Group Therapy for PTSD After Combat

(CAC Trial)

Overseen By Sheila Frankfurt, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Substance abuse, Suicidal ideation, Cognitive impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new group therapy approach to help combat Veterans manage PTSD (post-traumatic stress disorder). The focus is on creating a treatment specifically tailored to the unique experiences and needs of those who have faced combat situations. By developing a specialized therapy manual, the trial aims to enhance the options available for Veterans struggling to reintegrate into daily life after deployment. Veterans with combat experience, who are part of the Central Texas Veterans Healthcare System, and have faced moral injuries (events that deeply challenge personal ethics) are well-suited for participation in this trial. As an unphased trial, this study offers Veterans the opportunity to contribute to pioneering research that could lead to more effective PTSD treatments tailored to their unique experiences.

Do I need to stop my current medications for this PTSD group therapy trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this group therapy is safe for combat Veterans?

Research shows that group therapy can help reduce PTSD symptoms in veterans. Studies have demonstrated improvements in both the severity of PTSD symptoms and overall functioning for participants. One study tested group-based exposure therapy with over 100 veterans who had PTSD from war. Participants generally handled this type of group therapy well, without major problems. Another study found that trauma-focused group therapy reduced symptoms like avoiding certain situations and feeling emotionally numb.

While group therapy is not a medication, which often has more obvious side effects, it may still present emotional or psychological challenges for some participants. However, existing research suggests that the therapy is generally safe and can be helpful for veterans dealing with PTSD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this group therapy approach for PTSD after combat because it offers a unique, collective healing experience that differs from traditional one-on-one therapy. Unlike standard treatments like individual cognitive-behavioral therapy (CBT) or medication, this method emphasizes shared experiences, allowing veterans to connect and support each other in a structured group setting. This could enhance feelings of camaraderie and validation, which are crucial for those who have faced the isolating effects of combat trauma. This innovative approach could provide an effective, community-driven alternative for healing.

What evidence suggests that this group therapy is effective for PTSD?

Studies have shown that group therapy can effectively reduce PTSD symptoms in veterans. Research indicates that these therapies improve both symptom severity and overall daily functioning. In this trial, participants will engage in a group therapy manual specifically designed for combat veterans. One study found that veterans who participated in group-based exposure therapy reported significant improvements. Another report highlighted the benefits of moral healing in a group setting for combat-related PTSD. These findings suggest that group therapy could be a promising option for veterans dealing with posttraumatic stress disorder. ^{1 4 5 6 7}

Who Is on the Research Team?

Sheila Beth Frankfurt O'Brien, PhD

Principal Investigator

Central Texas Veterans Health Care System, Temple, TX

Are You a Good Fit for This Trial?

This trial is for English-speaking Veterans, aged 18 or older, enrolled in Central Texas Veterans Healthcare System who have combat experience and are struggling with reintegration due to moral injury. They must recognize their worst trauma as a morally injurious event, show significant functional impairment, and agree to the study's terms.

Inclusion Criteria

Report a PMIE as their worst trauma

Score 10 on the SDS

Enrolled in Central Texas Veterans Healthcare System

Exclusion Criteria

Veterans with untreated substance abuse disorder

Severe suicidal or homicidal ideation, defined using the C-SSRS

Scoring <18 on the MOCA, indicating potential for more than mild cognitive impairment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants engage in a relational dynamic-based group therapy to address moral injury and PTSD symptoms

6 weeks

Weekly therapy sessions

Follow-up

Participants are monitored for changes in PTSD symptoms, moral injury, and other outcomes

Up to 6 months

Periodic assessments

What Are the Treatments Tested in This Trial?

Interventions

• Open pilot trial of a group therapy manual

Trial Overview

The trial is testing a new group therapy manual designed specifically for combat veterans. It aims to address unique challenges faced by these individuals when reintegrating into civilian life after experiencing traumatic events during service.

How Is the Trial Designed?

Group I: Open Pilot Trial Experimental Treatment 1 Intervention

Open pilot trial of a group therapy manual.

Open pilot trial of a group therapy manual is already approved in United States for the following indications:

Approved in United States as Open Pilot Trial of a Group Therapy Manual for:

• Treatment of Moral Injury in Combat Veterans

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A meta-analysis of 48 randomized controlled trials (RCTs) on PTSD psychotherapy found no significant difference in treatment effects between trials that excluded participants with suicidal ideation (SI) and those that included them, indicating that SI exclusion does not notably affect outcomes.

This lack of significant impact suggests that clinical practice guidelines for PTSD treatments can be developed without the need for strict exclusion of individuals with SI, allowing for more inclusive research and potentially better treatment options for those at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exclusion of Suicidal Participants From Randomized Controlled Trials for Posttraumatic Stress Disorder: A Meta-Analysis. Brooks, E., Spokas, M., Goldschmidt, D.[2022]

A pilot study involving 38 active duty military personnel with combat-related PTSD showed significant improvements in symptom severity and overall functioning after group inpatient treatment.

The study found that group cohesion was a key predictor of treatment outcomes, accounting for over 50% of the variance in effectiveness, emphasizing the importance of supportive group dynamics in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of group cohesion in inpatient treatment of combat-related PTSD. Ellis, CC., Peterson, M., Bufford, R., et al.[2022]

Group-based interpersonal psychotherapy (IPT-G) for nine male Vietnam veterans with PTSD led to significant reductions in PTSD and depressive symptoms, with these improvements maintained at 2- and 4-month follow-ups.

