Stress Disorders, Post-TraumaticNCT06335589
Adapting Treatment Delivery to Improve Retention in Evidence-Based PTSD Treatment
A study testing EBP-Massed and EBP-TAU in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Posttraumatic stress disorder (PTSD) is prevalent among Veterans and effective evidence-based psychotherapies (EBPs) for PTSD have been implemented within the Veterans Health Administration (VHA). However, retention in PTSD EBPs is poor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- EBP-Massed and EBP-TAU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2024to 15 Sep 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans aged 18 years or older;
- meets criteria for current PTSD;
- willingness to be randomized to either condition (e.g., EBP-Massed or EBP-TAU);
- decision to receive CPT or PE in a treatment planning session with a Durham Trauma Recovery Program clinic provider;
- ability to provide informed consent
Who cannot join
- High acute suicide risk;
- active manic symptoms that would likely interfere with treatment;
- active psychotic symptoms that would likely interfere with treatment;
- currently in a concurrent trauma-focused evidence-based treatment for PTSD
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
About this study
Official title: Adapting Treatment Delivery to Improve Retention in Evidence-Based PTSD Treatment (CDA 21-191)
Posttraumatic stress disorder (PTSD) is prevalent among Veterans and effective evidence-based psychotherapies (EBPs) for PTSD have been implemented within the Veterans Health Administration (VHA). However, retention in PTSD EBPs is poor. Premature dropout is associated with worse clinical outcomes and greater healthcare utilization. Delivery of PTSD EBPs in a massed format, typically three or more days per week delivered within a month, have shown promise for increasing retention. The present study is a pilot feasibility and acceptability study comparing massed PTSD treatment to treatment as usual (e.g., typically weekly treatment).
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- EBP-Massed, EBP-TAU
- Keywords
- Stress Disorders, Post-Traumatic, Psychotherapy, Mental Health, Veterans
- Medical subject headings
- Stress Disorders, Post-Traumatic, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBP-MassedOther
CPT or PE will be delivered in a massed format (e.g., sessions at least 3 days per week)
EBP-TAUOther
CPT or PE will be delivered treatment as usual, which is typically once per week.
| Study group | Role | What they receive |
|---|---|---|
| EBP-Massed | Experimental | PTSD evidence-based psychotherapies are delivered in a massed format (e.g., intended be delivered at least three times per week). Receives: Other: EBP-Massed |
| EBP-TAU | Active comparator | PTSD evidence-based psychotherapies are delivered treatment as usual, which is typically once per week. Receives: Other: EBP-TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment completion
Proportion of Veterans who complete a full course of an assigned PTSD treatment
Measured: Immediately after treatment completion or discontinuation (weeks 0-20)
Acceptability of Intervention (AIM)
Veterans' perceived acceptability of massed treatment for PTSD; scale score ranges from 1-5; greater score = greater acceptability
Measured: Immediately after treatment completion or discontinuation (weeks 0-20)
Client Satisfaction Questionnaire-8 (CSQ-8)
Veterans' perceived satisfaction of assigned treatment; range 8-32; greater scores = greater satisfaction
Measured: Post-treatment (weeks 0-20)
Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Severity Score
PTSD Symptom Severity - Clinician Assessed; range 0-80; higher scores = greater severity.
Measured: Post-treatment (weeks 0-20)
Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Severity Score
PTSD Symptom Severity - Clinician Assessed; range 0-80; higher scores = greater severity.
Measured: 3 Month Follow up
Secondary outcomes (5)
Session attendance
The number of sessions attended of the assigned treatment
Measured: Post-treatment (weeks 0-20)
Patient Health Questionnaire-9 (PHQ-9)
Self-reported depression; range = 0-27; higher scores = more severe symptoms
Measured: Post-treatment (weeks 0-20)
Patient Health Questionnaire-9 (PHQ-9)
Self-reported depression; range = 0-27; higher scores = more severe symptoms
Measured: 3 Month Follow Up
Brief Inventory of Psychosocial Functioning (BIPF)
PTSD-related psychosocial functioning; higher scores = more functional impairment. Items are scored on a Likert scale from 0 (never) to 6 (always). Participants are instructed to skip any item that does not reflect a domain that they have participated in over the past 30 days. The B-IPF is scored by summing the scored items to create a total score, dividing the total score by the maximum possible score based on the number of items scored, and multiplying by 100.
Measured: Post-treatment (weeks 0-20)
Brief Inventory of Psychosocial Functioning (BIPF)
PTSD-related psychosocial functioning; higher scores = more functional impairment. Items are scored on a Likert scale from 0 (never) to 6 (always). Participants are instructed to skip any item that does not reflect a domain that they have participated in over the past 30 days. The B-IPF is scored by summing the scored items to create a total score, dividing the total score by the maximum possible score based on the number of items scored, and multiplying by 100.
