PTSDDESTRESS-TNCT01502449
Delivery of Self Training and Education for Stressful Situations-Telephone Version
A study testing DESTRESS-T in people with PTSD, run by Uniformed Services University of the Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD
- What is being tested?
- DESTRESS-T
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years
- DSM-IV diagnosis of PTSD (derived from the CAPS) due to combat in OIF/OEF deployment
- Active duty personnel
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fort Benning - Martin Army Community Hospital
Columbus, Georgia, 31905
Kristie L. Gore, Ph.D., 301-295-7351, kristie.gore@us.army.mil
Elizabeth Harper Cordova, MA, 301-295-7339, elizabeth.harper1@us.army.mil
About this study
Official title: Randomized Trial of Telephonic Psychotherapy and Case Management for Combat-Related Posttraumatic Stress Disorder
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.
Read the 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.
- Conditions
- PTSD
- Being tested
- DESTRESS-T, Optimized Usual Care (OUC)
- Keywords
- telemedicine, telephonic, PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DESTRESS-TBehavioural
Also called Delivery of Self-Training for Stressful Situations, Telephonic version
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Optimized Usual Care (OUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 weeks, 18 weeks, and 24 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: baseline, 12 week, 18 week, and 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed National Military Medical Center, United States Department of Defense, US Department of Veterans Affairs
- Responsible party
- Principal investigator, Charles Engel, Uniformed Services University of the Health Sciences
- Investigators
- COL Charles C. Engel, MD, MPH, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502449
- Sponsor's protocol ID
- D10-I-AR-J5-786
- Acronym
- DESTRESS-T
- Status last verified
- Jan 2012
- First submitted
- 12 Dec 2011
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Telephonic Psychotherapy and Case Management for Combat-Related Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01502449
- Acronym / sponsor ID
- DESTRESS-T / D10-I-AR-J5-786
- Conditions
- PTSD
- Keywords
- telemedicine, telephonic, PTSD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Collaborators
- Walter Reed National Military Medical Center, United States Department of Defense, US Department of Veterans Affairs
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 30 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DESTRESS-T | Experimental | Behavioral: DESTRESS-TUsual 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 |
| Optimized Usual Care (OUC) | Active comparator | Other: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age>18 years
- DSM-IV diagnosis of PTSD (derived from the CAPS) due to combat in OIF/OEF deployment
- Active duty personnel
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DESTRESS-TAlso: Delivery of Self-Training for Stressful Situations, Telephonic versionUsual 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 | Behavioural | DESTRESS-T |
| 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. | Other | Optimized Usual Care (OUC) |
Primary outcome
Posttraumatic Stress Disorder Checklist - Civilian Version (PCL)
Time frame: Baseline, 12 weeks, 18 weeks, and 24 weeks
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.
7 secondary outcomes
Medical Outcomes Survey Short-Form-12 (SF-12)
Time frame: Baseline, 12 weeks, 18 weeks, and 24 weeks
World Health Organization Health & Work Performance Questionnaire (HPQ)
Time frame: Baseline, 12 weeks, 18 weeks, and 24 weeks
Patient Health Questionnaire (PHQ)
Time frame: Baseline, 12 weeks, 18 weeks, and 24 weeks
Generalized Anxiety Symptom Severity (GAD-7)
Time frame: Baseline
Sheehan Disability Scale (SDS)
Time frame: baseline, 12 week, 18 week and 24 week
Alcohol Use Disorders Identification Test-Civilian version (AUDIT-C)
Time frame: baseline, 12 week, 18 week, and 24 week
Numeric Rating Scale for Pain (NRS).
Time frame: baseline, 12 week, 18 week, and 24 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
COL Charles C. Engel, MD, MPH principal investigator
Uniformed Services University of the Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DESTRESS-T in people with PTSD, run by Uniformed Services University of the Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Harper Cordova, MA (301-295-7339, elizabeth.harper1@us.army.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttraumatic Stress Disorder Checklist - Civilian Version (PCL) (time frame: Baseline, 12 weeks, 18 weeks, and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2012.