- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05870384
Application of Group Interpersonal Psychotherapy (IPT-G) to Family Members Caring for Patients With Schizophrenia (IPT-G)
Effects of Group Interpersonal Psychotherapy (IPT-G) Applied to Family Members Who Caregivers of Patients With Schizophrenia on Caregiver Burden, Social Support, Expression of Emotion, Stigma, and Adherence to Treatment
The goal of this re-measured quasi-experimental study is to evaluate the effect of Group Interpersonal Psychotherapy (IPT-G) intervention given to caregiver family members of people with schizophrenia on caregiver burden, perception of social support and stigma, adherence to treatment in people with schizophrenia they care for, and emotional expression in both caregivers and people with schizophrenia they care for. The main hypotheses it aims to test are:
- IPT-G intervention will reduce the caregiver burden of caregivers of individuals with schizophrenia.
- IPT-G intervention will increase the perceived social support levels of caregivers of individuals with schizophrenia.
- IPT-G intervention will reduce the level of stigma of caregivers of individuals with schizophrenia.
- IPT-G intervention will reduce the level of emotional expression of caregivers of individuals with schizophrenia.
- IPT-G intervention applied to caregivers will increase the level of adherence to treatment of individuals with schizophrenia they care for.
- IPT-G intervention applied to caregivers will reduce the emotional expression levels of individuals with schizophrenia they care for.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bolu Province
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Bolu, Bolu Province, Turkey, 141000
- Faculty of Health Sciences
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be between the ages of 18-65
- Being able to speak and understand fluent Turkish,
- Being the primary caregiver of a family member with one of the Schizophrenic Disorders and Psychotic Disorders,
- Caring for a family member with Schizophrenia and Schizophrenia Spectrum Disorder for at least 6 months.
- Both the caregiver and the patient voluntarily agree to participate in the study.
Exclusion Criteria:
- Having a dismissive attachment style (to be evaluated by the researcher),
- Having antisocial personality traits (to be evaluated by the researcher),
- Having narcissistic personality traits (to be evaluated by the researcher),
- Having active suicidal ideation (to be evaluated by the investigator).
Removal criteria:
- Not attending more than two sessions of the 7-session intensive/group phase
- Failure to comply with the norms and rules of group therapy (continuity, confidentiality, respectful communication, interaction with group members, participation)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Psychotherapy
Group psychotherapy will be applied to a single intervention group.
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Ten sessions of IPT-G, which focuses on the common problem area of patient relatives, will be applied.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in caregiver burden evaluated with the Zarit Caregiver Burden Scale (ZCBS)
Time Frame: Change in caregiver burden at 6 months
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The primary outcome measure of the study is the care burden. Caregivers' burden will be evaluated with repeated tests before and after the intervention. For this, the "Zarit Caregiver Burden Scale (ZCBS)" scale will be used.The scale will be applied only to caregivers who participate in the group psychotherapy intervention. Zarit Caregiver Burden Scale (ZCBS): The scale consists of 22 items. It includes the negative effects of caregiving on physical, mental health, social activity and economic resources.The total score varies between 22-110. The higher the scores, the higher the level of burden. It is expected that the burden of care score will decrease in the measurements made after the intervention. |
Change in caregiver burden at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in expression of emotion evaluated with Expression of Emotion Scale and Level of Expressed Emotion Scale
Time Frame: Change in expression of emotion at 6 months
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Expression of emotion will be measured both in caregivers participating in group psychotherapy intervention and in patients they care for without intervention with repeated tests before and after the intervention. Expression of Emotion Scale: This scale will be filled by caregivers. The scale consists of 41 "true/false" questions. The higher the scores, the higher the level of emotional expression. The total score ranges from 0 to 41.It is expected that the expression of emotion score will decrease in the measurements made after the intervention. Level of Expressed Emotion Scale:This scale will be filled by patients. The scale asks patients to evaluate the attitude of their caregivers towards them. The scale consists of 60 "true/false" questions. The total score ranges from 0 to 60.It is expected that the expression of emotion score will decrease in the measurements made after the intervention. |
