Digital Cognitive Behavioral Therapy for Insomnia in China

Sponsor
Peking University (Other)
Overall Status
Completed
CT.gov ID
NCT05416346
Collaborator
(none)
217
1
2
2
108.3

Study Details

Study Description

Brief Summary

Digital cognitive behavioral therapy for insomnia (dCBT-i) is found to be effective but is rarely used in China. Hence, the investigators developed an automated Chinese dCBT-i program and examined its feasibility, acceptability, and preliminary effectiveness in individuals with insomnia symptoms.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Digital Cognitive Behavioral Therapy
  • Behavioral: Sleep Hygiene Education (SHE)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
217 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Feasibility and Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in China: A Pilot Randomized Controlled Trial
Actual Study Start Date :
Apr 12, 2021
Actual Primary Completion Date :
Jun 12, 2021
Actual Study Completion Date :
Jun 12, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: dCBT-i

The dCBT-i group received the whole intervention

Behavioral: Digital Cognitive Behavioral Therapy
Cognitive behavioral therapy for insomnia (CBT-i) has been showed to be effective in reducing insomnia symptoms and insomnia-related symptoms, including sleepiness, dysfunctional beliefs and attitudes about sleep, anxiety and depressive symptoms

Active Comparator: Sleep Hygiene Education (SHE)

The SHE group received sleep hygiene education delivered in text form, and the same intervention as the dCBT-i group did after four weeks.

Behavioral: Digital Cognitive Behavioral Therapy
Cognitive behavioral therapy for insomnia (CBT-i) has been showed to be effective in reducing insomnia symptoms and insomnia-related symptoms, including sleepiness, dysfunctional beliefs and attitudes about sleep, anxiety and depressive symptoms

Behavioral: Sleep Hygiene Education (SHE)
The SHE group received sleep hygiene education delivered in text form, and the same intervention as the dCBT-i group did after four weeks.

Outcome Measures

Primary Outcome Measures

  1. sleep diary [week 4]

    recording one's sleep efficiency, total sleep time, sleep onset latency, wakefulness after sleep onset, and subjective sleep quality

  2. Sleep Condition Indicator-8 [week 4]

    Sleep Condition Indicator-8 is an 8-item scale validated against Diagnostic and Statistical Manual-5 criteria, concerning sleep quality and daytime personal functioning. It scores between 0 to 32, with higher scores meaning better sleep.

Secondary Outcome Measures

  1. the Insomnia Severity Index 7-item version [week 4]

    It scores between 0 to 28, with higher scores meaning more severe insomnia.

  2. the Dysfunctional Beliefs and Attitudes about Sleep Scale 16-item version [week 4]

    It scores between 16 to 80, with higher scores meaning more dysfunctional beliefs.

  3. the Epworth Sleepiness Scale [week 4]

    It scores between 0 to 24, with higher scores meaning greater sleepiness.

  4. the Patient Health Questionnaire 9-item version [week 4]

    It scores between 0 to 27, with higher scores meaning higher depressive symptoms.

  5. the Generalized Anxiety Disorder 7-item version [week 4]

    It scores between 0 to 21, with higher scores meaning higher anxious symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • were aged 18 or older;

  • had a positive screening result for chronic insomnia, i.e., a score of 16 or lower on the Sleep Condition Indicator (SCI);

  • had stable access to the internet via a smartphone.

Exclusion Criteria:
  • additional sleeping conditions except for insomnia (such as restless legs syndrome and sleep apnea);

  • psychosis or mania;

  • serious physical health concerns necessitating surgery or with prognosis <6 months;

  • undergoing medical or psychological treatment for insomnia with a health professional;

  • habitual night shift, evening, or rotating shift-workers.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Beijing Beijing China

Sponsors and Collaborators

  • Peking University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University
ClinicalTrials.gov Identifier:
NCT05416346
Other Study ID Numbers:
  • dCBT-i-Chinese
First Posted:
Jun 13, 2022
Last Update Posted:
Jun 16, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 16, 2022