Measured: 3 Month Follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start24 Jun 2024
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Massed PTSD treatment (e.g., cognitive processing therapy \[CPT\] or prolonged exposure \[PE\] therapy delivered at least 3 times per week) will be compared to CPT \& PE delivered as usual, which is usually once per week.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Stephanie Y Wells, PhD MS BA, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335589
- Sponsor's protocol ID
- CDX 24-002
- Status last verified
- Jan 2026
- First submitted
- 6 Mar 2024
- Last updated
- 13 Jan 2026
- Results posted
- No
- 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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Treatment Delivery to Improve Retention in Evidence-Based PTSD Treatment (CDA 21-191)
- ClinicalTrials.gov ID
- NCT06335589
- Acronym / sponsor ID
- CDX 24-002
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Stress Disorders, Post-Traumatic, Psychotherapy, Mental Health, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 28 Mar 2024 (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.
Posttraumatic stress disorder (PTSD) is prevalent among Veterans and effective evidence-based psychotherapies (EBPs) for PTSD have been implemented within the Veterans Health Administration (VHA). However, retention in PTSD EBPs is poor. Premature dropout is associated with worse clinical outcomes and greater healthcare utilization. Delivery of PTSD EBPs in a massed format, typically three or more days per week delivered within a month, have shown promise for increasing retention. The present study is a pilot feasibility and acceptability study comparing massed PTSD treatment to treatment as usual (e.g., typically weekly treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Massed PTSD treatment (e.g., cognitive processing therapy [CPT] or prolonged exposure [PE] therapy delivered at least 3 times per week) will be compared to CPT \& PE delivered as usual, which is usually once per week.
| Arm | Type | Receives |
|---|---|---|
| EBP-Massed | Experimental | Other: EBP-MassedPTSD evidence-based psychotherapies are delivered in a massed format (e.g., intended be delivered at least three times per week). |
| EBP-TAU | Active comparator | Other: EBP-TAUPTSD evidence-based psychotherapies are delivered treatment as usual, which is typically once per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veterans aged 18 years or older;
- meets criteria for current PTSD;
- willingness to be randomized to either condition (e.g., EBP-Massed or EBP-TAU);
- decision to receive CPT or PE in a treatment planning session with a Durham Trauma Recovery Program clinic provider;
- ability to provide informed consent
Key exclusion criteria (4 listed)
- High acute suicide risk;
- active manic symptoms that would likely interfere with treatment;
- active psychotic symptoms that would likely interfere with treatment;
- currently in a concurrent trauma-focused evidence-based treatment for PTSD
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 |
|---|---|---|
| EBP-MassedCPT or PE will be delivered in a massed format (e.g., sessions at least 3 days per week) | Other | EBP-Massed |
| EBP-TAUCPT or PE will be delivered treatment as usual, which is typically once per week. | Other | EBP-TAU |
Primary outcome
Treatment completion
Time frame: Immediately after treatment completion or discontinuation (weeks 0-20)
Proportion of Veterans who complete a full course of an assigned PTSD treatment
Acceptability of Intervention (AIM)
Time frame: Immediately after treatment completion or discontinuation (weeks 0-20)
Veterans' perceived acceptability of massed treatment for PTSD; scale score ranges from 1-5; greater score = greater acceptability
Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: Post-treatment (weeks 0-20)
Veterans' perceived satisfaction of assigned treatment; range 8-32; greater scores = greater satisfaction
Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Severity Score
Time frame: Post-treatment (weeks 0-20)
PTSD Symptom Severity - Clinician Assessed; range 0-80; higher scores = greater severity.
Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Severity Score
Time frame: 3 Month Follow up
PTSD Symptom Severity - Clinician Assessed; range 0-80; higher scores = greater severity.
5 secondary outcomes
Session attendance
Time frame: Post-treatment (weeks 0-20)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Post-treatment (weeks 0-20)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 3 Month Follow Up
Brief Inventory of Psychosocial Functioning (BIPF)
Time frame: Post-treatment (weeks 0-20)
Brief Inventory of Psychosocial Functioning (BIPF)
Time frame: 3 Month Follow 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 13 Jan 2026.
- 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.
Stephanie Y Wells, PhD MS BA principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBP-Massed and EBP-TAU in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development 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 5 inclusion and 4 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 13 Jan 2026. 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?
Treatment completion (time frame: Immediately after treatment completion or discontinuation (weeks 0-20)). The study lists 5 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 13 Jan 2026.