- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07641270
Effects of the Integrated Grief Therapy on Psychological Resilience, Post-Traumatic Growth, Traumatic Stress, and Grief Processes in Earthquake Survivors
Effects of the Integrated Grief Therapy on Earthquake Survivors
This study evaluates the effectiveness of an Integrated Grief Therapy (IGT) group program for adults affected by the February 6, 2023 earthquake in Türkiye. Many earthquake survivors experience psychological difficulties such as traumatic stress, grief, and reduced resilience after losing loved ones, homes, and a sense of safety. This study aims to determine whether a structured group-based therapy program can help improve psychological well-being and reduce distress.
A total of 190 adult participants who experienced the earthquake were included in the study. Participants were randomly assigned to either an experimental group or a waitlist control group. The experimental group participated in an 8-session Integrated Grief Therapy program delivered face-to-face by trained mental health professionals. The program included psychoeducation about grief, emotional expression, cognitive and behavioral coping strategies, and activities designed to support meaning-making and adaptation after loss. The control group continued to receive routine psychosocial support services available in the community but did not participate in the structured therapy during the study period.
All participants completed standardized psychological assessments before and after the intervention. These assessments measured psychological resilience, post-traumatic growth, grief-related difficulties, and traumatic stress symptoms.
The study aims to determine whether participants who receive the Integrated Grief Therapy program show greater improvements in resilience and post-traumatic growth, and greater reductions in traumatic stress and grief symptoms, compared to those who do not receive the intervention during the same period.
The findings from this study may help inform the development of effective, scalable mental health interventions for individuals affected by large-scale disasters.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Mersin, Turkey (Türkiye)
- Psychosocial Support and Grief Therapy Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 to 45 years
- Individuals who were present in Hatay, Türkiye during the 2023 Türkiye-Syria earthquakes
- Individuals directly affected by the earthquake
- Ability to provide informed consent
- Willingness to participate in group-based psychological intervention sessions
Exclusion Criteria:
- Current diagnosis of a psychotic disorder or severe mental disorder
- Severe cognitive impairment or neurological condition
- Acute suicidal risk requiring immediate intervention or hospitalization
- Currently receiving intensive psychiatric or psychological treatment
- Substance use disorder in an acute or severe phase
- Inability to commit to attending the full intervention program
- Declined or withdrew informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Integrated Grief Therapy (IGT)
Participants receiving 8-session group-based Integrated Grief Therapy program
|
Integrated Grief Therapy (IGT) is a structured, 8-session group intervention developed to support individuals coping with loss after a disaster.
The program integrates elements of cognitive-behavioral therapy, humanistic approaches, and grief-focused techniques.
It includes psychoeducation about grief, identification and restructuring of maladaptive thoughts, emotional expression, interpersonal sharing, and meaning-making activities such as memory exercises and completion letters.
The intervention aims to enhance psychological resilience, promote post-traumatic growth, and reduce traumatic stress and grief symptoms.
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No Intervention: Waitlist Control / Treatment as Usual
Participants receiving routine psychosocial support only
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological Resilience Score
Time Frame: 8 week
|
Psychological resilience will be assessed using the Psychological Resilience Scale for Adults.
Total scores range from 33 to 165, with higher scores indicating greater psychological resilience.
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8 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression Score
Time Frame: 8 week
|
Depression symptoms will be assessed using the Depression subscale of the Depression Anxiety Stress Scales, a self-report instrument.
The subscale consists of 7 items with total scores ranging from 0 to 42.
Higher scores indicate greater depression severity.
|
8 week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 67000
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Group Therapy Intervention Plan
Title of the intervention:
Structured Group Therapy Program for Individuals Exposed to Trauma and Loss
Purpose of the intervention:
The purpose of this group therapy program is to reduce psychological distress among individuals who have experienced traumatic events and loss, provide a safe environment for emotional sharing, strengthen coping skills, enhance perceived social support, and improve overall psychosocial functioning.
Target group:
Adults experiencing psychological distress following earthquake exposure, displacement, bereavement, uncertainty, grief, and trauma-related experiences.
A separate protocol may be developed for adolescents if needed.
Mode of delivery:
Face-to-face, closed-group format
Group structure:
Each group will consist of 8-12 participants. Each group will be facilitated by one group therapist and one co-facilitator/observer.
Facilitators:
Psychologists or mental health professionals trained in trauma, grief, crisis inter
IPD Sharing Time Frame
Understanding trauma and grief reactions
Objective:
To normalize participants' reactions and provide psychoeducation regarding trauma and grief.
Content:
Common emotional, cognitive, and physical reactions after trauma The individual and variable nature of grief Addressing the question: "Are my reactions normal?" Increasing awareness of symptoms and stress responses
Techniques:
Psychoeducation, group sharing, emotion-awareness exercises
IPD Sharing Access Criteria
Inclusion Criteria Age 18 years or older Exposure to trauma, loss, displacement, or related distressing experiences Self-reported psychological distress related to these experiences Willingness to participate in group sessions Ability to attend sessions regularly Provision of informed consent Exclusion Criteria Active psychotic symptoms Severe cognitive impairment Acute suicide risk Severe substance intoxication during participation Clinical instability that would significantly impair participation in a group setting
Participants meeting exclusion criteria will be referred to appropriate mental health services when necessary.
Safety and Ethical Considerations Written or verbal informed consent will be obtained from all participants. Confidentiality will be emphasized at the beginning of the group process. Participants may withdraw from the study/intervention at any time without penalty.
Individuals who experience significant emotional distress during sessions will be assessed individ
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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