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

Primary Purpose

Alzheimer's Disease, Amyotrophic Lateral Sclerosis, Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laughter Therapy
Sponsored by
Brown, Theodore R., M.D., MPH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alzheimer's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Evergreen Healthcare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laughter therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

The General Self-Efficacy Scale (GSE)
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).

Full Information

First Posted
April 21, 2016
Last Updated
September 24, 2018
Sponsor
Brown, Theodore R., M.D., MPH
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1. Study Identification

Unique Protocol Identification Number
NCT02750982
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown, Theodore R., M.D., MPH

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Amyotrophic Lateral Sclerosis, Brain Injury, Huntington's Disease, Multiple Sclerosis, Parkinson's Disease, Stroke, Spinal Cord Injury

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laughter therapy
Arm Type
Experimental
Arm Description
effects of Laughter therapy (LT) on mood, self-efficacy and other wellness measures in people with neurological conditions.
Intervention Type
Other
Intervention Name(s)
Laughter Therapy
Intervention Description
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 Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9, for depression)
Description
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).
Time Frame
Change from Baseline to 8 weeks
Title
Generalized Anxiety Disorder 7-item scale (GAD-7, for anxiety)
Description
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).
Time Frame
Change from Baseline to 8 weeks
Secondary Outcome Measure Information:
Title
The General Self-Efficacy Scale (GSE)
Description
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).
Time Frame
Change from Baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore R Brown, MD, MPH
Organizational Affiliation
Evergreen Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evergreen Healthcare
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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