LOL-HD: The Effects of Laughter Therapy on Hemodialysis on Depression

• Sponsor: Satellite Healthcare (Other)
• Overall Status: Completed
• CT.gov ID: NCT04098627
• Collaborator: (none)
• Enrollment: 152
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.9
• Patients Per Site Per Month: 12.8

Study Details

Study Description

Brief Summary

End stage kidney disease is associated with increased depression. Laughter is associated with improvement in depression in chronic disease. The study objective was to measure the effect of intradialytic group laughter therapy on anxiety and depression. Pragmatic randomized controlled trial conducted in 10 hemodialysis centers in Northern California. The intervention group received a once weekly 30-minute long group laughter therapy session for 8 weeks. Primary outcome was depression score as measured using the Patient Health Questionnaire.

Condition or Disease	Intervention/Treatment	Phase
End Stage Kidney Disease	Behavioral: Laughter Therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 152 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Statistical Analysis Blinded
• Primary Purpose: Health Services Research
• Official Title: The Effects of Laughter Therapy on Hemodialysis on Depression: A Pragmatic Randomized Controlled Trial
• Actual Study Start Date: Apr 1, 2018
• Actual Primary Completion Date: May 7, 2018
• Actual Study Completion Date: Mar 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Once weekly 30-minute long group laughter therapy session for 8 weeks while patients are on dialysis	Behavioral: Laughter Therapy; Once weekly 30-minute long group laughter therapy session for 8 weeks
No Intervention: Usual Care Usual care

Outcome Measures

Primary Outcome Measures

1. Depression [8 weeks]

   Change in General Anxiety Disorder Scale 2 (GAD -2) in intervention group compared to change in the usual care group. The construct is the screening measure of depression which is calculated by the sum of 2 items on a scale of 0 to 3. A score of 3 or greater for depression is considered positive for screening purposes. The higher the sore the greater the chance of depression risk and thus the worse outcome.

Secondary Outcome Measures

1. Anxiety [8 weeks]

   Change in the anxiety subscale of the Patient Health Questionnaire 4 (PHQ4) in intervention group compared to change in the usual care group.The construct is the screening measure of anxiety which is calculated by the sum of 2 items on a scale of 0 to 3. A score of 3 or greater for anxiety is considered positive for screening purposes. The higher the sore the greater the chance of anxiety risk and thus the worse outcome.

2. Subjective Wellbeing [8 weeks]

   Change in Subjective Wellbeing using the 7 item Personal Wellbeing Index (PWI) in the intervention group compared to change in the usual care group. Subjective wellbeing measures the construct of long term happiness. The Personal Wellbeing Index (PWI) is a 7 item validated scale that rates satisfaction with life in seven domains: standard of living, health, achievements in life, relationships, safety, community and future security, on an 11-point scale. The higher the rating the better the outcome. Measures are individually scored and cumulatively scored.

3. Patient reported outcome measures (PROMs) [8 weeks]

   Change in PROMS using the 6 item London Evaluation of Illness (LEVIL) in the intervention group compared to change in the usual care group. LEVIL is a 6 item visual analogue scale (VAS) developed and used in hemodialysis patients that measures general wellbeing (GWB), pain, sleep, breathing, energy, and appetite. The anchors for GWB, sleep and appetite were "very poor"-"excellent," for pain and breathing "extreme"-"no problem" and for energy "extremely fatigued"-"full of energy." For each domain the VAS allowed free selection of status along a line from worst (0) to best (100). Measures are individually scored and cumulatively scored.

4. Psychological Distress - Patient Health Questionnaire 4 (PHQ4) [8 weeks]

   Change in Psychological Distress, as measured by the Patient Health Questionnaire 4 (PHQ4), in intervention group compared to change in the usual care group. The construct is the screening measure of psychological distress which is calculated by the sum of 4 items on a scale of 0 to 3. A score of 0 to 2 is no distress, 3-5 is mild distress, 6-8 is moderate distress and 9-12 is severe distress. The higher the sore the greater the psychological distress and thus the worse outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of end stage kidney disease (ESKD) and currently undergoing hemodialysis at a Satellite Healthcare Hemodialysis Center

• Ability to understand English

Exclusion Criteria:

• Cognitive impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Satellite Healthcare	San Jose	California	United States	95821

Sponsors and Collaborators

• Satellite Healthcare

Investigators

• Principal Investigator: Paul N Bennett, PhD, Satellite Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Satellite Healthcare
• ClinicalTrials.gov Identifier: NCT04098627
• Other Study ID Numbers: SIH109_LOLRCT
• First Posted: Sep 23, 2019
• Last Update Posted: Oct 3, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Satellite Healthcare: laughter; depression; hemodialysis
• Additional relevant MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Depression

Study Results

No Results Posted as of Oct 3, 2019