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

Completed · Not applicable

Conditions studied: Posttraumatic Stress Disorder

In brief

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).

Key facts

Study ID

NCT03110302

Run by

Veterans Medical Research Foundation

People needed

175

Starts

2012-10-01

Expected to finish

2018-07-01

Last updated by the study team

2019-05-14

Who can join

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

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.

Where it is running

• VA San Diego Healthcare System — San Diego, California, United States

Full record on ClinicalTrials.gov

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