NCT07028346

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Jun 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Jun 2025Aug 2026

First Submitted

Initial submission to the registry

June 11, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

June 16, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

June 11, 2025

Last Update Submit

June 18, 2025

Conditions

Keywords

Substance abusesubstance misusesleep disturbancessleep problem

Outcome Measures

Primary Outcomes (4)

  • Insomnia Severity Index

    From enrollment to the end of treatment at 8 weeks

  • Pittsburgh Sleep Quality Index

    From enrollment to the end of treatment at 8 weeks

  • Drug Use Disorders Identification Test

    From enrollment to the end of treatment at 8 weeks

  • Alcohol Use Disorders Identification Test

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

  • Sensitivity to Reward Scales from Sensitivity to Reward and Sensitivity to Punishment Questionnaire

    From enrollment to the end of treatment at 8 weeks

  • Computerized Iowa Gambling Task

    From enrollment to the end of treatment at 8 weeks

Other Outcomes (1)

  • Client Satisfaction Questionnaire (CSQ-8)

    At the end of treatment at 8 weeks

Study Arms (2)

CBTi Group

EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Behavioral: Cognitive Behavioral Therapy for Insomnia

Sleep Education Group

ACTIVE COMPARATOR

Sleep Education

Behavioral: Sleep Education

Interventions

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.

CBTi Group
Sleep EducationBEHAVIORAL

Sleep Education group comprises psychoeducation sessions on sleep hygiene.

Sleep Education Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who receive treatment services at Substance Abuse Assessment Clinic and other psychiatric out-patient clinics of Kwai Chung Hospital;
  • 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);
  • Individuals who have sleep disturbances, confirmed by a score higher than or equal to 8 on the Insomnia Severity Index (ISI).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related DisordersParasomnias

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 19, 2025

Study Start

June 16, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

June 24, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

IPD will not be shared because of organizational policy.