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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 353

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