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

April 26, 2023 updated by: Marie-Pierre St-Onge, Columbia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Well-Being and Sleep Hygiene
Participants in the experimental group will receive an intervention focused on both principles of psychological well-being and sleep hygiene education.
Behavioral: Well-Being Intervention
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.
Behavioral: Sleep Hygiene
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.
Active Comparator: Sleep Hygiene (Control)
Participants in the control group will receive sleep hygiene education alone.
Behavioral: Sleep Hygiene
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to immediate post-intervention
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.
Baseline to immediate post-intervention
Changes in total sleep time
Time Frame: Baseline to immediate post-intervention
Measured by self-reported sleep diary
Baseline to immediate post-intervention
Changes in sleep onset latency
Time Frame: Baseline to immediate post-intervention
Measured by self-reported sleep diary
Baseline to immediate post-intervention
Changes in wake after sleep onset
Time Frame: Baseline to immediate post-intervention
Measured by self-reported sleep diary
Baseline to immediate post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to immediate post-intervention
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.
Baseline to immediate post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2020

Primary Completion (Actual)

January 17, 2021

Study Completion (Actual)

April 20, 2022

Study Registration Dates

First Submitted

March 18, 2020

First Submitted That Met QC Criteria

March 19, 2020

First Posted (Actual)

March 20, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AAAS8486

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Investigators can request de-identified data after the primary outcomes of this research project are published. Requests should be made in writing to the PI.

IPD Sharing Time Frame

12 months after the completion of the study.

IPD Sharing Access Criteria

Request data in writing by contacting the PI.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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