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

Examining the Efficacy, Feasibility, and Acceptability of the DeST-ACT: Trauma-Focused Acceptance and Commitment Therapy Program on Life Satisfaction in Earthquake Survivors

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06429852
Enrollment
40
Registered
2024-05-28
Start date
2024-06-30
Completion date
2024-10-31
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma and Stressor Related Disorders

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.

Detailed description

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.

Interventions

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

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

Sponsors

CanSagligi Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Engaged Living ScaleAt baseline, after 4 weeks, after 8 weeksThe 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.
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)At baseline, after 4 weeks, after 8 weeksThe 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.
Depression Anxiety and Stress Scale 21 (DASS-21)At baseline, after 4 weeks, after 8 weeksThe 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.

Secondary

MeasureTime frameDescription
Drop Rateafter 8 weeksTo evaluate acceptability, participants' attendance rates to the program will be recorded.
Acceptance and Action Questionnaire-2 (AAQ-2)At baseline, after 4 weeks, after 8 weeksThe AAQ-2 is a measure designed to evaluate experiential avoidance. The scale consists of 7 items rated on a 7-point Likert scale, with scores ranging from a minimum of 7 to a maximum of 49. Higher scores indicate greater experiential avoidance.
Therapy Satisfaction Questionnaireafter 4 weekIt is a semi-structured form designed by the researchers to assess acceptability and perceived effectiveness. The form consists of 10 questions, each scored on a scale from 0 (not at all) to 4 (completely).

Other

MeasureTime frameDescription
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.Caps-5 is a structured clinical interview form developed to assess PTSD symptoms and symptom severity. The CAPS-5 consists of questions that assess the frequency and severity of each symptom, the impact of the symptoms on the patient's social and occupational functioning, and the total severity of symptoms. Turkish validity and reliability study was conducted and Cronbach's Alpha values were higher than 0.87 for all symptom dimensions.

Countries

Turkey (Türkiye)

Contacts

Primary ContactAleyna Güleryüz, BA
aleyna-glrz@outlook.com02122696611
Backup ContactSevinç Ulusoy, MD
sevinc_ulusoy@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026