Clinical trial NCT01502449: Delivery of Self Training and Education for Stressful Situations-Telephone Version
Official title: Randomized Trial of Telephonic Psychotherapy and Case Management for Combat-Related Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PTSD
Keywords: telemedicine, telephonic, PTSD
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
Collaborators: name: Walter Reed National Military Medical Center
name: United States Department of Defense
name: US Department of Veterans Affairs
First posted: 2011-12-30
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Posttraumatic Stress Disorder Checklist - Civilian Version (PCL)
timeFrame: Baseline, 12 weeks, 18 weeks, and 24 weeks
Secondary outcomes:
measure: Medical Outcomes Survey Short-Form-12 (SF-12)
timeFrame: Baseline, 12 weeks, 18 weeks, and 24 weeks
measure: World Health Organization Health & Work Performance Questionnaire (HPQ)
timeFrame: Baseline, 12 weeks, 18 weeks, and 24 weeks
measure: Patient Health Questionnaire (PHQ)
timeFrame: Baseline, 12 weeks, 18 weeks, and 24 weeks
measure: Generalized Anxiety Symptom Severity (GAD-7)
timeFrame: Baseline
measure: Sheehan Disability Scale (SDS)
timeFrame: baseline, 12 week, 18 week and 24 week
measure: Alcohol Use Disorders Identification Test-Civilian version (AUDIT-C)
timeFrame: baseline, 12 week, 18 week, and 24 week
measure: Numeric Rating Scale for Pain (NRS).
timeFrame: baseline, 12 week, 18 week, and 24 week
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Fort Benning - Martin Army Community Hospital
state: Georgia
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: COL Charles C. Engel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: