Posttraumatic Stress DisorderNCT02586064
Comparative Effectiveness of Two Treatments for Veterans With PTSD
A study testing Interpersonal Therapy for PTSD and Prolonged Exposure in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Interpersonal problems such as relationship conflict and social isolation are common among Veterans with PTSD and serve as barriers to successful posttraumatic adjustment. The main interventions for PTSD at VA facilities, i.e., Prolonged Exposure, Cognitive Processing Therapy, and Trauma-Focused CBT, do not directly… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Interpersonal Therapy for PTSD and Prolonged Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2016to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Southeast Louisiana Veterans Health Care System, New Orleans, LA
New Orleans, Louisiana, 70112
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908
About this study
Official title: Interpersonal Therapy for Veterans With PTSD
Interpersonal problems such as relationship conflict and social isolation are common among Veterans with PTSD and serve as barriers to successful posttraumatic adjustment. The main interventions for PTSD at VA facilities, i.e., Prolonged Exposure, Cognitive Processing Therapy, and Trauma-Focused CBT, do not directly target these relationship difficulties and many Veterans do not complete these treatments. Couple and family approaches for PTSD address relationship problems, but logistical problems make it difficult for couples to attend sessions and these approaches do not involve Veterans who are socially isolated or unmarried. There is accumulating evidence that Interpersonal Psychotherapy (IPT) for PTSD may be effective in reducing symptoms and improving interpersonal functioning. This study, a randomized controlled trial, aims to provide evidence regarding whether IPT for PTSD could be a useful addition to current treatments delivered at the VA.
Read the detailed description
The strong relationship between posttraumatic stress disorder (PTSD) and interpersonal problems is well documented. PTSD is highly associated with relationship discord, increased intimate partner violence, and difficulties in connecting with others, leading to social isolation. These types of conflicts, as well as the social withdrawal that is common among Veterans with PTSD, diminish the Veteran's opportunities for interaction with supportive others, and serve as a barrier to successful posttraumatic adjustment. Treatments that have been "rolled out" nationally in VAMCs, e.g., Prolonged Exposure, Cognitive Processing Therapy, and Trauma-Focused CBT, do not directly target these relationship difficulties. Furthermore, data show that only a limited number of Veterans has fully engaged with these interventions. Evidence-based interventions of couples therapy are available, but are not logistically feasible for many couples and do not address the problems of those who are socially isolated. This application proposes a randomized clinical trial of Interpersonal Psychotherapy (IPT-PTSD) as a treatment for Veterans with PTSD and relationship problems. Pilot data suggest that this type of treatment may provide a useful alternative strategy for Veterans who would prefer an individual, relationship-focused approach. The investigators propose comparing IPT-PTSD with Prolonged Exposure (PE), an evidence based treatment for PTSD used in the VHA system. The investigators hypothesize that IPT-PTSD will be statistically equivalent to PE in reducing PTSD symptom severity, and superior to PE in improving interpersonal functioning. IPT-PTSD is also hypothesized to be more effective than PE in improving social adjustment and quality of life. Exploratory analyses will examine whether IPT-PTSD is more effective than PE in reducing suicidal ideation, and will examine hypothesized mediators of improvement in PTSD symptoms in IPT-PTSD.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Interpersonal Therapy for PTSD, Prolonged Exposure
- Keywords
- posttraumatic stress disorder, Veterans, Psychotherapy, Randomized Controlled Trial, Treatment
- 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.
Interpersonal Therapy for PTSDBehavioural
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.
Prolonged ExposureBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal Psychotherapy for PTSD | Experimental | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Receives: Behavioral: Interpersonal Therapy for PTSD |
| Prolonged Exposure | Active comparator | Exposure based intervention including exposure to memories and avoided places and activities Receives: Behavioral: Prolonged Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinician Administered PTSD Scale (CAPS-5)
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.
Measured: 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)
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.
