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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifaceted intervention | Experimental | Patients, their caregivers and family members will received the educational and motivational interventions |
|
| Active Comparator | Active Comparator | Usual Care The usual care group received routine counseling performed by the psychiatrist and nurses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multifaceted intervention | Behavioral | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boostan | Ahvāz | Iran | ||||
| Ebn'e Sina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28446253 | Derived | Pakpour AH, Modabbernia A, Lin CY, Saffari M, Ahmadzad Asl M, Webb TL. Promoting medication adherence among patients with bipolar disorder: a multicenter randomized controlled trial of a multifaceted intervention. Psychol Med. 2017 Oct;47(14):2528-2539. doi: 10.1017/S003329171700109X. Epub 2017 Apr 27. |
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|
| Routine counseling | Behavioral |
|
| 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 |
| Mashhad |
| Iran |
| 22 Bahman Hospital | Qazvin | 3419759811 | Iran |
| Psychiatry Center | Semnan | Iran |
| Shahid Mahallati | Tabriz | Iran |
| Iran Psychiatry | Tehran | Iran |
| Maymanat | Tehran | Iran |
| Roozbeh | Tehran | Iran |
| Baharan | Zahedan | Iran |
| Dr. Beheshti | Zanjan | Iran |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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