Trauma and Stressor Related DisordersNCT06429852
Efficacy, Feasibility, and Acceptability of the DeST-ACT: Trauma-Focused Acceptance and Commitment Therapy Program
A study testing The DeST-ACT Trauma-Focused Acceptance and Commitment Therapy Program in people with Trauma and Stressor Related Disorders, run by CanSagligi Foundation at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trauma and Stressor Related Disorders
- What is being tested?
- The DeST-ACT Trauma-Focused Acceptance and Commitment Therapy Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2024to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sevinç Ulusoy, MD contact
Turkey (Türkiye)1 site
Cansagligi Foundation Center for Contextual Behavioral Science
Istanbul, Uskudar
Eda Aksoy, eda.aksoy@cansagligivakfi.org
Sevinç Ulusoy, MD
About this study
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
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.
Read the 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.
- Conditions
- Trauma and Stressor Related Disorders
- Being tested
- The DeST-ACT Trauma-Focused Acceptance and Commitment Therapy Program
- Medical subject headings
- Trauma and Stressor Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The DeST-ACT Trauma-Focused Acceptance and Commitment Therapy ProgramBehavioural
The Trauma-focused psychosocial intervention program consists of 4 sessions online therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At baseline, after 4 weeks, after 8 weeks
Secondary outcomes (3)
Acceptance and Action Questionnaire-2 (AAQ-2)
The 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.
Measured: At baseline, after 4 weeks, after 8 weeks
Therapy Satisfaction Questionnaire
It 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).
Measured: after 4 week
Drop Rate
To evaluate acceptability, participants' attendance rates to the program will be recorded.
Measured: after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study startJun 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma and Stressor Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a quantitative, randomized controlled trial with two groups, including a pre-test and repeated post-tests.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CanSagligi Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevinc Ulusoy, CanSagligi Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429852
- Sponsor's protocol ID
- CSV202403
- Status last verified
- Jun 2024
- First submitted
- 21 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06429852
- Acronym / sponsor ID
- CSV202403
- Conditions
- Trauma and Stressor Related Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CanSagligi FoundationUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be a quantitative, randomized controlled trial with two groups, including a pre-test and repeated post-tests.
| Arm | Type | Receives |
|---|---|---|
| DeST-ACT Intervention Group | Experimental | Behavioral: The DeST-ACT Trauma-Focused Acceptance and Commitment Therapy ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The DeST-ACT Trauma-Focused Acceptance and Commitment Therapy ProgramThe Trauma-focused psychosocial intervention program consists of 4 sessions online therapy. | Behavioural | DeST-ACT Intervention Group |
Primary outcome
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
Time frame: At baseline, after 4 weeks, after 8 weeks
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.
Depression Anxiety and Stress Scale 21 (DASS-21)
Time frame: At baseline, after 4 weeks, after 8 weeks
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.
Engaged Living Scale
Time frame: At baseline, after 4 weeks, after 8 weeks
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.
3 secondary outcomes
Acceptance and Action Questionnaire-2 (AAQ-2)
Time frame: At baseline, after 4 weeks, after 8 weeks
Therapy Satisfaction Questionnaire
Time frame: after 4 week
Drop Rate
Time frame: after 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevinç Ulusoy, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The DeST-ACT Trauma-Focused Acceptance and Commitment Therapy Program in people with Trauma and Stressor Related Disorders, run by CanSagligi Foundation at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleyna Güleryüz, BA (02122696611, aleyna-glrz@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5) (time frame: At baseline, after 4 weeks, after 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.