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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Trial of Telephonic Psychotherapy and Case Management for Combat-Related Posttraumatic Stress Disorder

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: DESTRESS-T
* Other: Optimized Usual Care (OUC)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DESTRESS-T<br>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<br>* 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<br>* Other names: Delivery of Self-Training for Stressful Situations, Telephonic version;|
| Active Comparator: Optimized Usual Care (OUC)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline, 12 weeks, 18 weeks, and 24 weeks | 
| Generalized Anxiety Symptom Severity (GAD-7) | Generalized anxiety symptoms will be assessed using the GAD-7, a brief measure designed for use in general health settings. | Baseline | 
| Sheehan Disability Scale (SDS) | The SDS is a three-item self-reporting tool measuring the impairment of a disability on work, social life and family life/home responsibilities. SDS is scored on a 10-point scale with 0 being not at all disrupted and being 10 extremely disrupted with any item scoring above 5 indicating a significant functional impairment in that domain. It has been used as an outcome measure in studies of PTSD due to its construct criterion related validity. | baseline, 12 week, 18 week and 24 week | 
| Alcohol Use Disorders Identification Test-Civilian version (AUDIT-C) | Audit-C is a brief screen that has been found to effectively discriminate between patients with a history of drinking problems and those without such a history, including hazardous drinking. Its brevity ensures that clinicians will remember it, and administration time is minimal. A positive total score is an indication for further screening and assessment | baseline, 12 week, 18 week, and 24 week | 
| Numeric Rating Scale for Pain (NRS). | The NRS directs participants to rate pain intensity using three, 11-point, 0 (no pain) to 10 (pain as bad as you can imagine) numeric rating scales. Instructions ask participants to Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours, pain at its worst, and pain at its least. The NRS will be used in this study to evaluate the effect of acupuncture on comorbid symptoms of pain. | baseline, 12 week, 18 week, and 24 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine, telephonic, PTSD