Alcohol Use DisorderNCT06779006
Effectiveness of Internet-Based Self-Help ACT With Behavioral Activation in Improving Alcohol Use Abstinence Among Ethnic Minority Young Adults With Alcohol Use Disorder
A study testing Self-help acceptance and commitment therapy with behavioral activation in people with Alcohol Use Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The goal of this clinical trial is to examine the preliminary effectiveness and feasibility of internet-based self-help acceptance and commitment therapy with behavioral activation for ethnic minority young adults with alcohol use disorder. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Self-help acceptance and commitment therapy with behavioral activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Sep 2024to 28 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Hong Kong ethnic minority young adults
- They have to read, write, and speak English
- Their age will range from 18 to 25
- They will be voluntary to participate
- Participants should have smartphones or other electronic devices to access the internet
- They must have AUD based on DSM-5 criteria.
Who cannot join
- Currently having psychiatric problems, other mental health problems, being actively involved in suicidal attempts, or immediate care
- Having a plan to go out of Hong Kong during intervention implementation
- Having no access to the internet, smart telephone, or other electronic devices
- Have participated in another psychosocial or pharmacological intervention for AUD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Internet-Based Self-Help ACT With Behavioral Activation in Improving Alcohol Use Abstinence Among Ethnic Minority Young Adults With Alcohol Use Disorder in Hong Kong, 2024: A Pilot Randomized Controlled Trial
The goal of this clinical trial is to examine the preliminary effectiveness and feasibility of internet-based self-help acceptance and commitment therapy with behavioral activation for ethnic minority young adults with alcohol use disorder. The main questions it aims to answer are:
- Is the internet-based self-help acceptance and commitment therapy with Behavioral activation (self-help iACT-BA) feasible and acceptable for ethnic minority young adults with AUD?
- Does the self-help iACT-BA promote greater abstinence from alcohol use compared to treatment as usual (TAU) in ethnic minority young adults diagnosed with AUD? Researchers will compare self-help iACT-BA to treatment as usual (TAU) to see if self-help iACT-BA works to treat alcohol use disorder in ethnic minority young adults.
Read more
Participants will:
- Received a self-help iACT-BA module every week for 6 weeks. or a placebo every day for 4 months
- Access the module every week, read the material, practice, and complete home assignments.
- Conditions
- Alcohol Use Disorder
- Being tested
- Self-help acceptance and commitment therapy with behavioral activation
- Keywords
- Acceptance and commitment therapy, Behavioral activation, Ethnic minority young adults, Alcohol abuse, Alcohol use disorder
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help acceptance and commitment therapy with behavioral activationBehavioural
Internet-based self-help acceptance and commitment therapy with behavioral activation
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | The intervention group will receive online-based integrated ACT with BA therapy. The protocol of this therapy is adapted from the ACT manual, self-help protocols for mental health problems, and behavioral activation treatment for substance use and depression. Receives: Behavioral: Self-help acceptance and commitment therapy with behavioral activation |
| Control Arm | No intervention | The control group will be assigned to receive Treatment as Usual (TAU). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening rate
calculated as the number of Hong Kong ethnic minority young adults screened by the research assistant divided by the number of Hong Kong ethnic minority young adults available for screening during the recruitment period.
Measured: 3 months
Eligibility rate
Calculated as the number of eligible ethnic minority young adults divided by the number of screened ethnic minority young adults.
Measured: 3 months
Consent rate
calculated as the number of eligible ethnic minority young adults who join the study divided by the number of eligible ethnic minority young adults.
Measured: 3 months
Randomization rate
calculated as the number of ethnic minority young adults who are randomized into the experimental and control groups, divided by the number of eligible ethnic minority young adults who consent to join the study
Measured: 2 weeks
Attendance rate
calculated as the number of subjects in the experimental group who complete the intervention divided by the number of subjects randomized into the experimental group.
Measured: 6 weeks
Adherence rate
calculated as the number of subjects in the experimental group who practice the ACT skills gained in the intervention divided by the number of subjects randomized into the experimental group
Measured: 6 weeks
Retention rate
calculated the number of subjects who remain in the study, divided by the number of subjects who are randomized
Measured: 6 weeks
Completion rate
calculated as the number of subjects who answer the questionnaires divided by the number of questionnaires distributed
Measured: 6 weeks
Missing data
percentage of missing in the dataset. Unknown or blank values will be regarded
Measured: 6 weeks
Adverse events
unfavorable and unintended events that are absent from baseline, or appear to worsen from baseline during the study period
Measured: 6 weeks
Secondary outcomes (4)
Abstinence rate
It will be calculated by dividing the number of non-drinking days recorded during intervention by the total number of intervention days and multiplying the result by 100.
Measured: 6 weeks
Average number of drinks consumed per day
Calculated as the total number of drinks during the intervention period divided by the total number of intervention days.
