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

NCT02290847 | Completed DMC

• 1 other identifier: HSC20140055H
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder; PTSD

Outcome Measures

Primary Outcomes (2)

• PTSD Check List - DSM-5 (PCL-5), to assess change in PTSD symptomatology from baseline throughout treatment and at multiple follow up points

  The PCL-5 is a 20-item self-report measure based upon the DSM-5 criteria for PTSD that evaluates how much participants have been bothered by PTSD symptoms in the past month as a result of a specific life event. Each item of the PCL-5 is scored on a five point scale ranging from 0 "not at all") to 4 ("extremely).

  Baseline, Weekly during therapy (6 time points), 1 month Post-tx follow up, 2 Month Follow-Up, 3 Month Follow-Up, 4 Month Follow-Up, 5 Month Follow-Up, 6 Month Follow-Up

• Clinician-Administered PTSD Scale - 5 (CAPS-5); to assess change in PTSD symptomatology and/or diagnosis from baseline to multiple follow up points

  The CAPS-5 is a structured interview that assesses the DSM-5 criteria for PTSD (Weathers et al., 2013). Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme) and combines information about frequency and intensity for each symptom. Validation studies are nearly complete to establish the psychometric properties of the CAPS-5. This interview is very similar to its predecessor, the CAPS for DSM-IV, which has been considered the gold standard for evaluating PTSD (Weathers, Keane, \& Davidson, 2001). In addition to reflecting diagnostic changes for PTSD in DSM-5, the CAPS-5 differs from the CAPS in that frequency and intensity ratings for each symptom are no longer scored separately, so the severity rating for each item determines whether a symptom is present or not. Subscale scores are calculated by summing severity scores for items in the following PTSD symptom clusters: re-experiencing, avoidance, negative alterations in cognitions and mood, and hyperarousal.

  Baseline, 1-month Post-tx Follow-Up, 3-month Follow-Up, 6-month Follow-Up

Study Arms (3)

In-Home Therapy

ACTIVE COMPARATOR

Cognitive Processing Therapy (CPT-C) will be delivered to participants face to face in their homes by a certified therapist.

Behavioral: Cognitive Processing Therapy (cognitive only version; CPT-C)

In-Office Therapy

ACTIVE COMPARATOR

Cognitive Processing Therapy (CPT-C) will be delivered to participants face to face in a mental health clinic office setting by a certified therapist.

Behavioral: Cognitive Processing Therapy (cognitive only version; CPT-C)

Telebehavioral Health

ACTIVE COMPARATOR

Cognitive Processing Therapy (CPT-C) will be delivered to participants over the internet using video conferencing software by a certified therapist.

Behavioral: Cognitive Processing Therapy (cognitive only version; CPT-C)

Interventions

Cognitive Processing Therapy (cognitive only version; CPT-C) BEHAVIORAL

CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions (Resick, Monson, \& Chard, 2008; Resick \& Schnicke, 1993). CPT is delivered in three phases: education, processing, and challenging. The manualized treatment focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world.

In-Home Therapy; In-Office Therapy; Telebehavioral Health

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Duke University: collaborator
• VA Boston Healthcare System: collaborator
• South Texas Veterans Health Care System: collaborator

Study Sites (1)

Strong Star

San Antonio, Texas, 78229, United States

Location

Related Publications (4)

• Moring JC, Dismuke-Greer CE, Resick PA, Young-McCaughan S, Ortman J, McGeary C, Straud CL, Mackintosh MA, Acierno R, Rauch SAM, Morland LA, Peterson AL. Cost-effectiveness of evidence-based psychotherapies for PTSD: An examination of different treatment delivery modalities. Psychol Serv. 2026 Jan 26. doi: 10.1037/ser0001010. Online ahead of print.

  PMID: 41587192 DERIVED

• Moring JC, Peterson AL, Straud CL, Ortman J, Mintz J, Young-McCaughan S, McGeary CA, McGeary DD, Litz BT, Macdonald A, Roache JD, Resick PA, For The Strong Star Consortium. The interactions between patient preferences, expectancies, and stigma contribute to posttraumatic stress disorder treatment outcomes. J Trauma Stress. 2023 Dec;36(6):1126-1137. doi: 10.1002/jts.22982. Epub 2023 Oct 26.

  PMID: 37883128 DERIVED

• McGeary CA, Morland LA, Resick PA, Straud CL, Moring JC, Sohn MJ, Mackintosh MA, Young-McCaughan S, Acierno R, Rauch SAM, Mintz J, McGeary DD, Wells SY, Grubbs K, Nabity PS, McMahon CJ, Litz BT, Velligan DI, Macdonald A, Mata-Galan E, Holliday SL, Dillon KH, Roache JD, Peterson AL. Impact and efficiency of treatment across two PTSD clinical trials comparing in-person and telehealth service delivery formats. Psychol Serv. 2024 Feb;21(1):73-81. doi: 10.1037/ser0000774. Epub 2023 Jun 22.

  PMID: 37347913 DERIVED

• Peterson AL, Mintz J, Moring JC, Straud CL, Young-McCaughan S, McGeary CA, McGeary DD, Litz BT, Velligan DI, Macdonald A, Mata-Galan E, Holliday SL, Dillon KH, Roache JD, Bira LM, Nabity PS, Medellin EM, Hale WJ, Resick PA. In-office, in-home, and telehealth cognitive processing therapy for posttraumatic stress disorder in veterans: a randomized clinical trial. BMC Psychiatry. 2022 Jan 17;22(1):41. doi: 10.1186/s12888-022-03699-4.

  PMID: 35038985 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Alan Peterson, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 14, 2014
• Study Start: September 19, 2014
• Primary Completion: May 14, 2019
• Study Completion: November 6, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-06

Locations

US (1)