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Not yet recruitingNCT07028346Updated Jun 24, 2025

Exploring Substance Use, Sleep Disturbances and Reward Sensitivity

An interventional study of Cognitive Behavioral Therapy for Insomnia and Sleep Education in Substance Abuse and Sleep Disturbances, sponsored by Kwai Chung Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-24.

Sponsored by Kwai Chung Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

According to foreign medical studies, substance use is closely related to reward sensitivity and sleep patterns. The purpose of this research is to understand the relationship between these three factors, which will help improve medical treatment and overall care for substance misuse in the future. Participants will be randomized into CBTi and sleep education groups, and their substance/ alcohol use, sleep parameters and reward sensitivity will be measured at multiple time points.

Read the detailed description

The study will invite approximately 154 individuals who have misused alcohol or drugs in the past three months and have symptoms of insomnia to participate. After completing the screening, participants who meet the study criteria will be asked to fill out five additional research questionnaires and take a 15-minute computer-based reward sensitivity test. Participants will then be randomly assigned, in a 1:1 ratio, to one of the following groups:

  1. A three-session cognitive behavioral therapy (CBT) group (the first session lasts 60 minutes, with subsequent sessions not exceeding 30 minutes) and two follow-up phone calls (each lasting around 20 minutes).
  2. A three-session sleep education group (the first session lasts 60 minutes, with subsequent sessions not exceeding 30 minutes) and two follow-up phone calls (each lasting around 20 minutes).

All participants will be invited to complete additional research questionnaires and computer-based tests in the 4th and 8th weeks after the group sessions begin.

02

Conditions studied

  • Substance Abuse
  • Sleep Disturbances

Keywords

  • Substance abuse
  • substance misuse
  • sleep disturbances
  • sleep problem
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's planned enrollment of 154 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

This is the only study on the registry with Kwai Chung Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Individuals who receive treatment services at Substance Abuse Assessment Clinic and other psychiatric out-patient clinics of Kwai Chung Hospital;
  2. Individuals who have problematic substance or alcohol use in the past 3 months, confirmed by scores higher than or equal to 1 in both part 1 and part 2 of Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS);
  3. Individuals who have sleep disturbances, confirmed by a score higher than or equal to 8 on the Insomnia Severity Index (ISI).

Exclusion criteria

Exclusion Criteria:

  1. Individuals who cannot understand Cantonese, or cannot read Traditional Chinese
  2. Individuals who cannot provide informed consent due to, for example, intoxication or abnormal mental state
  3. Individuals who report abnormal or unstable mental states, such as active psychotic symptoms or acute intoxication, at any point of the study
  4. Individuals who work overnight or have rotating shifts
  5. Individuals who report pregnancy or medical conditions (including sleep apnea) that may have a severe impact on sleep
  6. Individuals who use hypnotics regularly
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
154 participants (estimated)

Study arms

  • Experimental
    CBTi Group

    Cognitive Behavioral Therapy for Insomnia

    Behavioral: Cognitive Behavioral Therapy for Insomnia

  • Active comparator
    Sleep Education Group

    Sleep Education

    Behavioral: Sleep Education

Interventions

  • BehavioralCognitive Behavioral Therapy for Insomnia

    Cognitive Behavioral Therapy for Insomnia (CBT-I) is a first-line, non-medication treatment for insomnia that helps individuals identify and change the thoughts and behaviors that contribute to their sleep problems.

  • BehavioralSleep Education

    Sleep Education group comprises psychoeducation sessions on sleep hygiene.

06

What researchers measure

Primary outcomes

  1. Insomnia Severity Index

    Time frame: From enrollment to the end of treatment at 8 weeks

  2. Pittsburgh Sleep Quality Index

    Time frame: From enrollment to the end of treatment at 8 weeks

  3. Drug Use Disorders Identification Test

    Time frame: From enrollment to the end of treatment at 8 weeks

  4. Alcohol Use Disorders Identification Test

    Time frame: From enrollment to the end of treatment at 8 weeks

Secondary outcomes

  1. Sensitivity to Reward Scales from Sensitivity to Reward and Sensitivity to Punishment Questionnaire

    Scores ranges from 0 to 48. Higher scores indicate greater sensitivity to reward, suggesting an increased behavioral tendency toward reward-seeking stimuli.

    Time frame: From enrollment to the end of treatment at 8 weeks

  2. Computerized Iowa Gambling Task

    Time frame: From enrollment to the end of treatment at 8 weeks

Other outcomes

  1. Client Satisfaction Questionnaire (CSQ-8)

    Scores ranges from 8 to 32. Higher scores reflect greater overall satisfaction with services received, indicating a more positive client experience.

    Time frame: At the end of treatment at 8 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

  • Protocol and statistical analysis plan · May 29, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — IPD will not be shared because of organizational policy.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07028346
Lead sponsor
Kwai Chung Hospital
Collaborators
The University of Hong Kong
Responsible party
Fritz Yeung (Clinical Psychologist, Kwai Chung Hospital) — Principal investigator
First posted
Jun 19, 2025
Start date
Jun 16, 2025 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Jun 24, 2025

Study contacts

Mr. Lam
Contact
fritzyeung@ha.org.hk
852-2959-8539

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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