PTSDNCT02457780
Stress Management Program for World Trade Center (WTC) Responders
A study testing Relaxation Response Resiliency Program (3RP) and Health Enhancement Program (HEP) in people with PTSD and Signs and Symptoms, Respiratory, run by Stony Brook University at 1 site in United States.
Trial summary
Many responders to the World Trade Center (WTC) disaster continue to experience significant mental and physical health problems. Two of the most common health problems, post-traumatic stress disorder (PTSD) symptoms and respiratory illness, often occur together. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Signs and Symptoms, Respiratory
- What is being tested?
- Relaxation Response Resiliency Program (3RP) and Health Enhancement Program (HEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PCL score equal to or greater than 35
- 2 or more lower respiratory symptoms
Who cannot join
- Regular elicitation of the relaxation response
- History of psychosis
- Current unmanaged bipolar disorder
- History of suicide attempt --OR-- current ideation with plan or intent
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University, Putnam Hall
Stony Brook, New York, 11794
About this study
Official title: Mind-Body Treatment for WTC Responders With Comorbid PTSD and Respiratory Illness
Many responders to the World Trade Center (WTC) disaster continue to experience significant mental and physical health problems. Two of the most common health problems, post-traumatic stress disorder (PTSD) symptoms and respiratory illness, often occur together. Mental health conditions, such as PTSD, make physical illnesses worse and interfere with treatment. The primary goal of this study is to test a mind-body treatment designed to reduce both PTSD and respiratory symptoms.
Read the detailed description
Mind-body interventions including relaxation training and other coping skills are effective for patients with both mental and physical health problems. A leading mind-body treatment is the Relaxation Response Resiliency Program (3RP) developed at Harvard. This treatment has been shown to reduce both mental and physical health symptoms.
The objective of this study is to adapt the 3RP to WTC responders and test its ability to reduce both PTSD and respiratory symptoms. This treatment will be compared to a Health Enhancement Program that addresses negative health behaviors. The investigators will randomly assign 175 patients with ongoing WTC-related PTSD and respiratory illness to the 3RP or Health Enhancement Program and will assess outcomes immediately after the treatment and at 3 and 6 month follow-ups.
- Conditions
- PTSD, Signs and Symptoms, Respiratory
- Being tested
- Relaxation Response Resiliency Program (3RP), Health Enhancement Program (HEP)
- Keywords
- PTSD, Trauma, World Trade Center, Respiratory, Mind-Body
- Medical subject headings
- Stress Disorders, Post-Traumatic, Signs and Symptoms, Respiratory, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation Response Resiliency Program (3RP)Behavioural
Also called Stress Management and Resiliency Training (SMART)
The 3RP is designed to decrease psychiatric and physical health symptoms and build resiliency by teaching skills to (1) elicit the relaxation response, (2) decrease stress reactivity and (3) increase social connectedness. Eliciting the relaxation response involves sustained mental focus with an attitude of receptive awareness with strategies aimed at reducing muscle tension, breathing rate, heart rate, and blood pressure. Decreasing stress reactivity involves increasing awareness of the stress response and learning skills to proactively address stress. Increasing connectedness involves skills to promote positive growth, self-efficacy and social support. Other skills and experiential exercises focus on increasing acceptance, optimism, empathy, and appreciation to promote resiliency.
Health Enhancement Program (HEP)Behavioural
The HEP is designed to address comorbid physical and mental health symptoms via psychoeducation, self-monitoring and goal setting techniques. It is an 8 session manualized group intervention which addresses topics including sleep hygiene, nutrition, exercise, working with a healthcare team, and substance use. The program uses a variety of in-session activities to engage participants in discussion related to self-care and wellness principles. Relapse prevention and long-term goal setting are addressed. The program is designed to be implemented by professionals with a background in mental health.
| Study group | Role | What they receive |
|---|---|---|
| Relaxation Response Resiliency Program | Experimental | The Relaxation Response Resiliency Program (3RP) is an 8-session (90min/session) group based intervention which includes a variety of skills and techniques designed to address chronic stress. Techniques used include psychoeducation on healthy lifestyle behaviors, goal-setting, CBT skills, relaxation training and self-monitoring. Receives: Behavioral: Relaxation Response Resiliency Program (3RP) |
| Health Enhancement Program | Active comparator | The Health Enhancement Program (HEP) is an 8-session (90min/session) group based intervention which includes psychoeducation and self-monitoring of health behaviors (e.g., sleep hygiene, nutrition, exercise, substance use etc). Receives: Behavioral: Health Enhancement Program (HEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report WTC-related PTSD Symptoms
Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S)
Measured: Change from baseline in WTC-related PTSD symptoms at 6-months
Clinician Rated WTC-related PTSD Symptoms
Assessed via clinician interview (SCID for DSM-IV-TR).
Measured: Change from baseline in WTC-related PTSD symptoms at 6-months
Secondary outcomes (2)
Lower Respiratory Symptoms
Assessed via self-report
Measured: Change from baseline in lower respiratory symptoms at 6-months
Pulmonary Functioning
Assessed via spirometry
Measured: Change from baseline in pulmonary functioning at 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startAug 2013
- Primary completionDec 2016
- Study completionDec 2016
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Sponsor
- Investigators
- Adam Gonzalez, PhD, Principal investigator, Stony Brook University Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457780
- Sponsor's protocol ID
- 1U01OH010524-01
- Status last verified
- Dec 2016
- First submitted
- 4 May 2015
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind-Body Treatment for WTC Responders With Comorbid PTSD and Respiratory Illness
- ClinicalTrials.gov ID
- NCT02457780
- Acronym / sponsor ID
- 1U01OH010524-01
- Conditions
- PTSD, Signs and Symptoms, Respiratory
- Keywords
- PTSD, Trauma, World Trade Center, Respiratory, Mind-Body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- Aug 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 May 2015 (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.
Many responders to the World Trade Center (WTC) disaster continue to experience significant mental and physical health problems. Two of the most common health problems, post-traumatic stress disorder (PTSD) symptoms and respiratory illness, often occur together. Mental health conditions, such as PTSD, make physical illnesses worse and interfere with treatment. The primary goal of this study is to test a mind-body treatment designed to reduce both PTSD and respiratory symptoms.
Detailed description
Mind-body interventions including relaxation training and other coping skills are effective for patients with both mental and physical health problems. A leading mind-body treatment is the Relaxation Response Resiliency Program (3RP) developed at Harvard. This treatment has been shown to reduce both mental and physical health symptoms.
The objective of this study is to adapt the 3RP to WTC responders and test its ability to reduce both PTSD and respiratory symptoms. This treatment will be compared to a Health Enhancement Program that addresses negative health behaviors. The investigators will randomly assign 175 patients with ongoing WTC-related PTSD and respiratory illness to the 3RP or Health Enhancement Program and will assess outcomes immediately after the treatment and at 3 and 6 month follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxation Response Resiliency Program | Experimental | Behavioral: Relaxation Response Resiliency Program (3RP)The Relaxation Response Resiliency Program (3RP) is an 8-session (90min/session) group based intervention which includes a variety of skills and techniques designed to address chronic stress. Techniques used include psychoeducation on healthy lifestyle behaviors, goal-setting, CBT skills, relaxation training and self-monitoring. |
| Health Enhancement Program | Active comparator | Behavioral: Health Enhancement Program (HEP)The Health Enhancement Program (HEP) is an 8-session (90min/session) group based intervention which includes psychoeducation and self-monitoring of health behaviors (e.g., sleep hygiene, nutrition, exercise, substance use etc). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- PCL score equal to or greater than 35
- 2 or more lower respiratory symptoms
Key exclusion criteria (4 listed)
- Regular elicitation of the relaxation response
- History of psychosis
- Current unmanaged bipolar disorder
- History of suicide attempt --OR-- current ideation with plan or intent
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 |
|---|---|---|
| Relaxation Response Resiliency Program (3RP)Also: Stress Management and Resiliency Training (SMART)The 3RP is designed to decrease psychiatric and physical health symptoms and build resiliency by teaching skills to (1) elicit the relaxation response, (2) decrease stress reactivity and (3) increase social connectedness. Eliciting the relaxation response involves sustained mental focus with an attitude of receptive awareness with strategies aimed at reducing muscle tension, breathing rate, heart rate, and blood pressure. Decreasing stress reactivity involves increasing awareness of the stress response and learning skills to proactively address stress. Increasing connectedness involves skills to promote positive growth, self-efficacy and social support. Other skills and experiential exercises focus on increasing acceptance, optimism, empathy, and appreciation to promote resiliency. | Behavioural | Relaxation Response Resiliency Program |
| Health Enhancement Program (HEP)The HEP is designed to address comorbid physical and mental health symptoms via psychoeducation, self-monitoring and goal setting techniques. It is an 8 session manualized group intervention which addresses topics including sleep hygiene, nutrition, exercise, working with a healthcare team, and substance use. The program uses a variety of in-session activities to engage participants in discussion related to self-care and wellness principles. Relapse prevention and long-term goal setting are addressed. The program is designed to be implemented by professionals with a background in mental health. | Behavioural | Health Enhancement Program |
Primary outcome
Self-report WTC-related PTSD Symptoms
Time frame: Change from baseline in WTC-related PTSD symptoms at 6-months
Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S)
Clinician Rated WTC-related PTSD Symptoms
Time frame: Change from baseline in WTC-related PTSD symptoms at 6-months
Assessed via clinician interview (SCID for DSM-IV-TR).
2 secondary outcomes
Lower Respiratory Symptoms
Time frame: Change from baseline in lower respiratory symptoms at 6-months
Pulmonary Functioning
Time frame: Change from baseline in pulmonary functioning at 6-months
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 22 Dec 2016.
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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.
Adam Gonzalez, PhD principal investigator
Stony Brook University Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Response Resiliency Program (3RP) and Health Enhancement Program (HEP) in people with PTSD and Signs and Symptoms, Respiratory, run by Stony Brook University 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 2 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 22 Dec 2016. 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?
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?
Self-report WTC-related PTSD Symptoms (time frame: Change from baseline in WTC-related PTSD symptoms at 6-months). 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 22 Dec 2016.