Comparative Effectiveness of Stress Management

NCT03203902 | Completed DMC

• 1 other identifier: AAAR4338
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Keywords

Therapeutic touch; Post-traumatic Stress Disorder; Homeless

Outcome Measures

Primary Outcomes (1)

• 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

  baseline and 7 weeks

Secondary Outcomes (1)

• Difference in Score on World Health Quality of Life Scale between pre- and post-intervention

  baseline and 7 weeks

Study Arms (3)

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.

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.

Other: Psychoeducation and Therapeutic Touch

Control

NO INTERVENTION

No intervention

Interventions

Psychoeducation and Therapeutic Touch OTHER

6-week, 1-hour psychoeducation group followed by 30-minute therapeutic touch

Psychoeducation and Sham Therapeutic Touch; Psychoeducation and Therapeutic Touch

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe behavioral or anger management disorder

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (15)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 27544890 BACKGROUND

• Harvey 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.

  PMID: 26925705 BACKGROUND

• Roe 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.

  PMID: 25457442 BACKGROUND

• Meissner 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.

  PMID: 26236381 BACKGROUND

• Nourbakhsh 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.

  PMID: 27487406 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 21228402 BACKGROUND

• Hammerschlag 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.

  PMID: 25181286 BACKGROUND

• Jain 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.

  PMID: 23025129 BACKGROUND

• Krucoff 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.

  PMID: 11685160 BACKGROUND

• Tabatabaee 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.

  PMID: 27194823 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Sharon Gutman, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants receiving sham and authentic therapeutic touch will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rehabilitation and Regenerative Medicine

Model Details: Three arm, randomized controlled design

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: June 29, 2017
• Study Start: September 10, 2017
• Primary Completion: January 10, 2018
• Study Completion: January 10, 2018
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)