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

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. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Amyotrophic Lateral Sclerosis Brain Injury Huntington's Disease Multiple Sclerosis Parkinson's Disease Stroke Spinal Cord Injury Other: Laughter Therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Single-Arm Prospective Investigation of the Effects of Laughter Therapy on Mood, Stress, and Self-Efficacy in People With Central Nervous System Disorders.
Study Start Date : July 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Laughter therapy
effects of Laughter therapy (LT) on mood, self-efficacy and other wellness measures in people with neurological conditions.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT02750982


Locations
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United States, Washington
Evergreen Healthcare
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Brown, Theodore R., M.D., MPH
Investigators
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Principal Investigator: Theodore R Brown, MD, MPH Evergreen Healthcare
More Information
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Responsible Party: Theodore R Brown, M.D., MPH, Brown, Theodore R., M.D., MPH
ClinicalTrials.gov Identifier: NCT02750982    
Other Study ID Numbers: TRBROWN201601
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Parkinson Disease
Multiple Sclerosis
Alzheimer Disease
Brain Injuries
Spinal Cord Injuries
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Huntington Disease
Sclerosis
Wounds and Injuries
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dementia
Tauopathies
Neurocognitive Disorders
Mental Disorders
Craniocerebral Trauma
Trauma, Nervous System
Spinal Cord Diseases