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Completed

NCT Number: NCT04316663

Well-being Promotion and Sleep Hygiene Education to Improve Sleep Quality

The overall goal of this project is to evaluate the effect of enhanced psychological well-being on sleep quality. This study will demonstrate whether combining an intervention designed to promote psychological well-being with sleep hygiene education improves sleep quality in a non-clinical population of distressed adults reporting poor sleep in the absence of a diagnosed sleep disorder. The investigators expect an intervention combining elements of psychological well-being and sleep hygiene education to result in significant improvements in sleep quality measures from baseline to post-intervention, and greater improvements in sleep quality measures at post-intervention as compared with sleep hygiene education alone.

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Key information

Conditions

Poor Quality Sleep Behavior Dyssomnias Health Behavior Mental Disorders Nervous System Diseases Personal Satisfaction Psychological Well-Being Sleep Disorders, Intrinsic Sleep Hygiene Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

Psychological distress is often associated with poor sleep quality. The role of psychological well-being has often been neglected and most interventions for sleep improvement have focused primarily on sleep disorders. This approach is limited to those individuals who have specific conditions and little resources have been directed to the promotion of sleep quality in the general population.

This study will be a pilot parallel-arm, randomized controlled trial to assess the baseline associations between psychological well-being and different measures of sleep outcomes, determine the effect of elements of a psychological well-being promoting intervention on sleep quality, and examine effect size estimates of key sleep-related outcomes (duration, efficiency, quality) to provide essential data to inform a main efficacy trial.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-65 years
  • Distress according to the Perceived Stress Scale
  • Poor sleep quality according to the Pittsburgh Sleep Quality Index
  • No diagnosis of sleep disorders
  • English fluency
  • Access to a computer with an Internet connection

Exclusion criteria

  • Inability to provide informed consent for any reason
  • Cognitive impairment according to the Montreal Cognitive Assessment
  • Suspected presence of sleep apnea according to the Berlin Questionnaire
  • Diagnosis of a chronic medical or psychiatric condition
  • Severe depression or suicidal thoughts or wishes according to the Beck Depression Inventory
  • Body Mass Index (BMI) ≥ 35 kg/m2
  • Chronic use of medications for sleep or chronic medical and psychiatric conditions
  • Any current psychological or behavioral intervention administered by a health care provider or as part of a research project
  • Shift workers
  • Pregnant women
  • Parents or caregivers of newborns (<1 year)
  • Heavy drinkers (≥ 8 drinks/week for women and ≥ 15 drinks/week for men)
  • Binge drinkers (≥ 4 drinks on a single occasion within about 2 hours for women and ≥ 5 drinks on a single occasion within about 2 hours for men
  • Use of recreational or street drugs
  • Heavy smokers (≥ 20 cigarettes daily)
  • Heavy caffeine users (> 400 mg a day, corresponding to about 4 or 5 cups of coffee)

Treatment and study plan

Well-Being Intervention

Behavioral

The main aim of the well-being intervention is to reduce levels of distress through the promotion of psychological well-being. Key components of the intervention are self-monitoring of instances of well-being and what leads to their interruption (i.e., thoughts and behaviors), cognitive restructuring of interfering thoughts, and homework assignments to address dysfunctional behaviors and increase exposure to optimal experiences. Participants will become aware of their functioning based on six different dimensions of psychological well-being (i.e., self-acceptance, positive relations with others, autonomy, environmental mastery, purpose in life, and personal growth), and will be guided in finding a balance within each dimension.

Sleep Hygiene

Behavioral

The main aim of sleep hygiene education is to provide participants with a set of behavioral and environmental recommendations intended to promote healthy sleep. During the intervention, participants will become aware of their own sleep patterns, will learn about healthy sleep habits, and will be encouraged to follow a set of recommendations to improve their sleep. Key components of the intervention are sleep hygiene and education.

Primary outcomes

  1. Change in sleep quality: Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline to immediate post-intervention

    Measured by the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-rating scale for the assessment of sleep quality over a 1-month time interval. The PSQI yields 7 component scores and one global score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is given a score from 0-3. The global score is calculated by summing the seven component scores, providing an overall score ranging from 0-21, where lower scores indicate a higher sleep quality.

  2. Change in insomnia severity: Insomnia Severity Index (ISI)

    Time frame: Baseline to immediate post-intervention

    Measured by the Insomnia Severity Index (ISI), a 7-item self-rated questionnaire to measure insomnia severity in the past 2 weeks. The total score ranges from 0-28, with higher scores indicating greater severity of insomnia. Scores of 8-14, 15-21, and 22-28 are indicative of subthreshold, moderate, and severe clinical insomnia, respectively.

  3. Changes in total sleep time

    Time frame: Baseline to immediate post-intervention

    Measured by self-reported sleep diary

  4. Changes in sleep onset latency

    Time frame: Baseline to immediate post-intervention

    Measured by self-reported sleep diary

  5. Changes in wake after sleep onset

    Time frame: Baseline to immediate post-intervention

    Measured by self-reported sleep diary

Secondary outcomes

  1. Change in psychological distress

    Time frame: Baseline to immediate post-intervention

    Measured by the Symptom Questionnaire (SQ), a 92-item self-rating scale for the assessment of psychological distress over a 1-week time interval. The SQ yields 4 main scales: anxiety, depression, somatization, and hostility. Each scale can be further divided into 2 sub-scales: one concerned with symptoms (17 items) and the other with well-being (6 items). Answers on each item are dichotomous (i.e., yes/no or true false). Scales and subscales can be scored separately, and the sum of the 4 main scale scores yields a total distress score. A response of yes/true for a symptom item gives 1 point, and a response of no/false for a well-being question gives 1 point for a score ranging from 0-23 for each main scale and 0-17 for each subscale, where a higher score indicates greater distress. If the well-being score is calculated separately the raw score can be subtracted from 6 for a score ranging from 0-6, where a higher score indicates greater well-being.

  2. Change in psychological well-being

    Time frame: Baseline to immediate post-intervention

    Measured by the Psychological Well-being scale, a 42-item self-rating scale for the assessment of 6 dimensions of psychological well-being: self-acceptance, positive relations with others, autonomy, environmental mastery, purpose in life, and personal growth. Each of the 42 six-point response items are given a score from 1-6, with questions phrased in the negative reversed (e.g., 1 to 6, 6 to 1). The total score in each dimension ranges from 7-42, and all the dimensions scores are summed to give a final total ranging from 42-252, with higher scores indicating greater psychological well-being.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Well-being Promotion and Sleep Hygiene Education to Improve Sleep Quality in a Non-clinical Population of Distressed Adults Reporting Poor Sleep: A Pilot Parallel-arm, Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 20, 2020
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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