Measured: 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 outcomes (12)
Change in PTSD Checklist for DSM-5 Military Version (PCL-M)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline to 6 months posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study start1 Sep 2016
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Georgetown University, Southeast Louisiana Veterans Health Care System
- Responsible party
- Sponsor
- Investigators
- Tracie M. Shea, PhD, Principal investigator, Providence VA Medical Center, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586064
- Sponsor's protocol ID
- D1783-R
- Other IDs
- I01RX001783
- Status last verified
- Jun 2021
- First submitted
- 20 Oct 2015
- Last updated
- 7 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: not developed yet
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interpersonal Therapy for Veterans With PTSD
- ClinicalTrials.gov ID
- NCT02586064
- Acronym / sponsor ID
- D1783-R
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- posttraumatic stress disorder, Veterans, Psychotherapy, Randomized Controlled Trial, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Georgetown University, Southeast Louisiana Veterans Health Care System
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 26 Oct 2015 (estimated)
- Results
- Posted 7 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interpersonal problems such as relationship conflict and social isolation are common among Veterans with PTSD and serve as barriers to successful posttraumatic adjustment. The main interventions for PTSD at VA facilities, i.e., Prolonged Exposure, Cognitive Processing Therapy, and Trauma-Focused CBT, do not directly target these relationship difficulties and many Veterans do not complete these treatments. Couple and family approaches for PTSD address relationship problems, but logistical problems make it difficult for couples to attend sessions and these approaches do not involve Veterans who are socially isolated or unmarried. There is accumulating evidence that Interpersonal Psychotherapy (IPT) for PTSD may be effective in reducing symptoms and improving interpersonal functioning. This study, a randomized controlled trial, aims to provide evidence regarding whether IPT for PTSD could be a useful addition to current treatments delivered at the VA.
Detailed description
The strong relationship between posttraumatic stress disorder (PTSD) and interpersonal problems is well documented. PTSD is highly associated with relationship discord, increased intimate partner violence, and difficulties in connecting with others, leading to social isolation. These types of conflicts, as well as the social withdrawal that is common among Veterans with PTSD, diminish the Veteran's opportunities for interaction with supportive others, and serve as a barrier to successful posttraumatic adjustment. Treatments that have been "rolled out" nationally in VAMCs, e.g., Prolonged Exposure, Cognitive Processing Therapy, and Trauma-Focused CBT, do not directly target these relationship difficulties. Furthermore, data show that only a limited number of Veterans has fully engaged with these interventions. Evidence-based interventions of couples therapy are available, but are not logistically feasible for many couples and do not address the problems of those who are socially isolated. This application proposes a randomized clinical trial of Interpersonal Psychotherapy (IPT-PTSD) as a treatment for Veterans with PTSD and relationship problems. Pilot data suggest that this type of treatment may provide a useful alternative strategy for Veterans who would prefer an individual, relationship-focused approach. The investigators propose comparing IPT-PTSD with Prolonged Exposure (PE), an evidence based treatment for PTSD used in the VHA system. The investigators hypothesize that IPT-PTSD will be statistically equivalent to PE in reducing PTSD symptom severity, and superior to PE in improving interpersonal functioning. IPT-PTSD is also hypothesized to be more effective than PE in improving social adjustment and quality of life. Exploratory analyses will examine whether IPT-PTSD is more effective than PE in reducing suicidal ideation, and will examine hypothesized mediators of improvement in PTSD symptoms in IPT-PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Psychotherapy for PTSD | Experimental | Behavioral: Interpersonal Therapy for PTSDRelationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions |
| Prolonged Exposure | Active comparator | Behavioral: Prolonged ExposureExposure based intervention including exposure to memories and avoided places and activities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Interpersonal Therapy for PTSDRelationally 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. | Behavioural | Interpersonal Psychotherapy for PTSD |
| Prolonged ExposureAim 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). | Behavioural | Prolonged Exposure |
Primary outcome
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.
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.
12 secondary outcomes
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
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
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
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
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
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
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
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
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
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.
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.
GAD - 7 Generalized Anxiety Disorder
Time frame: Baseline to 6 months posttreatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. not developed yet
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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.
Tracie M. Shea, PhD principal investigator
Providence VA Medical Center, Providence, RI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Therapy for PTSD and Prolonged Exposure in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 2 sites 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 7 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. 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 7 Jul 2021.