Post-Traumatic Stress DisorderPhase 3NCT00941629
Comparison of Videoconference and Face-to-Face Delivery of Cognitive Processing Therapy for Posttraumatic Stress Disorder
A Phase 3 study testing Cognitive Processing Therapy (CPT) in people with Post-Traumatic Stress Disorder, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the equivalence of CPT treatment delivered remotely via telemental health (TMH) over videoconferencing or via traditional face-to face (FTF) treatment to veterans who have Post-traumatic Stress Disorder (PTSD) from a military-related stressor (i.e., combat, sexual assault… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Cognitive Processing Therapy (CPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2009to Nov 2013
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Literate in written English
- Fluent in spoken English
- Verified status as an OEF/OIF veteran
- Current PTSD diagnosis
- Index traumatic event related to military services
- If taking psychotropic medication, remains stable
Who cannot join
- Under 18 years of age
- Not literate in written English
- Not fluent in spoke English
- Current uncontrolled psychotic or bipolar disorder
- Substance dependence
- Current uncontrolled suicidal or homicidal ideation
- Significant cognitive impairment that would interfere with completion of therapy tasks
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Edward J. Hines Jr. Veterans Hospital, Cares Research Foundation FWA00001322
Hines, Illinois, 60141
Wm. S.Middleton Memorial Veterans Hospital
Madison, Wisconsin, 53705
About this study
Official title: Randomized Controlled Equivalence Trial Comparing Videoconference and Face-to-Face Delivery of Cognitive Processing Therapy for PTSD
The purpose of this study is to evaluate the equivalence of CPT treatment delivered remotely via telemental health (TMH) over videoconferencing or via traditional face-to face (FTF) treatment to veterans who have Post-traumatic Stress Disorder (PTSD) from a military-related stressor (i.e., combat, sexual assault, non-combat physical assault). The secondary objective is to determine if patients' ratings of PTSD symptoms, affect, social adjustment, therapy alliance, treatment satisfaction and therapist satisfaction, are equivalent between service-delivery conditions (TMH vs. FTF). A final objective is to develop web-based practice assignments to assist participants in the TMH condition with treatment adherence (completion of the between- session practice assignments).
Read the detailed description
PTSD is the most common mental health diagnosis affecting service men and women who have served in Iraq and Afghanistan (OEF/OIF). Despite unprecedented efforts by the Dept. of Defense (DoD) and Dept. of Veterans Affairs (VA) to treat these service personnel with mental disorders, significant gaps in the continuum of care for psychological health remain, specifically related to which services are offered, where services are offered, and who receives services. The DoD and VA have also attempted to address problems with accessibility through the development of a video teleconference (VTC) network to ensure that service members have access to top-quality specialized medical care regardless of their geographical location. Provision of medical treatment over VTC is often referred to as telemedicine; telemental health (TMH) refers to the provision of mental health treatment over the same system. A handful of studies have shown that psychiatry (primarily medication management) delivered over TMH systems can be as effective as face-to-face (FTF) treatment as long as the equipment and band-width are capable of delivering the communication in near real time.TMH is an increasingly common method of providing psychological treatment to service members with PTSD and other mental health problems, and yet there are no randomized trials of TMH provision of an empirically validated treatment for PTSD compared with FTF treatment. Therefore, this study aims to evaluate the treatment outcomes of patients with PTSD treated with CPT either remotely via TMH or traditionally in FTF treatment.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Cognitive Processing Therapy (CPT)
- Keywords
- PTSD, Telemedicine, Clinical Trial, Psychotherapy
- 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.
Cognitive Processing Therapy (CPT)Behavioural
Also called CPT
Patients with PTSD receive a trauma-focused, cognitive-behavioral intervention in Face-to -Face treatment.
Cognitive Processing Therapy (CPT)Behavioural
Also called CPT
Provision of Cognitive Processing Therapy over teleconference network (telemental health; telehealth)
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Processing Therapy FTF | Active comparator | Cognitive Processing Therapy delivered in traditional face-to-face sessions (FTF) Receives: Behavioral: Cognitive Processing Therapy (CPT) |
| Cognitive Processing Therapy TMH | Experimental | Cognitive Processing Therapy delivered over videoconferencing equipment to a distant location (or telemental health; TMH) Receives: Behavioral: Cognitive Processing Therapy (CPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Clinician Administered PTSD Scale(CAPS) score.
Measured: At baseline, post-treatment( after 6 weeks) and the 3-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startDec 2009
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Tracey L Smith, Ph.D., Principal investigator, Wm.S. Middleton Memorial Veterans Hospital FWA 00005784
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941629
- Sponsor's protocol ID
- HSLC-IRB #H2013-0037
- Other IDs
- PT075415
- Status last verified
- Sep 2015
- First submitted
- 15 Jul 2009
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Miles SR, Smith TL, Maieritsch KP, Ahearn EP. Fear of Losing Emotional Control Is Associated With Cognitive Processing Therapy Outcomes in U.S. Veterans of Afghanistan and Iraq. J Trauma Stress. 2015 Oct;28(5):475-9. doi: 10.1002/jts.22036. Epub 2015 Sep 23.
