In-Home Exposure Therapy for Veterans With Post Traumatic Stress Disorder (PTSD)

NCT03110302 | Completed DMC

• 1 other identifier: W81XWH-12- 1-0614
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines clinical and process outcomes following variable length prolonged exposure (PE) for posttraumatic stress disorder (PTSD) delivered by one of three treatment modalities: home-based telehealth (HBT), office-based telehealth (OBT), or in-home-in-person (IHIP).

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder; Telehealth; Video teleconferencing; In home therapy; Prolonged Exposure

Outcome Measures

Primary Outcomes (1)

• Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

  The CAPS is a clinician-administered interview that assesses PTSD severity and diagnostic threshold. CAPS questions are designed to assess DSM-5 PTSD diagnostic criteria. CAPS has become the "gold standard" semistructured interview for assessing PTSD in the general population.

  From baseline to 9 months

Secondary Outcomes (5)

• Change in Beck Depression Inventory (BDI-II)

  From baseline to 9 months

• Change in PTSD Checklist (PCL-5)

  From baseline to 9 months

• Change in Client Satisfaction Questionnaire (CSQ) - Short form

  From baseline to 3 months

• Change in Therapist Satisfaction Questionnaire (TSQ)

  From baseline to 3 months

• Change in Working Alliance Inventory - Short form (WAI-S)

  From baseline to 3 months

Study Arms (3)

Office-based telehealth (OBT)

ACTIVE COMPARATOR

Veterans come to a VA clinic and meet with a therapist via telehealth, using videoconferencing technology

Behavioral: Prolonged exposure

Home-based telehealth (HBT)

ACTIVE COMPARATOR

Veterans stay at home and meet with the therapist via telehealth, using videoconferencing technology

Behavioral: Prolonged exposure

In home, in person (IHIP)

EXPERIMENTAL

Therapist goes to the Veterans' homes to provide the psychotherapy

Behavioral: Prolonged exposure

Interventions

Prolonged exposure BEHAVIORAL

PE is a manualized treatment developed by Dr. Edna Foa and her colleagues. In all three treatment modalities, 7-15 weekly, 90 minute individual sessions of PE will be provided. PE is based on emotional processing theory, which proposes that avoidance and negative thoughts about the self and the world maintain PTSD symptoms over time. According to emotional processing theory, effective treatment requires repeated activation of the trauma memory (as through memory and in vivo exposure) and incorporation of corrective information into the trauma fear structure. PE has several primary components: (1) psychoeducation about PTSD and avoidance; (2) imaginal exposure with processing, wherein the participant describes the traumatic memory aloud many times and discusses it with the therapist afterward; and (3) in-vivo exposure, wherein the participant engages in feared, but safe, activities that have been avoided since the traumatic event (e.g., crowded places, driving).

Also known as: PE

Home-based telehealth (HBT); In home, in person (IHIP); Office-based telehealth (OBT)

Eligibility Criteria

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

You may qualify if:

• Military Veterans enrolled in a program at VASDHS;
• primary diagnosis of PTSD as a consequence of any index traumatic event. The diagnosis will include a clear memory of the traumatic event and the 17 other core symptoms of PTSD from the DSM-IV. Note that comorbid mood and anxiety disorders are expected and will be permitted (to maximize generalizability) if PTSD symptoms are judged to be predominant based on primacy and severity of symptoms. The proposed treatment often concurrently ameliorates depression and anxiety symptoms;
• age 18 or older; and
• Primary residence within 35 miles of the center point of La Jolla, CA center (to make therapist travel to home sites feasible for this project). This will include the major cities of San Diego, Chula Vista (23 miles Southeast; 30 minutes), La Mesa (19 miles East; 25 minutes), Coronado (18 miles South; 30 minutes), Oceanside (36 miles Southeast; 39 minutes), Escondido (27 miles northeast; 35 minutes) and San Ysidro (28 miles South; 32 minutes).

You may not qualify if:

• unmanaged dementia, psychosis or manic episodes in past year (assessed by phone screen, chart review, and clinician judgment);
• substance or alcohol dependence in past 60 days (as assessed by the Alcohol Use Disorders Identification Test \[AUDIT\]);
• concurrent psychotherapies targeting PTSD (Veterans who are engaged in treatment for non PTSD symptoms, such as 12-step programs for substance problems or couples therapy for relationship issues, will remain eligible); and
• severe physical disease or disorder (e.g., cardiovascular or respiratory disease; severe impairments in speech, vision, or hearing) that would make it difficult to ensure regular attendance at psychotherapy sessions or would significantly impede learning (as assessed during phone screen discussion with potential participants). Potential participants who have had changes in the type and dosage of psychotropic medications in the preceding 60 days will be asked to wait until their medication regimen has stabilized to minimize treatment confounds. Psychotropic medication use will also be monitored to determine whether random assignment to treatment conditions resulted in unequal rates of use. As recommended by Bradley and colleagues, individuals with suicidal ideation will not be excluded from the study a priori, but rather suicidal urges or plans will be assessed throughout the study and appropriately addressed (by intervention or referral). The depression measure (the BDI-II) assesses suicidality explicitly (item 9). Dr. Thorp has extensive experience working with suicidal individuals and teaching crisis management skills, and the other study therapists will be trained in these skills as well.

Sponsors & Collaborators

• Veterans Medical Research Foundation: lead
• United States Department of Defense: collaborator

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Related Publications (1)

• Morland LA, Mackintosh MA, Glassman LH, Wells SY, Thorp SR, Rauch SAM, Cunningham PB, Tuerk PW, Grubbs KM, Golshan S, Sohn MJ, Acierno R. Home-based delivery of variable length prolonged exposure therapy: A comparison of clinical efficacy between service modalities. Depress Anxiety. 2020 Apr;37(4):346-355. doi: 10.1002/da.22979. Epub 2019 Dec 24.

  PMID: 31872563 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Leslie Morland, PsyD

  VA San Diego and University of California, San Diego

  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: March 30, 2017
• First Posted: April 12, 2017
• Study Start: October 1, 2012
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: May 14, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)