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Trial record 3 of 51 for:    psychoeducation | Not yet recruiting Studies

Comparative Effectiveness of Stress Management

This study is not yet open for participant recruitment.
Verified June 2017 by Sharon Gutman, Columbia University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03203902
First Posted: June 29, 2017
Last Update Posted: June 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sharon Gutman, Columbia University
  Purpose
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.

Condition Intervention
Stress Other: Psychoeducation and Therapeutic Touch

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Three arm, randomized controlled design
Masking: Single (Participant)
Masking Description:
Participants receiving sham and authentic therapeutic touch will be masked.
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Stress Management Using Psychoeducation Versus Therapeutic Touch for Formerly Homeless Adults With Mental Illness and Substance Use Histories

Further study details as provided by Sharon Gutman, Columbia University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Difference in Score on World Health Quality of Life Scale between pre- and post-intervention [ Time Frame: baseline and 7 weeks ]
    5-point, 26-item scale that takes approximately 15 minutes to complete


Estimated Enrollment: 30
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Psychoeducation and Therapeutic Touch

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.

Other: Psychoeducation and Therapeutic Touch
6-week, 1-hour psychoeducation group followed by 30-minute therapeutic touch
Placebo Comparator: Psychoeducation and Sham Therapeutic Touch

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.

Other: Psychoeducation and Therapeutic Touch
6-week, 1-hour psychoeducation group followed by 30-minute therapeutic touch
No Intervention: Control
No intervention

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Current supportive housing resident
  • History of homelessness
  • History of mental illness

Exclusion Criteria:

  • Severe behavioral or anger management disorder
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203902


Contacts
Contact: Sharon Gutman, PhD 212-305-8703 sg2422@cumc.columbia.edu

Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Sharon Gutman, PhD Columbia University
  More Information

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
Prakash S, Chowdhury AR, & Gupta, A. (2015). Monitoring the human health by measuring the biofield

Responsible Party: Sharon Gutman, Professor of Rehabilitation and Regenerative Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03203902     History of Changes
Other Study ID Numbers: AAAR4338
First Submitted: June 28, 2017
First Posted: June 29, 2017
Last Update Posted: June 29, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sharon Gutman, Columbia University:
Therapeutic touch
Post-traumatic Stress Disorder
Homeless