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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single-Arm Prospective Investigation of the Effects of Laughter Therapy on Mood, Stress, and Self-Efficacy in People With Central Nervous System Disorders.

Conditions
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Alzheimer's Disease, Amyotrophic Lateral Sclerosis, Brain Injury, Huntington's Disease, Multiple Sclerosis, Parkinson's Disease, Stroke, Spinal Cord Injury

Intervention / Treatment
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* Other: Laughter Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laughter therapy<br>effects of Laughter therapy (LT) on mood, self-efficacy and other wellness measures in people with neurological conditions. | Other: Laughter Therapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire (PHQ-9, for depression) | 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). | Change from Baseline to 8 weeks | 
| Generalized Anxiety Disorder 7-item scale (GAD-7, for anxiety) | 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). | Change from Baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The General Self-Efficacy Scale (GSE) | 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). | Change from Baseline to 8 weeks |