NCT02750982

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

2.1 years

First QC Date

April 21, 2016

Last Update Submit

September 24, 2018

Conditions

Alzheimer's DiseaseAmyotrophic Lateral SclerosisBrain InjuryHuntington's DiseaseMultiple SclerosisParkinson's DiseaseStrokeSpinal Cord Injury

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • The General Self-Efficacy Scale (GSE)

    Change from Baseline to 8 weeks

Study Arms (1)

Laughter therapy

EXPERIMENTAL

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

Other: Laughter Therapy

Interventions

Laughter TherapyOTHER

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

Laughter therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evergreen Healthcare

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseAmyotrophic Lateral SclerosisBrain InjuriesHuntington DiseaseMultiple SclerosisParkinson DiseaseStrokeSpinal Cord Injuries

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersSpinal Cord DiseasesMotor Neuron DiseaseTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBasal Ganglia DiseasesChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesParkinsonian DisordersSynucleinopathiesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Theodore R Brown, MD, MPH

    Evergreen Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., MPH

Study Record Dates

First Submitted

April 21, 2016

First Posted

April 26, 2016

Study Start

July 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

September 26, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)