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

Not Applicable

Completed

• Conditions: Amyotrophic Lateral Sclerosis; Brain Injury; Huntington's Disease; Multiple Sclerosis; Stroke; Alzheimer's Disease; Parkinson's Disease; Spinal Cord Injury
• Interventions: Other: Laughter Therapy

• Registration Number: NCT02750982
• Lead Sponsor: Brown, Theodore R., M.D., MPH

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 Timeline

• Study First Submitted: 2016-04-21
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-26
• Study Start: 2016-07
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-24
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laughter therapy	Laughter Therapy	effects of Laughter therapy (LT) on mood, self-efficacy and other wellness measures in people with neurological conditions.

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9, for depression)	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)	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

Name	Time	Method
The General Self-Efficacy Scale (GSE)	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).

Trial Locations

Locations (1)

Evergreen Healthcare; 🇺🇸 Kirkland, Washington, United States