Telemental Health and Cognitive Processing Therapy for Rural Combat Veterans With Posttraumatic Stress Disorder

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The immediate objective of this project was to evaluate the clinical effectiveness of a telemental health modality (video-teleconferencing) for providing an evidence-based group intervention (Cognitive Processing Therapy; CPT) to rural OIF/OEF Reservists, National Guardsmen, and veterans suffering with PTSD.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD

NCT02362477

Posttraumatic Stress Disorder

COMPLETED PHASE3

The Effects of Home-Based Telemental Health for Rural Veterans With PTSD

NCT02295410

Stress Disorders, Post-Traumatic

COMPLETED

Comparison of Videoconference and Face-to-Face Delivery of Cognitive Processing Therapy for Posttraumatic Stress Disorder

NCT00941629

Post-Traumatic Stress Disorder

COMPLETED PHASE3

Cognition and Psychotherapy in PTSD

NCT03641924

Posttraumatic Stress Disorder (PTSD)

COMPLETED

Assessment and Treatment of Cognitive Functioning Deficits in Veterans With PTSD

NCT03696225

Posttraumatic Stress Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The project was a 5-year prospective randomized clinical trial which conducted a direct comparison of the VTC and in-person modalities using rigorous methodology and a sophisticated analysis of equivalency between clinical and process outcome domains. In addition, cost effectiveness of this modality will be addressed. Approximately 130 combat Reservists, National Guardsmen, or veterans were recruited from multiple clinical sites. Prospective participants received a comprehensive assessment at baseline to determine eligibility. The exclusion criteria selected are consistent with large PTSD randomized clinical trials as well as research using the CPT protocol with military populations with PTSD. The treatment was delivered twice a week over 6 weeks by a doctoral level psychologist. Quality control procedures were incorporated into the study's design to ensure integrity, fidelity and standard administration of the CPT intervention across both conditions. Participants received additional assessments at mid-treatment, immediately post-treatment, and at 3 and 6 months post-treatment. Outcome domains include: 1) clinical outcomes (symptom severity, social functioning); 2) process outcomes (perception of treatment, satisfaction, group therapy alliance, treatment compliance, and attrition and treatment credibility); and (3) cost-effectiveness outcomes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Posttraumatic Stress Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Videoteleconferencing CPT

The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.

Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.

Group Type EXPERIMENTAL

Cognitive Processing Therapy Group Videoteleconference

Intervention Type BEHAVIORAL

Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.

Face-to-Face CPT

The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.

Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.

Group Type ACTIVE_COMPARATOR

Cognitive Processing Therapy Group In-Person

Intervention Type BEHAVIORAL

Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive Processing Therapy Group Videoteleconference

Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.

Intervention Type BEHAVIORAL

Cognitive Processing Therapy Group In-Person

Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CPT-VT CPT-NP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* diagnosis of current combat related PTSD determined by the Clinician Administered PSTD Scale (CAPS-IV)
* participants taking psychoactive medications have to have a stable regimen for at least 45 days prior to study entry

Exclusion Criteria

* active psychotic symptoms/disorder as determined by the SCID for DSM-IV
* active homicidal or suicidal ideation as determined by the structured clinical interview
* any significant cognitive impairment or history of Organic Mental Disorder as determined by the structured clinical interview
* active (current) substance dependence as determined by the SCID (lifetime substance dependence/abuse not excluded)
* unwillingness to refrain from substance abuse during treatment
* female veterans

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No