PTSDNCT01033136
Exposure Therapy For Veterans With PTSD And Panic Attacks
A study testing Multiple Channel Exposure Therapy - Veterans and Cognitive Processing Therapy in people with PTSD and Panic Attacks, run by VA Office of Research and Development at 1 site in United States.
Trial summary
To evaluate the feasibility, acceptability and effectiveness of Multiple Channel Exposure Therapy-Veterans (MCET-V) as a treatment for returning service members with comorbid PTSD and panic disorder (PD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- PTSD, Panic Attacks
- What is being tested?
- Multiple Channel Exposure Therapy - Veterans and Cognitive Processing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2013to 1 Jan 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being a Veteran of any era;
- being enrolled in the TRP at the MEDVAMC, with a current diagnosis of PTSD and PD;
- being stable on psychotropic medication for 4 weeks before study participation; and
- being at least 18 years of age.
Who cannot join
- active substance dependence, or bipolar or psychotic disorders;
- severe depression and [active suicidal ideation and intent] (based on ADIS-IV \& BDI-II);
- cognitive impairment as indicated by the SLUMS; and
- Veterans currently receiving psychosocial treatment specifically targeting PTSD or panic symptoms.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
About this study
Official title: Exposure Therapy for Veterans With PTSD and Panic Attacks
To evaluate the feasibility, acceptability and effectiveness of Multiple Channel Exposure Therapy-Veterans (MCET-V) as a treatment for returning service members with comorbid PTSD and panic disorder (PD). This study will examine the effectiveness of MCET-V by comparing it to Cognitive Processing Therapy, a standard PTSD treatment.
Read the detailed description
With the increasing number of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF) Veterans returning from war-zone areas, many will experience anxiety disorders such as PTSD and comorbid problems. Currently, about one in every six OIF/OEF Veterans experiences PTSD and co-occurring PD. Although effective treatments exist for treating one or the other, we do not yet have treatments that can simultaneously target PTSD and PD. Thus, recent attention has focused on the development of multi-component treatments that simultaneously address PTSD and PD. This study is the first systematic investigation of a time-limited, multi-component cognitive-behavioral treatment for Veterans with specific comorbid anxiety problems. The purpose of the study is to evaluate the effectiveness of the multi-component cognitive-behavioral treatment in comparison to standard PTSD treatment in military personnel returning from active duty.
- Conditions
- PTSD, Panic Attacks
- Being tested
- Multiple Channel Exposure Therapy - Veterans, Cognitive Processing Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Channel Exposure Therapy - VeteransBehavioural
Also called MCET-V
MCET-V offers individual therapy that provides psychoeducation about panic attacks and trauma and involves behavioral and cognitive exposure exercises.
Cognitive Processing TherapyBehavioural
Also called CPT
CPT offers individual therapy that targets trauma and PTSD symptoms via cognitive restructuring.
| Study group | Role | What they receive |
|---|---|---|
| MCET-V | Experimental | Multiple Channel Exposure Therapy -Veterans (MCET-V) is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously. Receives: Behavioral: Multiple Channel Exposure Therapy - Veterans |
| CPT | Active comparator | Cognitive Processing Therapy (CPT) is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms. Receives: Behavioral: Cognitive Processing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups
The CAPS is a clinician-administered assessment of the presence and severity of PTSD symptoms. Scores range from 0 - 136, with higher scores indicating greater symptom severity.
Measured: Baseline, 1-week post-treatment and 3-month follow-up
Change in PDSS Scores Over Time for MCET-V and CPT Groups
The Panic Disorder Severity Scale (PDSS) is a clinician-rated assessment of the presence and severity of panic symptoms. Scores range from 0 - 28, with higher scores indicating greater symptom severity.
