Alzheimer's DiseaseNCT02750982
Laughter Therapy Effects on Mood, Stress and Self-efficacy in People With Neurological Diseases.
A study testing Laughter Therapy in people with Alzheimer's Disease and Amyotrophic Lateral Sclerosis, run by Brown, Theodore R., M.D., MPH at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer's Disease, Amyotrophic Lateral Sclerosis, Brain Injury
- What is being tested?
- Laughter Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- Untreated hernia.
- Persistent cough.
- Advanced hemorrhoids.
- Epilepsy.
- Uncontrolled Hypertension - SBP >170 or DBP >105.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Alzheimer's Disease, Amyotrophic Lateral Sclerosis, Brain Injury, Huntington's Disease, Multiple Sclerosis, Parkinson's Disease
- Being tested
- Laughter Therapy
- Medical subject headings
- Alzheimer Disease, Amyotrophic Lateral Sclerosis, Brain Injuries, Huntington Disease, Multiple Sclerosis, Parkinson Disease, Stroke, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Laughter therapy | Experimental | effects of Laughter therapy (LT) on mood, self-efficacy and other wellness measures in people with neurological conditions. Receives: Other: Laughter Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Change from Baseline to 8 weeks
Secondary outcomes (1)
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).
Measured: Change from Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown, Theodore R., M.D., MPH
- Responsible party
- Principal investigator, Theodore R Brown, Brown, Theodore R., M.D., MPH
- Investigators
- Theodore R Brown, MD, MPH, Principal investigator, Evergreen Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750982
- Sponsor's protocol ID
- TRBROWN201601
- Status last verified
- Sep 2018
- First submitted
- 21 Apr 2016
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02750982
- Acronym / sponsor ID
- TRBROWN201601
- Conditions
- Alzheimer's Disease, Amyotrophic Lateral Sclerosis, Brain Injury, Huntington's Disease, Multiple Sclerosis, Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Brown, Theodore R., M.D., MPH
- Study start
- Jul 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laughter therapy | Experimental | Other: Laughter Therapyeffects of Laughter therapy (LT) on mood, self-efficacy and other wellness measures in people with neurological conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laughter TherapyLaughter 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 | Other | Laughter therapy |
Primary outcome
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).
1 secondary outcome
The General Self-Efficacy Scale (GSE)
Time frame: Change from Baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore R Brown, MD, MPH principal investigator
Evergreen Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter Therapy in people with Alzheimer's Disease and Amyotrophic Lateral Sclerosis, run by Brown, Theodore R., M.D., MPH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-9, for depression) (time frame: Change from Baseline to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.