PTSDNCT03533608
Optimizing Treatment Response in VA Specialized Intensive/Inpatient PTSD Programs
A study testing Group PE in people with PTSD, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Prolonged Exposure therapy (PE) is a first-line treatment for posttraumatic stress disorder; however few VA patients receive this treatment. One of the barriers to PE receipt is that this treatment is only available in an individual (one-on-one) format, whereas many VA mental health clinics provide the majority of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- Group PE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2018to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria are current engagement in treatment at the Battle Creek VA PTSD Residential Rehabilitation Treatment Program.
Who cannot join
- Exclusion criteria are severe cognitive impairment that in the judgment of the PI or the patient's clinical providers make it unlikely that the patient can adhere to the study protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
Battle Creek VA Medical Center, Battle Creek, MI
Battle Creek, Michigan, 49037
About this study
Official title: Pilot Study of Group Prolonged Exposure in Residential Treatment (CDA 15-251)
Prolonged Exposure therapy (PE) is a first-line treatment for posttraumatic stress disorder; however few VA patients receive this treatment. One of the barriers to PE receipt is that this treatment is only available in an individual (one-on-one) format, whereas many VA mental health clinics provide the majority of their psychotherapy services in group format. In particular, PTSD residential rehabilitation programs (RRTPs) offer most programming in group format. Thus, the current study was designed to pilot test a group format of PE in RRTPs.
Read the detailed description
Fifty Veterans who are currently receiving treatment in the PTSD RRTP at a Midwest VA will be recruited to participate in a Group PE protocol. Participants will engage in 12, 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms. PTSD symptoms will be measured via the PCL-5. The goal of this pilot study will be to determine whether or not it will be feasible to conduct a full-scale trial of Group PE in the current setting by testing the process, resources, management, and scientific basis of the planned trial. As such, the proposed study will primarily assess feasibility outcomes and not efficacy outcomes. The investigators will assess number of participants screened, number meeting inclusion criteria, adherence of participants to the proposed treatment (measured via number of sessions attended), standard deviation of the outcome measure (PCL-5), response rates to questionnaires, and loss to follow-up. The investigators will also measure clinicians' adherence to protocol and acceptability of the treatment to patients.
- Conditions
- PTSD
- Being tested
- Group PE
- Keywords
- PTSD, Prolonged Exposure, Group Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group PEBehavioural
Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Group PE | Experimental | Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms. Receives: Behavioral: Group PE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Symptoms
PTSD symptoms will be measured via the PCL-5 at baseline, 6-week, and 2-months. The PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Patients are asked to rate how bothered they are by each item in the past month on a 5-point likert scale ranging from 0-4 (not at all, a little bit, moderately, quite a bit, extremely). Items are summed together and a PCL-5 cut point score of 33 is used for provisional PTSD diagnosis. Change = (Week 6 score-Baseline score) and (2 month score-Baseline score).
Measured: Baseline, 6-week, and 2-months
Change in Depression Symptoms
Depressive symptoms will be measured via the PHQ-9 at baseline, 6-weeks, and 2-months. The PHQ-9 is a 9-item self-report measure that assesses the presence and severity of depressive symptoms. Patients are asked to rate the presence of symptoms over the past 2 weeks on a 4-point likert scale ranging from 0-3 (not at all, several days, more than half the days, nearly every day). Individual items are summed together and Total scores ranging from 5-9 indicate mild depression, 10-14 indicate moderate depression, 15-19 indicate moderately severe depression, and 20-27 indicate severe depression. Change = (Week 6 score-Baseline score) and (2 month score-Baseline score).
