ISRCTN13694016进行中（未招募）未知
A randomised, open-label, parallel-group study examining outcomes of Breaking Free Online computer-assisted-therapy plus standard treatment versus standard treatment alone in participants with substance use disorders: a telehealth approach
The Breaking Free Group (a wholly owned subsidiary of TELUS Health (UK) Ltd)0 个研究点目标入组 183 人开始时间: 2021年5月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 183
研究概览
简要总结
2023 Protocol article in https://doi.org/10.1186/s13722-023-00391-0 (added 05/06/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged =18 years or above on the day of consent
- •2. Experiencing problem alcohol and/or drug use at the time of consent, as determined by Investigator
- •3. Problem alcohol or drug use present for =12 months at the time of consent, as self-reported
- •4. Willing to comply with an 8-week treatment programme for problem alcohol and/or drug use
- •5. Willing to provide outcome measures post-treatment, and at 3- and 6-months follow-up
- •6. Able to read, write and communicate in the English language
- •7. Able to access an internet enabled device for the duration of the study
- •8. Able to access a telephone or video-communication enabled device for the duration of the 8-week treatment period
- •9. Willing and able to give informed consent for participation in the study, and capable of understanding and complying with protocol requirements
排除标准
- •Current participant exclusion criteria as of 05/07/2023:
- •1. Participation in any other alcohol and/or drug-related clinical studies within 12 months prior to the date of consent
- •2. Detention under the Mental Health Act at the time of consent
- •3. Clinically significant intellectual or developmental disability which may impair the ability to engage with the Breaking Free Online treatment programme and/or complete the necessary assessment measures included in the methodology, as determined by the Investigator
- •4. Pregnancy (as self-reported) at the time of consent
- •5. Use of the Breaking Free Online programme for the purposes of alcohol or drug use intervention within 12 months prior to study enrolment
- •Previous participant exclusion criteria:
- •1. Participation in any other alcohol and/or drug-related clinical studies within 12 months prior to the date of consent
- •2. Detention under the Mental Health Act at the time of consent
- •3. Clinically significant intellectual or developmental disability which may impair the ability to engage with the Breaking Free Online treatment programme and/or complete the necessary assessment measures included in the methodology, as determined by the Investigator
- •4. Pregnancy (as self-reported) at the time of consent
- •5. Previous use of the Breaking Free Online programme for the purposes of alcohol or drug use intervention
研究者
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