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NCT04241094 · ClinicalTrials.gov registry record · NA

Teaching Loved Ones to Help Veterans Optimize Their PTSD Care and Healing

A NA study, sponsored by VA Office of Research and Development.

Completed
Registry status
NA
Development phase
28
Enrollment target

NCT04241094: Completed NA study, sponsored by VA Office of Research and Development.

NCT04241094 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT04241094, a NA study, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
NA
Development phase
28 participants
Enrollment target

Study Summary

PTSD occurs in as many as 17% of US military Veterans and is associated with a host of negative, long-term consequences to the individual, their families, and society at large. EBPs, such as Prolonged Exposure, result in clinically significant symptom relief for many. Yet, these therapies have proven less effective for military personnel and Veterans and treatment dropout rates are high. The investigators' team surveyed Veterans initiating EBPs for PTSD and a family member across four VA medical centers (N = 598; Project HomeFront). The investigators found that Veterans were more than twice as likely to complete EBPs when loved ones encouraged them to confront distress and that Veterans experienced greater treatment gains when they shared more with their loved ones about their treatment. A couples-based, exposure therapy for PTSD that integrates intimate partners into every session of PE could provide the opportunity to mobilize the whole household in the service of EBP engagement, while extending the goals of therapy beyond symptom reduction to family functioning. The investigators anticipate this intervention will teach couples to embrace a lifestyle that supports confronting trauma-related distress, so the Veteran and his/her family can achieve optimal functional outcomes.

Primary Outcome

Structured clinical interview assessing symptoms of PTSD. CAPS-5 is a 30-item questionnaire, corresponding to the DSM-5 diagnosis for PTSD. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Crite

Interventions

  • BEHAVIORAL Loved one assisted treatment

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2020-11-02
Est. Completion 2022-06-30
Phase NA
VA Office of Research and Development

1,668 total trials

What the finished NCT04241094 record still lists

NCT04241094 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Loved one assisted treatment is the first listed.

NCT04241094 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04241094 about?

NCT04241094 is a clinical study titled "Teaching Loved Ones to Help Veterans Optimize Their PTSD Care and Healing". PTSD occurs in as many as 17% of US military Veterans and is associated with a host of negative, long-term consequences to the individual, their families, and society at large. EBPs, such as Prolonged Exposure, result in clinically significant symptom relief for many. Yet, these therapies have prove...

What is the current status of trial NCT04241094?

This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2020-11-02. Estimated completion is 2022-06-30.

What interventions are being tested in trial NCT04241094?

The interventions under investigation include: Loved one assisted treatment (BEHAVIORAL).

Who is sponsoring clinical trial NCT04241094?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04241094's enrollment target sits among peer trials

28 1704th of 2000 higher than 293 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04241094, the US trial registry maintained by the National Library of Medicine. NCT04241094 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.