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

Not Applicable

Completed

• Conditions: Patients With Bipolar Disorders
• Interventions: Behavioral: Multifaceted intervention; Behavioral: Routine counseling

• Registration Number: NCT02241863
• Lead Sponsor: Qazvin University Of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-14
• Study First Posted: 2014-09-16
• Primary Completion: 2015-09
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

1. age ≥18 years
2. meeting DSM-IV criteria for bipolar I or II disorder
3. concurrently treated with a mood stabilizer
4. not currently in weekly or biweekly psychotherapy
5. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multifaceted intervention	Multifaceted intervention	Patients, their caregivers and family members will received the educational and motivational interventions
Active Comparator	Routine counseling	Usual Care The usual care group received routine counseling performed by the psychiatrist and nurses.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in Montgomery Asberg Depression Rating Scale	Changes from baseline, 1 Months and 6 months after the intervention
Plasma level of mood stabilizer	Changes from baseline, 1 Months and 6 months after the intervention
Changes in coping planning	Changes from baseline, 1 Months and 6 months after the intervention	A self-reported questionnaire on five 5-point scale that ranged from 1 (strongly disagree) to 5 (strongly agree)
Changes in Young Mania Rating Scale (YMRS)	Changes from baseline, 1 Months and 6 months after the intervention
Changes in action planning	Changes from baseline, 1 Months and 6 months after the intervention	A self-reported questionnaire on five 5-point scale that ranged from 1 (strongly disagree) to 5 (strongly agree)
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

Trial Locations

Locations (10)

Boostan; 🇮🇷 Ahvaz, Iran, Islamic Republic of

Ebn'e Sina; 🇮🇷 Mashhad, Iran, Islamic Republic of

Psychiatry Center; 🇮🇷 Semnān, Iran, Islamic Republic of

Shahid Mahallati; 🇮🇷 Tabriz, Iran, Islamic Republic of

22 Bahman Hospital; 🇮🇷 Qazvin, Iran, Islamic Republic of

Iran Psychiatry; 🇮🇷 Tehran, Iran, Islamic Republic of

Maymanat; 🇮🇷 Tehran, Iran, Islamic Republic of

Roozbeh; 🇮🇷 Tehran, Iran, Islamic Republic of

Baharan; 🇮🇷 Zahedan, Iran, Islamic Republic of

Dr. Beheshti; 🇮🇷 Zanjan, Iran, Islamic Republic of