Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07028346

Exploring Substance Use, Sleep Disturbances and Reward Sensitivity

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Substance Abuse Chemically-Induced Disorders Mental Disorders Nervous System Diseases Parasomnias Sleep Disturbances Sleep Wake Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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:

  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia

Behavioral

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.

Sleep Education

Behavioral

Sleep Education group comprises psychoeducation sessions on sleep hygiene.

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

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

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

  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)

    Time frame: At the end of treatment at 8 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mr. Lam

CONTACT

[email protected]

852-2959-8539

Sponsors and collaborators

Lead sponsor

Kwai Chung Hospital

Other

Collaborators

  • The University of Hong Kong

Registry information

Official study title

An Exploratory Study of the Relationship Between Substance Use, Sleep Disturbances and Reward Sensitivity - A Randomized Control Trial of Cognitive Behavioral Therapy for Insomnia

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 19, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.