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

Not Applicable

Completed

• Conditions: Poor Quality Sleep
• Interventions: Behavioral: Well-Being Intervention; Behavioral: Sleep Hygiene

• Registration Number: NCT04316663
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed Description

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-03-18
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-20
• Study Start: 2020-04-28
• Primary Completion: 2021-01-17
• Study Completion: 2022-04-20
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Well-Being and Sleep Hygiene	Sleep Hygiene	Participants in the experimental group will receive an intervention focused on both principles of psychological well-being and sleep hygiene education.
Sleep Hygiene (Control)	Sleep Hygiene	Participants in the control group will receive sleep hygiene education alone.
Well-Being and Sleep Hygiene	Well-Being Intervention	Participants in the experimental group will receive an intervention focused on both principles of psychological well-being and sleep hygiene education.

Primary Outcome Measures

Name	Time	Method
Changes in sleep onset latency	Baseline to immediate post-intervention	Measured by self-reported sleep diary
Change in insomnia severity: Insomnia Severity Index (ISI)	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.
Changes in wake after sleep onset	Baseline to immediate post-intervention	Measured by self-reported sleep diary
Change in sleep quality: Pittsburgh Sleep Quality Index (PSQI)	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.
Changes in total sleep time	Baseline to immediate post-intervention	Measured by self-reported sleep diary

Secondary Outcome Measures

Name	Time	Method
Change in psychological well-being	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.
Change in psychological distress	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.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States