Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT05975918
Status:
UNKNOWN
Last Update Posted:
2023-08-04
First Post:
2023-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Motivational Interview Intervention for Caregivers of Individuals With Severe Mental Disorders
Sponsor:
Kocaeli University
Organization:
Study Overview
Official Title:
The Effect of Motivational Interview Intervention for Caregivers of Individuals With Severe Mental Disorders on Psychological Distress and Coping Attitudes
Status:
UNKNOWN
Status Verified Date:
2023-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Serious mental illnesses are all chronic illnesses such as schizophrenia, schizoaffective disorder, and other psychotic disorders, major depression, and bipolar disorder, which cause impaired functioning in areas such as activities of daily living, self-care, social relationships, professional and academic life, quality time, etc. These chronic illnesses are a significant source of stress for the patient and family members. With the transition to community-based practices in the care of chronic mental illnesses, t he duties of families have increased and as a result, have had significant negative effects on caregiver and family functioning.
Caregivers face many challenges and these challenges cause caregivers to experience feelings such as anxiety, stress, fear, guilt, helplessness, hopelessness, powerlessness, loss, and anger. It is understood that families are in significant need of psychosocial support interventions that will enable them to develop effective coping methods and reduce stress and anxiety.
Themotivationall Interviewing Technique is one of the methods that can be applied to the caregivers of individuals diagnosed with chronic mental illness to adapt to the situation and cope with the difficulties they experience. Motivational Interviewing does not deal with issues such as teaching new information or ensuring acceptance of the past. It focuses on the individual's current stress, anxiety and dilemmas, goals, and plans. Studies show that any intervention that will contribute to the caregiver's coping attitude and psychological distress level will also support the empowerment of the sick individual. For this purpose, the study was planned to determine the effect of motivational interviewing intervention for caregivers of individuals with serious mental disorders on psychological distress and coping attitudes.
Caregivers face many challenges and these challenges cause caregivers to experience feelings such as anxiety, stress, fear, guilt, helplessness, hopelessness, powerlessness, loss, and anger. It is understood that families are in significant need of psychosocial support interventions that will enable them to develop effective coping methods and reduce stress and anxiety.
Themotivationall Interviewing Technique is one of the methods that can be applied to the caregivers of individuals diagnosed with chronic mental illness to adapt to the situation and cope with the difficulties they experience. Motivational Interviewing does not deal with issues such as teaching new information or ensuring acceptance of the past. It focuses on the individual's current stress, anxiety and dilemmas, goals, and plans. Studies show that any intervention that will contribute to the caregiver's coping attitude and psychological distress level will also support the empowerment of the sick individual. For this purpose, the study was planned to determine the effect of motivational interviewing intervention for caregivers of individuals with serious mental disorders on psychological distress and coping attitudes.
Detailed Description:
Before starting the study, approval was obtained from the Kocaeli Health and Technology University Non-Interventional Research Ethics Committee dated 2023-38 and numbered 2023-38, and institutional permission was obtained from the community mental health center where the study would be conducted.
In the calculation of the sample of the study, the power analysis based on the statistics obtained from the study titled "Psychological distress, perceived stigma, and coping among caregivers of patients with schizophrenia" was taken as "α=0.05, 1-β (Power)= 0.95 and effect size=0.77" and accordingly, it was determined that a total of 36 people should be taken, 18 people in each group. In order to meet the sampling, possible losses and parametric test assumptions, it was decided to include a total of 60 people, 30 people each in the experimental and control groups.
The randomization method (a stratified sample list (including gender, age and number of rows) will be created by a third person who is not part of the research team, and a simple random number table will be used to assign the caregivers to the experimental and control groups) will be used.
The implementation of the research will be done in two phases. Phase 1: Piloting, identification of the intervention and control groups and pretesting
* The 6-session motivational interviewing intervention, which will be finalized according to expert opinions, will be piloted and the results will be evaluated. The intervention steps that require revision will be organized and the sample selection phase will begin.
* Caregivers who meet the research criteria and agree to participate in the study will be assigned to the experimental and control groups by randomization method.
* The experimental and control groups will be informed about the study through preliminary interviews and data (Caregiver Descriptive Characteristics Form, Patient Descriptive Characteristics Form, Depression Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale) will be collected through pre-tests.
Phase 2: Intervention In the study, the intervention group will receive individual interviews based on motivational interviewing techniques, while the control group will receive a one-day group psychoeducation on coping with stress and problem solving skills.
Within the scope of this research, a total of 6 sessions of motivational interviewing interventions will be provided to the caregivers in the experimental group in 45-minute sessions. Pre-tests will be completed by adding an additional session to the first session and post-tests will be completed at the end of the last session.
Quantitative data will be analyzed with SPSS 25.0 package program using descriptive statistics (frequency distribution table) and inferential statistical tests. Significance will be evaluated at p\<0.05 level.
In the calculation of the sample of the study, the power analysis based on the statistics obtained from the study titled "Psychological distress, perceived stigma, and coping among caregivers of patients with schizophrenia" was taken as "α=0.05, 1-β (Power)= 0.95 and effect size=0.77" and accordingly, it was determined that a total of 36 people should be taken, 18 people in each group. In order to meet the sampling, possible losses and parametric test assumptions, it was decided to include a total of 60 people, 30 people each in the experimental and control groups.
The randomization method (a stratified sample list (including gender, age and number of rows) will be created by a third person who is not part of the research team, and a simple random number table will be used to assign the caregivers to the experimental and control groups) will be used.
The implementation of the research will be done in two phases. Phase 1: Piloting, identification of the intervention and control groups and pretesting
* The 6-session motivational interviewing intervention, which will be finalized according to expert opinions, will be piloted and the results will be evaluated. The intervention steps that require revision will be organized and the sample selection phase will begin.
* Caregivers who meet the research criteria and agree to participate in the study will be assigned to the experimental and control groups by randomization method.
* The experimental and control groups will be informed about the study through preliminary interviews and data (Caregiver Descriptive Characteristics Form, Patient Descriptive Characteristics Form, Depression Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale) will be collected through pre-tests.
Phase 2: Intervention In the study, the intervention group will receive individual interviews based on motivational interviewing techniques, while the control group will receive a one-day group psychoeducation on coping with stress and problem solving skills.
Within the scope of this research, a total of 6 sessions of motivational interviewing interventions will be provided to the caregivers in the experimental group in 45-minute sessions. Pre-tests will be completed by adding an additional session to the first session and post-tests will be completed at the end of the last session.
Quantitative data will be analyzed with SPSS 25.0 package program using descriptive statistics (frequency distribution table) and inferential statistical tests. Significance will be evaluated at p\<0.05 level.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: