StressNCT03203902
Comparative Effectiveness of Stress Management
A study testing Psychoeducation and Therapeutic Touch in people with Stress, run by Columbia University at 1 site in United States.
Trial summary
Many formerly homeless adults with chronic mental illness experience treatment resistant symptoms for which pharmaceutical agents and cognitive behavioral therapy are not effective. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Psychoeducation and Therapeutic Touch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2017to 10 Jan 2018
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current supportive housing resident
- History of homelessness
- History of mental illness
Who cannot join
- Severe behavioral or anger management disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Comparative Effectiveness of Stress Management Using Psychoeducation Versus Therapeutic Touch for Formerly Homeless Adults With Mental Illness and Substance Use Histories
Many formerly homeless adults with chronic mental illness experience treatment resistant symptoms for which pharmaceutical agents and cognitive behavioral therapy are not effective. Although formerly homeless adults with chronic mental illness typically receive medical and psychiatric services to manage their illness, chronic stress and post-traumatic stress disorder (PTSD) acquired from homelessness are difficult to resolve and many adults experience relapse that can result in housing loss. Therapeutic touch is a complementary and alternative treatment that has been shown to be effective at reducing stress, anxiety, and pain in a variety of diagnoses including cancer, cardiac disease, chronic pain syndromes, and PTSD in veterans. In this study the investigators aim to determine whether a 30-minute therapeutic touch session combined with a conventional 1-hour psychoeducation group delivered over 6 weeks can more effectively reduce stress compared to conventional psychoeducation alone. The ability to reduce stress levels and maintain emotional equilibrium is critical for this population to manage illness symptoms effectively and stave off the incidence of relapse, rehospitalizations, and housing loss.
Read the detailed description
In 2015, approximately 600,000 people were reported to be homeless on any given night in the United States and 1.6 million used homeless shelter services. One-third of homeless adults who received shelter services were diagnosed with chronic mental illness (e.g., schizophrenia, bipolar disorder, major depression) and two-thirds had substance use disorders.
Once housed in supportive living residences, formerly homeless adults with mental illness commonly continue to experience high levels of stress, anxiety, depression, and post-traumatic stress disorder (PTSD), despite receiving medical and psychiatric services. Stress that is not sufficiently addressed can frequently lead to rehospitalizations and subsequent loss of housing. Although stress has been successfully treated with anti-anxiety pharmaceuticals, cognitive behavioral therapies, and support groups in adults in the larger population, formerly homeless adults with chronic mental illness tend to experience greater treatment resistance to such interventions or respond positively for short intervals and then relapse.
One nonpharmacological intervention that has gained increasing support in the last two decades is therapeutic touch. Therapeutic touch, also referred to as healing touch and touch therapy, is a complementary and alternative treatment in which practitioners seek to alleviate or reduce pain, stress, or anxiety through direct hand contact with a client's bio- or energy field. A bio- or energy field is defined in quantum physics as an interconnected web of energy that surrounds living organisms and may regulate emotional states and physical health. Although the existence of energy fields is increasingly accepted in the scientific community, the precise roles of and mechanisms through which energy fields work are not understood. While eastern health practitioners have for centuries used therapies addressing energy fields-for example, acupuncture, acupressure, Ayurveda, qi gong-western practitioners have only begun using such therapies in the last century. The most common western names for energy field therapy are therapeutic touch, healing touch, Reiki, and touch therapy-all of which have growing bodies of evidence supporting their effectiveness in the reduction of stress, anxiety, and pain in various diagnostic populations including cancer, cardiovascular disease, and chronic pain syndromes.
Although there is evidence that therapeutic touch can help reduce symptoms of PTSD in veterans, and stress and anxiety in cancer and cardiac patients, little information exists about whether therapeutic touch can reduce stress in formerly homeless adults with chronic mental illness. The ability to reduce stress in formerly homeless adults may help them manage illness symptoms better and prevent relapse for longer intervals.
In this comparative effectiveness study, the investigators will provide a conventional stress management psychoeducation group to 20 participants. Ten of these 20 participants will additionally receive 30 minutes of therapeutic touch delivered in a group setting. The remaining 10 participants will receive 30 minutes of sham therapeutic touch delivered in a group setting. Ten additional participants will be allocated to a control group with no intervention.
