Motivational Interviewing in Patients With Bipolar Disorder

NCT05428241 | Unknown DMC

• 1 other identifier: 60116787-020-155550
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: A poor therapeutic relationship, poor quality of life, impaired functioning, ineffective coping methods, and lack of motivation It is associated with poor adjustment (to symptoms, treatment, and environment) in patients with bipolar disorder. In order to achieve better compliance and results, the therapeutic relationship, coping skills, quality of life and functionality should be improved by increasing the motivation of individuals. Purpose: This study was planned to examine the effects of motivational interviewing on coping, functioning, adherence to treatment and quality of life in patients with bipolar disorder. Methods: In this single-blind, randomized controlled trial, simple randomization method and pretest-posttest control group design, experimental research design will be used. The work will take place at: Pamukkale University Health Research and Application Center, Psychiatric Hospital from July 2021 to February 2022 and including 48 individuals (24 in the experimental group and 24 in the control group). Working data it will be collected using personal information form, Morisky Medication Adherence Scale (MMAS), The World Health Organization Quality of Life Scale, the Short Form (WHOQOL-BREF), Assessment of Coping Attitudes Inventory (COPE), and Bipolar Disorder Functioning Questionnaire (BDFQ). The researchers will conduct a 6- session of motivational interviewing with the participants in the experimental group. No intervention will be made in the control group. Data will be analyzed on a pre-intervention, post-intervention and post-intervention 3 months (follow-up) basis.

Conditions

Motivational Interviews; Bipolar Disorder

Keywords

Motivational Interviews; Bipolar Disorder; Coping; Functionality; Treatment Adherence; Quality of Life

Outcome Measures

Primary Outcomes (4)

• Morisky Treatment Adherence Scale

  The scale consists of four likert-type two-answer questions. The questions are in the form of closed-ended "yes and no". If all questions are answered "no", drug compliance is considered high, if "yes" is answered for one or two questions, drug compliance is considered medium, if yes to three or four questions, drug compliance is considered low. In the scale, 0-1 points indicate low, 2-3 points moderate, and 4 points high adherence to treatment.

  Change from baseline Morisky Treatment Adherence Scale at 3 months

• The World Health Organization Quality of Life Instrument, Short Form

  It is a scale developed from the World Health Organization's WHOQOL-100 to assess quality of life. WHOQOL-BREF consists of 26 questions and four areas selected from WHOQOL-100. These 4 areas are physical, mental, social relations and environmental areas. The 3rd, 4th and 26th items of the scale are reverse scored. WHOQOL-BREF has Likert-type scoring ranging from 1 to 5. As the score obtained from the sub-domains of the scale increases, the quality of life increases.

  Change from baseline The World Health Organization Quality of Life Instrument, Short Form at 3 months

• Assessment of Coping Attitudes Inventory

  There are 60 questions in total and 15 subscales, each consisting of four questions. Each subscale is answered over four options. These answers are: 1=I would never do anything like this; 2=I do very little like this; 3=I do this moderately; 4=I usually do it like this. Positive reinterpretation and growth, use of beneficial social support, active coping, religious coping, joking, holding back, use of emotional social support, acceptance, suppression of other occupations, and planning subscales represent adaptive coping methods, while mental distancing, problem-focused and problem-focused and expressing emotions, denial, behavioral distancing, and substance use subscales are considered as maladaptive coping methods. As a result, the high scores to be obtained from the subscales give the possibility to comment on which coping attitude is used more by the individual.

  Change from baseline Assessment of Coping Attitudes Inventory at 3 months

• Bipolar Disorder Functioning Questionnaire

  The scale is in triple Likert type and the items are calculated by giving 1 point 'no or nothing', 2 points 'partly or sometimes', and 3 points 'yes or always'. The 1st and 3rd questions in the emotional functionality subscale, the 5th and 7th questions in the mental functionality subscale, the 8th, 10th and 11th questions in the sexual functionality subscale, and the 49th, 50th and 51st questions in the work subscale are reversed. is scored. The total score can range from 52 to 156. The scale does not have a cutoff score, and as the score increases, functionality also increases.

  Change from baseline Assessment of Coping Attitudes Inventory at 3 months

Secondary Outcomes (1)

• Number of health care uses

  Change in the number of initial health care use in the 3rd month

Study Arms (2)

Experimental

EXPERIMENTAL

Study group intervention consists 6-session Motivational Interviews and 3-month follow-up.

