- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03907995
Peer-led Group Intervention for Coping With Disaster
May 22, 2020 updated by: Eric Alan Storch, Baylor College of Medicine
The present project partners with leading faith communities in Houston to provide expert-led educational workshops to a diverse sample of adults on normative and concerning response to disaster.
Secondly implementing peer-led interventions where a trained adult leads others through an evidence-based manualized intervention.
Lastly, identifying and referring individuals who require more intensive services to a higher level of care.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Approximately 20% of individuals have significant behavioral health concerns.
Exposure to a disaster like Hurricane Harvey and its aftermath often exacerbates pre-existing issues and/or brings new issues, with post-traumatic stress presenting in manners such as anxiety, depression, conduct issues and/or somatic issues.
Approaches are needed that educate community members about both normative and concerning responses to disaster focused on coping skills development.
A particular approach, peer-led intervention groups have been shown effective at delivering these types of intervention.
Brief, psycho-educational peer-led programs have shown effectiveness in a variety of forums including helping promote adjustment among those who have experienced trauma.
There will be six group sessions every two weeks.
Sessions will include how to teach appropriate coping techniques to respond to the distress, confronting distressing memories related to the disaster, and emotion regulation techniques.
After the group sessions end, individuals who require a more intensive service will be referred to a higher level of care.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Baylor College of Medicine: Jamail Specialty Care Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years and older and English speaking.
Exclusion Criteria:
- Individuals under the age of 18 and non-English speaking and participants who do not wish to participate in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive Behavioral Therapy
The form of treatment will involve 6 group sessions every two weeks about an hour each.
Sessions consist of teaching a different coping technique in each session to help cope with disaster or other events.
|
The form of treatment will involve 6 group sessions every two weeks about an hour each.
Sessions consist of teaching a different coping technique in each session to help cope with disaster or other events.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PTSD Symptom Scale - Adult
Time Frame: Post-treatment, which is 12 weeks after baseline.
|
The PTSD Symptom Scale - Self Report is a 17-item, Likert-scale, self-report questionnaire designed to assess the symptoms of PTSD according to DSM-IV.
Each of the 17 items is rated on a scale from 0 to 3, with total score ranging from 0 to 51 by adding them up.
|
Post-treatment, which is 12 weeks after baseline.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Eric Storch, Ph.D., Baylor College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 29, 2019
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
April 4, 2019
First Submitted That Met QC Criteria
April 5, 2019
First Posted (Actual)
April 9, 2019
Study Record Updates
Last Update Posted (Actual)
May 27, 2020
Last Update Submitted That Met QC Criteria
May 22, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-44353
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Anger
-
Ege UniversityCompleted
-
naomi goldsteinNational Institute of Mental Health (NIMH)Completed
-
Walter Reed Army Institute of Research (WRAIR)Enrolling by invitation
-
Örebro University, SwedenKarolinska InstitutetCompletedMaladaptive Anger InhibitionSweden
-
Karolinska InstitutetCompletedInappropriate Anger ExpressionSweden
-
Florida State UniversityCompletedAnger | Smoking CessationUnited States
-
Kafkas UniversityCompleted
-
Mersin UniversityCompletedAnger Problems | Spiritual Well-beingTurkey (Türkiye)
-
Aydin Adnan Menderes UniversityCompletedAnger | Nurse's Role | Interpersonal RelationsTurkey
-
University of Colorado, DenverChildrens Hospital ColoradoRecruitingAnger | Irritable Mood | Temper TantrumUnited States
Clinical Trials on Cognitive Behavioral Therapy
-
Aleksandra StojanovicRecruitingAnxiety Disorders | Depression - Major Depressive DisorderSerbia
-
Eleos HealthMissouri Department of Mental HealthCompletedMood Disorders | Anxiety DisordersUnited States
-
Regionsenter for barn og unges psykiske helseThe Research Council of NorwayCompletedGeneralized Anxiety Disorder | Social Phobia | Separation Anxiety DisorderNorway
-
Claremont McKenna CollegeUniversity of California, Los AngelesCompleted
-
University of RochesterNational Institute of Nursing Research (NINR)CompletedDepression | Sleep | Stress Disorders, Post-TraumaticUnited States
-
University of South FloridaObsessive Compulsive FoundationCompletedObsessive Compulsive Disorder | Stepped Care Cognitive Behavioral TherapyUnited States
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
Vanderbilt UniversityNational Institute of Mental Health (NIMH)RecruitingDepressionUnited States
-
University of PittsburghWithdrawnPsychosis | Prodromal Symptoms | Prodromal Stage | Prodromal StatesUnited States
-
Duke UniversityCompleted