Multidimensional Sleep Health Intervention for Couples

Official title

DREAM-COUPLES: A Dyadic Multidimensional Sleep Health Intervention

Overview

The goal of this pilot dyadic study is to adapt a multidimensional sleep health (MDSH) intervention, previously disseminated at the individual level, for relationship partners, determine whether it improves sleep health and aspects of cardiometabolic health, and understand the role of dyadic dynamics in intervention effects. Can a dyadic MDSH intervention improve sleep health and blood pressure (primary outcomes) in relationship partners? Can a dyadic MDSH intervention improve anthropometric markers of adiposity, psychosocial indicators, stress, dyadic adjustment and coping, self-rated health (secondary outcomes) in relationship partners? As this is a single-arm study, there is no control group. All relationship partners will complete a three-tier screening process, attend two in-person visits to receive intervention materials, have blood pressure measured and sleep data collected using in-office and out-of-office monitors, participate in weekly check-in phone calls with research staff over the 8 weeks to support adherence and complete a voluntary follow-up phone call at 16 weeks to provide additional sleep health information. The multidimensional sleep health promotion intervention is based on evidence-based sleep hygiene education and established behavior change techniques and includes: report-back of sleep health profiles, S.M.A.R.T (specific, measurable, attainable, realistic, and timely) goal-setting and establishing a sleep health plan with a fixed sleep schedule, sleep health coaching and dyadic action planning, self-monitoring, virtual sleep hygiene education, motivational feedback, and addressing light and noise in the sleep environment. Mixed methods will be used to understand implementation metrics, processes, and outcomes to establish the successful completion and future expansion of the intervention within this context.

Detailed description

Sleep is a critical determinant of cardiometabolic health (CMH), yet most lifestyle interventions have focused exclusively on diet and physical activity, ignoring sleep as a modifiable behavioral target. There are limited behavioral sleep health interventions for improving CMH. To address this, the investigators developed the DREAM intervention, a multilevel multi-component intervention leveraging evidence-based behavior change techniques and addressing both individual behaviors and the sleep environment. To extend this work, the investigators are adapting the DREAM intervention to cohabitating couples, recognizing the critical role of dyadic dynamics in shaping sleep health and the importance of relationship partners in influencing each other's health behaviors.

This study will investigate whether a dyadic multidimensional sleep health (MDSH) intervention delivered to cohabitating relationship partners can improve objectively measured sleep health and cardiometabolic outcomes, including office and out-of-office blood pressure (BP) and anthropometric markers of adiposity. This study will also examine the intervention's effects on stress, psychosocial indicators, dyadic adjustment and coping, and self-rated health. The hypothesis is that targeting multiple interrelated sleep dimensions and leveraging health-promoting dyadic dynamics as a sustainable social support mechanism will improve MDSH and CMH.

This is a single arm, pre-post design intervention study. There is no randomization or control arm, and all eligible couples will receive the MDSH intervention. The study consists of three phases:

Screening Phase: Online/phone questionnaire screening followed by an in-person blood pressure assessment and 7-day sleep assessment (actigraphy and sleep diary) to confirm eligibility.

Intervention Phase (8 weeks): Eligible couples receive the full MDSH intervention, and complete two in-person visits at baseline and 8-weeks (endpoint).

Follow-Up Phase (16 weeks): A follow-up phone call is conducted at 16 weeks post-enrollment to collect sleep health information and assess sustainability of intervention effects.

Interventions

• Behavioral Multidimensional Sleep Health Promotion Intervention
  Standard American Heart Association (AHA) Life's Essential 8 (LE8) cardiovascular health educational materials and the 8-week MDSH intervention using evidence-based sleep hygiene education and established behavior change techniques that include: report back of objectively-assessed sleep health profiles, goal setting and dyadic MDSH planning, behavioral coaching (enhancing dyadic coping, communication, collaborative support) and sleep health education sessions, self-monitoring and motivational en

Primary outcome measures

• Change in office systolic blood pressure [Time frame: Baseline, 8 weeks]
• Change in office diastolic blood pressure [Time frame: Baseline, 8 weeks]
• Change in multidimensional sleep health [Time frame: Baseline, 8 weeks]
• Change in sleep duration [Time frame: Baseline, 8 weeks]
• Change in sleep regularity [Time frame: Baseline, 8 weeks]
• Changes in sleep efficiency [Time frame: Baseline, 8 weeks]
• Changes in sleep timing [Time frame: Baseline, 8 weeks]
• Changes in sleep alertness [Time frame: Baseline, 8 weeks]
• Change in sleep satisfaction [Time frame: Baseline, 8 weeks]
• Change in subjective sleep quality [Time frame: Baseline, 8 weeks, 16 weeks]

Secondary outcome measures (12)

• Change in body weight [Time frame: Baseline, 8 weeks]
• Change in waist circumference [Time frame: Baseline, 8 weeks]
• Change in diet quality [Time frame: Baseline, 8 weeks]
• Change in perceived stress [Time frame: Baseline, 8 weeks]
• Change in anxiety severity [Time frame: Baseline, 8 weeks]
• Change in depression severity [Time frame: Baseline, 8 weeks]
• Change in dyadic coping [Time frame: Baseline, 8 weeks]
• Change in dyadic adjustment [Time frame: Baseline, 8 weeks]
• Change in self-rated health [Time frame: Baseline, 8 weeks]
• Acceptability of Intervention [Time frame: Baseline, 8 weeks]
• Feasibility of Implementation [Time frame: Baseline, 8 weeks]
• Appropriateness of Implementation [Time frame: Baseline, 8 weeks]

Eligibility criteria

Inclusion criteria

• Adults aged 30-65 years
• English-speaking
• Systolic blood pressure greater than or equal to 120 mmHg (at minimum one individual in dyad)
• Sub-optimal sleep health (at minimum short/long sleep duration and/or irregular sleep patterns)

Exclusion criteria

• Optimal sleep health
• History of cardiovascular disease or cancer
• Not cognitively able to complete study requirements
• Known medical conditions that would prevent them from safely participating in the study (severe psychiatric disorders, neurological degenerative disease, substance abuse/dependence)
• History of severe depression or high risk of sleep apnea/use of a Continuous Positive Airway Pressure (CPAP) device
• Inability to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Columbia University — New York

Identifiers

NCT: NCT07603245 · AAAW0053

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