Substance Use Disorders (SUD)eScreeniPsyNCT01885026
Substance-focused SBI as a Complement to Internet-based Psychiatric Treatment: RCT
A study testing eScreen, Assessment only of alcohol and drug use. and Internet-based treatment for depression or anxiety in people with Substance Use Disorders (SUD), run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Objectives: This study evaluates the efficacy of eScreen for internet psychiatry patients treated for major depressive disorder, panic anxiety and social phobia. The eScreen brief Internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Substance Use Disorders (SUD)
- What is being tested?
- eScreen, Assessment only of alcohol and drug use. and Internet-based treatment for depression or anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteSweden
- Study dates
- Jul 2013to 31 Jan 2016
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- AUDIT >7 for men and AUDIT >5 for women, and/or DUDIT >0
Who cannot join
- DUDIT = 0 and AUDIT <8 (men) or <6 (women)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research
Stockholm, 11364
About this study
Official title: Substance-use Focused Screening and Brief Intervention as a Complement to Internet-based Psychiatric Treatment for Depression, Panic Disorder or Social Phobia: A Randomized Controlled Trial
Objectives: This study evaluates the efficacy of eScreen for internet psychiatry patients treated for major depressive disorder, panic anxiety and social phobia. The eScreen brief Internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. Progress over time is shown in diagrams detailing consumption levels.
Method: This is a two-armed randomized controlled design, measuring outcomes in terms of changes in problematic alcohol use up to one year after study recruitment. Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) and/or problematic drug use (DUDIT > 1 for both men and women) are randomized into one of two groups: T1, eScreen referral or Control group. Outcomes on alcohol and drug use as well as health-related symptoms are assessed after 3, 6 and 12 months.
The hypothesis is that the group receiving the eScreen intervention will reduce their alcohol/drug use to a larger extent than the control group at follow-up compared to the baseline level.
Read the detailed description
This study evaluated the efficacy of eScreen for internet psychiatry patients treated for major depressive disorder, panic anxiety and social phobia. The eScreen brief Internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. Progress over time is shown in diagrams detailing consumption levels. The design was a two-armed randomized controlled design, measuring outcomes in terms of changes in problematic alcohol use up to one year after study recruitment. Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) and/or problematic drug use (DUDIT > 1 for both men and women) were randomized into one of two groups: T1, eScreen referral or Control group. Outcomes on alcohol and drug use as well as health-related symptoms are assessed after 3, 6 and 12 months.
The hypothesis was that the group receiving the eScreen intervention would reduce their alcohol/drug use to a larger extent than the control group at follow-up compared to the baseline level. The results have not yet been analyzed due to technical issues. However, qualitative interviews have been conducted with participants and our intention is to publish the qualitative results in tandem with the quantitative results available.
- Conditions
- Substance Use Disorders (SUD)
- Being tested
- eScreen, Assessment only of alcohol and drug use., Internet-based treatment for depression or anxiety
- Keywords
- Randomized Controlled Trial, Alcohol, Drugs, Internet, Screening, Brief intervention
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eScreenBehavioural
Access to the eScreen platform offering assessment of alcohol and drug use, with automated feedback on problematic or non-problematic use. Follow-up over time based on user needs.
Assessment only of alcohol and drug use.Behavioural
Assessment of alcohol and drug use at baseline and follow-up.
Internet-based treatment for depression or anxietyBehavioural
Internet-based treatment for primary diagnoses of depression, panic anxiety or social phobia.
| Study group | Role | What they receive |
|---|---|---|
| eScreen | Experimental | Web based self-monitoring of problematic alcohol and drug use, and Internet-based treatment for depression or anxiety Receives: Behavioral: eScreen; Behavioral: Internet-based treatment for depression or anxiety |
| Control | Experimental | Assessment only of alcohol and drug use and Internet-based treatment for depression or anxiety Receives: Behavioral: Assessment only of alcohol and drug use.; Behavioral: Internet-based treatment for depression or anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the total AUDIT-C score
The primary outcome measure for this trial is the change in the total AUDIT score for the first three AUDIT questions, as a measure of alcohol consumption only, referred to as the AUDIT-C.
Measured: 3, 6 and 12 months
Secondary outcomes (1)
Alcohol Use Disorders Identification Test (AUDIT)
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startJul 2013
- Primary completion31 Jan 2016
- Study completion31 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Substance Use Disorders (SUD)Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne H Berman, Karolinska Institutet
- Investigators
- Anne H Berman, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885026
- Sponsor's protocol ID
- 2012/1138-31/1
- Other IDs
- KI 4-2007/2013
- Acronym
- eScreeniPsy
- Status last verified
- Oct 2018
- First submitted
- 20 Jun 2013
- Last updated
- 4 Oct 2018
- Results posted
- No
Publications
Sinadinovic K, Berman AH, Hasson D, Wennberg P. Internet-based assessment and self-monitoring of problematic alcohol and drug use. Addict Behav. 2010 May;35(5):464-70. doi: 10.1016/j.addbeh.2009.12.021. Epub 2010 Jan 4.
PubMed 20092953Sinadinovic K, Wennberg P, Berman AH. Targeting problematic users of illicit drugs with Internet-based screening and brief intervention: a randomized controlled trial. Drug Alcohol Depend. 2012 Nov 1;126(1-2):42-50. doi: 10.1016/j.drugalcdep.2012.04.016. Epub 2012 May 20.
PubMed 22613182Sinadinovic K, Wennberg P, Berman AH. Internet-based screening and brief intervention for illicit drug users: a randomized controlled trial with 12-month follow-up. J Stud Alcohol Drugs. 2014 Mar;75(2):313-8. doi: 10.15288/jsad.2014.75.313.
PubMed 24650825
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance-use Focused Screening and Brief Intervention as a Complement to Internet-based Psychiatric Treatment for Depression, Panic Disorder or Social Phobia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01885026
- Acronym / sponsor ID
- eScreeniPsy / 2012/1138-31/1
- Conditions
- Substance Use Disorders (SUD)
- Keywords
- Randomized Controlled Trial, Alcohol, Drugs, Internet, Screening, Brief intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 31 Jan 2016 (actual)
- First posted
- 24 Jun 2013 (estimated)
- 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.
Objectives: This study evaluates the efficacy of eScreen for internet psychiatry patients treated for major depressive disorder, panic anxiety and social phobia. The eScreen brief Internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. Progress over time is shown in diagrams detailing consumption levels.
Method: This is a two-armed randomized controlled design, measuring outcomes in terms of changes in problematic alcohol use up to one year after study recruitment. Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) and/or problematic drug use (DUDIT > 1 for both men and women) are randomized into one of two groups: T1, eScreen referral or Control group. Outcomes on alcohol and drug use as well as health-related symptoms are assessed after 3, 6 and 12 months.
The hypothesis is that the group receiving the eScreen intervention will reduce their alcohol/drug use to a larger extent than the control group at follow-up compared to the baseline level.
Detailed description
This study evaluated the efficacy of eScreen for internet psychiatry patients treated for major depressive disorder, panic anxiety and social phobia. The eScreen brief Internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. Progress over time is shown in diagrams detailing consumption levels. The design was a two-armed randomized controlled design, measuring outcomes in terms of changes in problematic alcohol use up to one year after study recruitment. Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) and/or problematic drug use (DUDIT > 1 for both men and women) were randomized into one of two groups: T1, eScreen referral or Control group. Outcomes on alcohol and drug use as well as health-related symptoms are assessed after 3, 6 and 12 months.
The hypothesis was that the group receiving the eScreen intervention would reduce their alcohol/drug use to a larger extent than the control group at follow-up compared to the baseline level. The results have not yet been analyzed due to technical issues. However, qualitative interviews have been conducted with participants and our intention is to publish the qualitative results in tandem with the quantitative results available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eScreen | Experimental | Behavioral: eScreen, Behavioral: Internet-based treatment for depression or anxietyWeb based self-monitoring of problematic alcohol and drug use, and Internet-based treatment for depression or anxiety |
| Control | Experimental | Behavioral: Assessment only of alcohol and drug use., Behavioral: Internet-based treatment for depression or anxietyAssessment only of alcohol and drug use and Internet-based treatment for depression or anxiety |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- AUDIT >7 for men and AUDIT >5 for women, and/or DUDIT >0
Key exclusion criteria (1 listed)
- DUDIT = 0 and AUDIT <8 (men) or <6 (women)
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 |
|---|---|---|
| eScreenAccess to the eScreen platform offering assessment of alcohol and drug use, with automated feedback on problematic or non-problematic use. Follow-up over time based on user needs. | Behavioural | eScreen |
| Assessment only of alcohol and drug use.Assessment of alcohol and drug use at baseline and follow-up. | Behavioural | Control |
| Internet-based treatment for depression or anxietyInternet-based treatment for primary diagnoses of depression, panic anxiety or social phobia. | Behavioural | Control, eScreen |
Primary outcome
Change in the total AUDIT-C score
Time frame: 3, 6 and 12 months
The primary outcome measure for this trial is the change in the total AUDIT score for the first three AUDIT questions, as a measure of alcohol consumption only, referred to as the AUDIT-C.
1 secondary outcome
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
- Background: PubMed 20092953Sinadinovic K, Berman AH, Hasson D, Wennberg P. Internet-based assessment and self-monitoring of problematic alcohol and drug use. Addict Behav. 2010 May;35(5):464-70. doi: 10.1016/j.addbeh.2009.12.021. Epub 2010 Jan 4.
- Background: PubMed 22613182Sinadinovic K, Wennberg P, Berman AH. Targeting problematic users of illicit drugs with Internet-based screening and brief intervention: a randomized controlled trial. Drug Alcohol Depend. 2012 Nov 1;126(1-2):42-50. doi: 10.1016/j.drugalcdep.2012.04.016. Epub 2012 May 20.
- Background: PubMed 24650825Sinadinovic K, Wennberg P, Berman AH. Internet-based screening and brief intervention for illicit drug users: a randomized controlled trial with 12-month follow-up. J Stud Alcohol Drugs. 2014 Mar;75(2):313-8. doi: 10.15288/jsad.2014.75.313.
- Link to participant registration site.Link provided by the sponsor.
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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.
Anne H Berman, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eScreen, Assessment only of alcohol and drug use. and Internet-based treatment for depression or anxiety in people with Substance Use Disorders (SUD), run by Karolinska Institutet at 1 site in Sweden.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Oct 2018. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the total AUDIT-C score (time frame: 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01885026, which also lists 3 linked publications.
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 4 Oct 2018.