NCT06655688

Brief Summary

This study aimed to evaluate the effect of ACT administered online to family members on self-stigmatization, coping with stress, and psychological resilience levels after the first psychotic attack (FPA).

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

October 19, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

October 20, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 30, 2025

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

October 19, 2024

Last Update Submit

May 25, 2025

Conditions

Keywords

First psychotic attackfamily membersAcceptance and Commitment Therapygroup therapycopingstigmatizationpsychiatric nursing

Outcome Measures

Primary Outcomes (1)

  • Self-Stigma Inventory for Families (SSI-F)

    The scale was developed to assess the self-stigmatization of family members of individuals diagnosed with schizophrenia. The scores that can be obtained from the scale, which includes 3 factors and 14 items in total, including internalized stereotypes and withdrawal from society, concealment of the disease and perceived worthlessness, vary between 14-70. A high score indicates a high level of self-stigmatization of the family member.

    6 month

Secondary Outcomes (2)

  • Stress Coping Scale

    6 month

  • Brief Resilience Scale

    6 month

Study Arms (2)

Experimental: ACT

EXPERIMENTAL

''Acceptance and Commitment Therapy (ACT) Based Intervention Program was applied to the intervention group.

Behavioral: Acceptance and Commitment Therapy

Control

NO INTERVENTION

Arm Description: Only data collection was carried out. No attempt was made by the researcher during the study.

Interventions

Acceptance and Commitment Therapy Based Intervention Program was applied to the intervention group in eight sessions online. Each session will last an average of 60-90 minutes. There will be two sessions for one group per week.

Experimental: ACT

Eligibility Criteria

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

You may qualify if:

  • Acceptance to participate in the research,
  • Being responsible for the care of an individual who has been diagnosed with schizophrenia and other psychotic disorders according to DSM-5 diagnostic criteria at least six months ago and at most five years ago,
  • Living with the patient for at least one year,
  • First-degree relatives (mother, father, siblings, adult children and spouse),
  • The home environment is suitable for online interviewing (having a computer/smartphone, internet at home, the patient can be alone in the room during the session, etc.),
  • Being literate,
  • Communication is not a problem.

You may not qualify if:

  • Refusal to participate in the research,
  • Responsible for the care of an individual diagnosed with schizophrenia and other psychotic disorders for less than six months or more than five years according to DSM-V diagnostic criteria,
  • Living with the patient for less than one year,
  • No first-degree relatives (mother, father, siblings, adult children and spouse),
  • The home environment is not suitable for online counseling (having a computer/smartphone, internet at home, the patient can be alone in the room during the session, etc.),
  • Illiteracy,
  • Communication problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saglik Bilimleri Universitesi

Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stereotyping

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Duygu Özer, Asst. Prof.

    Bartın Unıversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Experimental: Intervention group ''Acceptance and Commitment Therapy Based Intervention Program was applied to the intervention group Intervention: Behavioral: Acceptance and Commitment Therapy No Intervention: Control group Only data collection was carried out. No attempt was made by the researcher during the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Intervention and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

October 19, 2024

First Posted

October 23, 2024

Study Start

October 20, 2024

Primary Completion

November 30, 2024

Study Completion

June 1, 2025

Last Updated

May 30, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations