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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03907995
Other study ID # H-44353
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 29, 2019
Est. completion date December 31, 2019

Study information

Verified date May 2020
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
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.

Locations

Country Name City State
United States Baylor College of Medicine: Jamail Specialty Care Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
Baylor College of Medicine American National Red Cross

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary PTSD Symptom Scale - Adult 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.
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