Adapting Sleep and Yoga Interventions for Maximal Effectiveness in Low Income Populations (CALYPSO)

• ClinicalTrials.gov Identifier: NCT03392194
• Recruitment Status: Completed
• First Posted: January 5, 2018
• Results First Posted: August 21, 2019
• Last Update Posted: September 11, 2019
• Sponsor: Brigham and Women's Hospital
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Susan Redline, Brigham and Women's Hospital

Study Description

Brief Summary:

The purpose of this study is to evaluate the feasibility of conducting a future randomized control trial that will compare the efficacy of sleep behavioral interventions in a high-risk community including adapted sleep hygiene and yoga. The investigators will conduct a 40 person 12-week randomized control trial (RCT) in low-income housing population where half the participants will receive a community adapted sleep hygiene intervention (SH) and half will receive a community adapted sleep hygiene intervention and a yoga intervention. The investigators will evaluate the feasibility of recruiting from our target community, randomizing individuals to interventions delivered in community rooms with home-based practices, and delivering the targeted interventions with high adherence and fidelity.

Condition or disease	Intervention/treatment	Phase
Sleep	Behavioral: Sleep hygiene intervention; Behavioral: Yoga intervention	Not Applicable

Detailed Description:

Inadequate sleep is highly prevalent in low-socioeconomic status (SES) and minority groups and associated with multiple health problems. The root causes of inadequate sleep are often related to behavioral practices and stress, both of which may be favorably impacted using socio-contextually appropriate sleep hygiene recommendations and mind-body practices such as yoga. A preliminary RCT that will address the role of sleep behavioral interventions in a high-risk community will be conducted. This evidence is needed to guide mind-body therapies in low-SES communities in which such strategies are under-utilized to improve health.

The investigators have assembled a multidisciplinary team of experts in sleep medicine, complementary and integrative health, behavioral medicine, community engagement, social epidemiology, and clinical trials to conduct a planning study to adapt behavioral sleep interventions for residents in urban low-income housing and to evaluate their uptake and fidelity. The investigators have conducted qualitative formative evaluation work and conducted modified SH and Yoga pilot studies. In this phase, the investigators will deliver a 12-week trial testing the feasibility of (1) an adapted sleep hygiene intervention (SH) and (2) yoga + adapted sleep hygiene intervention SH+Y):

A. A Sleep Hygiene (SH) Intervention, addressing: beliefs and attitudes towards sleep; challenges for adhering to sleep hygiene recommendations given chaotic family routines, work schedules and bedroom conditions; strategies for overcoming barriers, and prioritization of recommendations most likely to be efficacious.

B. A Yoga (Y) Intervention: intervention intensity/duration and class format; tailored home-based recommendations for bedtime practice combining meditation, breathing and postures; tools to assess and enhance adherence; race/ethnicity concordance of the instructor and student; and use of peer yoga assistants.

The investigators aim to conduct a 40 person 12-week RCT of SH vs SH+Y to inform the design of a future large-scale RCT. The investigators will evaluate the feasibility of recruiting from our target community, randomizing individuals to interventions delivered in community rooms with home-based practices, and delivering the targeted interventions with high adherence and fidelity. The following will be evaluated:

• Reach of the target population: The number of potentially eligible individuals approached to participate will be tracked as well as the characteristics of individuals who do and do not choose to participate, and differences will be assessed. Reasons for choosing not to participate will be assessed using open ended questions (e.g., burden, perception of yoga, needs, etc.).
• Adoption and adherence: the proportion of individuals that sustain participation throughout the intervention will be assessed, and quantify attendance at classes and home-practices through logs and interim phone interviews. The investigators will describe patterns of dropout rates and adherence to the interventions by key demographic factors and by moderating and mediating factors.
• Implementation-consistency of delivery of the intervention: a checklist of core intervention elements will be used to document the degree to which core elements of the intervention was delivered as specified in the protocol.

The investigators will also assess the feasibility of collecting a range of baseline, outcome, process and mediator data and to generate data to support use of specific measures in a later trial, including patterns of missingness of data, distributions of data, correlations between outcomes, baseline factors and mediators, and evaluation of "dose-response" associations between time in intervention and sleep duration and efficiency.

