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Laughter Therapy Effects on Mood, Stress and Self-efficacy in People With Neurological Diseases.

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ClinicalTrials.gov Identifier: NCT02750982
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Theodore R Brown, Brown, Theodore R., M.D., MPH

Tracking Information
First Submitted Date  ICMJE April 21, 2016
First Posted Date  ICMJE April 26, 2016
Last Update Posted Date September 26, 2018
Study Start Date  ICMJE July 2016
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2016)
  • Patient Health Questionnaire (PHQ-9, for depression) [ Time Frame: Change from Baseline to 8 weeks ]
    Outcome measures will be completed at baseline, active-phase completion at week 8 and post-active phase week 8 (16 weeks post-start of active phase).
  • Generalized Anxiety Disorder 7-item scale (GAD-7, for anxiety) [ Time Frame: Change from Baseline to 8 weeks ]
    Outcome measures will be completed at baseline, active-phase completion at week 8 and post-active phase week 8 (16 weeks post-start of active phase).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02750982 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2016)
The General Self-Efficacy Scale (GSE) [ Time Frame: Change from Baseline to 8 weeks ]
Outcome measures will be completed at baseline, active-phase completion at week 8 and post-active phase week 8 (16 weeks post-start of active phase).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laughter Therapy Effects on Mood, Stress and Self-efficacy in People With Neurological Diseases.
Official Title  ICMJE A Single-Arm Prospective Investigation of the Effects of Laughter Therapy on Mood, Stress, and Self-Efficacy in People With Central Nervous System Disorders.
Brief Summary This is a prospective investigation of the effects of Laughter therapy (LT) on perceived stress, self-efficacy, mood and other wellness measures in people with the following neurological conditions: Alzheimer's disease, amyotrophic lateral sclerosis, brain injury, Huntington's Disease, multiple sclerosis, Parkinson's Disease, post-stroke, spinal cord injury.
Detailed Description Laughter therapy (LT) has potential benefits in treating illness. It combines laughter with breathing and body exercises to stimulate laughter, both real and artificial, in a group setting. Laughter therapy may help treating illness by strengthening breathing muscles, improving mood, and providing pain and stress relief. EvergreenHealth has presented laughter therapy classes to patients with Parkinson's disease and Multiple sclerosis and other neurological conditions. The therapy will be led by a certified laughter therapist and mental health professional.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Alzheimer's Disease
  • Amyotrophic Lateral Sclerosis
  • Brain Injury
  • Huntington's Disease
  • Multiple Sclerosis
  • Parkinson's Disease
  • Stroke
  • Spinal Cord Injury
Intervention  ICMJE Other: Laughter Therapy
Laughter Therapy (LT) involves simple exercises using playfulness, eye contact and chanting in forms of laughter. LT will be taught by a certified LT instructor in a group session. There will be 8 sessions per group with each session attended by 8-12 participants and lasting 60 minutes
Study Arms  ICMJE Experimental: Laughter therapy
effects of Laughter therapy (LT) on mood, self-efficacy and other wellness measures in people with neurological conditions.
Intervention: Other: Laughter Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2016)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis based on medical record review of one of the following neurological diseases: Alzheimer's disease, amyotrophic lateral sclerosis, brain injury, Huntington's Disease, Multiple Sclerosis, Parkinson's Disease, Post-Stroke, Spinal Cord Injury.
  • Medically stable for at least 2 months.
  • Not participating in Laughter therapy for 30 days prior to screening.

Exclusion Criteria:

  • Females who are pregnant
  • Any unstable medical condition
  • Severe cognitive deficits that would interfere with participation (e.g. unable to follow commands).
  • Severe abdominal pain, chest pain or back pain.
  • Abdominal, chest or back surgery within 90 days.
  • Psychosis or severe mental illness.
  • Untreated hernia.
  • Persistent cough.
  • Advanced hemorrhoids.
  • Epilepsy.
  • Uncontrolled Hypertension - SBP >170 or DBP >105.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02750982
Other Study ID Numbers  ICMJE TRBROWN201601
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Theodore R Brown, Brown, Theodore R., M.D., MPH
Study Sponsor  ICMJE Brown, Theodore R., M.D., MPH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Theodore R Brown, MD, MPH Evergreen Healthcare
PRS Account Brown, Theodore R., M.D., MPH
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP