Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03110302
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Veterans Medical Research Foundation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Prolonged exposure Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: In-Home Exposure Therapy for Veterans With Post Traumatic Stress Disorder (PTSD)
Actual Study Start Date : October 2012
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Office-based telehealth (OBT)
Veterans come to a VA clinic and meet with a therapist via telehealth, using videoconferencing technology
Behavioral: Prolonged exposure
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).
Other Name: PE

Active Comparator: Home-based telehealth (HBT)
Veterans stay at home and meet with the therapist via telehealth, using videoconferencing technology
Behavioral: Prolonged exposure
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).
Other Name: PE

Experimental: In home, in person (IHIP)
Therapist goes to the Veterans' homes to provide the psychotherapy
Behavioral: Prolonged exposure
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).
Other Name: PE




Primary Outcome Measures :
  1. Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: From baseline to 9 months ]
    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.


Secondary Outcome Measures :
  1. Change in Beck Depression Inventory (BDI-II) [ Time Frame: From baseline to 9 months ]
    The BDI is a well-established, 21-item self-report inventory designed to measure depressive symptomatology, including suicidality.

  2. Change in PTSD Checklist (PCL-5) [ Time Frame: From baseline to 9 months ]
    The PCL-5 is a gold-standard self-report questionnaire designed to assess PTSD symptom severity; there are 20 questions.

  3. Change in Client Satisfaction Questionnaire (CSQ) - Short form [ Time Frame: From baseline to 3 months ]
    This well-validated questionnaire consists of 8 items rated on a 5-point Likert scale ranging from "Not at all" to "Very much" and one free response question. The CSQ is designed to measure patient satisfaction with interpersonal and communication behaviors.

  4. Change in Therapist Satisfaction Questionnaire (TSQ) [ Time Frame: From baseline to 3 months ]
    The TSQ is a validated instrument filled out by the therapist and used to measure provider satisfaction with therapy. This questionnaire consists of 20 items that are rated on a 5-point likert scale raning from "Strongly agree" to "Strongly disagree."

  5. Change in Working Alliance Inventory - Short form (WAI-S) [ Time Frame: From baseline to 3 months ]
    The WAI measures therapeutic alliance between the therapist and patient. Both the patient and the therapist fill out the WAI. This 12-item inventory has 3 subscales: (1) Goals (agreement about therapy goals), (2) Tasks (agreement about issues to be worked on), and (3) Bonds (comfort level between participant and therapist).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110302


Locations
Layout table for location information
United States, California
VA San Diego Healthcare System Recruiting
San Diego, California, United States, 92161
Contact: Alma Canete    858-642-3012    acanete@vmrf.org   
Principal Investigator: Leslie Morland, Psy.D.         
Sponsors and Collaborators
Veterans Medical Research Foundation
United States Department of Defense

Layout table for additonal information
Responsible Party: Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT03110302     History of Changes
Other Study ID Numbers: W81XWH-12- 1-0614
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Veterans Medical Research Foundation:
Posttraumatic Stress Disorder
Telehealth
Video teleconferencing
In home therapy
Prolonged Exposure

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders