The Effect of a Theory Based Educational Intervention on Medication Adherence to and Removes of Related Barriers in Patients With Bipolar Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 270
- Locations
- 10
- Primary Endpoint
- changes in Patient-reported medication Adherence to mood stabilizers
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Multifaceted intervention
Patients, their caregivers and family members will received the educational and motivational interventions
Intervention: Multifaceted intervention (Behavioral)
Active Comparator
Usual Care The usual care group received routine counseling performed by the psychiatrist and nurses.
Intervention: Routine counseling (Behavioral)
Outcomes
Primary Outcomes
changes in Patient-reported medication Adherence to mood stabilizers
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
Investigators
Amir H Pakpour
Head of the Social Determinants of Health Research Center
Qazvin University Of Medical Sciences