Breaking Free Online computer-assisted-therapy plus standard treatment versus standard treatment alone in participants with substance use disorders
- Conditions
- Substance Use DisordersMental and Behavioural DisordersMental and behavioural disorders due to psychoactive substance use
- Registration Number
- ISRCTN13694016
- Lead Sponsor
- The Breaking Free Group (a wholly owned subsidiary of TELUS Health (UK) Ltd)
- Brief Summary
2023 Protocol article in https://doi.org/10.1186/s13722-023-00391-0 (added 05/06/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 183
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of Breaking Free Online measured using self-reported substance use using questions about weekly primary substance use (‘How many days in the past week did you use [primary substance]?’, and ‘How much [primary substance] did you use each day?’) and use and frequency of use of secondary substances (‘Do you use any other substances in addition to [primary substance]?’, ‘How many days in the past week did you use [secondary substance]?’, and ‘How much [secondary substance] did you use each day?’) at baseline, 8 weeks, 3, and 6 months
- Secondary Outcome Measures
Name Time Method 1. Efficacy of Breaking Free Online measured using the following at baseline, 8 weeks, 3, and 6 months:<br>1.1. Severity of substance dependence measured using the alcohol and drug-specific versions of the Severity of Dependence Scale (SDS) <br>1.2. Prevalence and severity of concurrent depression and anxiety measured using the Patient Health Questionnaire (PHQ-4)<br>1.3. Quality of life measured using the World Health Organization Quality of Life measure (WHOQoL-BREF)<br>1.4. Biopsychosocial functioning measured using Recovery Progression Measure (RPM)<br>2. Participant engagement with BFO measured using the following <br>2.1. The number of hours participant spends on BFO, the number of BCTs completed within BFO (how many of the 12 BCTs in the program were completed), and the total number of times each BCT was completed, captured by the backend BFO database during the 8 week treatment period<br>2.2. Qualitative data collected via semi-structured interviews with both participants and practitioners at 8 weeks