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

NCT05870384 | Withdrawn

• 1 other identifier: AIBU-PSK-MB-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Interpersonal Psychotherapy; Family Caregivers

Keywords

Interpersonal Psychotherapy; Schizophrenia; Caregiver Burden; Social Support; Social Stigma; Treatment Adherence and Compliance; Expressed Emotion

Outcome Measures

Primary Outcomes (1)

• 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.

  Change in caregiver burden at 6 months

Secondary Outcomes (4)

• Change in expression of emotion evaluated with Expression of Emotion Scale and Level of Expressed Emotion Scale

  Change in expression of emotion at 6 months

• Change in stigma evaluated with the Stigma Scale for the Families of Psychiatric Patients (SCFPP)

  Change in stigma at 6 months

• Change in perceived social support evaluated with the Multidimensional Scale of Perceived Social Support (MSPSS)

  Change in perceived social support at 6 months

• Change in medication adherence evaluated with the Medication Adherence Rating Scale (MARS)

  Change in medication adherence at 6 months

Study Arms (1)

Psychotherapy

EXPERIMENTAL

Group psychotherapy will be applied to a single intervention group.

Behavioral: Group Interpersonal Psychotherapy

Interventions

Group Interpersonal Psychotherapy BEHAVIORAL

Ten sessions of IPT-G, which focuses on the common problem area of patient relatives, will be applied.

Psychotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Faculty of Health Sciences

Bolu, Bolu, 141000, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 27032627 BACKGROUND

• Arslantas H. The burden of schizophrenia on caregivers. Current Approaches in Psychiatry. 2011; 3(2):251-277.

  BACKGROUND

• 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.

  PMID: 16448486 BACKGROUND

• Stuart S, Schultz J. IPT for Groups Clinician's Handbook. IPT Institute. 2016

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  RESULT

• 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.

  PMID: 29444721 RESULT

• 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.

  PMID: 16134403 RESULT

MeSH Terms

Conditions

Schizophrenia; Caregiver Burden; Social Stigma; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior; Social Behavior; Health Behavior

Study Officials

• Melisa Bulut

  Bolu Abant İzzet Baysal University

  STUDY DIRECTOR

• Nazmiye Yıldırım

  Bolu Abant İzzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2023
• First Posted: May 23, 2023
• Study Start: July 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: April 1, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)