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

NCT06429852 | Not Yet Recruiting

• 1 other identifier: CSV202403
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trauma and Stressor Related Disorders

Outcome Measures

Primary Outcomes (3)

• PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)

  The PCL-5 was developed based on the diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders-5, and its aim is to evaluate PTSD symptoms. The scale consists of 20 items rated on a 5-point Likert scale. Scores above 47 are indicative of PTSD.

  At baseline, after 4 weeks, after 8 weeks

• Depression Anxiety and Stress Scale 21 (DASS-21)

  The DASS-21 measures the dimensions of depression, stress, and anxiety. The scale consists of 21 items rated on a 4-point Likert scale ranging from 0 (Never) to 4 (Always) with scores ranging from a minimum of 0 to a maximum of 84. The Cronbach's alpha values for the scale, based on Turkish validity and reliability studies, are 0.80 for anxiety, 0.82 for depression, and 0.75 for stress.

  At baseline, after 4 weeks, after 8 weeks

• Engaged Living Scale

  The Engaged Living Scale is designed to evaluate values-based living. It consists of 16 items rated on a 5-point Likert scale, ranging from 1 (Totally Agree) to 5 (Totally Disagree), with scores ranging from a minimum of 16 to a maximum of 80. The scale, for which Turkish validity and reliability studies have been conducted, has two sub-dimensions: "valued living" and "life fulfillment." The Cronbach's alpha value for the Turkish version of the scale is 0.91, with 0.87 for the valued living sub-dimension and 0.86 for the life fulfillment sub-dimension.

  At baseline, after 4 weeks, after 8 weeks

Secondary Outcomes (3)

• Acceptance and Action Questionnaire-2 (AAQ-2)

  At baseline, after 4 weeks, after 8 weeks

• Therapy Satisfaction Questionnaire

  after 4 week

• Drop Rate

  after 8 weeks

Other Outcomes (1)

• Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS-5)

  The scale will be used to assess the inclusion criterion before the randomization.

Study Arms (2)

DeST-ACT Intervention Group

EXPERIMENTAL

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.

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

Waitlist Group

NO INTERVENTION

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.

Interventions

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

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

DeST-ACT Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CanSagligi Foundation: lead

Study Sites (1)

Cansagligi Foundation Center for Contextual Behavioral Science

Istanbul, Uskudar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Trauma and Stressor Related Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Aleyna Güleryüz, BA

CONTACT

02122696611; aleyna-glrz@outlook.com

Sevinç Ulusoy, MD

CONTACT

sevinc_ulusoy@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study will be a quantitative, randomized controlled trial with two groups, including a pre-test and repeated post-tests.

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: June 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)