Clinical trial NCT03110302: In-Home Exposure Therapy for Veterans With Post Traumatic Stress Disorder (PTSD)
Official title: In-Home Exposure Therapy for Veterans With Post Traumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Posttraumatic Stress Disorder
Telehealth
Video teleconferencing
In home therapy
Prolonged Exposure
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2017-04-12
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: This study will provide a certain type of exposure therapy, called prolonged exposure therapy (PE), to military Veterans with Post Traumatic Stress Disorder (PTSD). One hundred and seventy-five Veterans will participate in the study. The main study goal is to compare PE conducted in three different ways: (1) PE that is office-based (OB; Veterans come to a VA clinic and meet with a therapist via telehealth, using videoconferencing technology), (2) PE delivered via home-based telehealth (HBT; Veterans stay at home and meet with the therapist via telehealth, using videoconferencing technology), and (3) PE delivered in home, in person (IHIP; the therapist goes to the Veterans' homes to provide the psychotherapy). Symptoms of PTSD, depression, and anxiety will be examined at pre-treatment, post-treatment and at six-month follow up to determine if symptoms change over time. Study hypotheses state that the IHIP approach, compared to the other two approaches, will be more effective at reducing the PTSD symptoms experienced by these Veterans because it will help Veterans attend each session and complete the therapy "homework" assigned by the therapists (such as doing feared, but safe, activities around the house or the neighborhood). However, the delivery of IHIP may cost more than the delivery of PE via the other modalities.

Eligibility criteria: Inclusion Criteria:

1. Military Veterans enrolled in a program at VASDHS;
2. 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;
3. age 18 or older; and
4. 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).

Exclusion Criteria:

1. unmanaged dementia, psychosis or manic episodes in past year (assessed by phone screen, chart review, and clinician judgment);
2. substance or alcohol dependence in past 60 days (as assessed by the Alcohol Use Disorders Identification Test \[AUDIT\]);
3. 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
4. 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.

Primary outcomes:
measure: Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: From baseline to 9 months
Secondary outcomes:
measure: Change in Beck Depression Inventory (BDI-II)
timeFrame: From baseline to 9 months
measure: Change in PTSD Checklist (PCL-5)
timeFrame: From baseline to 9 months
measure: Change in Client Satisfaction Questionnaire (CSQ) - Short form
timeFrame: From baseline to 3 months
measure: Change in Therapist Satisfaction Questionnaire (TSQ)
timeFrame: From baseline to 3 months
measure: Change in Working Alliance Inventory - Short form (WAI-S)
timeFrame: From baseline to 3 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
Study officials:
affiliation: VA San Diego and University of California, San Diego
name: Leslie Morland, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.