## Protocol Section
### Identification Module
**NCT ID:** NCT06429852

**Brief Title:** The Impact, Feasibility, and Acceptability of the DeST-ACT Trauma-Focused Acceptance and Commitment Therapy Program

**Official Title:** Examining the Impact, Feasibility, and Acceptability of the DeST-ACT Trauma-Focused Acceptance and Commitment Therapy Program on Life Satisfaction in Earthquake Exposed Individuals

#### Organization Study ID Info
**ID:** CSV202403
#### Organization
**Class:** OTHER
**Full Name:** CanSagligi Foundation
### Status Module
#### Completion Date
**Date:** 2024-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** CanSagligi Foundation

#### Responsible Party

**Investigator Affiliation:** CanSagligi Foundation

**Investigator Full Name:** Sevinc Ulusoy

**Investigator Title:** MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 the effectiveness, feasibility, and acceptability of this program on 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. In this study, 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. In the 4-week program, each session is one day 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 Module

**Conditions:**

- Trauma and Stressor Related Disorders

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** The study will be a quantitative, randomized controlled trial consisting of two groups with a pre-test and repeated post-tests.

##### Masking Info

**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 will be blinded to the study. The therapy program will be conducted by independent therapists who will also be blinded to the study.

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

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

**Label:** DeST-ACT Intervention Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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 administered in the study. No measurements will be taken after the intervention.

**Label:** Waitlist Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- DeST-ACT Intervention Group

**Description:** Trauma-focused psychosocial intervention program consists of a 4 sessions online therapy.

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

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** 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.

**Measure:** Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

**Time Frame:** The scale will be used to assess the inclusion criterion before the randomization.

#### Primary Outcomes

**Description:** PCL-5 was developed by considering the diagnostic criteria in DSM-5, and its aim is to evaluate PTSD symptoms. The scale consists of 20 items with a 5-point Likert type. Scores above 47 are indicative of PTSD.

**Measure:** PTSD Checklist for DSM-5 (PCL-5)

**Time Frame:** At baseline, after 4 weeks, after 8 weeks

**Description:** DASS-21 measures the dimensions of depression, stress, and anxiety. The scale consists of 21 items with a 4-point Likert type ranging from 0 = Never to 4 = Always (minimum:0; maxiumum:84). The Cronbach's alpha value of the scale, for which Turkish validity and reliability studies have been conducted, is 0.80 for anxiety, 0.82 for depression and 0.75 for stress.

**Measure:** Depression Anxiety and Stress Scale 21 (DASS-21)

**Time Frame:** At baseline, after 4 weeks, after 8 weeks

**Description:** Engaged Living Scale is a measure aiming to evaluate values-based living. The scale consists of 16 items with a 5-point Likert type as 1= Totally Agree and 4 = Totally Disagree (minimum:16; maxiumum:64). 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 of the Turkish version of the scale was found to be .91; as for the valued living sub-dimension was .87 and for the life fulfillment sub-dimension was .86.

**Measure:** Engaged Living Scale

**Time Frame:** At baseline, after 4 weeks, after 8 weeks

#### Secondary Outcomes

**Description:** AAQ-2 is a measure aiming to evaluate experiential avoidance. The scale consists of 7-point Likert type (minimum:7 to maxiumum 49). Higher points indicate higher experiential avoidance.

**Measure:** Acceptance and Action Questionnaire-2

**Time Frame:** At baseline, after 4 weeks, after 8 weeks

**Description:** It is a semi-structured form designed by the researchers to assess acceptability and perceived effectiveness. It is a 10-question form scored between 0 (not at all) and 4 (completely).

**Measure:** Therapy Satisfaction Questionnaire

**Time Frame:** after 4 week

**Description:** To evaluate acceptability, participants attendance rate to the program will be recorded.

**Measure:** Drop Rate

**Time Frame:** after 8 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Volunteering to participate in the research
* During the earthquake of 6 February, being present in cities such as Kahramanmaraş, Gaziantep, Hatay, Adıyaman, Malatya where destruction occurred
* Being literate
* 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.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** aleyna-glrz@outlook.com

**Name:** Aleyna Güleryüz, BA

**Phone:** 02122696611

**Role:** CONTACT

**Contact 2:**

**Email:** sevinc_ulusoy@yahoo.com

**Name:** Sevinç Ulusoy, MD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Istanbul

**Contacts:**

***Contact 1:***

- **Email:** eda.aksoy@cansagligivakfi.org

- **Name:** Eda Aksoy

- **Role:** CONTACT

***Contact 2:***

- **Name:** Sevinç Ulusoy, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Aleyna Güleryüz, BA

- **Role:** SUB_INVESTIGATOR

**Country:** Turkey

**Facility:** Cansagligi Foundation Center for Contextual Behavioral Science

**State:** Uskudar

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Trauma

- ID: M222

- Name: Trauma and Stressor Related Disorders

- Relevance: HIGH

- As Found: Trauma and Stressor Related Disorders

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000068099

- Term: Trauma and Stressor Related Disorders

### Misc Info Module

- Version Holder: 2024-05-31
