Delivery of Self Training and Education for Stressful Situations-Telephone Version

Uniformed Services University of the Health Sciences91 enrolled

Overview

This study will evaluate a telephone-delivered cognitive-behavioral psychotherapy intervention designed for primary care treatment of combat-exposed service members with PTSD. The investigators will assess Posttraumatic Stress Disorder (PTSD) symptoms, mental health-related and occupational functioning, and symptoms of depression, anxiety, and somatization.

This is a randomized controlled trial that will compare DESTRESS-T to Optimized Usual Care (OUC). Optimized Usual Care is usual primary care PTSD treatment, plus a telephone care management program that includes: four outreach calls, feedback to the treating primary care provider (PCP), and care coordination.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

PTSD

Interventions

DESTRESS-TBEHAVIORAL

Usual primary care PTSD treatment, plus a telephone care management program that includes: four outreach calls, feedback to the treating primary care provider, and care coordination

Optimized Usual Care (OUC)OTHER

Optimized Usual Care is usual primary care PTSD treatment, plus a telephone care management program that includes: four outreach calls, feedback to the treating primary care provider (PCP), and care coordination.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age\>18 years * DSM-IV diagnosis of PTSD (derived from the CAPS) due to combat in OIF/OEF deployment * Active duty personnel Exclusion Criteria: * Active suicidal or violent ideation within the past two months as assessed by the MINI and a supplementary form developed by the project team (see Appendices) * Current participation in any active psychotherapy (e.g., psychoanalysis, CBT) for mood, anxiety or substance use disorders (as determined via service member self report and/or check of medical record) * Recurrent PTSD treatment failure in psychotherapy, as determined via consensus of study team members (Dr. Charles Engel, Dr. Brett Litz, and Dr. Kristie Gore) * Current alcohol dependence, as assessed by MINI * Acute psychosis, psychotic episode, or psychotic disorder diagnosis within the past year, as assessed by the MINI * Currently on an antipsychotic or mood-stabilizing agent for bipolar disorder or any disorder with psychotic features, as determined by medical record and/or self report * Unstable administration schedule or dosing of any antidepressant, anxiolytic, or sedative-hypnotic (i.e., will exclude for any related medication changes in the month prior to randomization), as determined by medical record or service member self report * Acute or unstable physical illness based on the judgment of the patient's primary care clinician and the study team.

Locations (1)

Fort Benning - Martin Army Community Hospital

Columbus, Georgia, United States

Outcomes

Primary Outcomes

Posttraumatic Stress Disorder Checklist - Civilian Version (PCL)

Symptoms of PTSD will be assessed using the PTSD Checklist-Civilian Version. The PCL is a self-report measure developed for measuring PTSD symptom severity and for estimating PTSD caseness when administration of a structured clinical interview is not feasible. Respondents rate PCL items on a 5-point scale ("not at all" through "extremely") to indicate the degree to which they have been bothered by each of 17 PTSD symptoms during the past month. Possible PCL scores range from 17 to 85.

Time frame: Baseline, 12 weeks, 18 weeks, and 24 weeks

Secondary Outcomes

Medical Outcomes Survey Short-Form-12 (SF-12)

The SF-12 is a commonly used measure of mental and physical functional status. The 12 items in the SF-12 are a subset of those in the SF-36. The SF-12 contains one or two items from each of the eight health scales: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, and role limitations due to emotional problems and mental health (psychological distress and psychological well being). The SF-12 will allow us to characterize the functional status of our sample.

Time frame: Baseline, 12 weeks, 18 weeks, and 24 weeks

World Health Organization Health & Work Performance Questionnaire (HPQ)

We will use the 21-item 7-day clinical trial version of the World Health Organization Health \& Work Performance Questionnaire (HPQ) to measure the impact of DESTRESS-PC on occupational functioning. The HPQ is a self-report questionnaire that obtains information about three types of workplace consequences: absenteeism (missed work days due to illness), presenteeism (low performance at work), and critical incidents.

Time frame: Baseline, 12 weeks, 18 weeks, and 24 weeks

Patient Health Questionnaire (PHQ)

The PHQ is a self-report assessment of common mental disorders developed specifically for primary care. PHQ allows brief provisional primary care diagnoses of a several disorders including major depression, panic disorder, other anxiety disorder, and multisomatoform disorder. We will use the PHQ for brief assessments of depression, anxiety (panic and generalized anxiety), and somatic symptom severity, assessments with excellent correspondence to DSM-IV diagnostic criteria.

Central Contacts

Elizabeth Harper Cordova, MA

CONTACT

301-295-7339 elizabeth.harper1@us.army.mil

Kristie Gore, Ph.D.

CONTACT

301-295-7351 kristie.gore@us.army.mil

Data from ClinicalTrials.gov

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