Measured: Baseline, 1-week post, and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study start1 Jan 2013
- Primary completion30 Sep 2016
- Study completion1 Jan 2017
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 PTSDStudies 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
- Single group
- Model description
- Multiple Channel Exposure Therapy is a behavioral treatment that simultaneously targets panic disorder and PTSD.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ellen Teng, PhD, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033136
- Sponsor's protocol ID
- CDA2-012-09F
- Status last verified
- Aug 2018
- First submitted
- 3 Dec 2009
- Last updated
- 17 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure Therapy for Veterans With PTSD and Panic Attacks
- ClinicalTrials.gov ID
- NCT01033136
- Acronym / sponsor ID
- CDA2-012-09F
- Conditions
- PTSD, Panic Attacks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 16 Dec 2009 (estimated)
- Results
- Posted 20 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the feasibility, acceptability and effectiveness of Multiple Channel Exposure Therapy-Veterans (MCET-V) as a treatment for returning service members with comorbid PTSD and panic disorder (PD). This study will examine the effectiveness of MCET-V by comparing it to Cognitive Processing Therapy, a standard PTSD treatment.
Detailed description
With the increasing number of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF) Veterans returning from war-zone areas, many will experience anxiety disorders such as PTSD and comorbid problems. Currently, about one in every six OIF/OEF Veterans experiences PTSD and co-occurring PD. Although effective treatments exist for treating one or the other, we do not yet have treatments that can simultaneously target PTSD and PD. Thus, recent attention has focused on the development of multi-component treatments that simultaneously address PTSD and PD. This study is the first systematic investigation of a time-limited, multi-component cognitive-behavioral treatment for Veterans with specific comorbid anxiety problems. The purpose of the study is to evaluate the effectiveness of the multi-component cognitive-behavioral treatment in comparison to standard PTSD treatment in military personnel returning from active duty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multiple Channel Exposure Therapy is a behavioral treatment that simultaneously targets panic disorder and PTSD.
| Arm | Type | Receives |
|---|---|---|
| MCET-V | Experimental | Behavioral: Multiple Channel Exposure Therapy - VeteransMultiple Channel Exposure Therapy -Veterans (MCET-V) is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously. |
| CPT | Active comparator | Behavioral: Cognitive Processing TherapyCognitive Processing Therapy (CPT) is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being a Veteran of any era;
- being enrolled in the TRP at the MEDVAMC, with a current diagnosis of PTSD and PD;
- being stable on psychotropic medication for 4 weeks before study participation; and
- being at least 18 years of age.
Key exclusion criteria (4 listed)
- active substance dependence, or bipolar or psychotic disorders;
- severe depression and [active suicidal ideation and intent] (based on ADIS-IV \& BDI-II);
- cognitive impairment as indicated by the SLUMS; and
- Veterans currently receiving psychosocial treatment specifically targeting PTSD or panic symptoms.
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 |
|---|---|---|
| Multiple Channel Exposure Therapy - VeteransAlso: MCET-VMCET-V offers individual therapy that provides psychoeducation about panic attacks and trauma and involves behavioral and cognitive exposure exercises. | Behavioural | MCET-V |
| Cognitive Processing TherapyAlso: CPTCPT offers individual therapy that targets trauma and PTSD symptoms via cognitive restructuring. | Behavioural | CPT |
Primary outcome
Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups
Time frame: Baseline, 1-week post-treatment and 3-month follow-up
The CAPS is a clinician-administered assessment of the presence and severity of PTSD symptoms. Scores range from 0 - 136, with higher scores indicating greater symptom severity.
Change in PDSS Scores Over Time for MCET-V and CPT Groups
Time frame: Baseline, 1-week post, and 3-month follow-up
The Panic Disorder Severity Scale (PDSS) is a clinician-rated assessment of the presence and severity of panic symptoms. Scores range from 0 - 28, with higher scores indicating greater symptom severity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ellen Teng, PhD principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple Channel Exposure Therapy - Veterans and Cognitive Processing Therapy in people with PTSD and Panic Attacks, run by VA Office of Research and Development 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 4 inclusion and 4 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 17 Sep 2018. 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?
Yes. Results are posted in the registry (first posted 20 Jul 2018). 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 PTSD Symptoms (CAPS) Between MCET-V and CPT Groups (time frame: Baseline, 1-week post-treatment and 3-month follow-up). 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 17 Sep 2018.