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DElivery of Self Training and Education for Stressful Situations-Primary Care Version (DESTRESS-PC)

Primary Purpose

Posttraumatic Stress Disorder (PTSD)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DESTRESS-PC
Optimized Usual Primary Care PTSD treatment
Sponsored by
Henry M. Jackson Foundation for the Advancement of Military Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder (PTSD) focused on measuring PTSD, combat trauma, telemedicine, primary care interventions, CBT, self-managed treatment, web-based intervention, internet treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Referred by a primary care providers in a participating primary care clinic.
  • Deployed to either Operation Iraqi Freedom or Enduring Freedom.
  • War-related trauma while deployed (may include military sexual trauma).
  • Current PTSD as addressed by the CAPS interview.
  • Reports routine access to computer, internet, and email.
  • Successfully uses Internet to coordinate baseline assessment appointment.
  • Provides research informed consent using local IRB-approved form.
  • Plans continued care at the enrolling primary care clinic for at least 4 months.

Exclusion Criteria:

  • Actively engaged in specialty mental health care in the previous two months.
  • Failed specialty mental health treatment for PTSD or associated condition.
  • Acute psychosis, psychotic episode, or psychotic disorder diagnosis within the past two years.
  • Active substance dependence disorder in the past year.
  • Active suicidal or violent ideation within the past two months.
  • Currently on an antipsychotic or mood-stabilizing agent.
  • Unstable administration schedule or dosing of any antidepressant, anxiolytic, or sedative-hypnotic (i.e., will exclude for any related medication changes in the two-months prior to randomization).
  • Acute or unstable physical illness.

Sites / Locations

  • Savannah Primary Care Clinic (Charleston VA)
  • Department of Veterans Affairs, Boston
  • Ralph H. Johnson VA Medical Center/Goose Creek Primary Care Clinic (Charleston VA)
  • Womack Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DESTRESS-PC

OUC

Arm Description

A brief, nurse-assisted, Internet-based online self-management tool for PTSD (DESTRESS-PC), based on empirically valid cognitive-behavioral therapy (CBT) strategies and designed for implementation in a primary care setting. DESTRESS-PC stands for DElivery of Self-TRaining and Education for Stressful Situations for Primary Care.

Optimized Usual Care (OUC) for PTSD--usual PTSD treatment offered within the primary care setting, optimized by training PC providers in PTSD identification and treatment and providing basic care management including phone check-ins to monitor symptoms and feedback to providers.

Outcomes

Primary Outcome Measures

PTSD Checklist (PCL)
Symptoms of PTSD were assessed using the PTSD Checklist-Military Version (PCL). 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.

Secondary Outcome Measures

PRIME-MD PHQ
The PHQ is a brief self-report assessment of common mental disorders developed specifically for primary care. PHQ allows brief provisional primary care diagnoses of several disorders including major depression, panic disorder, other anxiety disorder, and multi-somatoform disorder. We used the PHQ for baseline and follow-up assessments of depression, anxiety (panic and generalized anxiety), and somatic symptom severity, assessments with excellent correspondence to DSM-IV diagnostic criteria.
Medical Outcomes Study Short Form-36 (SF-36)
The SF-36 is a widely used measure of health related quality of life with established reliability and validity. The SF-36 was used to describe the study sample, compare functional status of the intervention groups at baseline, and assess change in functional over the course of the study.
Attitude Regarding Mental Health Treatments
We used two questions from Hoge and colleagues (2004): 'I don't trust mental health professionals,' and 'Mental health care doesn't work.' Both questions are rated using a five-point Likert-type scale. We also used two questions that rate attitudes regarding psychotherapy treatment ('Psychotherapy patients are wasting money,' and 'Therapy can help an individual'). The latter two questions, rated on the same 5-point scale, were part of a longer measure used to evaluate stigma in primary care patients with anxiety disorders.
World Health Organization Health and Performance Questionnaire (HPQ).
The HPQ is an assessment instrument to estimate the costs of workplace health problems using a self-report instrument. Specific areas assessed include job performance, absenteeism, and work related critical incidents.