PubMed 26397721
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Equivalence Trial Comparing Videoconference and Face-to-Face Delivery of Cognitive Processing Therapy for PTSD
- ClinicalTrials.gov ID
- NCT00941629
- Acronym / sponsor ID
- HSLC-IRB #H2013-0037
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- PTSD, Telemedicine, Clinical Trial, Psychotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- Dec 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 17 Jul 2009 (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.
The purpose of this study is to evaluate the equivalence of CPT treatment delivered remotely via telemental health (TMH) over videoconferencing or via traditional face-to face (FTF) treatment to veterans who have Post-traumatic Stress Disorder (PTSD) from a military-related stressor (i.e., combat, sexual assault, non-combat physical assault). The secondary objective is to determine if patients' ratings of PTSD symptoms, affect, social adjustment, therapy alliance, treatment satisfaction and therapist satisfaction, are equivalent between service-delivery conditions (TMH vs. FTF). A final objective is to develop web-based practice assignments to assist participants in the TMH condition with treatment adherence (completion of the between- session practice assignments).
Detailed description
PTSD is the most common mental health diagnosis affecting service men and women who have served in Iraq and Afghanistan (OEF/OIF). Despite unprecedented efforts by the Dept. of Defense (DoD) and Dept. of Veterans Affairs (VA) to treat these service personnel with mental disorders, significant gaps in the continuum of care for psychological health remain, specifically related to which services are offered, where services are offered, and who receives services. The DoD and VA have also attempted to address problems with accessibility through the development of a video teleconference (VTC) network to ensure that service members have access to top-quality specialized medical care regardless of their geographical location. Provision of medical treatment over VTC is often referred to as telemedicine; telemental health (TMH) refers to the provision of mental health treatment over the same system. A handful of studies have shown that psychiatry (primarily medication management) delivered over TMH systems can be as effective as face-to-face (FTF) treatment as long as the equipment and band-width are capable of delivering the communication in near real time.TMH is an increasingly common method of providing psychological treatment to service members with PTSD and other mental health problems, and yet there are no randomized trials of TMH provision of an empirically validated treatment for PTSD compared with FTF treatment. Therefore, this study aims to evaluate the treatment outcomes of patients with PTSD treated with CPT either remotely via TMH or traditionally in FTF treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Processing Therapy FTF | Active comparator | Behavioral: Cognitive Processing Therapy (CPT)Cognitive Processing Therapy delivered in traditional face-to-face sessions (FTF) |
| Cognitive Processing Therapy TMH | Experimental | Behavioral: Cognitive Processing Therapy (CPT)Cognitive Processing Therapy delivered over videoconferencing equipment to a distant location (or telemental health; TMH) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older
- Literate in written English
- Fluent in spoken English
- Verified status as an OEF/OIF veteran
- Current PTSD diagnosis
Key exclusion criteria (7 listed)
- Under 18 years of age
- Not literate in written English
- Not fluent in spoke English
- Current uncontrolled psychotic or bipolar disorder
- Substance dependence
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 |
|---|---|---|
| Cognitive Processing Therapy (CPT)Also: CPTPatients with PTSD receive a trauma-focused, cognitive-behavioral intervention in Face-to -Face treatment. | Behavioural | Cognitive Processing Therapy FTF |
| Cognitive Processing Therapy (CPT)Also: CPTProvision of Cognitive Processing Therapy over teleconference network (telemental health; telehealth) | Behavioural | Cognitive Processing Therapy TMH |
Primary outcome
The Clinician Administered PTSD Scale(CAPS) score.
Time frame: At baseline, post-treatment( after 6 weeks) and the 3-month follow-up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
- Derived from this study: PubMed 26397721Miles SR, Smith TL, Maieritsch KP, Ahearn EP. Fear of Losing Emotional Control Is Associated With Cognitive Processing Therapy Outcomes in U.S. Veterans of Afghanistan and Iraq. J Trauma Stress. 2015 Oct;28(5):475-9. doi: 10.1002/jts.22036. Epub 2015 Sep 23.
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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.
Tracey L Smith, Ph.D. principal investigator
Wm.S. Middleton Memorial Veterans Hospital FWA 00005784
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive Processing Therapy (CPT) in people with Post-Traumatic Stress Disorder, run by University of Wisconsin, Madison 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 7 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 2 Oct 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Clinician Administered PTSD Scale(CAPS) score. (time frame: At baseline, post-treatment( after 6 weeks) and the 3-month follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00941629, which also lists 1 linked publication.
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 2 Oct 2015.