Exploring Substance Use, Sleep Disturbances and Reward Sensitivity

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое Sleep Education
  Sleep Education group comprises psychoeducation sessions on sleep hygiene.

Первичные конечные точки

• Insomnia Severity Index [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Pittsburgh Sleep Quality Index [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Drug Use Disorders Identification Test [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Alcohol Use Disorders Identification Test [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Вторичные конечные точки (2)

• Sensitivity to Reward Scales from Sensitivity to Reward and Sensitivity to Punishment Questionnaire [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Computerized Iowa Gambling Task [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07028346 · CIRB-2025-173-4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