 (8.0)	3 (12.0)
Duration of illness
1-5 years	23 (92.0)	22 (88.0)	0.000¶	1	1.000NS
6-10 years	2 (8.0)	3 (12.0)
Present history of illness
HT	2 (8.0))	3 (12.0)	0.934￥	-	0.668NS
DM	4 (16.0)	6 (24.0)
None	19 (76.0)	16 (64.0)
Family history of psychiatric illness
Yes	8 (56.0)	8 (56.0)	-	-	-
No	17 (44.0)	17 (44.0)

*P- Significant at 0.05 level; NS=Non-significant; ^{^}Chi square; ^￥Fisher’s test; t=t-test t (48)=2.01

Table 4 shows the post-intervention comparison between experimental and comparison groups after the administration of intervention about outcome variables. Results about Medication adherence found that there was a significant time effect, group effect, and interaction effect with a large effect size since the calculated F value was significant at 0.05 level whereas global Functional variables had resulted only in the time effect with a large effect size but not in the group or interaction effect. The overall efficacy is important while employing two-way RM-ANOVA which tells whether group differences varied across time (time*group). Concerning medication adherence the overall efficacy was significant with a large effect size of η_p² = 0.305 means 30.5% was the effect size.

Table 4.

Post-intervention comparison of Outcome variables between Experimental and Comparison group participants [RM-ANOVA for mixed design (Two-way)] n=50

Variables	Time of Assessment	Mean±SD		Time Effect			Group Effect			Time*Group Effect (Overall efficacy)
		Experimental (n=25)	Control (n=25)	F	P	ηp2	F	P	ηp2	F	P	ηp2
Medication Adherence	Baseline T0	3.44±1.121	3.36±0.952	F (2,96)			F (1,48)			F (2,96)
	Post-test T1	9.76±0.436	9.76±0.436	566.406	<0.001***	0.922	24.495	<0.001***	0.338	21.052	<0.001***	0.305
	Post-test T2	9.20±0.707	6.96±1.620
Global functioning	Baseline T0	58.44±20.945	48.64±23.546	F (1.44,69.24)			F (1,48)			F (1.44,69.24)
	Post-test T1	43.64±13.410	35.68±18.765	65.783	<0.001***	0.578	2.880	0.096NS	0.057	0.417	0.595NS	0.009
	Post-test T2	39.04±15.032	32.24±17.950

*^,**^,***P- Significant at 0.05, 0.01 & 0.001 level: NS - Non-significant, η_p²=<0.06=Small, 0.06-0.14=Medium, >0.14=Large effect

Discussion

The present study aimed to evaluate of effectiveness of CREP on global functioning and medication adherence among patients with bipolar affective disorders. It is well well-known fact that bipolar affective disorder patients are so devastated that the individual’s ability to engage in social and occupational functioning is hugely suffered. Bipolar affective disorder are most common form of severe mental illness. In line with the literature, relapse, and readmissions are frequently observed and are associated with factors such as poor adherence to treatment, stressful events, maladaptive coping, lack of mental health knowledge, substance abuse, poor discharge planning, and the treatment setting.

In the present study, most participants reported a mean age between 33.16 ± 7.96 and 35.64 ± 8.703 years. Predominantly male (68%), belongs to Hindu religion (100%), related to education (58%) have primary education, (46%) were unemployed, (54%) income up to 10000/month with (52%) low socio-economic status, (100%) were from joint family and (70%) from urban place of residence.

Concerning clinical characteristics of the participants, the mean number of depressive and manic episodes was 1.60 ± 0.645 to 1.52 ± 0.714 and 1.24 ± 0.597 to 1.36 ± 0.700 respectively. Most participants (70%) have an onset of 18-28 years of age, with (90%) participants 1-5 years of duration of illness.

The pre-intervention indicated that 56% of participants were non-adherence to medication and 44% of participants moderately adherence to medication in the CREP group, whereas 64% of participants were non-adherence to medication and 36% of participants moderately adherence to medication in the control group. Concerning global functioning, mainstream 44% had moderate functional limitations in the CREP group, whereas 32% of participants had mild functional limitations in the control group [Figure 2].

