Clinical Effectiveness Trial of In-Home Cognitive Processing Therapy for Combat-Related PTSD

Completed · Not applicable

Conditions studied: Posttraumatic Stress Disorder, PTSD

In brief

The primary objective of this study is to evaluate the effectiveness of Cognitive Processing Therapy (cognitive only version; CPT-C) delivered using two different formats in the home setting for the treatment of combat-related PTSD as compared to conventional face-to-face CPT-C delivered in a mental health clinic. The study will include two different formats of in-home therapy: face-to-face in-home CPT-C and tele-behavioral health in-home CPT-C.

Key facts

Study ID

NCT02290847

Run by

The University of Texas Health Science Center at San Antonio

People needed

172

Starts

2014-09-19

Expected to finish

2019-11-06

Last updated by the study team

2020-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult male and female active duty military and Veterans, with any previous military deployment seeking treatment for PTSD
• Person has experienced a Criterion A event that is a specific combat-related event or high magnitude operational experience that occurred during a military deployment. The diagnosis of PTSD may be indexed to that event or to another Criterion A event.
• Diagnosis of PTSD determined by the Clinician-Administered PTSD Scale - Interview - Version 5 (CAPS-5).
• Speak and read English.
• Participants taking psychotropic medications agree to work with their prescriber to remain on stable doses of any prescribed psychotropic medications for the duration of the intervention and through the first follow-up assessment as much as possible and as medically indicated.
• Patient must reside within a 45-mile radius of the UTHSCSA STRONG STAR offices in San Antonio.
• To participate in telemedicine study arm, participants must have access to a computer with a high definition display, high speed internet access, and USB port for installation of the HD telemedicine camera, OR be willing to use STRONG STAR equipment with necessary specifications for the duration of the telemedicine treatment phase.
• The computer must be located in a private location where the participant will be able to control access during treatment encounters (ensuring their privacy and confidentiality).
• The computer must be accessible enough to the participant to allow for the frequency and required number of encounters for the CPT intervention.
• The computer must have high speed internet access (e.g., cable modem, USB, T1/T2 connection).
• If a firewall is present on the participant's computer system, the participant needs to be able to arrange for access control to the system to allow the telepresence encounter to occur (i.e., they must either be able to open ports through the firewall or know someone who can arrange this for them).
• The computer must be equipped with speakers or a standard headphone jack to allow access to audio output from the encounter (i.e., to be able to hear the therapist talking to them).
• Telemedicine will be mediated by the Cisco C20 Quickset Telepresence System, an encrypted and could-based system. Because encounters are cloud-based, any participant can use the system if they have a computer and web-browser capable of processing most modern commercial internet services. Computer operating system will not matter.

You may not qualify if…

• Current suicide or homicide risk meriting crisis intervention that is a higher priority than study participation.
• Endorsement of items pertaining to violence, arrest, probation, domestic abuse, or other issues that might suggest study staff would be at risk entering the home to deliver therapy as identified as part of the demographics.
• Alcohol and/or substance use that would prevent the participant from engaging in therapy.
• Active psychosis.
• Moderate to severe brain damage (as determined by the inability to comprehend the baseline screening questionnaires), as such individuals may be unable to fully benefit from the cognitive intervention.

Where it is running

• Strong Star — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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