Power analysis (sample size, evaluable subjects, etc.): The study is designed for feasibility and not powered to test the intervention effect. The SH+Y intervention will be considered as potentially efficacious if the estimates for the change scores (post-pre within and between group changes and their 95% confidence intervals) are consistent with clinically significant improvements in sleep duration (actigraphy sleep increases by > 30 minutes), sleep quality improves by > 0.3 standard deviations), or sleep hygiene (reduction in deviation in wake time relative to recommended wake time > 25%). The investigators will consider inclusion of specific measurements (mediators) in a future RCT based on: <10% missingness; correlation of change score or baseline score with outcomes of >.20; absence of redundancy with a simpler metric (r<.80).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Adapting Sleep and Yoga Interventions for Maximal Effectiveness in Low Income Populations
• Actual Study Start Date: January 10, 2018
• Actual Primary Completion Date: June 29, 2018
• Actual Study Completion Date: July 12, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sleep hygiene & Yoga (SH+Y); Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. After completing the SH sessions, they will receive 10 weeks of the yoga intervention (8 in-person yoga sessions and 2 weeks of yoga home practice maintenance assessment).	Behavioral: Sleep hygiene intervention; The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal.; Behavioral: Yoga intervention; Following the SH intervention, participants randomized to the SH+Y arm will participate in 8 weekly beginner level yoga classes. Classes will increase participants' skill and comfort with yoga postures and relaxing breathing exercises so that participants can adopt an evening yoga practice (10 weeks).
Active Comparator: Sleep hygiene (SH); Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment.	Behavioral: Sleep hygiene intervention; The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal.

Outcome Measures

Primary Outcome Measures :

1. Sleep Duration [ Time Frame: 12 weeks ]
   Change in sleep duration from baseline to follow-up measure by actigraphs. We will conduct a repeated measures ANCOVA, modeling time, intervention group and a time*intervention interaction. We will explore change in stress, anxiety, depressive symptoms, mindfulness, and sleep hygiene score as potential explanatory variables.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Verbally proficient in English
• Self-reported average (over the prior month) weekday sleep duration of < 6 hours
• Reside in a public housing

Exclusion Criteria:

• Severe physical conditions preventing participation in yoga, including major surgery or head injury in the prior 3 months, or unstable vertebral injury with inability to sit or lie down for 5 or more minutes; or glaucoma
• Major psychiatric disease (e.g. schizophrenia, depression, PTSD) resulting in hospitalization in the last year; or disease severity that, in the opinion of the investigator, would make it difficult for the participant to partake in the study activities.
• Severe sleep disorders: self-report of physician diagnosed insomnia requiring hypnotics more than 3 times/ week or an untreated known sleep disorder (sleep apnea, RLS), that in the opinion of the investigator, would make it difficult for the participant to achieve sleep hygiene goals.
• Needing an assistive device such as a walker or cane, frequent falls, history of stroke resulting in weakness or numbness interfering with moving easily, or other problems causing ongoing balance issues and difficulty walking
• Yoga class participation in last 6 weeks
• Known pregnancy.
• Participation in prior sleep and yoga study pilots

Contacts and Locations

Locations

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Brigham and Women's Hospital

National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Susan Redline, MD, MPH; Brigham and Women's Hospital

  Study Documents (Full-Text)

Documents provided by Susan Redline, Brigham and Women's Hospital:

Study Protocol and Statistical Analysis Plan  [PDF] February 16, 2018

Informed Consent Form  [PDF] April 11, 2018

More Information

Publications:

Spadola CE, Rottapel R, Khandpur N, Kontos E, Bertisch SM, Johnson DA, Quante M, Khalsa SBS, Saper RB, Redline S. Enhancing yoga participation: A qualitative investigation of barriers and facilitators to yoga among predominantly racial/ethnic minority, low-income adults. Complement Ther Clin Pract. 2017 Nov;29:97-104. doi: 10.1016/j.ctcp.2017.09.001. Epub 2017 Sep 4.

• Responsible Party: Susan Redline, Professor, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT03392194
• Other Study ID Numbers: 2017P002349; 1R34AT008923-01 ( U.S. NIH Grant/Contract )
• First Posted: January 5, 2018
• Results First Posted: August 21, 2019
• Last Update Posted: September 11, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• 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 Susan Redline, Brigham and Women's Hospital:

Behavioral interventions; Sleep hygiene; Yoga; Community research; Short sleep duration; Low-income population