The Effect of a Theory Based Educational Intervention on Medication Adherence to and Removes of Related Barriers in Patients With Bipolar Disorder
1 other identifier
interventional
270
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 4, 2014
CompletedFirst Posted
Study publicly available on registry
September 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedJanuary 11, 2023
January 1, 2023
1 year
September 4, 2014
January 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Plasma level of mood stabilizer
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
Changes in coping planning
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
- +4 more secondary outcomes
Study Arms (2)
Multifaceted intervention
EXPERIMENTALPatients, their caregivers and family members will received the educational and motivational interventions
Active Comparator
ACTIVE COMPARATORUsual Care The usual care group received routine counseling performed by the psychiatrist and nurses.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Boostan
Ahvāz, Iran
Ebn'e Sina
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
Related Publications (1)
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.
PMID: 28446253DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Social Determinants of Health Research Center
Study Record Dates
First Submitted
September 4, 2014
First Posted
September 16, 2014
Study Start
September 1, 2014
Primary Completion
September 1, 2015
Last Updated
January 11, 2023
Record last verified: 2023-01