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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBP-Massed | Experimental | PTSD evidence-based psychotherapies are delivered in a massed format (e.g., intended be delivered at least three times per week). |
|
| EBP-TAU | Active Comparator | PTSD evidence-based psychotherapies are delivered treatment as usual, which is typically once per week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBP-Massed | Other | CPT or PE will be delivered in a massed format (e.g., sessions at least 3 days per week) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment completion | Proportion of Veterans who complete a full course of an assigned PTSD treatment | 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 | 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 | 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. | 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. | 3 Month Follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Session attendance | The number of sessions attended of the assigned treatment | Post-treatment (weeks 0-20) |
| Patient Health Questionnaire-9 (PHQ-9) | Self-reported depression; range = 0-27; higher scores = more severe symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Y Wells, PhD MS BA | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705-3875 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 23, 2024 | Feb 10, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
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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.
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Clinical interviewers who assess primary outcomes will not be informed of participant's randomization assignment.
| EBP-TAU | Other | CPT or PE will be delivered treatment as usual, which is typically once per week. |
|
| Post-treatment (weeks 0-20) |
| Patient Health Questionnaire-9 (PHQ-9) | Self-reported depression; range = 0-27; higher scores = more severe symptoms | 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. | 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. | 3 Month Follow up |
| D001519 | Behavior |