Measured: 6 weeks
The number of drinking days
Calculated by counting the number of days on which a participant consumes alcohol during the intervention period.
Measured: 6 weeks
The number of heavy drinking days
The number of heavy drinking days during the intervention period (having 3 or more drinks per day for males and 4 or more drinks per day for females.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start15 Sep 2024
- Primary completion28 Mar 2025 (estimated)
- Study completion28 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Eva Ho, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779006
- Sponsor's protocol ID
- ACT-BA_AUD
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Internet-Based Self-Help ACT With Behavioral Activation in Improving Alcohol Use Abstinence Among Ethnic Minority Young Adults With Alcohol Use Disorder in Hong Kong, 2024: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06779006
- Acronym / sponsor ID
- ACT-BA_AUD
- Conditions
- Alcohol Use Disorder
- Keywords
- Acceptance and commitment therapy, Behavioral activation, Ethnic minority young adults, Alcohol abuse, Alcohol use disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 28 Mar 2025 (estimated)
- Study completion
- 28 Apr 2025 (estimated)
- First posted
- 16 Jan 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.
The goal of this clinical trial is to examine the preliminary effectiveness and feasibility of internet-based self-help acceptance and commitment therapy with behavioral activation for ethnic minority young adults with alcohol use disorder. The main questions it aims to answer are:
- Is the internet-based self-help acceptance and commitment therapy with Behavioral activation (self-help iACT-BA) feasible and acceptable for ethnic minority young adults with AUD?
- Does the self-help iACT-BA promote greater abstinence from alcohol use compared to treatment as usual (TAU) in ethnic minority young adults diagnosed with AUD? Researchers will compare self-help iACT-BA to treatment as usual (TAU) to see if self-help iACT-BA works to treat alcohol use disorder in ethnic minority young adults.
Participants will:
- Received a self-help iACT-BA module every week for 6 weeks. or a placebo every day for 4 months
- Access the module every week, read the material, practice, and complete home assignments.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Self-help acceptance and commitment therapy with behavioral activationThe intervention group will receive online-based integrated ACT with BA therapy. The protocol of this therapy is adapted from the ACT manual, self-help protocols for mental health problems, and behavioral activation treatment for substance use and depression. |
| Control Arm | No intervention | –The control group will be assigned to receive Treatment as Usual (TAU). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Hong Kong ethnic minority young adults
- They have to read, write, and speak English
- Their age will range from 18 to 25
- They will be voluntary to participate
- Participants should have smartphones or other electronic devices to access the internet
Key exclusion criteria (4 listed)
- Currently having psychiatric problems, other mental health problems, being actively involved in suicidal attempts, or immediate care
- Having a plan to go out of Hong Kong during intervention implementation
- Having no access to the internet, smart telephone, or other electronic devices
- Have participated in another psychosocial or pharmacological intervention for AUD.
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 |
|---|---|---|
| Self-help acceptance and commitment therapy with behavioral activationInternet-based self-help acceptance and commitment therapy with behavioral activation | Behavioural | Intervention Arm |
Primary outcome
Screening rate
Time frame: 3 months
calculated as the number of Hong Kong ethnic minority young adults screened by the research assistant divided by the number of Hong Kong ethnic minority young adults available for screening during the recruitment period.
Eligibility rate
Time frame: 3 months
Calculated as the number of eligible ethnic minority young adults divided by the number of screened ethnic minority young adults.
Consent rate
Time frame: 3 months
calculated as the number of eligible ethnic minority young adults who join the study divided by the number of eligible ethnic minority young adults.
Randomization rate
Time frame: 2 weeks
calculated as the number of ethnic minority young adults who are randomized into the experimental and control groups, divided by the number of eligible ethnic minority young adults who consent to join the study
Attendance rate
Time frame: 6 weeks
calculated as the number of subjects in the experimental group who complete the intervention divided by the number of subjects randomized into the experimental group.
Adherence rate
Time frame: 6 weeks
calculated as the number of subjects in the experimental group who practice the ACT skills gained in the intervention divided by the number of subjects randomized into the experimental group
Retention rate
Time frame: 6 weeks
calculated the number of subjects who remain in the study, divided by the number of subjects who are randomized
Completion rate
Time frame: 6 weeks
calculated as the number of subjects who answer the questionnaires divided by the number of questionnaires distributed
Missing data
Time frame: 6 weeks
percentage of missing in the dataset. Unknown or blank values will be regarded
Adverse events
Time frame: 6 weeks
unfavorable and unintended events that are absent from baseline, or appear to worsen from baseline during the study period
4 secondary outcomes
Abstinence rate
Time frame: 6 weeks
Average number of drinks consumed per day
Time frame: 6 weeks
The number of drinking days
Time frame: 6 weeks
The number of heavy drinking days
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-help acceptance and commitment therapy with behavioral activation in people with Alcohol Use Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening rate (time frame: 3 months). The study lists 10 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 16 Jan 2025.