Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05975918
Other study ID # 123456
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date August 1, 2025

Study information

Verified date July 2023
Source Kocaeli University
Contact Mehtap Akkoç, MSc
Phone +905052461846
Email mehtapsenerakkoc@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date August 1, 2025
Est. primary completion date October 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Motivational Interview
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.
Other:
Psychoeducation
2 hours of training on coping with stress and problem solving skills will be provided.

Locations

Country Name City State
Turkey Kocaeli Health and Tecnology University Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
6 weeks
Secondary 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.
6 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT06102850 - Adaptation of Critical Time Intervention for Young Adults With MH Challenges N/A
Completed NCT05649449 - Testing Self-Directed Care in Florida N/A
Not yet recruiting NCT05886595 - Being Young : My Mental Health
Recruiting NCT04157062 - An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder N/A
Completed NCT04505540 - Start Treatment and Recovery for Opioid Use Disorder N/A
Withdrawn NCT03236766 - Engaging Pacific Islander Perspectives on Mental Illness and Mental Health Services N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Not yet recruiting NCT04071145 - Using Sensors to Measure Drug Concentrations in Exhaled Breath
Completed NCT04457635 - Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders. N/A
Completed NCT01922258 - Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type Phase 3
Recruiting NCT06054061 - Evaluation the Efficacy "Think and Cope Positively" Program N/A
Completed NCT03118388 - Engaging Homeless Youth in Vocational Training to Meet Their Mental Health Needs Phase 2
Active, not recruiting NCT04196881 - Effect of Attention Deficit Hyperactivity Disorder Knowledge Improvement Program on Male Primary School Teachers N/A
Terminated NCT04028609 - Community Health Worker Intervention to Improve Post-Hospital Outcomes N/A
Active, not recruiting NCT03641664 - FCT Study: Reducing the Need for Out-of-Home Placements N/A
Completed NCT05019937 - Exploring Effectiveness and Mechanism of Change of an Implementation Strategy on Guideline Implementation in Schools N/A
Completed NCT03611998 - Survivors of Sex Trafficking: Occupation-Based Interventions for Executive Functioning N/A
Active, not recruiting NCT04148508 - App-based Mental Health Promotion in Young European Adults N/A
Completed NCT03704805 - Effect of a Psychological Intervention on Antiretroviral Therapy and Mental Health Outcomes in HIV-positive Adults in Zimbabwe N/A
Recruiting NCT05087446 - Effect of Early Assessment Team for Patients Referred to Outpatient Mental Health Care N/A