Laughter Therapy Effects on Mood, Stress and Self-efficacy in People With Neurological Diseases.
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ClinicalTrials.gov Identifier: NCT02750982 |
Recruitment Status :
Completed
First Posted : April 26, 2016
Last Update Posted : September 26, 2018
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer's Disease Amyotrophic Lateral Sclerosis Brain Injury Huntington's Disease Multiple Sclerosis Parkinson's Disease Stroke Spinal Cord Injury | Other: Laughter Therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
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 : | July 2016 |
Actual Primary Completion Date : | August 2018 |
Actual Study Completion Date : | August 2018 |

Arm | Intervention/treatment |
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Experimental: Laughter therapy
effects of Laughter therapy (LT) on mood, self-efficacy and other wellness measures in people with neurological conditions.
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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 |
- 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).
- 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).
- 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).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750982
United States, Washington | |
Evergreen Healthcare | |
Kirkland, Washington, United States, 98034 |
Principal Investigator: | Theodore R Brown, MD, MPH | Evergreen Healthcare |
Responsible Party: | Theodore R Brown, M.D., MPH, Brown, Theodore R., M.D., MPH |
ClinicalTrials.gov Identifier: | NCT02750982 |
Other Study ID Numbers: |
TRBROWN201601 |
First Posted: | April 26, 2016 Key Record Dates |
Last Update Posted: | September 26, 2018 |
Last Verified: | September 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Parkinson Disease Multiple Sclerosis Alzheimer Disease Brain Injuries Spinal Cord Injuries Motor Neuron Disease Amyotrophic Lateral Sclerosis Huntington Disease Sclerosis Wounds and Injuries Pathologic Processes Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Demyelinating Diseases Autoimmune Diseases Immune System Diseases Dementia Tauopathies Neurocognitive Disorders Mental Disorders Craniocerebral Trauma Trauma, Nervous System |