- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02586064
Comparative Effectiveness of Two Treatments for Veterans With PTSD
Interpersonal Therapy for Veterans With PTSD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Louisiana
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New Orleans, Louisiana, United States, 70112
- Southeast Louisiana Veterans Health Care System, New Orleans, LA
-
-
Rhode Island
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Providence, Rhode Island, United States, 02908
- Providence VA Medical Center, Providence, RI
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Veterans age 18 or older
- Experienced trauma while deployed to a war zone
- Meet DSM-5 criteria for PTSD and a minimum CAPS-5 score of 23
- Have at least one area of relationship dysfunction
- Consent to be randomized
Exclusion Criteria:
- Current severe substance use disorder
- Current psychotic symptoms
- Current mania or un-medicated Bipolar Disorder
- Imminent threat of suicide or homicide
- Victim or perpetrator of severe domestic violence in the past 12 months
- Currently receiving Cognitive Behavioral Therapy for PTSD
- Psychotropic medication start or dosage change within the prior 4 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interpersonal Psychotherapy for PTSD
Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions
|
Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms.
Consists of 12 individual weekly sessions of 45 to 50 minutes.
Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g.
communication analysis, decision analysis, role play).
Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.
|
Active Comparator: Prolonged Exposure
Exposure based intervention including exposure to memories and avoided places and activities
|
Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding.
12 individual weekly sessions of 90 minutes.
Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Clinician Administered PTSD Scale (CAPS-5)
Time Frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Structured interview for assessment of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome. |
Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Change in Inventory of Interpersonal Functioning (IIP-32)
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Self-report measure of Veterans' interpersonal difficulties. Scores range from a minimum value of 0 to a maximum value of 128, higher scores mean a worse outcome. |
Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PTSD Checklist for DSM-5 Military Version (PCL-M)
Time Frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Self report measure of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome. |
Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Change in Patient Health Questionnaire (PHQ)
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Self report measure of mood and anxiety symptoms. Scores range from a minimum value of 0 to a maximum value of 27, higher scores mean a worse outcome. |
Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other
Time Frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Self-report measure of a participant's subjective social support with regards to a participant's significant other. For each subscale, the mean of items is reported therefore for the Significant Other Subscale: Sum across items 1, 2, 5, & 10, then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome. |
Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family
Time Frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Self-report measure of a participant's subjective social support with regards to a participant's family. For each subscale, the mean of items is reported therefore for the Family Subscale: Sum across items 3, 4, 8, & 11 then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome. |
Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends
Time Frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Self-report measure of a participant's subjective social support with regards to a participant's family. For each subscale, the mean of items is reported therefore for the Friends Subscale: Sum across items 6, 7, 9, & 12 then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome. |
Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Change in Concise Health Risk Tracking Scale - Total (CHRT)
Time Frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Self report measure of suicidal ideation and related symptoms. Our study used a response scale of 1 to 5. The CHRT has 12 items, and the total score has a possible range of 12 to 60. Higher scores indicate more suicidal ideation and risk. |
Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Change in Concise Health Risk Tracking Scale (CHRT) - Propensity
Time Frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
The propensity subscale score includes 9 items assessing, hopelessness, self-worth and perceived social support, and the possible range for our study is 9 to 45 Higher scores indicate worse outcome. |
Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts
Time Frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
The CHRT Suicidal Thoughts subscale includes 3 items and has a possible range in our study from 3 to 15.
Higher scores indicate higher suicidal thoughts.
|
Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Change in Work and Social Adjustment Scale (WSAS)
Time Frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Self report measure of functional impairment in five areas of functioning (work, home management, social leisure, personal leisure, close relationships. Scores range from a minimum value of 0 to a maximum value of 40, higher scores mean a worse outcome. |
Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
|
Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life
Time Frame: Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks.
|
Measure of four domains related to quality of life: physical health, psychological, social relationships and environment. Data presented from Item 1 (Quality of Life) Scores range from a minimum value of 1 to a maximum value of 5, lower scores mean a worse outcome. |
Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks.
|
Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health
Time Frame: Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks.
|
Measure of four domains related to quality of life: physical health, psychological, social relationships and environment. Data presented from Item 2 (Satisfaction with Health). Scores range from a minimum value of 1 to a maximum value of 5, lower scores mean a worse outcome. |
Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks.
|
GAD - 7 Generalized Anxiety Disorder
Time Frame: Baseline to 6 months posttreatment
|
Measure of generalized anxiety amongst participants over time. Scores range from a minimum value of 0 to a maximum value of 21, higher scores mean a worse outcome. |
Baseline to 6 months posttreatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tracie M. Shea, PhD, Providence VA Medical Center, Providence, RI
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1783-R
- I01RX001783 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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