Clinical trial NCT06429852: Efficacy, Feasibility, and Acceptability of the DeST-ACT: Trauma-Focused Acceptance and Commitment Therapy Program
Official title: Examining the Efficacy, Feasibility, and Acceptability of the DeST-ACT: Trauma-Focused Acceptance and Commitment Therapy Program on Life Satisfaction in Earthquake Survivors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma and Stressor Related Disorders
Lead sponsor: CanSagligi Foundation
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a quantitative, randomized controlled trial with two groups, including a pre-test and repeated post-tests.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
timeFrame: At baseline, after 4 weeks, after 8 weeks
measure: Depression Anxiety and Stress Scale 21 (DASS-21)
timeFrame: At baseline, after 4 weeks, after 8 weeks
measure: Engaged Living Scale
timeFrame: At baseline, after 4 weeks, after 8 weeks
Secondary outcomes:
measure: Acceptance and Action Questionnaire-2 (AAQ-2)
timeFrame: At baseline, after 4 weeks, after 8 weeks
measure: Therapy Satisfaction Questionnaire
timeFrame: after 4 week
measure: Drop Rate
timeFrame: after 8 weeks
Other outcomes:
measure: Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS-5)
timeFrame: The scale will be used to assess the inclusion criterion before the randomization.
Locations:
city: Istanbul
country: Turkey
facility: Cansagligi Foundation Center for Contextual Behavioral Science
state: Uskudar
Study officials:
References: