CaregiverNCT05975918
The Effect of Motivational Interview Intervention for Caregivers of Individuals With Severe Mental Disorders
A study testing Motivational İnterview and Psychoeducation in people with Caregiver and Motivational Interview, run by Kocaeli University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver, Motivational Interview, Mental Disorder
- What is being tested?
- Motivational İnterview and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Being a paid caregiver
- No communication barriers
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli Health and Tecnology University
Kocaeli, 41275
About this study
Official title: The Effect of Motivational Interview Intervention for Caregivers of Individuals With Severe Mental Disorders on Psychological Distress and Coping Attitudes
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.
Read the 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.
- Conditions
- Caregiver, Motivational Interview, Mental Disorder
- Being tested
- Motivational İnterview, Psychoeducation
- Keywords
- motivational interview, coping attitudes, caregiver, Psychological Distress, severe mental disorder
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational İnterviewBehavioural
Also called Psychoeducation
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.
PsychoeducationOther
2 hours of training on coping with stress and problem solving skills will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Motivational İnterview | Experimental | 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). Receives: Behavioral: Motivational İnterview |
| Control | Other | 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). Receives: Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehtap Akkoç, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975918
- Sponsor's protocol ID
- 123456
- Status last verified
- Jul 2023
- First submitted
- 21 Jun 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interview Intervention for Caregivers of Individuals With Severe Mental Disorders on Psychological Distress and Coping Attitudes
- ClinicalTrials.gov ID
- NCT05975918
- Acronym / sponsor ID
- 123456
- Conditions
- Caregiver, Motivational Interview, Mental Disorder
- Keywords
- motivational interview, coping attitudes, caregiver, Psychological Distress, severe mental disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational İnterview | Experimental | Behavioral: Motivational İnterviewThe 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). |
| Control | Other | Other: PsychoeducationParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Being a paid caregiver
- No communication barriers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational İnterviewAlso: PsychoeducationParticipants 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. | Behavioural | Motivational İnterview |
| Psychoeducation2 hours of training on coping with stress and problem solving skills will be provided. | Other | Control |
Primary outcome
reducing psychological distress
Time frame: 6 weeks
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.
1 secondary outcome
increasing coping attitudes
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational İnterview and Psychoeducation in people with Caregiver and Motivational Interview, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehtap Akkoç, MSc (+905052461846, mehtapsenerakkoc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reducing psychological distress (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.