Motivational Interviewing in Patients With Bipolar Disorder
Primary Purpose
Motivational Interviews, Bipolar Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Assigned Interventions
Sponsored by
About this trial
This is an interventional supportive care trial for Motivational Interviews focused on measuring Motivational Interviews, Bipolar Disorder, Coping, Functionality, Treatment Adherence, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Pamukkale University, Faculty of Health Science, Departmant of Psychiatric Nursing
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
No Intervention
Arm Description
Study group intervention consists 6-session Motivational Interviews and 3-month follow-up.
Control group receives general care and the training booklet at the end of the study. Also includes 3-month follow-up.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Number of health care uses
According to the patient's declaration, number of hospitalizations.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05428241
Brief Title
Motivational Interviewing in Patients With Bipolar Disorder
Official Title
The Effect of Motivational Interviews on Coping, Functionality, Treatment Adherence and Quality of Life in Patients With Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
December 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Bipolar disorder is a serious mental disorder with depressive, manic or hypomanic episodes, which is completely normal or thought to be associated with minimal symptom levels, and is known to cause high mortality, morbidity, and loss of function in almost all areas. Gaining functionality in patients with bipolar disorder, improving their compliance with treatment and quality of life, and helping them to cope with stress are among the most important goals of treatment.
In individuals with bipolar disorder, stressful life events can lead to early onset of the disease, more frequent depression, psychotic symptoms, and problems such as anxiety. It is stated that patients with bipolar disorder have problems in interpersonal relationships and problems in coping with stress. When patients with a diagnosis of bipolar disorder in remission encounter a stressful life event, their functionality in the areas of work/school, family, and friends may be affected or even impaired.
Since bipolar disorder is a chronic disease, it is stated that it affects people's lives in terms of their functionality during remission periods as well as during attacks. Marriage-related problems, economic difficulties and substance use, together with the risk of suicide and irregular work history, can cause dysfunction in patients in wide psychosocial areas. It has been reported that the quality of life of patients whose functionality is impaired during the remission period also deteriorates.
Due to the early onset of bipolar disorder, the length of time until diagnosis, and inadequate treatment, it harms patients in terms of quality of life and expected psychosocial development. It is stated that depressive symptoms, being a woman, the length of time until the diagnosis, low socioeconomic and educational level are factors that increase the deterioration in the quality of life in rural areas in patients with bipolar disorder. In addition, the presence of another comorbidity accompanying bipolar disorder (anxiety, alcohol-substance addiction, etc.) also affects the quality of life. However, when the clinical studies on the disorder are examined, it is seen that the lack of compliance of the patients with the treatment causes the quality of life to deteriorate.
In bipolar disorder, low treatment compliance is caused by the patient's insufficient insight into the disease, reservations about the drug, negative clinical course of the disease, insufficient social and environmental support, economic difficulties, insufficient information about treatment, unfavorable conditions of the living environment or treatment center, the patient's and his/her environment's drug addiction. treatment and attitude towards bipolar disorder, prejudices caused by drug use in society, and cultural beliefs.
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. Nurses need to establish a therapeutic relationship in order for the nursing care to produce effective results during the recovery process of these patients.
In this study, it is thought that Motivational Interviewing may be effective in increasing effective coping skills, functionality, adherence to treatment and quality of life in patients with bipolar disorder, and may shed light and guide psychiatric nursing interventions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motivational Interviews, Bipolar Disorder
Keywords
Motivational Interviews, Bipolar Disorder, Coping, Functionality, Treatment Adherence, Quality of Life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled pre-post test design
Masking
ParticipantCare Provider
Masking Description
Participants and caregivers were not informed about intervention content and measurements.
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Study group intervention consists 6-session Motivational Interviews and 3-month follow-up.
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Control group receives general care and the training booklet at the end of the study. Also includes 3-month follow-up.
Intervention Type
Behavioral
Intervention Name(s)
Assigned Interventions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Morisky Treatment Adherence Scale
Description
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.
Time Frame
Change from baseline Morisky Treatment Adherence Scale at 3 months
Title
The World Health Organization Quality of Life Instrument, Short Form
Description
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.
Time Frame
Change from baseline The World Health Organization Quality of Life Instrument, Short Form at 3 months
Title
Assessment of Coping Attitudes Inventory
Description
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.
Time Frame
Change from baseline Assessment of Coping Attitudes Inventory at 3 months
Title
Bipolar Disorder Functioning Questionnaire
Description
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.
Time Frame
Change from baseline Assessment of Coping Attitudes Inventory at 3 months
Secondary Outcome Measure Information:
Title
Number of health care uses
Description
According to the patient's declaration, number of hospitalizations.
Time Frame
Change in the number of initial health care use in the 3rd month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Halis Yılmaz, Msc
Phone
+90 553 048 99 58
Email
halisyilmaz93@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gülay Yiğitoğlu, PhD
Phone
+90 258 296 60 00
Ext
4339
Email
gyigitoglu@pau.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülay Yiğitoğlu, PhD
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Halis Yılmaz, Msc
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University, Faculty of Health Science, Departmant of Psychiatric Nursing
City
Denizli
State/Province
Denizli, Kınıklı Kampus
ZIP/Postal Code
20160
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halis Yılmaz, Msc
Phone
+90 553 048 99 58
Email
halisyilmaz93@gmail.com
First Name & Middle Initial & Last Name & Degree
Gülay Yiğitoğlu, PhD
Phone
+90 258 6000
Ext
4339
Email
gyigitoglu@pau.edu.tr
First Name & Middle Initial & Last Name & Degree
Gülay Yiğitoğlu, PhD
First Name & Middle Initial & Last Name & Degree
Halis Yılmaz, Msc
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study results will be announced in a publication
IPD Sharing Time Frame
Findings can be shared after the study has been published.
IPD Sharing 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.
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
result
PubMed Identifier
24433493
Citation
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.
Results Reference
result
PubMed Identifier
22224961
Citation
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.
Results Reference
result
PubMed Identifier
29888541
Citation
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.
Results Reference
result
PubMed Identifier
31957686
Citation
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.
Results Reference
result
Learn more about this trial
Motivational Interviewing in Patients With Bipolar Disorder
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