While IPT-G improved interpersonal and global functioning, these gains were not sustained over time, suggesting a need for further research on strategies to prevent relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group interpersonal psychotherapy for veterans with posttraumatic stress disorder: a pilot study. Ray, RD., Webster, R.[2022]

In a study involving 34 participants with PTSD from motor vehicle accidents, those who underwent group cognitive behavioral treatment (GCBT) showed significant reductions in PTSD symptoms, with 88.3% no longer meeting PTSD criteria after treatment compared to only 31.3% in the minimum contact comparison group (MCC).

The benefits of GCBT were maintained for at least 3 months after treatment, and participants reported high satisfaction with the group format, indicating that GCBT can be an effective and well-received intervention for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group cognitive behavior therapy for chronic posttraumatic stress disorder: an initial randomized pilot study. Beck, JG., Coffey, SF., Foy, DW., et al.[2021]

The VA Cooperative Study 420 is a randomized clinical trial involving veterans with PTSD, comparing group psychotherapy that includes exposure therapy to a treatment focused on current interpersonal issues, delivered over 30 weeks with follow-up assessments at 7 and 12 months.

The study aims to evaluate the effectiveness of these treatments on PTSD severity and other related symptoms, while also addressing the challenges of conducting multisite trials in group therapy settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of Department of Veterans Affairs Cooperative Study no. 420: group treatment of posttraumatic stress disorder. Schnurr, PP., Friedman, MJ., Lavori, PW., et al.[2019]

Long-term group psychotherapy over five years significantly reduced PTSD symptoms in war veterans, as evidenced by a notable decrease in Clinician-Administered PTSD Scale scores (F=9.103, P=0.001).

While PTSD symptoms improved, the underlying personality traits and defense mechanisms of the veterans remained largely unchanged, indicating that traumatic experiences create deeply rooted psychological patterns that are resistant to change through psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term dynamic-oriented group psychotherapy of posttraumatic stress disorder in war veterans: prospective study of five-year treatment. Britvić, D., Radelić, N., Urlić, I.[2022]

Exposure therapy for PTSD in military populations shows medium to large effects compared to waitlist and treatment as usual, based on a meta-analysis of 19 studies involving 2905 participants.

Younger participants, more women, and those with fewer comorbid conditions or psychiatric medications experienced larger benefits from exposure therapy, suggesting that demographic and clinical factors may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure therapy for PTSD in military populations: A systematic review and meta-analysis of randomized clinical trials. McLean, CP., Levy, HC., Miller, ML., et al.[2022]

In a study of 198 veterans with PTSD, 70.7% completed treatment, with those in group present-centered treatment (GPCT) being significantly more likely to complete the program compared to those in group cognitive behavioral treatment (GBCT).

Factors such as older age, higher income, and better educational attainment were associated with higher treatment completion rates, while higher depressive symptoms and trauma burden were linked to noncompletion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of treatment completion in group psychotherapy for male veterans with posttraumatic stress disorder. Stoycos, SA., Berzenski, SR., Beck, JG., et al.[2023]

In a study involving 72 veterans with military sexual trauma-related PTSD, therapists' fidelity to cognitive processing therapy (CPT) significantly impacted treatment outcomes, with those receiving care from therapists with 'good' fidelity showing greater reductions in PTSD symptoms, negative cognitions, and depression.

The findings suggest that monitoring and maintaining therapist fidelity is crucial for improving the effectiveness of psychotherapy treatments in clinical trials, emphasizing the need for consistent therapeutic practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary examination of the role of psychotherapist fidelity on outcomes of cognitive processing therapy during an RCT for military sexual trauma-related PTSD. Holder, N., Holliday, R., Williams, R., et al.[2019]

A 9-month psychotherapy group for male Vietnam War veterans with PTSD, who also experienced childhood abuse, was developed to explore the connections between their combat experiences and earlier traumas.

This innovative approach differs from traditional PTSD treatments by focusing on both war and childhood traumas, potentially leading to better understanding and coping strategies for the veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double trauma: a group therapy approach for Vietnam Veterans suffering from war and childhood trauma. Goodman, M., Weiss, D.[2019]

Group therapy is proposed as a key treatment for Vietnam veterans with PTSD, addressing feelings of aloneness, guilt, and helplessness that arise from combat experiences.

The therapy model involves weekly sessions over a year, focusing on both combat-related trauma and relevant pre- and postwar issues, emphasizing the importance of timely integration of these topics for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychodynamic group treatment of posttraumatic stress disorder in Vietnam veterans. Koller, P., Marmar, CR., Kanas, N.[2019]

In a study of 53 adults with PTSD undergoing cognitive processing therapy (CPT), dropout rates were significantly higher (39.7%) compared to written exposure therapy (6.4%), indicating a need to address factors influencing treatment retention.

The research identified that higher levels of physiological distress and cognitive emotional processing were associated with lower dropout rates, while avoidance behaviors predicted higher dropout, suggesting that targeting these factors early in treatment could improve engagement and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of dropout in cognitive processing therapy for PTSD: An examination of in-session treatment processes. Shayani, DR., Canale, CA., Sloan, DM., et al.[2023]

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