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

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03110302
• Other study ID #: W81XWH-12- 1-0614
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: July 2018

Study information

• Verified date: May 2019
• Source: Veterans Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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).

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Veterans Medical Research Foundation	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Beck Depression Inventory (BDI-II)	The BDI is a well-established, 21-item self-report inventory designed to measure depressive symptomatology, including suicidality.	From baseline to 9 months
Secondary	Change in PTSD Checklist (PCL-5)	The PCL-5 is a gold-standard self-report questionnaire designed to assess PTSD symptom severity; there are 20 questions.	From baseline to 9 months
Secondary	Change in Client Satisfaction Questionnaire (CSQ) - Short form	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.	From baseline to 3 months
Secondary	Change in Therapist Satisfaction Questionnaire (TSQ)	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."	From baseline to 3 months
Secondary	Change in Working Alliance Inventory - Short form (WAI-S)	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).	From baseline to 3 months