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Multidimensional Sleep Health Intervention for Couples (DREAM-COUPLES)

31 de agosto de 2026 atualizado por: Nour Makarem, PhD, Columbia University

DREAM-COUPLES: A Dyadic Multidimensional Sleep Health Intervention

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

50

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • New York
      • New York, New York, Estados Unidos, 10032
        • Recrutamento
        • Columbia University
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  • Adults aged 30-65 years
  • English-speaking
  • Sub-optimal sleep health (at minimum one individual has to meet: 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
  • High risk of sleep apnea or use of a Continuous Positive Airway Pressure (CPAP) device
  • Inability to provide informed consent

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Multidimensional Sleep Health (MDSH) Promotion Intervention

Dyads will receive:

  1. An 8-week multi-component multidimensional sleep health promotion intervention that includes: 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 enhancement using a Fitbit and a participant manual, and inexpensive place-based solutions for light and noise as key upstream barriers to healthy sleep in urban settings.
  2. Cardiovascular health education materials based on the American Heart Association's Life's Essential 8 framework.
Comportamental: 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 enhancement using a Fitbit, weekly check-in calls, and a participant sleep health manual, and inexpensive place-based solutions for light, and noise as key upstream barriers to healthy sleep in urban settings.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in office systolic blood pressure
Prazo: Baseline, 8 weeks
The change in office systolic blood pressure (mmHg) from baseline to follow-up at 8 weeks will be calculated and compared across dyads.
Baseline, 8 weeks
Change in office diastolic blood pressure
Prazo: Baseline, 8 weeks
The change in office diastolic blood pressure (mmHg) from baseline to follow-up at 8 weeks will be calculated and compared across dyads.
Baseline, 8 weeks
Change in multidimensional sleep health
Prazo: Baseline, 8 weeks
Sleep health will be assessed using sleep duration, regularity, efficiency, and timing from wrist actigraphy and self-reported sleep satisfaction and alertness (measured by daytime sleepiness). Optimal sleep health will be defined as having an average sleep duration (hours/night) ≥ 7 hours and < 9 hours, regular sleep duration and timing (standard deviation of sleep duration and timing variables < 60 minutes), sleep efficiency (%) ≥ 85%, an earlier sleep period (sleep midpoint earlier than 4:00 AM), normal daytime sleepiness (Epworth Sleepiness Scale ≤ 10), and good self-rated sleep satisfaction or quality. Each individual component will receive a score of 1 if it meets the optimal sleep health definition or a score of 0 if it does not. Scores will range from 0-6, where higher scores (closer to 6) are defined as healthier sleep. Changes in the sleep health score (cumulative dimensions) from baseline to 8 weeks will be assessed.
Baseline, 8 weeks
Change in sleep duration
Prazo: Baseline, 8 weeks
Sleep duration will be assessed from wrist actigraphy. Optimal sleep duration will be defined as having an average sleep duration (hours/night) ≥ 7 hours and < 9 hours, given a score of 1 if met or 0 if not. Changes in sleep duration (continuous variable) from baseline to 8 weeks will be assessed.
Baseline, 8 weeks
Changes in sleep efficiency
Prazo: Baseline, 8 weeks
Sleep efficiency will be assessed from wrist actigraphy. Optimal sleep efficiency will be defined as having an average sleep efficiency (%) ≥ 85%, given a score of 1 if met or 0 if not. Changes in sleep efficiency (continuous variable) from baseline to 8 weeks will be assessed.
Baseline, 8 weeks
Changes in sleep timing
Prazo: Baseline, 8 weeks
Sleep timing will be assessed from wrist actigraphy. Optimal sleep timing will be defined as having an earlier sleep period (sleep midpoint earlier than 4:00 AM), given a score of 1 if met or 0 if not. Changes in sleep timing (continuous variable) from baseline to 8 weeks will be assessed.
Baseline, 8 weeks
Changes in sleep alertness
Prazo: Baseline, 8 weeks
Sleep alertness will be assessed from the self reported Epworth Sleepiness Scale (ESS). Optimal sleep alertness will be defined as having normal daytime sleepiness (ESS ≤ 10). Scores range from 0-24, where a score ≥ 11 indicated excessive daytime sleepiness. Changes in the ESS score (continuous variable) from baseline to 8 weeks will be assessed.
Baseline, 8 weeks
Change in sleep satisfaction
Prazo: Baseline, 8 weeks
Sleep satisfaction will be assessed from the consensus sleep diary. Sleep satisfaction is measured on a Likert scale (1 = very poor; 2 = poo; 3 = fair; 4 = good; 5 = very good). Change in sleep satisfaction from baseline and 8 weeks will be assessed.
Baseline, 8 weeks
Change in subjective sleep quality
Prazo: Baseline, 8 weeks, 16 weeks
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which captures seven clinical components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction) over the past month. The PSQI score ranges from 0-21 with higher scores suggesting significant sleep difficulties. The change in PSQI scores from baseline to follow-up at 8 weeks will be computed.
Baseline, 8 weeks, 16 weeks
Change in daytime blood pressure (during wake)
Prazo: Baseline, 8 weeks
Mean daytime blood pressure (mean of blood pressure readings during the wake period) will be computed using valid readings from 24-h ambulatory blood pressure monitoring. Changes in out-of-office daytime blood pressure metrics from baseline to follow-up at 8 weeks will be calculated.
Baseline, 8 weeks
Change in nighttime blood pressure (during sleep)
Prazo: Baseline, 8 weeks
Mean nighttime blood pressure (mean of blood pressure readings during the sleep period) will be computed using valid readings from 24-h ambulatory blood pressure monitoring. Changes in these out-of-office nighttime blood pressure metrics from baseline to follow-up at 8 weeks will be calculated.
Baseline, 8 weeks
Change in mean 24-hour blood pressure
Prazo: Baseline, 8 weeks
Mean 24-h blood pressure (mean of the wake and sleep blood pressure values, weighted by the relative amounts of time spent awake and asleep) will be computed using valid readings from 24-h ambulatory blood pressure monitoring. Changes in these out-of-office blood pressure metrics from baseline to follow-up at 8 weeks will be calculated and compared across dyads.
Baseline, 8 weeks
Change in sleep regularity
Prazo: Baseline, 8 weeks
Sleep regularity will be assessed from wrist actigraphy. Optimal sleep regularity will be defined as having a standard deviation of sleep duration and timing variables < 60 minutes, given a score of 1 if met or 0 if not. Changes in sleep duration standard deviation (SD) and sleep timing SD (continuous variable) from baseline to 8 weeks will be assessed.
Baseline, 8 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in body weight
Prazo: Baseline, 8 weeks
The change in body weight (lbs) from baseline to follow-up at 8 weeks will be calculated.
Baseline, 8 weeks
Change in waist circumference
Prazo: Baseline, 8 weeks
The change in waist circumference (inches) from baseline to follow-up at 8 weeks will be calculated.
Baseline, 8 weeks
Change in diet quality
Prazo: Baseline, 8 weeks
The Mediterranean Eating Pattern for Americans (MEPA) scale, which captures adherence to heart healthy dietary pattern, will be used to assess diet quality. The MEPA score ranges from 0-16 with higher scores indicating better diet quality. The change in MEPA scores from baseline to 8 weeks will be calculated.
Baseline, 8 weeks
Change in perceived stress
Prazo: Baseline, 8 weeks
The Perceived Stress Scale (PSS-10), which helps identify if individuals feel their lives are overloaded, unpredictable, or uncontrollable will be used to measure subjective perception of stress. The PSS-10 scores range from 0-40 with higher scores indicating higher perceived stress. The change in PSS-10 scores from baseline to 8 weeks will be calculated.
Baseline, 8 weeks
Change in anxiety severity
Prazo: Baseline, 8 weeks
The Generalized Anxiety Disorder-7 (GAD-7) measures anxiety symptom severity over the past two weeks, will be used to screen for generalized anxiety disorder and measure the severity of anxiety. The GAD-7 scores range from 0-21 with higher scores indicating higher levels of anxiety. The change in GAD-7 scores from baseline to 8 weeks will be calculated.
Baseline, 8 weeks
Change in depression severity
Prazo: Baseline, 8 weeks
The Patient Health Questionnaire-8 (PHQ-8) measures depression symptom severity over the past two weeks, will be used to measure the severity of depression and screen for depressive disorders. The PHQ-8 scores range from 0-24 with higher scores indicating higher depression severity. The change in PHQ-8 scores from baseline to 8 weeks will be calculated.
Baseline, 8 weeks
Change in dyadic coping
Prazo: Baseline, 8 weeks
The Dyadic Coping Inventory (DCI) is a self-report measure of stress communication and positive and negative forms of dyadic coping. This will be used to assess how couples manage stress together. DCI scores range from 35 to 145, with a higher score indicates higher dyadic coping, and DCI < 111 indicating low dyadic coping. The change in DCI scores from baseline to 8 weeks will be calculated.
Baseline, 8 weeks
Change in dyadic adjustment
Prazo: Baseline, 8 weeks
The Dyadic Adjustment Scale (DAS) measures relationship quality covering 4 subscales consensus, satisfaction, cohesion, and affectional. This will be used to measure the quality of marriage and similar intimate relationships. The DAS score ranges from 0 to 151, where a higher DAS score indicates better adjustment, and DAS < 98 indicating significant relationship distress/discord. The change in DAS scores from baseline to 8 weeks will be calculated.
Baseline, 8 weeks
Change in self-rated health
Prazo: Baseline, 8 weeks
Self-rated health will be measured using self-reported health on a Likert scale (excellent, very good, good, fair, poor) where 1 = Excellent and 5 = Poor. The change in self-rated health from baseline to 8 weeks will be calculated.
Baseline, 8 weeks
Acceptability of Intervention
Prazo: Baseline, 8 weeks
Acceptability will be measured by questionnaire. Items are adapted from the validated Acceptability of Implementation Measure (AIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better intervention acceptability. The items are analyzed individually and not summed to a total score.
Baseline, 8 weeks
Feasibility of Implementation
Prazo: Baseline, 8 weeks
Feasibility will be measured by questionnaire using items adapted from the validated Feasibility of Implementation Measure (FIM) and rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better feasibility. The items are analyzed individually and not summed to total score.
Baseline, 8 weeks
Appropriateness of Implementation
Prazo: Baseline, 8 weeks
Appropriateness will be measured by questionnaire. Items are adapted from the validated Implementation Appropriateness Measure (IAM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Complete disagree" and 5 indicating "Completely agree." Higher scores indicate better appropriateness. The items are analyzed individually and not summed to a total score.
Baseline, 8 weeks
Satisfaction with Intervention
Prazo: Baseline, 8 weeks
Participants' satisfaction with the study intervention will be assessed using the net promoter score, measured on a scale of 0 to 10. A higher score indicates greater satisfaction.
Baseline, 8 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Columbia University

Investigadores

  • Investigador principal: Nour Makarem, PhD, Columbia University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

8 de junho de 2026

Conclusão Primária (Estimado)

1 de junho de 2027

Conclusão do estudo (Estimado)

1 de junho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

13 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de maio de 2026

Primeira postagem (Real)

22 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • AAAW0053

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Data may be shared upon request to PI.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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