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Laughter Yoga Intervention for People With Major Depressive Disorder

Primary Purpose

Major Depressive Disorder, Mood Disorder, Depression

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Laughter Yoga
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Major Depressive Disorder focused on measuring Laughter Yoga, Major Depressive Disorder, Anxiety, Stress, Depression, Quality of Life, Mood Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Castle Peak Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Laughter Yoga (LY) Group

Treatment-as-usual (TAU)

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in Short form 12 item Health Survey (SF12v2) scores from baseline
SF12v2 will be used to measure patients self-reported physical and mental health-related quality of life.

Full Information

First Posted
May 18, 2017
Last Updated
February 21, 2019
Sponsor
The Hong Kong Polytechnic University
Collaborators
Community Psychiatric Service, Castle Peak Hospital, Tuen Mun, Hong Kong.
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1. Study Identification

Unique Protocol Identification Number
NCT03163940
Brief Title
Laughter Yoga Intervention for People With Major Depressive Disorder
Official Title
Laughter Yoga for Improving Depression, Anxiety and Stress in People Diagnosed With Major Depressive Disorder: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Community Psychiatric Service, Castle Peak Hospital, Tuen Mun, Hong Kong.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Mood Disorder, Depression
Keywords
Laughter Yoga, Major Depressive Disorder, Anxiety, Stress, Depression, Quality of Life, Mood Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laughter Yoga (LY) Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Treatment-as-usual (TAU)
Arm Type
No Intervention
Arm Description
The TAU will receive their usual routine community mental health care (including medications) and attend medical outpatient appointments as determined by their individual needs.
Intervention Type
Behavioral
Intervention Name(s)
Laughter Yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Depression, Anxiety and Stress Scale (DASS-21) scores from baseline
Description
Participants' levels of depression, anxiety and stress will be measured by using the Chinese version of the Depression Anxiety Stress Scale (DASS-21).
Time Frame
At baseline, immediately post intervention, and at 3 months after the intervention has been completed
Secondary Outcome Measure Information:
Title
Change in Short form 12 item Health Survey (SF12v2) scores from baseline
Description
SF12v2 will be used to measure patients self-reported physical and mental health-related quality of life.
Time Frame
At baseline, immediately post intervention, and at 3 months after the intervention has been completed
Other Pre-specified Outcome Measures:
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
CSQ8 will be used to measure patients' views about their satisfaction with the LY intervention.
Time Frame
Immediately post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Bressington, PhD
Organizational Affiliation
School of Nursing, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wai Tong Chien, PhD
Organizational Affiliation
School of Nursing, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Castle Peak Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10259963
Citation
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.
Results Reference
background
Citation
Attkisson, C.C. (2012). The CSQ Scales Reprint Portfolio. Mill Valley, CA: Tamalpais Matrix Systems, LLC.
Results Reference
background
PubMed Identifier
22128754
Citation
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.
Results Reference
background
PubMed Identifier
7726811
Citation
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.
Results Reference
background

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Laughter Yoga Intervention for People With Major Depressive Disorder

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