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

NCT03392194 | Completed Results DMC

• 2 other identifiers: 2017P0023491R34AT008923-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sleep Duration

  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.

  12 weeks

Study Arms (2)

Sleep hygiene & Yoga (SH+Y)

EXPERIMENTAL

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; Behavioral: Yoga intervention

Sleep hygiene (SH)

ACTIVE COMPARATOR

Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment.

Behavioral: Sleep hygiene intervention

Interventions

Sleep hygiene intervention BEHAVIORAL

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.

Sleep hygiene & Yoga (SH+Y); Sleep hygiene (SH)

Yoga intervention BEHAVIORAL

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).

Sleep hygiene & Yoga (SH+Y)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 29122272 BACKGROUND

MeSH Terms

Conditions

Sleep Hygiene

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Limitations and Caveats

This study was a developmental pilot to test novel interventions in the community. At this stage, sample sizes were not developed to achieve power and statistically reliable results.

Results Point of Contact

• Title: Dr. Susan Redline
• Organization: Brigham and Women's Hospital

SREDLINE@BWH.HARVARD.EDU

617-732-5859

Study Officials

• Susan Redline, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 5, 2018
• Study Start: January 10, 2018
• Primary Completion: June 29, 2018
• Study Completion: July 12, 2018
• Last Updated: September 11, 2019
• Results First Posted: August 21, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)