Clinical trial NCT02750982: Laughter Therapy Effects on Mood, Stress and Self-efficacy in People With Neurological Diseases.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Amyotrophic Lateral Sclerosis
Brain Injury
Huntington's Disease
Multiple Sclerosis
Parkinson's Disease
Stroke
Spinal Cord Injury
Lead sponsor: Brown, Theodore R., M.D., MPH
Sponsor class: INDIV
First posted: 2016-04-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9, for depression)
timeFrame: Change from Baseline to 8 weeks
measure: Generalized Anxiety Disorder 7-item scale (GAD-7, for anxiety)
timeFrame: Change from Baseline to 8 weeks
Secondary outcomes:
measure: The General Self-Efficacy Scale (GSE)
timeFrame: Change from Baseline to 8 weeks
Other outcomes:
Locations:
city: Kirkland
country: United States
facility: Evergreen Healthcare
state: Washington
Study officials:
affiliation: Evergreen Healthcare
name: Theodore R Brown, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: