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Completed

NCT Number: NCT02750982

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Amyotrophic Lateral Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Basal Ganglia Diseases Brain Diseases Brain Injuries Brain Injury Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniocerebral Trauma Dementia Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Huntington Disease Huntington's Disease Immune System Diseases Mental Disorders Metabolic Diseases Motor Neuron Disease Movement Disorders Multiple Sclerosis Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Parkinson Disease Parkinson's Disease Parkinsonian Disorders Proteostasis Deficiencies Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Stroke Synucleinopathies TDP-43 Proteinopathies Tauopathies Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evergreen Healthcare

Kirkland, Washington, 98034, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laughter therapy

Other

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

Primary outcomes

  1. Patient Health Questionnaire (PHQ-9, for depression)

    Time frame: 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).

  2. Generalized Anxiety Disorder 7-item scale (GAD-7, for anxiety)

    Time frame: 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 outcomes

  1. The General Self-Efficacy Scale (GSE)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Brown, Theodore R., M.D., MPH

Indiv

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 26, 2016
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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