Post Traumatic Stress Disorder (PTSD)NCT02723097
A Pilot Test of the Relaxation Response Resiliency Program (3RP) in Spanish Speaking World Trade Center Survivors With Post Traumatic Stress Disorder (PTSD)
A study testing 3 RP in people with Post Traumatic Stress Disorder (PTSD), run by NYU Langone Health at 1 site in United States.
Trial summary
The objective of this protocol is to test the feasibility and acceptability of the Relaxation Response Resiliency Program (3RP), a psychotherapy treatment providing a variety of mind body skills and interventions to decrease medical and mental health symptoms and build resilience, in Spanish-speaking World Trade… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder (PTSD)
- What is being tested?
- 3 RP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 11 Oct 2017
- 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
- score > or = 44 on the PTSD Checklist PCL, considered the broad definition of PTSD syndrome71
- report at least one LRS symptoms (i.e., shortness of breath, wheezing, dyspnea or cough).
- Spanish Speaking
Who cannot join
- regular practice of eliciting relaxation response (i.e., meditation, yoga) in the past 6 months,
- serious unmanaged mental illness including bipolar disorder, psychosis, and active substance misuse disorders;
- inability to participate in consecutive sessions over 3-month period.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
The objective of this protocol is to test the feasibility and acceptability of the Relaxation Response Resiliency Program (3RP), a psychotherapy treatment providing a variety of mind body skills and interventions to decrease medical and mental health symptoms and build resilience, in Spanish-speaking World Trade Center (WTC) survivors, and to examine its clinical effectiveness to reduce Post Traumatic Stress Disorder (PTSD), depression, anxiety, and lower respiratory symptoms (LRS) and improve psychosocial functioning.
- Conditions
- Post Traumatic Stress Disorder (PTSD)
- Being tested
- 3 RP
- 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.
3 RPBehavioural
Also called Relaxation Response Resiliency Program
| Study group | Role | What they receive |
|---|---|---|
| Relaxation Response Resiliency Program (3RP) | Experimental | Not described Receives: Behavioral: 3 RP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structured Clinical Interview (SCID-NP) for Diagnostic and Statistical Manual DSM-IV
State-of-the-art instrument for obtaining psychiatric diagnoses.
Measured: 1 Month
Symptom Severity using PTSD Checklist
Symptoms will be assessed with the PTSD Checklist (PCL), a 17-item self-report measure of current (past month) PTSD symptoms based on the DSM-IV criteria. It is a widely-used and validated measure of PTSD symptom severity.
Measured: 1 Month
Assessment of Anxiety Symptoms using Generalized Anxiety Disorder Scale (GAD-7)
Measured: 1 Month
Measure of Functional Impairment using the Range of Impaired Functioning Tool (RIFT)
widely-used instrument that taps the domains of work, household duties, interpersonal relationships, recreation, and subjective satisfaction with life. Each domain is rated on a five-point scale from very good to very poor. The total score is the sum of the different domains.
Measured: 1 Month
Assessment of Mindful attention using Mindful Attention Awareness Scale (MAAS)
The MAAS is a 15-item questionnaire on which respondents indicate, on a 6 point Likert-type scale (1 = almost always to 6 = almost never), their level of awareness and attention to present events and experiences.
Measured: 1 Month
Health Promoting Behaviors will be assessed with the Health Promoting Lifestyles Profile-II (HPLP-II)
he HPLP-II is a 52 item self-report inventory of health behaviors and has been used in previous mind-body treatment studies
Measured: 1 Month
Measure of treatment expectancy using the Treatment Credibility/Expectancy Questionnaire.
The 6-item Treatment Credibility/Expectancy Questionnaire (CEQ)84 will be used to examine treatment expectancy related to the 3RP.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study start1 Mar 2016
- Primary completion11 Oct 2017
- Study completion11 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucia Ferri, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723097
- Sponsor's protocol ID
- 15-00721
- Status last verified
- Oct 2017
- First submitted
- 24 Mar 2016
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Test of the Relaxation Response Resiliency Program (3RP) in Spanish Speaking World Trade Center Survivors With Post Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT02723097
- Acronym / sponsor ID
- 15-00721
- Conditions
- Post Traumatic Stress Disorder (PTSD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 11 Oct 2017 (actual)
- Study completion
- 11 Oct 2017 (actual)
- First posted
- 30 Mar 2016 (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 objective of this protocol is to test the feasibility and acceptability of the Relaxation Response Resiliency Program (3RP), a psychotherapy treatment providing a variety of mind body skills and interventions to decrease medical and mental health symptoms and build resilience, in Spanish-speaking World Trade Center (WTC) survivors, and to examine its clinical effectiveness to reduce Post Traumatic Stress Disorder (PTSD), depression, anxiety, and lower respiratory symptoms (LRS) and improve psychosocial functioning.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relaxation Response Resiliency Program (3RP) | Experimental | Behavioral: 3 RP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- score > or = 44 on the PTSD Checklist PCL, considered the broad definition of PTSD syndrome71
- report at least one LRS symptoms (i.e., shortness of breath, wheezing, dyspnea or cough).
- Spanish Speaking
Key exclusion criteria (3 listed)
- regular practice of eliciting relaxation response (i.e., meditation, yoga) in the past 6 months,
- serious unmanaged mental illness including bipolar disorder, psychosis, and active substance misuse disorders;
- inability to participate in consecutive sessions over 3-month period.
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 |
|---|---|---|
| 3 RPAlso: Relaxation Response Resiliency Program | Behavioural | Relaxation Response Resiliency Program (3RP) |
Primary outcome
Structured Clinical Interview (SCID-NP) for Diagnostic and Statistical Manual DSM-IV
Time frame: 1 Month
State-of-the-art instrument for obtaining psychiatric diagnoses.
Symptom Severity using PTSD Checklist
Time frame: 1 Month
Symptoms will be assessed with the PTSD Checklist (PCL), a 17-item self-report measure of current (past month) PTSD symptoms based on the DSM-IV criteria. It is a widely-used and validated measure of PTSD symptom severity.
Assessment of Anxiety Symptoms using Generalized Anxiety Disorder Scale (GAD-7)
Time frame: 1 Month
Measure of Functional Impairment using the Range of Impaired Functioning Tool (RIFT)
Time frame: 1 Month
widely-used instrument that taps the domains of work, household duties, interpersonal relationships, recreation, and subjective satisfaction with life. Each domain is rated on a five-point scale from very good to very poor. The total score is the sum of the different domains.
Assessment of Mindful attention using Mindful Attention Awareness Scale (MAAS)
Time frame: 1 Month
The MAAS is a 15-item questionnaire on which respondents indicate, on a 6 point Likert-type scale (1 = almost always to 6 = almost never), their level of awareness and attention to present events and experiences.
Health Promoting Behaviors will be assessed with the Health Promoting Lifestyles Profile-II (HPLP-II)
Time frame: 1 Month
he HPLP-II is a 52 item self-report inventory of health behaviors and has been used in previous mind-body treatment studies
Measure of treatment expectancy using the Treatment Credibility/Expectancy Questionnaire.
Time frame: 1 Month
The 6-item Treatment Credibility/Expectancy Questionnaire (CEQ)84 will be used to examine treatment expectancy related to the 3RP.
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 18 Oct 2017.
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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.
Lucia Ferri, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 RP in people with Post Traumatic Stress Disorder (PTSD), run by NYU Langone Health 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 3 inclusion and 3 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 18 Oct 2017. 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?
Structured Clinical Interview (SCID-NP) for Diagnostic and Statistical Manual DSM-IV (time frame: 1 Month). The study lists 7 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 18 Oct 2017.