Trauma and Stressor Related Disorders Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Cansagligi Foundation Center for Contextual Behavioral Science | Istanbul | Uskudar |
Lead Sponsor | Collaborator |
---|---|
CanSagligi Foundation |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS-5) | 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. | The scale will be used to assess the inclusion criterion before the randomization. | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. | At baseline, after 4 weeks, after 8 weeks | |
Secondary | 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). | after 4 week | |
Secondary | Drop Rate | To evaluate acceptability, participants' attendance rates to the program will be recorded. | after 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
Not yet recruiting |
NCT05225701 -
Efficacy of a Transdiagnostic Guided Internet-Delivered Intervention for Emotional, Trauma and Stress-Related Disorders.
|
N/A | |
Recruiting |
NCT05637320 -
Big Feelings: A Study on Children's Emotions in Therapy
|
N/A | |
Completed |
NCT03376633 -
The Impact of a School-Based, Trauma-Informed CBT Intervention for Young Women
|
N/A | |
Completed |
NCT03151681 -
The Trauma of Betrayal: Treating Adjustment Disorder With Reconsolidation Blockade Under Propranolol
|
Phase 2/Phase 3 | |
Completed |
NCT05729828 -
Psychometric Properties of the SMART Feeding Tool
|
||
Enrolling by invitation |
NCT06440460 -
Intergenerational Study of War-Affected Youth
|
||
Completed |
NCT05482724 -
Super Skills for Life Effectiveness in Clinical Settings
|
N/A | |
Not yet recruiting |
NCT06330753 -
Synergy Between Patient and Clinician: Using a Trauma-Informed Care Plan
|
N/A | |
Completed |
NCT06037005 -
The Effect of Cognitive Behavioral Therapy on Post-Traumatic Stress Symptoms in Nursing Students
|
N/A | |
Recruiting |
NCT03152175 -
Posttraumatic Stress Disorders in Police, Correctional Service Officers, and 911 Operators
|
Phase 2 | |
Recruiting |
NCT03887559 -
Group-based Stabilization and Skill Training for Patients With Lasting Posttraumatic Reactions in Mental Health Care
|
N/A | |
Recruiting |
NCT03984084 -
Biological Classification of Mental Disorders
|
||
Recruiting |
NCT06451523 -
Effects of "Alliance180 Program" on Well-Being
|
N/A | |
Not yet recruiting |
NCT06367556 -
Emotion and Symptom-Focused Engagement (EASE) for Caregivers
|
N/A | |
Terminated |
NCT04394156 -
Reducing Intrusive Memories in Refugees and Asylum Seekers With PTSD
|
N/A | |
Recruiting |
NCT05107752 -
Stellate Ganglion Block to Augment Trauma-focused Therapy Among Veterans With PTSD
|
Phase 2 | |
Terminated |
NCT05260541 -
A Clinical Trial of PRAX-114 in Participants With Post-Traumatic Stress Disorder
|
Phase 2 | |
Completed |
NCT05097352 -
Effects of a Short-term Exercise Intervention on Sleep in Women Exposed to Trauma: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT03777800 -
Body Therapy for War Veterans With Post Traumatic Stress Disorder (PTSD)
|
N/A |