NCT06368011

Brief Summary

The goal of study is to determine the effect of acceptance and commitment therapy-based psychoeducation on the level of stigmatization applied to relatives of schizophrenia patients. Type of study: This study was planned as a pretest-posttest quasi-experimental design with an observation and control group. Participants: The population of the study consisted of the relatives of schizophrenia patients who were registered and actively attending the Community Mental Health Center in a state hospital in Ankara. Intervention: Before the psychoeducation process started, personal information form and scales were applied to the relatives of the patients in the experimental and control groups. An ACT-based psychoeducation program consisting of 8 sessions was applied to the experimental group. each session lasted approximately 90 minutes. The control group did not receive any intervention. After the psychoeducation, the scales were reapplied to the experimental and control groups. In addition, the experimental group was asked to fill out the psychoeducation evaluation form. The scales were reapplied to the experimental group after the 1-month follow-up study and evaluated.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

March 18, 2024

Last Update Submit

April 15, 2024

Conditions

Keywords

acceptance and commitment therapyschizophreniafamilystigma

Outcome Measures

Primary Outcomes (3)

  • Stigma Scale for Relatives of Patients with Schizophrenia

    It is a 3-point Likert-type scale. Yes: 3, Sometimes: 2, No: 1 and is scored as followsThe lowest score that can be obtained from the scale is 17 and the highest score is 51.

    Pre-test (before the intervention), post test (ten weeks after the intervention) and one month after follow up

  • Stigma Scale for Relatives of Patients with Schizophrenia

    It is a 3-point Likert-type scale. Yes: 3, Sometimes: 2, No: 1 and is scored as followsThe lowest score that can be obtained from the scale is 17 and the highest score is 51.

    post test (ten weeks after the intervention)

  • Stigma Scale for Relatives of Patients with Schizophrenia

    It is a 3-point Likert-type scale. Yes: 3, Sometimes: 2, No: 1 and is scored as followsThe lowest score that can be obtained from the scale is 17 and the highest score is 51.

    one month after follow up

Secondary Outcomes (3)

  • Stigmatization Scale

    Pre-test (before the intervention), post test (ten weeks after the intervention) and one month after follow up

  • Stigmatization Scale

    post test (ten weeks after the intervention)

  • Stigmatization Scale

    one month after follow up

Study Arms (2)

experimental group:relatives of schizophrenia patients

EXPERIMENTAL

The population of the study consisted of the relatives of schizophrenia patients who were registered and actively attending the Ministry of Health Dr. Nafiz Körez Sincan State Hospital Community Mental Health Center.The sample size of the study was calculated at 95% confidence level according to the independent t test using 'G. Power-3.1.9.7' before the study was started.As a result of the analysis, the minimum sample size was calculated as 32, with 16 in the experimental group and 16 in the control group.

Behavioral: acceptance and commitment therapy

control group:relatives of schizophrenia patients

NO INTERVENTION

Interventions

Psychoeducation was delivered in 8 sessions lasting 90 minutes to two separate groups of 8-10 individuals in the experimental group.Group sessions were conducted once a week at the community mental health center under the leadership of the researcher.In total, the psychoeducation lasted 10 weeks, including make-up sessions.

experimental group:relatives of schizophrenia patients

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being a relative of a patient diagnosed with schizophrenia according to DSM-V diagnostic criteria
  • Living with the patient (family member living with the patient for at least 35 hours or more per week)
  • Volunteering to participate in the research,
  • To be able to read and write
  • years of age or older

You may not qualify if:

  • Not having attended any session of the eight-session training program and not having attended the make-up session
  • Not having participated in any of the pre-test, post-test and follow-up test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatay Mustafa Kemal Üniversitesi

Hatay, Turkey (Türkiye)

Location

MeSH Terms

Conditions

StereotypingSchizophreniaSocial Stigma

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
teaching assistant

Study Record Dates

First Submitted

March 18, 2024

First Posted

April 16, 2024

Study Start

April 15, 2023

Primary Completion

July 31, 2023

Study Completion

June 30, 2024

Last Updated

April 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Pre-test and post-test scores of relatives of schizophrenia patients will be matched with coding. relatives of schizophrenia patients will be asked to code the codes consisting of the first letter of their surname, the last two digits of their

Locations