Behavioral: Assigned Interventions

No Intervention

NO INTERVENTION

Control group receives general care and the training booklet at the end of the study. Also includes 3-month follow-up.

Interventions

Assigned Interventions BEHAVIORAL

Behavioral: 6 sessions of Motivational Interviewing and 3-month follow-up. 6 sessions of Motivational Interview will be applied to the working group. All sessions will be in the form of face-to-face meetings. Each interview will take an average of 45-60 minutes. With this intervention, it was aimed to increase the levels of coping with motivational interviewing, functionality, adherence to treatment and quality of life in bipolar disorder patients. Study data consists of personal information form, Morisky Treatment Adherence Scale (MMAS), World Health Organization Quality of Life Scale, Short Form (WHOQOL-BREF), Assessment of Coping Attitudes Inventory (COPE), Bipolar Disorder Functioning Questionnaire (BDFQ). Data will be analyzed pre-intervention, post-intervention and 3 months post-intervention. A drug and device will not be administered to participants.

Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be at least primary school graduate,
• Be willing to participate in research.
• Being between the ages of 18-65,
• Able to understand and speak Turkish,
• Patients who can understand scales and forms,
• Being registered in the euthymic period and Denizli Pamukkale University Health Research and Application Center Psychiatry Department Community Mental Health Center unit
• To have a diagnosis of bipolar disorder I-II for at least 1 year according to DSM-5 (The Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria.

You may not qualify if:

• Being under the age of 18 and over the age of 65,
• Being illiterate in Turkish,
• Having Mental Retardation,
• Being diagnosed with a mental illness other than bipolar disorder according to the DSM-5 (The Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria,
• Being in an manic or depressed attack period,
• Patients who have received or are continuing a similar education program.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University, Faculty of Health Science, Departmant of Psychiatric Nursing

Denizli, Denizli, Kınıklı Kampus, 20160, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 28446253 RESULT

• McKenzie K, Chang YP. The effect of nurse-led motivational interviewing on medication adherence in patients with bipolar disorder. Perspect Psychiatr Care. 2015 Jan;51(1):36-44. doi: 10.1111/ppc.12060. Epub 2014 Jan 17.

  PMID: 24433493 RESULT

• Laakso LJ. Motivational interviewing: addressing ambivalence to improve medication adherence in patients with bipolar disorder. Issues Ment Health Nurs. 2012 Jan;33(1):8-14. doi: 10.3109/01612840.2011.618238.

  PMID: 22224961 RESULT

• Ertem MY, Duman ZC. The effect of motivational interviews on treatment adherence and insight levels of patients with schizophrenia: A randomized controlled study. Perspect Psychiatr Care. 2019 Jan;55(1):75-86. doi: 10.1111/ppc.12301. Epub 2018 Jun 11.

  PMID: 29888541 RESULT

• Goldstein TR, Krantz ML, Fersch-Podrat RK, Hotkowski NJ, Merranko J, Sobel L, Axelson D, Birmaher B, Douaihy A. A brief motivational intervention for enhancing medication adherence for adolescents with bipolar disorder: A pilot randomized trial. J Affect Disord. 2020 Mar 15;265:1-9. doi: 10.1016/j.jad.2020.01.015. Epub 2020 Jan 7.

  PMID: 31957686 RESULT

MeSH Terms

Conditions

Bipolar Disorder; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Health Behavior; Behavior

Study Officials

• Gülay Yiğitoğlu, PhD

  Pamukkale University

  STUDY DIRECTOR

• Halis Yılmaz, Msc

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Halis Yılmaz, Msc

CONTACT

+90 553 048 99 58; halisyilmaz93@gmail.com

Gülay Yiğitoğlu, PhD

CONTACT

+90 258 296 60 00; gyigitoglu@pau.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants and caregivers were not informed about intervention content and measurements.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator-PhD Student

Model Details: Randomized controlled pre-post test design

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 23, 2022
• Study Start: July 1, 2022
• Primary Completion: August 15, 2023
• Study Completion: December 25, 2023
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Findings can be shared after the study has been published.
• Access Criteria: The sociodemographic and disease-related characteristics of the participants, the pre-post-test and follow-up findings including the answers to the research questions and statistical analyzes will be shared.

Locations

TU (1)