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Comparative Effectiveness of Stress Management

Sponsor
Columbia University (Other)
Overall Status
Completed
CT.gov ID
NCT03203902
Collaborator
(none)
20
Enrollment
1
Location
3
Arms
4
Actual Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: Psychoeducation and Therapeutic Touch
 N/A

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

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Three arm, randomized controlled designThree 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
Actual Study Start Date :
Sep 10, 2017
Actual Primary Completion Date :
Jan 10, 2018
Actual Study Completion Date :
Jan 10, 2018

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Difference in Score on Perceived Stress Scale between pre- and post-intervention [baseline and 7 weeks]

    5-point, 10-item Likert scale that takes approximately 5 minutes to complete

Secondary Outcome Measures

  1. Difference in Score on World Health Quality of Life Scale between pre- and post-intervention [baseline and 7 weeks]

    5-point, 26-item scale that takes approximately 15 minutes to complete

Eligibility Criteria

Criteria

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

  • Current supportive housing resident

  • History of homelessness

  • History of mental illness

Exclusion Criteria:
  • Severe behavioral or anger management disorder

Contacts and Locations

Locations

Site City State Country Postal Code
1 Columbia University Medical Center New York New York United States 10032

Sponsors and Collaborators

  • Columbia University

Investigators

  • Principal Investigator: Sharon Gutman, PhD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sharon Gutman, Professor of Rehabilitation and Regenerative Medicine, Columbia University
ClinicalTrials.gov Identifier:
NCT03203902
Other Study ID Numbers:
  • AAAR4338
First Posted:
Jun 29, 2017
Last Update Posted:
Jan 25, 2018
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
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, Professor of Rehabilitation and Regenerative Medicine, Columbia University
Therapeutic touch
Post-traumatic Stress Disorder
Homeless

Study Results

No Results Posted as of Jan 25, 2018