NCT03163940

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable major-depressive-disorder

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.2 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

February 22, 2019

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

May 18, 2017

Last Update Submit

February 21, 2019

Conditions

Major Depressive DisorderMood DisorderDepression

Keywords

Laughter YogaMajor Depressive DisorderAnxietyStressDepressionQuality of LifeMood Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in Depression, Anxiety and Stress Scale (DASS-21) scores from baseline

    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 Outcomes (1)

  • Change in Short form 12 item Health Survey (SF12v2) scores from baseline

    At baseline, immediately post intervention, and at 3 months after the intervention has been completed

Other Outcomes (1)

  • Client Satisfaction Questionnaire (CSQ-8)

    Immediately post intervention

Study Arms (2)

Laughter Yoga (LY) Group

EXPERIMENTAL

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

Treatment-as-usual (TAU)

NO INTERVENTION

The TAU will receive their usual routine community mental health care (including medications) and attend medical outpatient appointments as determined by their individual needs.

Interventions

Laughter YogaBEHAVIORAL

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.

Laughter Yoga (LY) Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Castle Peak Hospital

Hong Kong, Hong Kong

Location

Related Publications (4)

  • Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.

    PMID: 10259963BACKGROUND

  • Attkisson, C.C. (2012). The CSQ Scales Reprint Portfolio. Mill Valley, CA: Tamalpais Matrix Systems, LLC.

    BACKGROUND

  • Lam ET, Lam CL, Fong DY, Huang WW. Is the SF-12 version 2 Health Survey a valid and equivalent substitute for the SF-36 version 2 Health Survey for the Chinese? J Eval Clin Pract. 2013 Feb;19(1):200-8. doi: 10.1111/j.1365-2753.2011.01800.x. Epub 2011 Nov 29.

    PMID: 22128754BACKGROUND

  • Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

    PMID: 7726811BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, MajorMood DisordersDepressionAnxiety Disorders

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Depressive DisorderMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Daniel Bressington, PhD

    School of Nursing, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

  • Wai Tong Chien, PhD

    School of Nursing, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2017

First Posted

May 23, 2017

Study Start

June 1, 2017

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

February 22, 2019

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)