The Effect of a Theory Based Educational Intervention on Medication Adherence to and Removes of Related Barriers in Patients With Bipolar Disorder

Study Overview
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Brief Summary
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Despite an increasing pharmacopoeia of effective medications for the treatment of bipolar disorder, patient outcomes continue to be impacted by treatment adherence. Non-adherence to treatments is also a major obstacle in translating efficacy in research settings into effectiveness in clinical practice. Non-adherence with bipolar disorder (BD) medication treatment dramatically worsens outcomes. Reasons for non-adherence among individuals with BD are multi-dimensional, and it has been suggested that a multifaceted intervention will be more effective. The study is aimed to assess the effectiveness of a multifaceted intervention on enhancing medications adherence in patients with bipolar disorders.

Conditions
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Patients With Bipolar Disorders

Intervention / Treatment
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* Behavioral: Multifaceted intervention
* Behavioral: Routine counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥18 years meeting DSM-IV criteria for bipolar I or II disorder concurrently treated with a mood stabilizer not currently in weekly or biweekly psychotherapy Persian speaking. Exclusion Criteria: DSM-IV drug or alcohol misuse disorders (excluding nicotine), pregnancy or planning pregnancy in the next year requiring changing the drug or the dose of a mood stabilizer evidence of severe DSM-IV borderline personality Unable or unwilling to give written informed consent. An organic cerebral cause for bipolar disorder-for example, multiple sclerosis or stroke. intellectual disability

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multifaceted intervention<br>Patients, their caregivers and family members will received the educational and motivational interventions | Behavioral: Multifaceted intervention<br>* Supportive intervention: care giver, health care providers, and patient's family members (including disease knowledge, treatment t of the disease, medication problems or adverse effects, the importance of medication adherence, supervision taking medications by the patients as prescribed). patient education: about the disease and treatment, consuming regularly the pills motivational intervening, self-monitoring planning. Patients will attend in five motivational interviewing sessions regularly to facilitating and engaging intrinsic motivation within the patients in order to change medication adherence behavior.<br>|
| Active Comparator: Active Comparator<br>Usual Care The usual care group received routine counseling performed by the psychiatrist and nurses. | Behavioral: Routine counseling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in Patient-reported medication Adherence to mood stabilizers | The Medication Adherence Report Scale (MARS-5) will be used for assessing medication adherence to the mood stabilizers | changes from baseline, 1 Months and 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma level of mood stabilizer |  | Changes from baseline, 1 Months and 6 months after the intervention | 
| Changes in action planning | A self-reported questionnaire on five 5-point scale that ranged from 1 (strongly disagree) to 5 (strongly agree) | Changes from baseline, 1 Months and 6 months after the intervention | 
| Changes in coping planning | A self-reported questionnaire on five 5-point scale that ranged from 1 (strongly disagree) to 5 (strongly agree) | Changes from baseline, 1 Months and 6 months after the intervention | 
| Changes in quality of life |  | Changes from baseline, 1 Months and 6 months after the intervention | 
| Changes in psychological predictors of medication adherence (intention, perceived behavioral control ,Self-monitoring and Behaviour Automaticity) |  | Changes from baseline, 1 Months and 6 months after the intervention | 
| Changes in Global Impression for Bipolar Disorder Severity scale (CGI-BP-S) |  | Changes from baseline, 1 Months and 6 months after the intervention | 
| Changes in Beliefs about Medicines Questionnaire (BMQ) |  | Changes from baseline, 1 Months and 6 months after the intervention | 
| Changes in Young Mania Rating Scale (YMRS) |  | Changes from baseline, 1 Months and 6 months after the intervention | 
| Changes in Montgomery Asberg Depression Rating Scale |  | Changes from baseline, 1 Months and 6 months after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bipolar disorders, medication adherence, psychological intervention, multifaceted intervention