Measured: Baseline, 6 weeks, 2-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Jun 2018
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Model description
- Participants will engage in 12, 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Rebecca Kaufman Sripada, PhD MS, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533608
- Sponsor's protocol ID
- CDX 18-002
- Other IDs
- CDA 15-251
- Status last verified
- Jul 2023
- First submitted
- 10 May 2018
- Last updated
- 25 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Group Prolonged Exposure in Residential Treatment (CDA 15-251)
- ClinicalTrials.gov ID
- NCT03533608
- Acronym / sponsor ID
- CDX 18-002
- Conditions
- PTSD
- Keywords
- PTSD, Prolonged Exposure, Group Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Posted 5 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prolonged Exposure therapy (PE) is a first-line treatment for posttraumatic stress disorder; however few VA patients receive this treatment. One of the barriers to PE receipt is that this treatment is only available in an individual (one-on-one) format, whereas many VA mental health clinics provide the majority of their psychotherapy services in group format. In particular, PTSD residential rehabilitation programs (RRTPs) offer most programming in group format. Thus, the current study was designed to pilot test a group format of PE in RRTPs.
Detailed description
Fifty Veterans who are currently receiving treatment in the PTSD RRTP at a Midwest VA will be recruited to participate in a Group PE protocol. Participants will engage in 12, 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms. PTSD symptoms will be measured via the PCL-5. The goal of this pilot study will be to determine whether or not it will be feasible to conduct a full-scale trial of Group PE in the current setting by testing the process, resources, management, and scientific basis of the planned trial. As such, the proposed study will primarily assess feasibility outcomes and not efficacy outcomes. The investigators will assess number of participants screened, number meeting inclusion criteria, adherence of participants to the proposed treatment (measured via number of sessions attended), standard deviation of the outcome measure (PCL-5), response rates to questionnaires, and loss to follow-up. The investigators will also measure clinicians' adherence to protocol and acceptability of the treatment to patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will engage in 12, 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.
| Arm | Type | Receives |
|---|---|---|
| Group PE | Experimental | Behavioral: Group PEParticipants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria are current engagement in treatment at the Battle Creek VA PTSD Residential Rehabilitation Treatment Program.
Key exclusion criteria (1 listed)
- Exclusion criteria are severe cognitive impairment that in the judgment of the PI or the patient's clinical providers make it unlikely that the patient can adhere to the study protocol.
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 |
|---|---|---|
| Group PEParticipants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms. | Behavioural | Group PE |
Primary outcome
Change in PTSD Symptoms
Time frame: Baseline, 6-week, and 2-months
PTSD symptoms will be measured via the PCL-5 at baseline, 6-week, and 2-months. The PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Patients are asked to rate how bothered they are by each item in the past month on a 5-point likert scale ranging from 0-4 (not at all, a little bit, moderately, quite a bit, extremely). Items are summed together and a PCL-5 cut point score of 33 is used for provisional PTSD diagnosis. Change = (Week 6 score-Baseline score) and (2 month score-Baseline score).
Change in Depression Symptoms
Time frame: Baseline, 6 weeks, 2-months
Depressive symptoms will be measured via the PHQ-9 at baseline, 6-weeks, and 2-months. The PHQ-9 is a 9-item self-report measure that assesses the presence and severity of depressive symptoms. Patients are asked to rate the presence of symptoms over the past 2 weeks on a 4-point likert scale ranging from 0-3 (not at all, several days, more than half the days, nearly every day). Individual items are summed together and Total scores ranging from 5-9 indicate mild depression, 10-14 indicate moderate depression, 15-19 indicate moderately severe depression, and 20-27 indicate severe depression. Change = (Week 6 score-Baseline score) and (2 month score-Baseline score).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for PTSD
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Active, not recruitingObservational study
Trauma-Related Attributions in Trauma Treatment: An Observational Study
PTSD
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Recruiting
Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry-Guided Breathing Therapy
Written Exposure Therapy, Breathing Techniques
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.
Rebecca Kaufman Sripada, PhD MS principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group PE in people with PTSD, run by VA Office of Research and Development at 2 sites 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 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 5 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in PTSD Symptoms (time frame: Baseline, 6-week, and 2-months). The study lists 2 primary outcomes in all. 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 25 Jul 2023.