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

Sponsor

Brown, Theodore R., M.D., MPH (Other)

Overall Status

Completed

CT.gov ID

NCT02750982

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

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 :

Jul 1, 2016

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

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

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

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.