Change in expression of emotion at 6 months
|
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Change in stigma evaluated with the Stigma Scale for the Families of Psychiatric Patients (SCFPP)
Time Frame: Change in stigma at 6 months
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Stigma will be evaluated with repeated tests before and after the intervention. For this, the "Stigma Scale for the Families of Psychiatric Patients (SCFPP)" scale will be used.The scale will be applied only to caregivers who participate in the group psychotherapy intervention. Stigma Scale for the Families of Psychiatric Patients (SCFPP): The scale consists of 17 items. Scoring of the scale is made as the lowest 1 and the highest 3 points; cut-off score was calculated as 1.67.The higher the scores, the higher the level of stigma.It is expected that the stigma score will decrease in the measurements made after the intervention. |
Change in stigma at 6 months
|
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Change in perceived social support evaluated with the Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: Change in perceived social support at 6 months
|
Perceived social support will be evaluated with repeated tests before and after the intervention. For this, the "Multidimensional Scale of Perceived Social Support (MSPSS)" scale will be used.The scale will be applied only to caregivers who participate in the group psychotherapy intervention. Multidimensional Scale of Perceived Social Support (MSPSS): The scale consists of 12 items. The total score varies between 0-84. A high score indicates high perceived social support. It is expected that the perceived social support score will increase in the measurements made after the intervention. |
Change in perceived social support at 6 months
|
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Change in medication adherence evaluated with the Medication Adherence Rating Scale (MARS)
Time Frame: Change in medication adherence at 6 months
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Medication adherence will be evaluated with repeated tests before and after the intervention. For this, the "Medication Adherence Rating Scale (MARS)" scale will be used.The scale will be applied to patients cared for by caregivers participating in the intervention. Medication Adherence Rating Scale (MARS):The scale consists of 10 "yes/no" questions.The total score varies between 1-10.Low scores on the scale indicate poor adherence to treatment, and high scores indicate high adherence to treatment. 1 and 7 points shows that poor adherence to treatment, between 8 and 10 were high. It is expected that the perceived social support score will increase in the measurements made after the intervention. |
Change in medication adherence at 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Melisa Bulut, Bolu Abant Izzet Baysal University
- Principal Investigator: Nazmiye Yıldırım, Bolu Abant Izzet Baysal University
Publications and helpful links
General Publications
- Cuijpers P, Donker T, Weissman MM, Ravitz P, Cristea IA. Interpersonal Psychotherapy for Mental Health Problems: A Comprehensive Meta-Analysis. Am J Psychiatry. 2016 Jul 1;173(7):680-7. doi: 10.1176/appi.ajp.2015.15091141. Epub 2016 Apr 1.
- Arslantas H. The burden of schizophrenia on caregivers. Current Approaches in Psychiatry. 2011; 3(2):251-277.
- Chang KH, Horrocks S. Lived experiences of family caregivers of mentally ill relatives. J Adv Nurs. 2006 Feb;53(4):435-43. doi: 10.1111/j.1365-2648.2006.03732.x.
- Stuart S, Schultz J. IPT for Groups Clinician's Handbook. IPT Institute. 2016
- Chen WY, Lukens E. Well being, depressive symptoms, and burden among parent and sibling caregivers of persons with severe and persistent mental illness. Social Work in Mental Health. 2011; 9(6): 397-416.
- Durmaz H, Okanli A. Effects of interpersonal psychotherapy (ipt) techniques and psychoeducation on self-efficacy and care burden in families of patients with schizophrenia. American Journal of Family Therapy. 2021; 49(4): 373-391.
- Mutamba BB, Kane JC, de Jong JTVM, Okello J, Musisi S, Kohrt BA. Psychological treatments delivered by community health workers in low-resource government health systems: effectiveness of group interpersonal psychotherapy for caregivers of children affected by nodding syndrome in Uganda. Psychol Med. 2018 Nov;48(15):2573-2583. doi: 10.1017/S0033291718000193. Epub 2018 Feb 15.
- Glanville DN, Dixon L. Caregiver burden, family treatment approaches and service use in families of patients with schizophrenia. Isr J Psychiatry Relat Sci. 2005;42(1):15-22.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-PSK-MB-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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