- Conditions
- Stress
- Being tested
- Psychoeducation and Therapeutic Touch
- Keywords
- Therapeutic touch, Post-traumatic Stress Disorder, Homeless
- 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.
Psychoeducation and Therapeutic TouchOther
6-week, 1-hour psychoeducation group followed by 30-minute therapeutic touch
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation and Therapeutic Touch | Active comparator | 6-week psychoeducation group. The following 1-hour modules will be delivered:
Week 1: Anger Management and Conflict Negotiation Week 2: Meditation and Breathing Techniques Week 3: Nutrition Week 4: Exercise, Leisure, and Recreation Week 5: Sleep Week 6: Wellness Recovery Action Plan (WRAP)
Directly after the psychoeducation group is completed, 30-minute therapeutic touch will be administered. Receives: Other: Psychoeducation and Therapeutic Touch |
| Psychoeducation and Sham Therapeutic Touch | Placebo comparator | 6-week psychoeducation group. The following 1-hour modules will be delivered:
Week 1: Anger Management and Conflict Negotiation Week 2: Meditation and Breathing Techniques Week 3: Nutrition Week 4: Exercise, Leisure, and Recreation Week 5: Sleep Week 6: Wellness Recovery Action Plan (WRAP)
Directly after the psychoeducation group is completed, 30-minute sham therapeutic touch will be administered. Receives: Other: Psychoeducation and Therapeutic Touch |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Score on Perceived Stress Scale between pre- and post-intervention
5-point, 10-item Likert scale that takes approximately 5 minutes to complete
Measured: baseline and 7 weeks
Secondary outcomes (1)
Difference in Score on World Health Quality of Life Scale between pre- and post-intervention
5-point, 26-item scale that takes approximately 15 minutes to complete
Measured: baseline and 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start10 Sep 2017
- Primary completion10 Jan 2018
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Model description
- Three arm, randomized controlled design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Gutman, Columbia University
- Investigators
- Sharon Gutman, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203902
- Sponsor's protocol ID
- AAAR4338
- Status last verified
- Jan 2018
- First submitted
- 28 Jun 2017
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
US Department of Housing and Urban Development. (2015) 2015 Annual Homeless Assessment Report (AHAR) to Congress (November 2015). Retrieved from https://www.hudexchange.info/resources/documents/2015-AHAR-Part-1.pdf
Treatment Advocacy Center. (2014) Eliminating barriers to the treatment of mental illness. How many individuals with a serious mental illness are homeless? Retrieved from http://www.treatmentadvocacycenter.org/problem/consequences-ofnon-treatment/2058
Office of National Drug Control Policy. (n.d.) Chapter 3. Integrate treatment for substance use disorders into mainstream health care and expand support for recovery. Retrieved from https://www.whitehouse.gov/ondcp/chapter-integrate-treatment-forsubstance-use-disorders
Lippert AM & Lee BA. Stress, coping, and mental health differences among homeless people. Sociological Inquiry. 2015 85(3), 343-374. doi:10.1111/soin.12080
Lee CM, Mangurian C, Tieu L, Ponath C, Guzman D, Kushel M. Childhood Adversities Associated with Poor Adult Mental Health Outcomes in Older Homeless Adults: Results From the HOPE HOME Study. Am J Geriatr Psychiatry. 2017 Feb;25(2):107-117. doi: 10.1016/j.jagp.2016.07.019. Epub 2016 Aug 17.
PubMed 27544890Harvey PD, Rosenthal JB. Treatment resistant schizophrenia: Course of brain structure and function. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Oct 3;70:111-6. doi: 10.1016/j.pnpbp.2016.02.008. Epub 2016 Feb 27.
PubMed 26925705Roe CA, Sonnex C, Roxburgh EC. Two meta-analyses of noncontact healing studies. Explore (NY). 2015 Jan-Feb;11(1):11-23. doi: 10.1016/j.explore.2014.10.001. Epub 2014 Oct 23.
