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

January 9, 2023 updated by: Amir H Pakpour, Qazvin University Of Medical Sciences
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Ahvaz, Iran, Islamic Republic of
        • Boostan
      • Mashhad, Iran, Islamic Republic of
        • Ebn'e Sina
      • Qazvin, Iran, Islamic Republic of, 3419759811
        • 22 Bahman Hospital
      • Semnān, Iran, Islamic Republic of
        • Psychiatry Center
      • Tabriz, Iran, Islamic Republic of
        • Shahid Mahallati
      • Tehran, Iran, Islamic Republic of
        • Iran Psychiatry
      • Tehran, Iran, Islamic Republic of
        • Maymanat
      • Tehran, Iran, Islamic Republic of
        • Roozbeh
      • Zahedan, Iran, Islamic Republic of
        • Baharan
      • Zanjan, Iran, Islamic Republic of
        • Dr. Beheshti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
changes from baseline, 1 Months and 6 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma level of mood stabilizer
Time Frame: Changes from baseline, 1 Months and 6 months after the intervention
Changes from baseline, 1 Months and 6 months after the intervention
Changes in action planning
Time Frame: 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 from baseline, 1 Months and 6 months after the intervention
Changes in coping planning
Time Frame: 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 from baseline, 1 Months and 6 months after the intervention
Changes in quality of life
Time Frame: Changes from baseline, 1 Months and 6 months after the intervention
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)
Time Frame: Changes from baseline, 1 Months and 6 months after the intervention
Changes from baseline, 1 Months and 6 months after the intervention
Changes in Global Impression for Bipolar Disorder Severity scale (CGI-BP-S)
Time Frame: Changes from baseline, 1 Months and 6 months after the intervention
Changes from baseline, 1 Months and 6 months after the intervention
Changes in Beliefs about Medicines Questionnaire (BMQ)
Time Frame: Changes from baseline, 1 Months and 6 months after the intervention
Changes from baseline, 1 Months and 6 months after the intervention
Changes in Young Mania Rating Scale (YMRS)
Time Frame: Changes from baseline, 1 Months and 6 months after the intervention
Changes from baseline, 1 Months and 6 months after the intervention
Changes in Montgomery Asberg Depression Rating Scale
Time Frame: Changes from baseline, 1 Months and 6 months after the intervention
Changes from baseline, 1 Months and 6 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qazvin University Of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

September 14, 2014

First Posted (Estimate)

September 16, 2014

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 353

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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