Clinical trial NCT05870384: Application of Group Interpersonal Psychotherapy (IPT-G) to Family Members Caring for Patients With Schizophrenia
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
Overall status: WITHDRAWN
Phase: NA
Conditions: Interpersonal Psychotherapy
Family Caregivers
Keywords: Interpersonal Psychotherapy
Schizophrenia
Caregiver Burden
Social Support
Social Stigma
Treatment Adherence and Compliance
Expressed Emotion
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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:

1. IPT-G intervention will reduce the caregiver burden of caregivers of individuals with schizophrenia.
2. IPT-G intervention will increase the perceived social support levels of caregivers of individuals with schizophrenia.
3. IPT-G intervention will reduce the level of stigma of caregivers of individuals with schizophrenia.
4. IPT-G intervention will reduce the level of emotional expression of caregivers of individuals with schizophrenia.
5. IPT-G intervention applied to caregivers will increase the level of adherence to treatment of individuals with schizophrenia they care for.
6. 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.

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)

Primary outcomes:
measure: Change in caregiver burden evaluated with the Zarit Caregiver Burden Scale (ZCBS)
timeFrame: Change in caregiver burden at 6 months
Secondary outcomes:
measure: Change in expression of emotion evaluated with Expression of Emotion Scale and Level of Expressed Emotion Scale
timeFrame: Change in expression of emotion at 6 months
measure: Change in stigma evaluated with the Stigma Scale for the Families of Psychiatric Patients (SCFPP)
timeFrame: Change in stigma at 6 months
measure: Change in perceived social support evaluated with the Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Change in perceived social support at 6 months
measure: Change in medication adherence evaluated with the Medication Adherence Rating Scale (MARS)
timeFrame: Change in medication adherence at 6 months
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Faculty of Health Sciences
state: Bolu Province
Study officials:
affiliation: Bolu Abant İzzet Baysal University
name: Melisa Bulut
role: STUDY_DIRECTOR
affiliation: Bolu Abant İzzet Baysal University
name: Nazmiye Yıldırım
role: PRINCIPAL_INVESTIGATOR
References:
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