Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04241094
Enrollment
28
Registered
2020-01-27
Start date
2020-11-02
Completion date
2022-06-30
Last updated
2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder, Couples therapy, Psychotherapy, Veterans

Brief 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.

Detailed description

The investigators aim to improve the mental health, family functioning, and well-being of Veterans with posttraumatic stress disorder (PTSD) through developing and evaluating a trauma-focused, couple therapy for PTSD. The investigators will use strategies from Integrative Behavioral Couple Therapy (ICBT) to help intimate partners support Veterans during exposure therapy for PTSD (Prolonged Exposure; PE). The investigators anticipate this approach will increase Veterans' engagement in PE, but also improve relationship functioning, family functioning, and social functioning. Family involvement has been highlighted as a fertile avenue for improving the outcomes for patients with PTSD, yet families are infrequently integrated into evidence-based psychotherapies (EBPs). The investigators' goals are highly consistent with RR&D's mission to promote research that leverages family support as a pathway to reintegration and optimizes meaningful recovery and functioning. Objectives. The investigators will complete stages 1A and 1B of the Stage Model of Treatment Development. Specifically, the investigators will: (1) Expand the treatment outline using content experts and feedback from key stakeholders (Veterans, intimate partners, providers, and VA mental health leadership). (2) Conduct a pilot open trial to assess (a) the acceptability of treatment components, structure, and materials, (b) the feasibility of the intervention (retention and intervention fidelity), and (c) the study approach (screening, recruitment, and assessment process). (3) Explore the preliminary effects of the intervention on select outcomes including overall functioning, mental health functioning, social functioning, family functioning, and potential mechanisms (social control, subjective norms, and the degree to which Veterans rely on their partners for support). Methods: To accomplish Aim 1, the investigators will expand the outline for the intervention into an initial treatment manual through meetings with content experts and stakeholder feedback. Next, the investigators will develop fidelity checklists and revise the treatment manual through conducting the intervention with 2-3 couples. To accomplish Aims 2 and 3, the investigators will evaluate the intervention in a non-randomized, open trial with 10 Veterans diagnosed with PTSD and their intimate partners. Veterans will complete baseline and posttreatment structured diagnostic interviews. Both members of the couple will complete baseline surveys, posttreatment surveys, and posttreatment qualitative exit interviews. Using data obtained from the open trial, the investigators will assess the intervention's acceptability, feasibility, mechanisms, and outcomes. Upon completion of this proposal, the investigators will be well positioned to apply for Merit funding for a randomized clinical trial (Stage 2 of the Stage Model of Treatment Development) of this innovative, exposure based, couple therapy.

Interventions

BEHAVIORALLoved one assisted treatment

The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Open trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Enrolled in VHA care * Clinically significant PTSD symptoms * Have a LO (loved one/intimate partner) with whom they have been in a romantic relationship with for 6 months * Will allow a LO to participate * Willing to be seen via telehealth when in-person treatment options aren't available.

Exclusion criteria

* Actively suicidal/homicidal with intent and/or plan * Episode of mania/ psychosis in past 3 months * Severe substance use problem in past 3 months * Moderate relationship violence * Veteran has underlying medical condition or a planned medical procedure likely to impair ability to engage in treatment. * LO screens positive for PTSD * Veteran and/or LO fails to complete baseline survey

Design outcomes

Primary

MeasureTime frameDescription
Clinician Administered PTSD Scale for DSM-5 to Assess Changes in PTSD Symptoms.Up to 26 weeks post baselineStructured 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, Criterion E (items 15-20). A symptom cluster score may also be calculated for dissociation by summing items 19 and 20. Severity scores range from 0 to 80 and higher scores correspond with more severe symptoms of PTSD.

Countries

United States

Participant flow

Recruitment details

28 Veterans were consented and signed informed consent for the study. Only 20 of those 28 went forward with the COACH treatment.

Pre-assignment details

The numbers in this chart are counted as individual participants. 28 participants (16 Veterans and 12 loved ones) consented to the study. Of those 28, only 20 participants (10 Veterans and 10 loved ones) started treatment in the study.

Participants by arm

ArmCount
Loved One Assisted Treatment
The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2. Loved one assisted treatment: The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2.
20
Total20

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDropped out of treatment4
Overall StudyIneligible after clinical assessment2
Overall StudyLost to Follow-up2

Baseline characteristics

CharacteristicLoved One Assisted Treatment
Age, Categorical
Loved Ones
<=18 years
0 Participants
Age, Categorical
Loved Ones
>=65 years
0 Participants
Age, Categorical
Loved Ones
Between 18 and 65 years
10 Participants
Age, Categorical
Veterans
<=18 years
0 Participants
Age, Categorical
Veterans
>=65 years
0 Participants
Age, Categorical
Veterans
Between 18 and 65 years
10 Participants
Ethnicity (NIH/OMB)
Loved ones
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Loved ones
Not Hispanic or Latino
10 Participants
Ethnicity (NIH/OMB)
Loved ones
Unknown or Not Reported
0 Participants
Ethnicity (NIH/OMB)
Veterans
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Veterans
Not Hispanic or Latino
10 Participants
Ethnicity (NIH/OMB)
Veterans
Unknown or Not Reported
0 Participants
Length of relationship
Loved ones
11+ years
3 Participants
Length of relationship
Loved ones
1-4 years
3 Participants
Length of relationship
Loved ones
5-10 years
3 Participants
Length of relationship
Loved ones
6+ months
1 Participants
Length of relationship
Veterans
11+ years
3 Participants
Length of relationship
Veterans
1-4 years
3 Participants
Length of relationship
Veterans
5-10 years
3 Participants
Length of relationship
Veterans
6+ months
1 Participants
Race (NIH/OMB)
Loved ones
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Loved ones
Asian
1 Participants
Race (NIH/OMB)
Loved ones
Black or African American
0 Participants
Race (NIH/OMB)
Loved ones
More than one race
1 Participants
Race (NIH/OMB)
Loved ones
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Loved ones
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
Loved ones
White
8 Participants
Race (NIH/OMB)
Veterans
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Veterans
Asian
0 Participants
Race (NIH/OMB)
Veterans
Black or African American
0 Participants
Race (NIH/OMB)
Veterans
More than one race
1 Participants
Race (NIH/OMB)
Veterans
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Veterans
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
Veterans
White
8 Participants
Sex: Female, Male
Loved ones
Female
7 Participants
Sex: Female, Male
Loved ones
Male
3 Participants
Sex: Female, Male
Veterans
Female
4 Participants
Sex: Female, Male
Veterans
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 20
other
Total, other adverse events
0 / 20
serious
Total, serious adverse events
0 / 20

Outcome results

Primary

Clinician Administered PTSD Scale for DSM-5 to Assess Changes in PTSD Symptoms.

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, Criterion E (items 15-20). A symptom cluster score may also be calculated for dissociation by summing items 19 and 20. Severity scores range from 0 to 80 and higher scores correspond with more severe symptoms of PTSD.

Time frame: Up to 26 weeks post baseline

Population: Veteran participants

ArmMeasureValue (MEAN)Dispersion
Loved One Assisted Treatment at BaselineClinician Administered PTSD Scale for DSM-5 to Assess Changes in PTSD Symptoms.35.3 score on scaleStandard Deviation 9.12
Loved One Assisted Treatment at PosttreatmentClinician Administered PTSD Scale for DSM-5 to Assess Changes in PTSD Symptoms.11.33 score on scaleStandard Deviation 7.26

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026