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Application of Group Interpersonal Psychotherapy (IPT-G) to Family Members Caring for Patients With Schizophrenia (IPT-G)

Primary Purpose

Interpersonal Psychotherapy, Family Caregivers

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group Interpersonal Psychotherapy
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Interpersonal Psychotherapy focused on measuring Interpersonal Psychotherapy, Schizophrenia, Caregiver Burden, Social Support, Social Stigma, Treatment Adherence and Compliance, Expressed Emotion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Faculty of Health SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psychotherapy

Arm Description

Group psychotherapy will be applied to a single intervention group.

Outcomes

Primary Outcome Measures

Change in caregiver burden evaluated with the Zarit Caregiver Burden Scale (ZCBS)
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.

Secondary Outcome Measures

Change in expression of emotion evaluated with Expression of Emotion Scale and Level of Expressed Emotion Scale
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 stigma evaluated with the Stigma Scale for the Families of Psychiatric Patients (SCFPP)
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 perceived social support evaluated with the Multidimensional Scale of Perceived Social Support (MSPSS)
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 medication adherence evaluated with the Medication Adherence Rating Scale (MARS)
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.

Full Information

First Posted
March 25, 2023
Last Updated
July 19, 2023
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT05870384
Brief Title
Application of Group Interpersonal Psychotherapy (IPT-G) to Family Members Caring for Patients With Schizophrenia
Acronym
IPT-G
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Family members who care for individuals with a chronic mental illness such as schizophrenia are exposed to many risks such as stress, fatigue, depression, care burden, stigma, problems in family and interpersonal relationships, conflicts, financial difficulties, social isolation, disruption of daily routines. IPT is a short-term psychotherapy that works on specific interpersonal problem areas associated with depression, anxiety, and general psychological distress. IPT focuses on the following interpersonal problem areas: grief or complicated dispute, bereavement, role, role transition, interpersonal deficits . In these problem areas, IPT is applied individually as well as as group psychotherapy. IPT-G is carried out with group members who share a common distress. IPT-G is more structured than individual IPT. There is a practitioner's guide. IPT-G has a specific agenda, structure and defined endpoint. In IPT-G, the group usually has 6-10 members. Sessions last approximately 90 minutes. The main objectives of IPT-G can be summarized as 1) psychoeducation, 2) increasing social support, 3) solving interpersonal problems. In this sense, the application of IPT-G in the caregivers of individuals with schizophrenia may be promising both for the caregivers and the patients they care for. Therefore, family members who care for individuals diagnosed with schizophrenia living in Turkey/Bolu province, who are willing to participate in the IPT-G intervention, and who meet the inclusion/exclusion criteria of the study will constitute the sample of the study. Participants will be selected from the caregivers of the patients reached from Bolu Abant İzzet Baysal University, İzzet Baysal Training and Research Hospital and Bolu İzzet Baysal Mental Health and Diseases Hospital. A poster inviting the caregivers of the patients will be prepared and hung in the hospitals. Group psychotherapy intervention for the caregivers of patients who meet the inclusion and exclusion criteria of the study will be carried out in a training room in Bolu Abant İzzet Baysal University, Faculty of Health Sciences, Department of Nursing, where the researchers work. The group therapy will be made by the researcher, a licensed psychotherapist. IPT-G will only be applied to caregivers. No application will be made to the patients. In addition, it will be measured whether the intervention applied to the caregivers indirectly has any effect on the patient. Persons to be included in the application will be informed about the application. Signed consent will be obtained. In order to include individuals in the IPT-G intervention, the researcher who will conduct the application will conduct two one-on-one interviews with caregivers to evaluate whether they are suitable for group intervention. The therapist will include caregivers with a similar problem focus in the group. Since it is suggested that the IPT-G group intervention should consist of 6-10 people, this number will be taken as the basis. Group therapy will be done once a week. Sessions will last approximately 90 minutes. The intervention will be completed in a total of ten sessions, with two-session individual interviews and eight-session group sessions. Measurement tools will be applied to caregivers and the patients they care for at the beginning of the group therapy, at the end of the last session, at the end of the third month following the end of the sessions, and at the end of the sixth month following the end of the sessions. A total of four measurements will be made. Scales and sociodemographic data form will be used as data collection tools.Sociodemographic data collection form, Emotional Expression Scale Caregiver Version, Stigma Scale for the Families of Psychiatric Patients (SCFPP), Zarit Caregiver Burden Interview, Multidimensional Scale of Perceived Social Support will be administered face-to-face to caregivers in the IPT-G intervention. The Patient Version of the Emotion Expression Scale and The Medication Adherence Report Scale will be applied to the individuals diagnosed with schizophrenia, who are cared for by the caregivers in the IPT-G intervention.At the end of the experiment, the "t-test for dependent groups" will be used, in which the averages of the pre-test and post-test scores are compared whether the results are significant or not.The research complies with the ethical principles of benefit and non-harm. There is no aspect of the research that could pose a risk or cause harm to the participants. The research intervention is envisaged to provide beneficial outcomes to the participants. Shares made during individual interviews and group sessions will be kept confidential under the principle of protecting privacy. Privacy and confidentiality is the norm of the group and compliance by all participants will be contractually assured and encouraged. Researchers will not share therapy notes unless they pose a risk to the individual, his/her environment and other third parties, unless there is a judicial process.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interpersonal Psychotherapy, Family Caregivers
Keywords
Interpersonal Psychotherapy, Schizophrenia, Caregiver Burden, Social Support, Social Stigma, Treatment Adherence and Compliance, Expressed Emotion

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study is a single group Remeasurement Quasi-experimental Study. The intervention in the study is the application of IPT-G to the caregivers of the patients with schizophrenia. The intervention consists of 10 sessions to be held once a week. The first 2 sessions will be individual, followed by 8 group sessions. Sessions will last an average of 90 minutes. The group is a closed group, no new participants will be accepted after the sessions have started. The study will measure the impact of the therapy on both the caregivers and patients, with follow-up evaluations at 3 and 6 months after the sessions. At the end of the experiment, the "t-test for dependent groups" will be used, in which the averages of the pre-test and post-test scores are compared whether the results are significant or not.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psychotherapy
Arm Type
Experimental
Arm Description
Group psychotherapy will be applied to a single intervention group.
Intervention Type
Behavioral
Intervention Name(s)
Group Interpersonal Psychotherapy
Intervention Description
Ten sessions of IPT-G, which focuses on the common problem area of patient relatives, will be applied.
Primary Outcome Measure Information:
Title
Change in caregiver burden evaluated with the Zarit Caregiver Burden Scale (ZCBS)
Description
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.
Time Frame
Change in caregiver burden at 6 months
Secondary Outcome Measure Information:
Title
Change in expression of emotion evaluated with Expression of Emotion Scale and Level of Expressed Emotion Scale
Description
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.
Time Frame
Change in expression of emotion at 6 months
Title
Change in stigma evaluated with the Stigma Scale for the Families of Psychiatric Patients (SCFPP)
Description
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.
Time Frame
Change in stigma at 6 months
Title
Change in perceived social support evaluated with the Multidimensional Scale of Perceived Social Support (MSPSS)
Description
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.
Time Frame
Change in perceived social support at 6 months
Title
Change in medication adherence evaluated with the Medication Adherence Rating Scale (MARS)
Description
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.
Time Frame
Change in medication adherence at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melisa Bulut
Phone
+903742541000
Ext
6124
Email
melisa.bulut@ibu.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Nazmiye Yıldırım
Phone
+903742541000
Ext
6100
Email
nazmiyeyildirim@ibu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melisa Bulut
Organizational Affiliation
Bolu Abant İzzet Baysal University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nazmiye Yıldırım
Organizational Affiliation
Bolu Abant İzzet Baysal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health Sciences
City
Bolu
State/Province
Bolu Province
ZIP/Postal Code
141000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melisa Bulut, RN

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27032627
Citation
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.
Results Reference
background
Citation
Arslantas H. The burden of schizophrenia on caregivers. Current Approaches in Psychiatry. 2011; 3(2):251-277.
Results Reference
background
PubMed Identifier
16448486
Citation
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.
Results Reference
background
Citation
Stuart S, Schultz J. IPT for Groups Clinician's Handbook. IPT Institute. 2016
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
result
PubMed Identifier
29444721
Citation
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.
Results Reference
result
PubMed Identifier
16134403
Citation
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.
Results Reference
result

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Application of Group Interpersonal Psychotherapy (IPT-G) to Family Members Caring for Patients With Schizophrenia

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