CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 76 enrolled
Drug / intervention
Well-Being Intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04316663
NCT04316663N/ACompleted

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

Columbia University·interventional·Posted Mar 20, 2020·Updated Apr 27, 2023

In Brief

A clinical study evaluating Well-Being Intervention and Sleep Hygiene for Poor Quality Sleep. Completed, enrolled 76 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 20, 2020
Enrollment StartApr 28, 2020
Primary CompletionJan 17, 2021
Study CompletionApr 20, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 6.3 years ago

Interventions

Well-Being Interventionbehavioral

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 Hygienebehavioral

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.