Laughter Yoga Intervention for People With Major Depressive Disorder
Condition: Major Depressive Disorder; Mood Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mood Disorders
Study type: Interventional

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.
    

Intervention name(s): Laughter Yoga
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Laughter Yoga; Major Depressive Disorder; Anxiety; Stress; Depression; Quality of Life; Mood Disorder