Full Information

First Posted
March 26, 2010
Last Updated
January 11, 2012
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
United States Department of Defense, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01474057
Brief Title
DElivery of Self Training and Education for Stressful Situations-Primary Care Version
Acronym
DESTRESS-PC
Official Title
Online Early Resilience Intervention for Combat-Related PTSD in Military Primary Healthcare Settings: A Randomized Trial of "DESTRESS-PC"
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
United States Department of Defense, National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will compare a cognitive-behavioral online self-management intervention designed for primary care treatment of war-related PTSD to a control intervention, "optimized usual primary care PTSD treatment". Patients with PTSD will be trained to use the online PTSD treatment website and asked to do so three times per week for six weeks. They will have phone and email access to a nurse trained to assist them in their treatment program. Three scheduled phone check-ins during the six week treatment period will provide ongoing contact with patients during treatment. The investigators will assess PTSD symptoms, depression, anxiety and somatic symptoms, physical health status and occupational functioning on three occasions: before the intervention, at the end of the treatment period, and six weeks after the end of treatment.
Detailed Description
The study is a multi-site trial evaluating the efficacy of DESTRESS-PC (DElivery of Self-TRaining and Education for Stressful Situations, primary care version), a brief, web-based self-management intervention for PTSD designed for delivery in primary care. Participants randomized to DESTRESS-PC log on to a secure website for self-CBT 3 times per week for 6 weeks and receive RN nurse care manager ("DESTRESS Nurse") contact every two weeks. DESTRESS Nurses introduce the approach, monitor, answer questions, and insure primary care provider collaboration. The control intervention is optimized usual primary care. Blinded raters assess PTSD symptoms, depression, anxiety, somatic symptoms, physical health status, and occupational functioning at four timepoints. All study participants receive RN care management and are under the care of a primary care provider trained in evidence-based PTSD treatment who receives status reports from the DESTRESS nurse to include baseline psychiatric status.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder (PTSD)
Keywords
PTSD, combat trauma, telemedicine, primary care interventions, CBT, self-managed treatment, web-based intervention, internet treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DESTRESS-PC
Arm Type
Experimental
Arm Description
A brief, nurse-assisted, Internet-based online self-management tool for PTSD (DESTRESS-PC), based on empirically valid cognitive-behavioral therapy (CBT) strategies and designed for implementation in a primary care setting. DESTRESS-PC stands for DElivery of Self-TRaining and Education for Stressful Situations for Primary Care.
Arm Title
OUC
Arm Type
Active Comparator
Arm Description
Optimized Usual Care (OUC) for PTSD--usual PTSD treatment offered within the primary care setting, optimized by training PC providers in PTSD identification and treatment and providing basic care management including phone check-ins to monitor symptoms and feedback to providers.
Intervention Type
Behavioral
Intervention Name(s)
DESTRESS-PC
Intervention Description
An online nurse-assisted, self-management intervention designed for primary care treatment of war-related PTSD, this intervention will consist of 3 weekly logins to a secure website for a period of 6 weeks. A "DESTRESS Nurse" will train the participant to use the website and will monitor their progress and report key information back to the primary care physician.
Intervention Type
Other
Intervention Name(s)
Optimized Usual Primary Care PTSD treatment
Intervention Description
Participants receive usual Primary Care treatment that is administered by the primary care physician; the DESTRESS Nurse monitors the participants' progress throughout the study.
Primary Outcome Measure Information:
Title
PTSD Checklist (PCL)
Description
Symptoms of PTSD were assessed using the PTSD Checklist-Military Version (PCL). 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 and 6 weeks, 12 weeks, and 18 weeks post randomization
Secondary Outcome Measure Information:
Title
PRIME-MD PHQ
Description
The PHQ is a brief self-report assessment of common mental disorders developed specifically for primary care. PHQ allows brief provisional primary care diagnoses of several disorders including major depression, panic disorder, other anxiety disorder, and multi-somatoform disorder. We used the PHQ for baseline and follow-up assessments of depression, anxiety (panic and generalized anxiety), and somatic symptom severity, assessments with excellent correspondence to DSM-IV diagnostic criteria.
Time Frame
baseline and 6 weeks,12 weeks, and 18 weeks post randomization
Title
Medical Outcomes Study Short Form-36 (SF-36)
Description
The SF-36 is a widely used measure of health related quality of life with established reliability and validity. The SF-36 was used to describe the study sample, compare functional status of the intervention groups at baseline, and assess change in functional over the course of the study.
Time Frame
baseline, 6 wks, 12 wks, and 18wks
Title
Attitude Regarding Mental Health Treatments
Description
We used two questions from Hoge and colleagues (2004): 'I don't trust mental health professionals,' and 'Mental health care doesn't work.' Both questions are rated using a five-point Likert-type scale. We also used two questions that rate attitudes regarding psychotherapy treatment ('Psychotherapy patients are wasting money,' and 'Therapy can help an individual'). The latter two questions, rated on the same 5-point scale, were part of a longer measure used to evaluate stigma in primary care patients with anxiety disorders.
Time Frame
baseline, 6 weeks, 12 weeks, and 18 weeks
Title
World Health Organization Health and Performance Questionnaire (HPQ).
Description
The HPQ is an assessment instrument to estimate the costs of workplace health problems using a self-report instrument. Specific areas assessed include job performance, absenteeism, and work related critical incidents.
Time Frame
baseline, 6 weeks, 12 weeks, and 18 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Referred by a primary care providers in a participating primary care clinic. Deployed to either Operation Iraqi Freedom or Enduring Freedom. War-related trauma while deployed (may include military sexual trauma). Current PTSD as addressed by the CAPS interview. Reports routine access to computer, internet, and email. Successfully uses Internet to coordinate baseline assessment appointment. Provides research informed consent using local IRB-approved form. Plans continued care at the enrolling primary care clinic for at least 4 months. Exclusion Criteria: Actively engaged in specialty mental health care in the previous two months. Failed specialty mental health treatment for PTSD or associated condition. Acute psychosis, psychotic episode, or psychotic disorder diagnosis within the past two years. Active substance dependence disorder in the past year. Active suicidal or violent ideation within the past two months. Currently on an antipsychotic or mood-stabilizing agent. Unstable administration schedule or dosing of any antidepressant, anxiolytic, or sedative-hypnotic (i.e., will exclude for any related medication changes in the two-months prior to randomization). Acute or unstable physical illness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles C. Engel, M.D., M.P.H.
Organizational Affiliation
Uniformed Services University of the Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Savannah Primary Care Clinic (Charleston VA)
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Department of Veterans Affairs, Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Ralph H. Johnson VA Medical Center/Goose Creek Primary Care Clinic (Charleston VA)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Womack Army Medical Center
City
Ft. Bragg
State/Province
South Carolina
ZIP/Postal Code
28310
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17974932
Citation
Litz BT, Engel CC, Bryant RA, Papa A. A randomized, controlled proof-of-concept trial of an Internet-based, therapist-assisted self-management treatment for posttraumatic stress disorder. Am J Psychiatry. 2007 Nov;164(11):1676-83. doi: 10.1176/appi.ajp.2007.06122057.
Results Reference
background
Citation
Litz, BT, Williams, L, Wang, J, Bryant, R, and Engel, CC. A Therapist-Assisted Internet Self-Help Program for Traumatic Stress. Professional Psychology: Research and Practice 35(6):628-634, 2004.
Results Reference
background
PubMed Identifier
34015141
Citation
Simon N, Robertson L, Lewis C, Roberts NP, Bethell A, Dawson S, Bisson JI. Internet-based cognitive and behavioural therapies for post-traumatic stress disorder (PTSD) in adults. Cochrane Database Syst Rev. 2021 May 20;5(5):CD011710. doi: 10.1002/14651858.CD011710.pub3.
Results Reference
derived

Learn more about this trial

DElivery of Self Training and Education for Stressful Situations-Primary Care Version

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