Substance AbuseNCT07028346
Exploring Substance Use, Sleep Disturbances and Reward Sensitivity
A study testing Cognitive Behavioral Therapy for Insomnia and Sleep Education in people with Substance Abuse and Sleep Disturbances, run by Kwai Chung Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse, Sleep Disturbances
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia and Sleep Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 16 Jun 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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:
- 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.
- Conditions
- Substance Abuse, Sleep Disturbances
- Being tested
- Cognitive Behavioral Therapy for Insomnia, Sleep Education
- Keywords
- Substance abuse, substance misuse, sleep disturbances, sleep problem
- Medical subject headings
- Substance-Related Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
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 EducationBehavioural
Sleep Education group comprises psychoeducation sessions on sleep hygiene.
| Study group | Role | What they receive |
|---|---|---|
| CBTi Group | Experimental | Cognitive Behavioral Therapy for Insomnia Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Sleep Education Group | Active comparator | Sleep Education Receives: Behavioral: Sleep Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
Measured: From enrollment to the end of treatment at 8 weeks
Pittsburgh Sleep Quality Index
Measured: From enrollment to the end of treatment at 8 weeks
Drug Use Disorders Identification Test
Measured: From enrollment to the end of treatment at 8 weeks
Alcohol Use Disorders Identification Test
Measured: 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
Scores ranges from 0 to 48. Higher scores indicate greater sensitivity to reward, suggesting an increased behavioral tendency toward reward-seeking stimuli.
Measured: From enrollment to the end of treatment at 8 weeks
Computerized Iowa Gambling Task
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start16 Jun 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kwai Chung Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, Fritz Yeung, Kwai Chung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028346
- Sponsor's protocol ID
- CIRB-2025-173-4
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because of organizational policy.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07028346
- Acronym / sponsor ID
- CIRB-2025-173-4
- Conditions
- Substance Abuse, Sleep Disturbances
- Keywords
- Substance abuse, substance misuse, sleep disturbances, sleep problem
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Kwai Chung HospitalUniversity, hospital or other
- Collaborators
- The University of Hong Kong
- Study start
- 16 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBTi Group | Experimental | Behavioral: Cognitive Behavioral Therapy for InsomniaCognitive Behavioral Therapy for Insomnia |
| Sleep Education Group | Active comparator | Behavioral: Sleep EducationSleep Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for InsomniaCognitive 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. | Behavioural | CBTi Group |
| Sleep EducationSleep Education group comprises psychoeducation sessions on sleep hygiene. | Behavioural | Sleep Education Group |
Primary outcome
Insomnia Severity Index
Time frame: From enrollment to the end of treatment at 8 weeks
Pittsburgh Sleep Quality Index
Time frame: From enrollment to the end of treatment at 8 weeks
Drug Use Disorders Identification Test
Time frame: From enrollment to the end of treatment at 8 weeks
Alcohol Use Disorders Identification Test
Time frame: From enrollment to the end of treatment at 8 weeks
2 secondary outcomes
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
Computerized Iowa Gambling Task
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No. IPD will not be shared because of organizational policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia and Sleep Education in people with Substance Abuse and Sleep Disturbances, run by Kwai Chung Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mr. Lam (852-2959-8539, fritzyeung@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.