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

NCT01502449 | Unknown DMC

• 1 other identifier: D10-I-AR-J5-786
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD

Keywords

telemedicine, telephonic, PTSD

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 12 weeks, 18 weeks, and 24 weeks

Secondary Outcomes (7)

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

  Baseline, 12 weeks, 18 weeks, and 24 weeks

• World Health Organization Health & Work Performance Questionnaire (HPQ)

  Baseline, 12 weeks, 18 weeks, and 24 weeks

• Patient Health Questionnaire (PHQ)

  Baseline, 12 weeks, 18 weeks, and 24 weeks

• Generalized Anxiety Symptom Severity (GAD-7)

  Baseline

• Sheehan Disability Scale (SDS)

  baseline, 12 week, 18 week and 24 week

Study Arms (2)

DESTRESS-T

EXPERIMENTAL

Usual primary care PTSD treatment, plus a telephone care management program over 8 weeks that includes: four outreach calls, feedback to the treating primary care provider, and care coordination

Behavioral: DESTRESS-T

Optimized Usual Care (OUC)

ACTIVE COMPARATOR

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.

Other: Optimized Usual Care (OUC)

Interventions

DESTRESS-T BEHAVIORAL

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

Also known as: Delivery of Self-Training for Stressful Situations, Telephonic version

DESTRESS-T

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.

Optimized Usual Care (OUC)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years
• DSM-IV diagnosis of PTSD (derived from the CAPS) due to combat in OIF/OEF deployment
• Active duty personnel

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead
• Walter Reed National Military Medical Center: collaborator
• United States Department of Defense: collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Fort Benning - Martin Army Community Hospital

Columbus, Georgia, 31905, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• COL Charles C. Engel, MD, MPH

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dir., Deployment Health Clinical Center; Associate Professor, psychiatry, USUHS

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 30, 2011
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 12, 2012

Record last verified: 2012-01

Locations

US (1)