PubMed 25457442Meissner K, Koch A. Sympathetic Arousal during a Touch-Based Healing Ritual Predicts Increased Well-Being. Evid Based Complement Alternat Med. 2015;2015:641704. doi: 10.1155/2015/641704. Epub 2015 Jul 5.
PubMed 26236381Nourbakhsh MR, Bell TJ, Martin JB, Arab AM. The Effects of Oscillatory Biofield Therapy on Pain and Functional Limitations Associated with Carpal Tunnel Syndrome: Randomized, Placebo-Controlled, Double-Blind Study. J Altern Complement Med. 2016 Nov;22(11):911-920. doi: 10.1089/acm.2016.0083. Epub 2016 Aug 3.
PubMed 27487406Prakash S, Chowdhury AR, & Gupta, A. (2015). Monitoring the human health by measuring the biofield
Anderson JG, Taylor AG. Effects of healing touch in clinical practice: a systematic review of randomized clinical trials. J Holist Nurs. 2011 Sep;29(3):221-8. doi: 10.1177/0898010110393353. Epub 2011 Jan 12.
PubMed 21228402Hammerschlag R, Marx BL, Aickin M. Nontouch biofield therapy: a systematic review of human randomized controlled trials reporting use of only nonphysical contact treatment. J Altern Complement Med. 2014 Dec;20(12):881-92. doi: 10.1089/acm.2014.0017.
PubMed 25181286Jain S, McMahon GF, Hasen P, Kozub MP, Porter V, King R, Guarneri EM. Healing Touch with Guided Imagery for PTSD in returning active duty military: a randomized controlled trial. Mil Med. 2012 Sep;177(9):1015-21. doi: 10.7205/milmed-d-11-00290.
PubMed 23025129Krucoff MW, Crater SW, Green CL, Maas AC, Seskevich JE, Lane JD, Loeffler KA, Morris K, Bashore TM, Koenig HG. Integrative noetic therapies as adjuncts to percutaneous intervention during unstable coronary syndromes: Monitoring and Actualization of Noetic Training (MANTRA) feasibility pilot. Am Heart J. 2001 Nov;142(5):760-9. doi: 10.1067/mhj.2001.119138.
PubMed 11685160Tabatabaee A, Tafreshi MZ, Rassouli M, Aledavood SA, AlaviMajd H, Farahmand SK. Effect of Therapeutic Touch in Patients with Cancer: a Literature Review. Med Arch. 2016 Apr;70(2):142-7. doi: 10.5455/medarh.2016.70.142-147. Epub 2016 Apr 1.
PubMed 27194823
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Stress Management Using Psychoeducation Versus Therapeutic Touch for Formerly Homeless Adults With Mental Illness and Substance Use Histories
- ClinicalTrials.gov ID
- NCT03203902
- Acronym / sponsor ID
- AAAR4338
- Conditions
- Stress
- Keywords
- Therapeutic touch, Post-traumatic Stress Disorder, Homeless
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 29 Jun 2017 (actual)
- 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 formerly homeless adults with chronic mental illness experience treatment resistant symptoms for which pharmaceutical agents and cognitive behavioral therapy are not effective. Although formerly homeless adults with chronic mental illness typically receive medical and psychiatric services to manage their illness, chronic stress and post-traumatic stress disorder (PTSD) acquired from homelessness are difficult to resolve and many adults experience relapse that can result in housing loss. Therapeutic touch is a complementary and alternative treatment that has been shown to be effective at reducing stress, anxiety, and pain in a variety of diagnoses including cancer, cardiac disease, chronic pain syndromes, and PTSD in veterans. In this study the investigators aim to determine whether a 30-minute therapeutic touch session combined with a conventional 1-hour psychoeducation group delivered over 6 weeks can more effectively reduce stress compared to conventional psychoeducation alone. The ability to reduce stress levels and maintain emotional equilibrium is critical for this population to manage illness symptoms effectively and stave off the incidence of relapse, rehospitalizations, and housing loss.
Detailed description
In 2015, approximately 600,000 people were reported to be homeless on any given night in the United States and 1.6 million used homeless shelter services. One-third of homeless adults who received shelter services were diagnosed with chronic mental illness (e.g., schizophrenia, bipolar disorder, major depression) and two-thirds had substance use disorders.
Once housed in supportive living residences, formerly homeless adults with mental illness commonly continue to experience high levels of stress, anxiety, depression, and post-traumatic stress disorder (PTSD), despite receiving medical and psychiatric services. Stress that is not sufficiently addressed can frequently lead to rehospitalizations and subsequent loss of housing. Although stress has been successfully treated with anti-anxiety pharmaceuticals, cognitive behavioral therapies, and support groups in adults in the larger population, formerly homeless adults with chronic mental illness tend to experience greater treatment resistance to such interventions or respond positively for short intervals and then relapse.
One nonpharmacological intervention that has gained increasing support in the last two decades is therapeutic touch. Therapeutic touch, also referred to as healing touch and touch therapy, is a complementary and alternative treatment in which practitioners seek to alleviate or reduce pain, stress, or anxiety through direct hand contact with a client's bio- or energy field. A bio- or energy field is defined in quantum physics as an interconnected web of energy that surrounds living organisms and may regulate emotional states and physical health. Although the existence of energy fields is increasingly accepted in the scientific community, the precise roles of and mechanisms through which energy fields work are not understood. While eastern health practitioners have for centuries used therapies addressing energy fields-for example, acupuncture, acupressure, Ayurveda, qi gong-western practitioners have only begun using such therapies in the last century. The most common western names for energy field therapy are therapeutic touch, healing touch, Reiki, and touch therapy-all of which have growing bodies of evidence supporting their effectiveness in the reduction of stress, anxiety, and pain in various diagnostic populations including cancer, cardiovascular disease, and chronic pain syndromes.
Although there is evidence that therapeutic touch can help reduce symptoms of PTSD in veterans, and stress and anxiety in cancer and cardiac patients, little information exists about whether therapeutic touch can reduce stress in formerly homeless adults with chronic mental illness. The ability to reduce stress in formerly homeless adults may help them manage illness symptoms better and prevent relapse for longer intervals.
In this comparative effectiveness study, the investigators will provide a conventional stress management psychoeducation group to 20 participants. Ten of these 20 participants will additionally receive 30 minutes of therapeutic touch delivered in a group setting. The remaining 10 participants will receive 30 minutes of sham therapeutic touch delivered in a group setting. Ten additional participants will be allocated to a control group with no intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Three arm, randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation and Therapeutic Touch | Active comparator | Other: Psychoeducation and Therapeutic Touch6-week psychoeducation group. The following 1-hour modules will be delivered: Week 1: Anger Management and Conflict Negotiation Week 2: Meditation and Breathing Techniques Week 3: Nutrition Week 4: Exercise, Leisure, and Recreation Week 5: Sleep Week 6: Wellness Recovery Action Plan (WRAP) Directly after the psychoeducation group is completed, 30-minute therapeutic touch will be administered. |
| Psychoeducation and Sham Therapeutic Touch | Placebo comparator | Other: Psychoeducation and Therapeutic Touch6-week psychoeducation group. The following 1-hour modules will be delivered: Week 1: Anger Management and Conflict Negotiation Week 2: Meditation and Breathing Techniques Week 3: Nutrition Week 4: Exercise, Leisure, and Recreation Week 5: Sleep Week 6: Wellness Recovery Action Plan (WRAP) Directly after the psychoeducation group is completed, 30-minute sham therapeutic touch will be administered. |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current supportive housing resident
- History of homelessness
- History of mental illness
Key exclusion criteria (1 listed)
- Severe behavioral or anger management disorder
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 |
|---|---|---|
| Psychoeducation and Therapeutic Touch6-week, 1-hour psychoeducation group followed by 30-minute therapeutic touch | Other | Psychoeducation and Sham Therapeutic Touch, Psychoeducation and Therapeutic Touch |
Primary outcome
Difference in Score on Perceived Stress Scale between pre- and post-intervention
Time frame: baseline and 7 weeks
5-point, 10-item Likert scale that takes approximately 5 minutes to complete
1 secondary outcome
Difference in Score on World Health Quality of Life Scale between pre- and post-intervention
Time frame: baseline and 7 weeks
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 25 Jan 2018.
