Anxiety DisorderNCT03907995
Peer-led Group Intervention for Coping With Disaster
A study testing Cognitive Behavioral Therapy in people with Anxiety Disorder and PTSD, run by Baylor College of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder, PTSD, Depressive Symptoms
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2019to 31 Dec 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older and English speaking.
Who cannot join
- Individuals under the age of 18 and non-English speaking and participants who do not wish to participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine: Jamail Specialty Care Center
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Anxiety Disorder, PTSD, Depressive Symptoms, Anger, Depressive Disorder
- Being tested
- Cognitive Behavioral Therapy
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Post-Traumatic, Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called Skills for Psychological Recovery, CBT
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-treatment, which is 12 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start29 May 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American National Red Cross
- Responsible party
- Principal investigator, Eric Alan Storch, Baylor College of Medicine
- Investigators
- Eric Storch, Ph.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907995
- Sponsor's protocol ID
- H-44353
- Status last verified
- May 2020
- First submitted
- 4 Apr 2019
- Last updated
- 27 May 2020
- Results posted
- 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 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-led Group Intervention for Coping With Disaster
- ClinicalTrials.gov ID
- NCT03907995
- Acronym / sponsor ID
- H-44353
- Conditions
- Anxiety Disorder, PTSD, Depressive Symptoms, Anger, Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- American National Red Cross
- Study start
- 29 May 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 9 Apr 2019 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years and older and English speaking.
Key exclusion criteria (1 listed)
- Individuals under the age of 18 and non-English speaking and participants who do not wish to participate in this study.
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 |
|---|---|---|
| Cognitive Behavioral TherapyAlso: Skills for Psychological Recovery, CBTThe 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. | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- 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.
Eric Storch, Ph.D. principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Anxiety Disorder and PTSD, run by Baylor College of Medicine at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 May 2020. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Symptom Scale - Adult (time frame: Post-treatment, which is 12 weeks after baseline.). 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 27 May 2020.