Laughter Yoga Intervention for People With Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT03163940|
Recruitment Status : Completed
First Posted : May 23, 2017
Last Update Posted : February 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Mood Disorder Depression||Behavioral: Laughter Yoga||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Laughter Yoga for Improving Depression, Anxiety and Stress in People Diagnosed With Major Depressive Disorder: A Feasibility Study|
|Actual Study Start Date :||June 1, 2017|
|Actual Primary Completion Date :||August 1, 2018|
|Actual Study Completion Date :||August 1, 2018|
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.
- 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).
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163940
|The Castle Peak Hospital|
|Hong Kong, Hong Kong|
|Principal Investigator:||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|