Laughter Yoga Intervention for People With Major Depressive Disorder

February 21, 2019 updated by: The Hong Kong Polytechnic University

Laughter Yoga for Improving Depression, Anxiety and Stress in People Diagnosed With Major Depressive Disorder: A Feasibility Study

The present study will adopt a non-blinded parallel-group randomized controlled trial design that involves a Laughter Yoga group (intervention) and a treatment-as-usual group (Control). It aims to determine the feasibility of using LY intervention on patients with Major depressive disorder (MDD), and also to evaluate the potential effect of the intervention on comorbid depression, anxiety and stress for these patients. It is hypothesized that, LY group, as compared to the TAU group, will have significantly lower symptoms of depression, anxiety and stress, but greater improvements in self-reported mental health/physical health-related quality of life immediately post intervention and at 3 months' follow-up.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

72 community dwelling people with co-morbid symptoms of depression, anxiety and stress who are diagnosed and treated for major depressive disorder (MDD) will be recruited into the study from the Community Psychiatric Service (CPS) of Castle Peak Hospital. After baseline measurements, 36 participants will be randomly allocated into the Laughter Yoga group (LY) or Treatment-as-usual group (TAU).

The LY intervention will be delivered by a certified lead LY trainer and monitored by three Co-Is and/or Research Assistants. The LY participants will be asked to attend a total of eight 45-minutes sessions of group-based laughter yoga over a 4 week period. TAU participants will receive their usual routine community mental health care.

All data collection will be conducted by a trained research assistant. Demographic data and all the relevant clinical/treatment data will be collected at baseline, whereas outcome data will be collected at three time points: Baseline, after the 4 weeks' intervention period, and at 3 months after finishing the intervention.

The level of depression, anxiety and stress will be the primary outcome of the study. They will be measured by the Chinese version of the Depression Anxiety Stress Scale (DASS-21) developed by Lovibond and Lovibond (1995) . The secondary outcome will be quality of life (physical and mental health related), which will be assessed with the short Form 12 item (version 2) Health Survey (SF12v2) (Lam et al., 2014). The Chinese language version of the client satisfaction questionnaire (CSQ-8)(Attkisson and Zwick, 1982; Attkisson, 2012) will be used to measure patient's view about their satisfaction with the LY intervention immediately post intervention. To explore patient's experience on the LY intervention, a sample of 12 patients who received the LY intervention will be invited to a short individual interview with the research assistant at three months' follow-up. Trial feasibility data, such as refusal rate, response rate, drop out, attendance rate will also be recorded throughout the study.

Descriptive statistics will be used to contextualize the demographic and clinical characteristics of the study population at baseline. The baseline variables will be compared between the groups so that potential confounders will be identified and where necessary adjusted for. For pre-test and post-test comparisons between the two groups, ANOVA test will be adopted if satisfactory normality of data is established. Otherwise, Kruskal-Wallis test will be used.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Castle Peak Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with and being treated for a major depressive disorder (F32, F33: ICD-10-CM) as confirmed by a psychiatrist
  • Not receiving any other yoga or humour based intervention (currently or within the last three months)
  • Be able to commit to attend the LY groups
  • Current use of antidepressant for depression and with no plans to change the medication during the next 3 months
  • Able to speak Chinese/English
  • Able to provide written informed consent and considered safe and competent to participate in the study (as suggested by the attending psychiatrist),
  • With co-morbid residual symptoms of anxiety, stress or depression (determined by minimum baseline DASS scores of 10 (depression), or 8 (anxiety) and/or 15 (stress).

Exclusion Criteria:

  • A history of bipolar disorder or schizophrenia
  • Physical health problems which may present risks if engaging in LY (i.e. hernia, injuries, etc. determined by the attending psychiatrist)
  • Having co-morbidity of another chronic physical and/or mental health problem such as learning disability, substance misuse disorders and organic brain diseases
  • Receiving any talking therapies at recruitment or throughout the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Laughter Yoga (LY) Group
The LY session will be offered twice weekly, for 45 minutes each time. Each participant will be asked to attend a total of 8 groups (over 4 weeks).
Behavioral: Laughter Yoga
A LY group will be composed of 8-12 participants. Each sessions will include 4 essential elements steps of laughter yoga, laughter meditation and grounding exercises. The 4 steps of laughter yoga are 1) warm up exercise, 2) deep breathing exercises, 3) childlike playfulness and 4) laughter exercises. The laughter meditation is a deeper experience of unconditional laughter in which laughter often comes in natural waves and it becomes infectious and set off a chain reaction to infect other people. The grounding exercises allow individuals to ground the energy of laughter and relax. The LY intervention will be facilitated by a certified lead LY trainer.
NO_INTERVENTION: Treatment-as-usual (TAU)
The TAU will receive their usual routine community mental health care (including medications) and attend medical outpatient appointments as determined by their individual needs.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Depression, Anxiety and Stress Scale (DASS-21) scores from baseline
Time Frame: At baseline, immediately post intervention, and at 3 months after the intervention has been completed
Participants' levels of depression, anxiety and stress will be measured by using the Chinese version of the Depression Anxiety Stress Scale (DASS-21).
At baseline, immediately post intervention, and at 3 months after the intervention has been completed

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Short form 12 item Health Survey (SF12v2) scores from baseline
Time Frame: At baseline, immediately post intervention, and at 3 months after the intervention has been completed
SF12v2 will be used to measure patients self-reported physical and mental health-related quality of life.
At baseline, immediately post intervention, and at 3 months after the intervention has been completed

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: Immediately post intervention
CSQ8 will be used to measure patients' views about their satisfaction with the LY intervention.
Immediately post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Community Psychiatric Service, Castle Peak Hospital, Tuen Mun, Hong Kong.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel Bressington, PhD, School of Nursing, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • G-UAB6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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