Figure 2.

Baseline comparison of Outcome variables between experimental and control group participants

Post-intervention time effect on global functioning but no group or interaction effect, indicate that functioning improved with time in both groups and there was no difference between the groups [Figure 3].

Figure 3.

Estimated marginal means of global functioning (Time/Group)

According to a 2-year follow-up study on the efficacy of the Community re-entry module (CRM) for patients with schizophrenia in Beijing, China. In comparison with those in the psychoeducation group, participants in the CRM group fared significantly better in social functioning at the 6-month, 12-month, 18-month, and 24-month follow-up assessments. In the present study, results are controverting to this study as there was short follow-up, a possible difference in social support.[17]

Improvement in medication adherence was also an objective but present study results indicate that the community re-entry program achieved its objective and led to a substantial and meaningful difference in patients in relation to medication adherence. Medication adherence found that there was a significant time effect, group effect, and interaction effect with a large effect size [Figure 4].

Figure 4.

Estimated marginal means of Medication adherence (Time/Group)

Few studies also indicate that incorporating non-pharmacological approaches such as CRP into pharmacological approaches can be effective in strengthening the effectiveness of these approaches, and further reducing the positive syndrome, which in turn plays a role in improving the treatment outcome and controlling the disease faster and more effectively; because such an intervention is effective in increasing patients’ information and improves their therapeutic attitude and adherence.[20]

CREP group experienced significantly less relapse than those in the control group during the 1-month follow-up. This suggests that the decreased psychotic symptoms and insight could be translated into a persistent reduction in rates of relapse and re-hospitalization. A Chinese a study of similar design on the efficacy of the community re-entry module for patients with schizophrenia outcome at 2-year follow-up shows that participants in the CRM group experienced significantly less relapse and re-hospitalization than those in the psychoeducation group during the 24-month follow-up.[16]

Study limitations and recommendations

Firstly Community re-entry program delivered to patients with bipolar affective disorder was originally designed to improve global functioning and medication adherence following hospital. The sample studied was small and restricted to only one institute. Therefore the results could not be generalized to other patient populations and other clinical settings. Secondly, some differences were made in the present study community re-entry program from the actual community re-entry module with permission, which is mentioned in the methodology. Thirdly limitations to the validity of their data because participant responses were self-reported in the medication adherence rating sheet and WHODAS 2.0. 36 item tool. Fourthly the major limitation of this study was that subjects were followed for only one month after discharge from the inpatient ward. The community re-entry program increased the attendance rates for the first post-discharge appointment, but no way guarantees the continuing care of the patients.

Minor modifications the researcher felt to incorporate in the main study are continuous interaction to establish rapport, merging content-based pictures/graphical aids in video and workbook to enhance the concentration of the participants during the intervention sessions, reinforcement to the patients who complete session activities/assignments, will have two contact numbers to contact.

Conclusion

Despite the above-mentioned limitations, CREP appears to be a feasible and effective method for training patients with bipolar affective disorder in an in-patient setting before discharge. It effectively maintains the improvement in clinical condition achieved during hospitalization, specifically medication adherence and its management of simple side effects. BPAD is a long-term mental disorder, many times patients come across stressful situations and non-adherence to medication, consequently it requires skill training programs to improve medication adherence, social adjustment, and quality of life of patients, and it can be achieved by CREP in an in-patient setting.

Author contributions

J: Conceptualization, Data curation, Formal Analysis, Funding acquisition, Investigation, Methodology, Project administration, Resources, Software, -Validation, Visualization, Writing – original draft. SR: Conceptualization, Investigation, Methodology, Resources, Software, Supervision, Validation, Visualization, Writing – review and editing. PK: Conceptualization, Formal Analysis, Investigation, Methodology, Project administration, Resources, Software, Supervision, Validation, Visualization, -Writing – review and editing. MS: Conceptualization, Data curation, Investigation, Methodology, Project administration, -Software, Supervision, Validation, Visualization, -Writing – review and editing.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil