Clinical trial NCT02241863: The Effect of a Theory Based Educational Intervention on Medication Adherence to and Removes of Related Barriers in Patients With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Bipolar Disorders
Keywords: bipolar disorders
medication adherence
psychological intervention
multifaceted intervention
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: changes in Patient-reported medication Adherence to mood stabilizers
timeFrame: changes from baseline, 1 Months and 6 months follow-up
Secondary outcomes:
measure: Plasma level of mood stabilizer
timeFrame: Changes from baseline, 1 Months and 6 months after the intervention
measure: Changes in action planning
timeFrame: Changes from baseline, 1 Months and 6 months after the intervention
measure: Changes in coping planning
timeFrame: Changes from baseline, 1 Months and 6 months after the intervention
measure: Changes in quality of life
timeFrame: Changes from baseline, 1 Months and 6 months after the intervention
measure: Changes in psychological predictors of medication adherence (intention, perceived behavioral control ,Self-monitoring and Behaviour Automaticity)
timeFrame: Changes from baseline, 1 Months and 6 months after the intervention
measure: Changes in Global Impression for Bipolar Disorder Severity scale (CGI-BP-S)
timeFrame: Changes from baseline, 1 Months and 6 months after the intervention
measure: Changes in Beliefs about Medicines Questionnaire (BMQ)
timeFrame: Changes from baseline, 1 Months and 6 months after the intervention
measure: Changes in Young Mania Rating Scale (YMRS)
timeFrame: Changes from baseline, 1 Months and 6 months after the intervention
measure: Changes in Montgomery Asberg Depression Rating Scale
timeFrame: Changes from baseline, 1 Months and 6 months after the intervention
Other outcomes:
Locations:
city: Ahvaz
country: Iran, Islamic Republic of
facility: Boostan
city: Mashhad
country: Iran, Islamic Republic of
facility: Ebn'e Sina
city: Qazvin
country: Iran, Islamic Republic of
facility: 22 Bahman Hospital
city: Semnān
country: Iran, Islamic Republic of
facility: Psychiatry Center
city: Tabriz
country: Iran, Islamic Republic of
facility: Shahid Mahallati
city: Tehran
country: Iran, Islamic Republic of
facility: Iran Psychiatry
city: Tehran
country: Iran, Islamic Republic of
facility: Maymanat
city: Tehran
country: Iran, Islamic Republic of
facility: Roozbeh
city: Zahedan
country: Iran, Islamic Republic of
facility: Baharan
city: Zanjan
country: Iran, Islamic Republic of
facility: Dr. Beheshti
Study officials:
References:
citation: 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.