The Effect of a Theory Based Educational Intervention on Medication Adherence to and Removes of Related Barriers in Patients With Bipolar Disorder
- Conditions
- Patients With Bipolar Disorders
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
- 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.
- 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
- 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
22 Bahman Hospital
🇮🇷Qazvin, Iran, Islamic Republic of
Psychiatry Center
🇮🇷Semnān, Iran, Islamic Republic of
Shahid Mahallati
🇮🇷Tabriz, 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
Boostan🇮🇷Ahvaz, Iran, Islamic Republic of