Clinical trial NCT05428241: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Motivational Interviews
Bipolar Disorder
Keywords: Motivational Interviews
Bipolar Disorder
Coping
Functionality
Treatment Adherence
Quality of Life
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled pre-post test design
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Morisky Treatment Adherence Scale
timeFrame: Change from baseline Morisky Treatment Adherence Scale at 3 months
measure: The World Health Organization Quality of Life Instrument, Short Form
timeFrame: Change from baseline The World Health Organization Quality of Life Instrument, Short Form at 3 months
measure: Assessment of Coping Attitudes Inventory
timeFrame: Change from baseline Assessment of Coping Attitudes Inventory at 3 months
measure: Bipolar Disorder Functioning Questionnaire
timeFrame: Change from baseline Assessment of Coping Attitudes Inventory at 3 months
Secondary outcomes:
measure: Number of health care uses
timeFrame: Change in the number of initial health care use in the 3rd month
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University, Faculty of Health Science, Departmant of Psychiatric Nursing
state: Denizli, Kınıklı Kampus
Study officials:
affiliation: Pamukkale University
name: Gülay Yiğitoğlu, PhD
role: STUDY_DIRECTOR
affiliation: Pamukkale University
name: Halis Yılmaz, Msc
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.