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

Primary Purpose

Patients With Bipolar Disorders

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Multifaceted intervention
Routine counseling
Sponsored by
Qazvin University Of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Bipolar Disorders focused on measuring bipolar disorders, medication adherence, psychological intervention, multifaceted intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boostan
  • Ebn'e Sina
  • 22 Bahman Hospital
  • Psychiatry Center
  • Shahid Mahallati
  • Iran Psychiatry
  • Maymanat
  • Roozbeh
  • Baharan
  • Dr. Beheshti

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multifaceted intervention

Active Comparator

Arm Description

Patients, their caregivers and family members will received the educational and motivational interventions

Usual Care The usual care group received routine counseling performed by the psychiatrist and nurses.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Plasma level of mood stabilizer
Changes in action planning
A self-reported questionnaire on five 5-point scale that ranged from 1 (strongly disagree) to 5 (strongly agree)
Changes in coping planning
A self-reported questionnaire on five 5-point scale that ranged from 1 (strongly disagree) to 5 (strongly agree)
Changes in quality of life
Changes in psychological predictors of medication adherence (intention, perceived behavioral control ,Self-monitoring and Behaviour Automaticity)
Changes in Global Impression for Bipolar Disorder Severity scale (CGI-BP-S)
Changes in Beliefs about Medicines Questionnaire (BMQ)
Changes in Young Mania Rating Scale (YMRS)
Changes in Montgomery Asberg Depression Rating Scale

Full Information

First Posted
September 4, 2014
Last Updated
January 9, 2023
Sponsor
Qazvin University Of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02241863
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qazvin University Of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Bipolar Disorders
Keywords
bipolar disorders, medication adherence, psychological intervention, multifaceted intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multifaceted intervention
Arm Type
Experimental
Arm Description
Patients, their caregivers and family members will received the educational and motivational interventions
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Usual Care The usual care group received routine counseling performed by the psychiatrist and nurses.
Intervention Type
Behavioral
Intervention Name(s)
Multifaceted intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Routine counseling
Primary Outcome Measure Information:
Title
changes in Patient-reported medication Adherence to mood stabilizers
Description
The Medication Adherence Report Scale (MARS-5) will be used for assessing medication adherence to the mood stabilizers
Time Frame
changes from baseline, 1 Months and 6 months follow-up
Secondary Outcome Measure Information:
Title
Plasma level of mood stabilizer
Time Frame
Changes from baseline, 1 Months and 6 months after the intervention
Title
Changes in action planning
Description
A self-reported questionnaire on five 5-point scale that ranged from 1 (strongly disagree) to 5 (strongly agree)
Time Frame
Changes from baseline, 1 Months and 6 months after the intervention
Title
Changes in coping planning
Description
A self-reported questionnaire on five 5-point scale that ranged from 1 (strongly disagree) to 5 (strongly agree)
Time Frame
Changes from baseline, 1 Months and 6 months after the intervention
Title
Changes in quality of life
Time Frame
Changes from baseline, 1 Months and 6 months after the intervention
Title
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
Title
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
Title
Changes in Beliefs about Medicines Questionnaire (BMQ)
Time Frame
Changes from baseline, 1 Months and 6 months after the intervention
Title
Changes in Young Mania Rating Scale (YMRS)
Time Frame
Changes from baseline, 1 Months and 6 months after the intervention
Title
Changes in Montgomery Asberg Depression Rating Scale
Time Frame
Changes from baseline, 1 Months and 6 months after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Boostan
City
Ahvaz
Country
Iran, Islamic Republic of
Facility Name
Ebn'e Sina
City
Mashhad
Country
Iran, Islamic Republic of
Facility Name
22 Bahman Hospital
City
Qazvin
ZIP/Postal Code
3419759811
Country
Iran, Islamic Republic of
Facility Name
Psychiatry Center
City
Semnān
Country
Iran, Islamic Republic of
Facility Name
Shahid Mahallati
City
Tabriz
Country
Iran, Islamic Republic of
Facility Name
Iran Psychiatry
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Maymanat
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Roozbeh
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Baharan
City
Zahedan
Country
Iran, Islamic Republic of
Facility Name
Dr. Beheshti
City
Zanjan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
28446253
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.
Results Reference
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The Effect of a Theory Based Educational Intervention on Medication Adherence to and Removes of Related Barriers in Patients With Bipolar Disorder

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