NCT07643714

Brief Summary

This randomized controlled trial aimed to examine the effects of Acceptance and Commitment Therapy (ACT)-based psychoeducation program on psychological resilience, stress management, and caregiver burden in caregivers of individuals with mental disorders. Participants were randomly assigned to either the intervention or control group. The intervention group received ACT-based psychoeducation while the control group received no intervention. H1-1: The mean psychological resilience scores of caregivers in the intervention group who received the ACT-based psychoeducation program are significantly higher compared to caregivers in the control group. H1-2: The mean stress management scores of caregivers in the intervention group who received the ACT-based psychoeducation program are significantly higher compared to caregivers in the control group. H1-3: The mean caregiver burden scores of caregivers in the intervention group who received the ACT-based psychoeducation program are significantly lower compared to caregivers in the control group. H1-4: The effects of the ACT-based psychoeducation program on psychological resilience, stress management, and caregiver burden differ significantly between caregivers of individuals diagnosed with schizophrenia and caregivers of individuals diagnosed with bipolar disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 6, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 8, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

Acceptance and Commitment TherapyPsychoeducationCaregiverPsychological ResilienceStress ManagementMental DisordersSchizophreniaBipolar Disorder

Outcome Measures

Primary Outcomes (3)

  • Psychological Resilience

    Measured with the Psychological Resilience Scale for Adults at baseline, post-intervention, and at 2-month follow-up

    Baseline, post-intervention (8 weeks), and 2-month follow-up

  • Stress Management

    Measured with the Stress Coping Styles Scale at baseline, post-intervention, and at 2-month follow-up

    Baseline, post-intervention (8 weeks), and 2-month follow-up

  • Caregiver Burden

    Measured with the Caregiver Burden Scale at baseline, post-intervention, and at 2-month follow-up

    Baseline, post-intervention (8 weeks), and 2-month follow-up

Secondary Outcomes (1)

  • Psychological Flexibility

    Baseline, post-intervention (8 weeks), and 2-month follow-up

Study Arms (4)

Schizophrenia - Intervention Group

EXPERIMENTAL

Caregivers of individuals diagnosed with schizophrenia who participated in the ACT-based psychoeducation program

Behavioral: ACT-Based Psychoeducation Program

Schizophrenia - Control Group (No intervention)

NO INTERVENTION

Caregivers of individuals with schizophrenia who received no intervention.

Bipolar Disorder - Intervention Group

EXPERIMENTAL

Caregivers of individuals with bipolar disorder who received ACT-based psychoeducation.

Behavioral: ACT-Based Psychoeducation Program

Bipolar Disorder - Control Group

NO INTERVENTION

Caregivers of individuals with bipolar disorder who received no intervention

Interventions

ACT-based psychoeducation program delivered to caregivers of individuals with mental disorders (schizophrenia and bipolar disorder). The program was based on Acceptance and Commitment Therapy principles and consisted of 8 sessions. It aimed to improve psychological resilience, stress management, and reduce caregiver burden. Sessions were conducted in group format.

Bipolar Disorder - Intervention GroupSchizophrenia - Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older Being a first-degree caregiver of an individual with severe mental disorder followed at a CMHC or outpatient clinic Turkish-speaking and at least primary school graduate No communication problems and open to cooperation Not having participated in any ACT-based or similar psychoeducation program in the last 6 months No alcohol/substance use disorder No psychiatric diagnosis Having regularly attended the intervention sessions -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Necip Fazil City Hospital, Psychiatry Outpatient Clinic and Community Mental Health Center

Kahramanmaraş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Caregiver BurdenMental DisordersSchizophreniaBipolar Disorder

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorSchizophrenia Spectrum and Other Psychotic DisordersBipolar and Related DisordersMood Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 11, 2026

Study Start

October 6, 2025

Primary Completion

November 24, 2025

Study Completion

January 19, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared as this is a doctoral dissertation study conducted at a single institution.

Locations