- BackgroundUS Department of Housing and Urban Development. (2015) 2015 Annual Homeless Assessment Report (AHAR) to Congress (November 2015). Retrieved from https://www.hudexchange.info/resources/documents/2015-AHAR-Part-1.pdf
- BackgroundTreatment Advocacy Center. (2014) Eliminating barriers to the treatment of mental illness. How many individuals with a serious mental illness are homeless? Retrieved from http://www.treatmentadvocacycenter.org/problem/consequences-ofnon-treatment/2058
- BackgroundOffice of National Drug Control Policy. (n.d.) Chapter 3. Integrate treatment for substance use disorders into mainstream health care and expand support for recovery. Retrieved from https://www.whitehouse.gov/ondcp/chapter-integrate-treatment-forsubstance-use-disorders
- BackgroundLippert AM & Lee BA. Stress, coping, and mental health differences among homeless people. Sociological Inquiry. 2015 85(3), 343-374. doi:10.1111/soin.12080
- Background: PubMed 27544890Lee CM, Mangurian C, Tieu L, Ponath C, Guzman D, Kushel M. Childhood Adversities Associated with Poor Adult Mental Health Outcomes in Older Homeless Adults: Results From the HOPE HOME Study. Am J Geriatr Psychiatry. 2017 Feb;25(2):107-117. doi: 10.1016/j.jagp.2016.07.019. Epub 2016 Aug 17.
- Background: PubMed 26925705Harvey PD, Rosenthal JB. Treatment resistant schizophrenia: Course of brain structure and function. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Oct 3;70:111-6. doi: 10.1016/j.pnpbp.2016.02.008. Epub 2016 Feb 27.
- Background: PubMed 25457442Roe CA, Sonnex C, Roxburgh EC. Two meta-analyses of noncontact healing studies. Explore (NY). 2015 Jan-Feb;11(1):11-23. doi: 10.1016/j.explore.2014.10.001. Epub 2014 Oct 23.
- Background: PubMed 26236381Meissner K, Koch A. Sympathetic Arousal during a Touch-Based Healing Ritual Predicts Increased Well-Being. Evid Based Complement Alternat Med. 2015;2015:641704. doi: 10.1155/2015/641704. Epub 2015 Jul 5.
- Background: PubMed 27487406Nourbakhsh MR, Bell TJ, Martin JB, Arab AM. The Effects of Oscillatory Biofield Therapy on Pain and Functional Limitations Associated with Carpal Tunnel Syndrome: Randomized, Placebo-Controlled, Double-Blind Study. J Altern Complement Med. 2016 Nov;22(11):911-920. doi: 10.1089/acm.2016.0083. Epub 2016 Aug 3.
- BackgroundPrakash S, Chowdhury AR, & Gupta, A. (2015). Monitoring the human health by measuring the biofield
- Background: PubMed 21228402Anderson JG, Taylor AG. Effects of healing touch in clinical practice: a systematic review of randomized clinical trials. J Holist Nurs. 2011 Sep;29(3):221-8. doi: 10.1177/0898010110393353. Epub 2011 Jan 12.
- Background: PubMed 25181286Hammerschlag R, Marx BL, Aickin M. Nontouch biofield therapy: a systematic review of human randomized controlled trials reporting use of only nonphysical contact treatment. J Altern Complement Med. 2014 Dec;20(12):881-92. doi: 10.1089/acm.2014.0017.
- Individual participant dataSharing planned: No
Related trials for Stress
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Active, not recruiting
Chicago Parent Program for Foster and Kinship Caregivers
Behavior Problem, Parenting
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
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.
Sharon Gutman, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation and Therapeutic Touch in people with Stress, run by Columbia 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 3 inclusion and 1 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 25 Jan 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. Some participants in this study may receive a placebo. 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?
Difference in Score on Perceived Stress Scale between pre- and post-intervention (time frame: baseline and 7 weeks). 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 NCT03203902, which also lists 15 linked publications.
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 25 Jan 2018.