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Group Therapy for PTSD After Combat (CAC Trial)

Q: How many participants has the research team recruited for this trial?

Affirmative. According to the clinicaltrials.gov website, this research is actively recruiting participants as of February 2nd 2022. The trial was first advertised on February 1st and 12 individuals need to be enrolled at a single medical site.

Q: Are there any vacancies for participants in this clinical trial?

The current status of this clinical trial is recruiting, as indicated on the official listing hosted on clinicaltrials.gov. The original posting date was February 1st 2022 and it has been newly updated as recently as today (February 2nd 2022).

Q: What are the expected results of this inquiry?

This research trial's primary outcome is to measure the Alteration in Feasibility of Intervention Measure (FIM) over a 6-month period. Additionally, the Group Cohesion Scale-Revised (GCS), Religious and Spiritual Struggles Scale (RSSS), and Beck Scale for Suicide Ideation (BSS) will be evaluated. The GCS uses a Likert-style scale ranging from 0 to 4 where higher scores mean greater group cohesion; RSSS applies a range of 0 to 5 with higher scores indicating more religious or spiritual strife; BSS utilizes 0 to 3 with lower numbers suggesting less severe suicidal ideation

Phase < 1

Recruiting

Led By Sheila Frankfurt, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 years or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre intervention (baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months

Awards & highlights

CAC Trial Summary

This trial will test a new form of group therapy for combat Veterans with PTSD, which could have a significant impact on VA care.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this is a psychological intervention involving group therapy sessions rather than medication or medical procedures, side effects may include emotional discomfort or distress related to discussing traumatic experiences.

CAC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

CAC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre intervention (baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre intervention (baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre intervention (baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Acceptability of Intervention Measure (AIM)

Change in Feasibility of Intervention Measure (FIM)

Change in Implementation Appropriateness Measure (IAM)

+1 more

Secondary outcome measures

Change in Beck Depression Inventory-II (BDI-II)

Change in Beck Scale for Suicide Ideation (BSS)

Change in Expressions of Moral Injury Scale (EMIS)

+6 more

Other outcome measures

Columbia Suicide Severity Rating Scale (C-SSRS)

CAC Trial Design

1Treatment groups

Experimental Treatment

Group I: Open Pilot TrialExperimental Treatment1 Intervention

Open pilot trial of a group therapy manual.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,272 Total Patients Enrolled

5 Trials studying Moral Injury

456 Patients Enrolled for Moral Injury

Sheila Frankfurt, PhDPrincipal InvestigatorCentral Texas Veterans Health Care System, Temple, TX

Media Library

Open pilot trial of a group therapy manual Clinical Trial Eligibility Overview. Trial Name: NCT05020587 — Phase < 1

Moral Injury Research Study Groups: Open Pilot Trial

Moral Injury Clinical Trial 2023: Open pilot trial of a group therapy manual Highlights & Side Effects. Trial Name: NCT05020587 — Phase < 1

Open pilot trial of a group therapy manual 2023 Treatment Timeline for Medical Study. Trial Name: NCT05020587 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants has the research team recruited for this trial?

"Affirmative. According to the clinicaltrials.gov website, this research is actively recruiting participants as of February 2nd 2022. The trial was first advertised on February 1st and 12 individuals need to be enrolled at a single medical site."

Answered by AI

Are there any vacancies for participants in this clinical trial?

"The current status of this clinical trial is recruiting, as indicated on the official listing hosted on clinicaltrials.gov. The original posting date was February 1st 2022 and it has been newly updated as recently as today (February 2nd 2022)."

Answered by AI

What are the expected results of this inquiry?

"This research trial's primary outcome is to measure the Alteration in Feasibility of Intervention Measure (FIM) over a 6-month period. Additionally, the Group Cohesion Scale-Revised (GCS), Religious and Spiritual Struggles Scale (RSSS), and Beck Scale for Suicide Ideation (BSS) will be evaluated. The GCS uses a Likert-style scale ranging from 0 to 4 where higher scores mean greater group cohesion; RSSS applies a range of 0 to 5 with higher scores indicating more religious or spiritual strife; BSS utilizes 0 to 3 with lower numbers suggesting less severe suicidal ideation"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Consulting After Combat: Interviewing Veterans to Develop a Therapy to Restore Functioning and Reintegration After Moral Injury Events

2022. "Consulting After Combat: Interviewing Veterans to Develop a Therapy to Restore Functioning and Reintegration After Moral Injury Events". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05020587.

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