search
Back to results

The Effect of Motivational Interview Intervention for Caregivers of Individuals With Severe Mental Disorders

Primary Purpose

Caregiver, Motivational Interview, Mental Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Motivational İnterview
Psychoeducation
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Caregiver focused on measuring motivational interview, coping attitudes, caregiver, Psychological Distress, severe mental disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Being responsible for the care of individuals receiving services from the Community Mental Health Center Being the patient's primary caregiver for more than 6 months Over 18 years of age No other person to whom he/she is obliged to provide care Exclusion Criteria: Being a paid caregiver No communication barriers

Sites / Locations

  • Kocaeli Health and Tecnology University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Motivational İnterview

Control

Arm Description

The participants in the experimental group will be informed about the study through pre-interviews and data (Caregiver Identifying Characteristics Form, Patient Identifying Characteristics Form, Depression, Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale) will be collected through pre-tests. A motivational interview intervention consisting of a total of 6 interviews will be conducted.Then, data will be collected with posttest (Caregiver Descriptive Characteristics Form, Patient Descriptive Characteristics Form, Depression Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale).

Participants in the control group will be informed about the study through pre-interviews and data (Caregiver Identifying Characteristics Form, Patient Identifying Characteristics Form, Depression, Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale) will be collected through pre-tests. 2 hours of training on coping with stress and problem solving skills will be provided. Then, data will be collected with posttest (Caregiver Descriptive Characteristics Form, Patient Descriptive Characteristics Form, Depression Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale).

Outcomes

Primary Outcome Measures

reducing psychological distress
AIl participants will be pretested and the test will be repeated after 6 weeks. Depression, Anxiety, and Stress Scale (DASS-21) will be applied as the pretest-posttest. The posttest mean scores are expected to be low after the motivational interview intervention was applied to the experimental group for 6 weeks after the pretest. Depression, Anxiety, and Stress Scale (DASS-21) This scale is a 4-point Likert-type scale and consists of seven questions each measuring "depression, stress, and anxiety dimensions". Getting 5 points or more from the depression sub-dimension, 4 points or more from the anxiety sub-dimension, and 8 points or more from the stress sub-dimension indicates that the individual has a related problem.

Secondary Outcome Measures

increasing coping attitudes
All participants will be pretested and the test will be repeated after 6 weeks. The coping Attitudes Assessment Scale will be applied as a pretest-posttest. The posttest mean scores are expected to be low after the motivational interview intervention was applied to the experimental group for 6 weeks after the pretest. Coping Attitudes Assessment Scale The highest score that can be obtained from the scale is 160, and the lowest score is 40. A high score on the scale means a high level of coping attitude, and a low score means a low level of coping attitude.

Full Information

First Posted
June 21, 2023
Last Updated
July 27, 2023
Sponsor
Kirsehir Ahi Evran University
search

1. Study Identification

Unique Protocol Identification Number
NCT05975918
Brief Title
The Effect of Motivational Interview Intervention for Caregivers of Individuals With Severe Mental Disorders
Official Title
The Effect of Motivational Interview Intervention for Caregivers of Individuals With Severe Mental Disorders on Psychological Distress and Coping Attitudes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran 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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver, Motivational Interview, Mental Disorder
Keywords
motivational interview, coping attitudes, caregiver, Psychological Distress, severe mental disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motivational İnterview
Arm Type
Experimental
Arm Description
The participants in the experimental group will be informed about the study through pre-interviews and data (Caregiver Identifying Characteristics Form, Patient Identifying Characteristics Form, Depression, Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale) will be collected through pre-tests. A motivational interview intervention consisting of a total of 6 interviews will be conducted.Then, data will be collected with posttest (Caregiver Descriptive Characteristics Form, Patient Descriptive Characteristics Form, Depression Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale).
Arm Title
Control
Arm Type
Other
Arm Description
Participants in the control group will be informed about the study through pre-interviews and data (Caregiver Identifying Characteristics Form, Patient Identifying Characteristics Form, Depression, Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale) will be collected through pre-tests. 2 hours of training on coping with stress and problem solving skills will be provided. Then, data will be collected with posttest (Caregiver Descriptive Characteristics Form, Patient Descriptive Characteristics Form, Depression Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale).
Intervention Type
Behavioral
Intervention Name(s)
Motivational İnterview
Other Intervention Name(s)
Psychoeducation
Intervention Description
Participants in the experimental group will be informed about the study through pre-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. A motivational interview intervention consisting of a total of 6 interviews will be conducted.
Intervention Type
Other
Intervention Name(s)
Psychoeducation
Intervention Description
2 hours of training on coping with stress and problem solving skills will be provided.
Primary Outcome Measure Information:
Title
reducing psychological distress
Description
AIl participants will be pretested and the test will be repeated after 6 weeks. Depression, Anxiety, and Stress Scale (DASS-21) will be applied as the pretest-posttest. The posttest mean scores are expected to be low after the motivational interview intervention was applied to the experimental group for 6 weeks after the pretest. Depression, Anxiety, and Stress Scale (DASS-21) This scale is a 4-point Likert-type scale and consists of seven questions each measuring "depression, stress, and anxiety dimensions". Getting 5 points or more from the depression sub-dimension, 4 points or more from the anxiety sub-dimension, and 8 points or more from the stress sub-dimension indicates that the individual has a related problem.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
increasing coping attitudes
Description
All participants will be pretested and the test will be repeated after 6 weeks. The coping Attitudes Assessment Scale will be applied as a pretest-posttest. The posttest mean scores are expected to be low after the motivational interview intervention was applied to the experimental group for 6 weeks after the pretest. Coping Attitudes Assessment Scale The highest score that can be obtained from the scale is 160, and the lowest score is 40. A high score on the scale means a high level of coping attitude, and a low score means a low level of coping attitude.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being responsible for the care of individuals receiving services from the Community Mental Health Center Being the patient's primary caregiver for more than 6 months Over 18 years of age No other person to whom he/she is obliged to provide care Exclusion Criteria: Being a paid caregiver No communication barriers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehtap Akkoç, MSc
Phone
+905052461846
Email
mehtapsenerakkoc@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sevil Yılmaz, PhD
Phone
+905332069290
Email
sevilyilmaz72@yahoo.com
Facility Information:
Facility Name
Kocaeli Health and Tecnology University
City
Kocaeli
ZIP/Postal Code
41275
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Motivational Interview Intervention for Caregivers of Individuals With Severe Mental Disorders

We'll reach out to this number within 24 hrs