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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Multiple Sclerosis; Parkinson's Disease; Brain Injury; Amyotrophic Lateral Sclerosis; Alzheimer's Disease; Spinal Cord Injury; Huntington's Disease
• Intervention / Treatment: Other: Laughter Therapy

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: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Kirkland, Washington, United States, 98034
      • Evergreen Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brown, Theodore R., M.D., MPH
• Investigators: Principal Investigator: Theodore R Brown, MD, MPH, Evergreen Healthcare

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: April 21, 2016
• First Submitted That Met QC Criteria: April 22, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurocognitive Disorders; Genetic Diseases, Inborn; Neuromuscular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Craniocerebral Trauma; Trauma, Nervous System; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Heredodegenerative Disorders, Nervous System; Dementia; Tauopathies; Cognition Disorders; Chorea; Multiple Sclerosis; Sclerosis; Parkinson Disease; Brain Injuries; Wounds and Injuries; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Alzheimer Disease; Spinal Cord Injuries; Huntington Disease
• Other Study ID Numbers: TRBROWN201601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No