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Not yet recruiting NCT07028346

Exploring Substance Use, Sleep Disturbances and Reward Sensitivity

No phase Interventional Substance Abuse Sleep Disturbances

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive Behavioral Therapy for Insomnia, Sleep Education.
Who it may be relevant to
Registry conditions: Substance Abuse, Sleep Disturbances. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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:

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.

Interventions

  • Behavioral Cognitive 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.
  • Behavioral Sleep Education
    Sleep Education group comprises psychoeducation sessions on sleep hygiene.

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07028346 · CIRB-2025-173-4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