ClinicalTrials.Veeva

Menu

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

Columbia University logo

Columbia University

Status

Completed

Conditions

Poor Quality Sleep

Treatments

Behavioral: Well-Being Intervention
Behavioral: Sleep Hygiene

Study type

Interventional

Funder types

Other

Identifiers

NCT04316663
AAAS8486

Details and patient eligibility

About

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.

Full 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.

Enrollment

76 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

76 participants in 2 patient groups

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems