Efficacy, Feasibility, and Acceptability of the DeST-ACT: Trauma-Focused Acceptance and Commitment Therapy Program

NCT ID: NCT06429852

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2024-10-31

Brief Summary

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The aim of this study is to develop a post-earthquake, trauma-focused Acceptance and Commitment Therapy (ACT)-based psychosocial intervention program (DeST-ACT) and to examine its effectiveness, feasibility, and acceptability of this program in enhancing life satisfaction and psychological flexibility in individuals exposed to earthquake trauma.

In this regard, the main hypothesis is that the DeST-ACT psychosocial intervention program is effective, feasible, and acceptable among individuals exposed to earthquake trauma, including both primary and secondary outcomes of the program.

Detailed Description

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This quantitative, randomized controlled trial involves two groups and includes a pre-test and repeated post-tests. The study aims to assess the effectiveness, feasibility, and acceptability of the developed DeST-ACT program in addressing post-traumatic stress disorder, psychological flexibility, life satisfaction, values-based living, and depression-anxiety-stress levels in individuals affected by the February 6, 2023 earthquake. Participants will be randomly assigned to experimental and control groups in a 1:1 ratio using an internet-based block randomization program.

The DeST-ACT psychosocial intervention program consists of a 4-session online intervention supported by self-help materials. Each session in the 4-week program is held once a week for 50 minutes.

The main hypotheses are:

* The intervention group will demonstrate a significant decrease in Post Traumatic Stress Disorder (PTSD) and depression-anxiety-stress levels compared to the control group.
* The intervention group will experience a greater increase in values-based living, life satisfaction, and psychological flexibility over time compared to the control group.
* The intervention group will demonstrate a significant decrease in PTSD and depression-anxiety-stress levels compared to baseline measures.
* The intervention group will experience a greater increase in values-based living, life satisfaction, and psychological flexibility over time compared to baseline measures.

Conditions

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Trauma and Stressor Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will be a quantitative, randomized controlled trial with two groups, including a pre-test and repeated post-tests.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Randomization will be conducted by a research assistant using an internet-based program following the pre-test. The pre-test and post-tests will be administered by a different researcher who is blinded to the study. The therapy program will be conducted by independent therapists who are also blinded to the study.

Study Groups

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DeST-ACT Intervention Group

Participants in the intervention group will undergo the DeST-ACT psychosocial intervention. This program includes a 4-session online intervention supplemented with self-help materials. These materials comprise concise texts designed to reinforce the skills covered in each session.

Group Type EXPERIMENTAL

The DeST-ACT Trauma-Focused Acceptance and Commitment Therapy Program

Intervention Type BEHAVIORAL

The Trauma-focused psychosocial intervention program consists of 4 sessions online therapy.

Waitlist Group

The other group will consist of participants on the wait-list. Similar to those in the intervention group, participants in the waitlist group will undergo research assessments at baseline, post-therapy, and 1 month after therapy. Subsequently, they will be included in the 4-session intervention program. No measurements will be taken after the intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The DeST-ACT Trauma-Focused Acceptance and Commitment Therapy Program

The Trauma-focused psychosocial intervention program consists of 4 sessions online therapy.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Volunteering to participate in the research
* Being present in cities such as Kahramanmaras, Gaziantep, Hatay, Adiyaman, or Malatya during the earthquake on February 6, where destruction occurred
* Being literate
* Being able to have an online interview with the therapist
* Having sub-threshold PTSD or PTSD

Exclusion Criteria

* Being in other cities at the time of the earthquake and not being exposed to the earthquake
* Having visual and/or hearing problems
* Having any psychotic disorder, experiencing an active mood episode, or having conditions such as intellectual disability or dementia that would prevent participation in therapy
* Starting a new psychiatric treatment during the research period or having a change in medication or dosage within the last 3 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CanSagligi Foundation

OTHER

Sponsor Role lead

Responsible Party

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Sevinc Ulusoy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cansagligi Foundation Center for Contextual Behavioral Science

Istanbul, Uskudar, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Aleyna Güleryüz, BA

Role: CONTACT

02122696611

Sevinç Ulusoy, MD

Role: CONTACT

Facility Contacts

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Eda Aksoy

Role: primary

Other Identifiers

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CSV202403

Identifier Type: -

Identifier Source: org_study_id

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