Substance DependenceNCT03000699
Efficacy of Cognitive Bias Modification in Residential Treatment for Addiction
A study testing Cognitive Bias Modification in people with Substance Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether computer bias modification for interpretation bias (CBM-I) is effective in the reduction of suicidal ideation in substance use disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Dependence
- What is being tested?
- Cognitive Bias Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2017to 31 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Exhibit moderate suicide risk or greater
- Be enrolled in the Addictions Services inpatient program
- Fluent in reading English
- Capacity to give informed consent
Who cannot join
- A lifetime diagnosis of a psychotic or bipolar disorder
- Significant neurological disorder or psychical illness likely to interfere with participation
- Psychotropic medication changes within the past two weeks
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether computer bias modification for interpretation bias (CBM-I) is effective in the reduction of suicidal ideation in substance use disorders.
Read the detailed description
Eighty-eight adult inpatients completing residential treatment in the Addictions Services at the Centre for Addiction and Mental Health (CAMH) will be randomized to receive CBM-I daily for one week, adjunct to the residential psychosocial treatment or to an assessment-only control condition. Participants will complete clinical measures consisting of interviews and questionnaires measuring suicidal ideation, hopelessness, depression, negative affect, and interpretation biases before, during and after treatment.
- Conditions
- Substance Dependence
- Being tested
- Cognitive Bias Modification
- Keywords
- cognitive bias modification, interpretation bias, suicidal ideation, depression
- Medical subject headings
- Substance-Related Disorders, Suicidal Ideation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Bias ModificationBehavioural
Training paragraphs describe scenarios designed to be ambiguous at the outset and to resolve in a positive direction, with the intention of establishing a learning contingency between the ambiguity at the beginning of the scenario and the positive resolution that becomes clear towards the end of the statement.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Bias Modification | Experimental | 64 training paragraphs, approximately 10-20 seconds each, digitally recorded and presented stereophonically through headphones, delivered over the course of one week. Receives: Behavioral: Cognitive Bias Modification |
| Assessment-Only Control | No intervention | No training will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Columbia-Suicide Severity Rating Scale, Screen Version (C-SSRS)
This scale quantifies the severity of suicidal ideation and behaviour.
Measured: Seven days
Secondary outcomes (4)
Beck Hopelessness Scale (BHS)
This questionnaire assesses thoughts and emotions associated with the future.
Measured: Seven days
Beck Depression Inventory II (BDI-II)
This questionnaire assesses severity of depressive symptoms and cognitions.
Measured: Seven days
Positive and Negative Affect Schedule (PANAS)
This questionnaire assesses current positive and negative mood
Measured: Seven days
Scrambled Sentences Tests
This computer test will be used as an implicit measure of negative interpretation bias.
Measured: Seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start1 Mar 2017
- Primary completion1 Oct 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance DependenceStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe 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
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Responsible party
- Principal investigator, Lena Quilty, Centre for Addiction and Mental Health
- Investigators
- Lena C Quilty, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000699
- Sponsor's protocol ID
- 077/2016
- Status last verified
- Jan 2019
- First submitted
- 20 Dec 2016
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cognitive Bias Modification in Residential Treatment for Addiction
- ClinicalTrials.gov ID
- NCT03000699
- Acronym / sponsor ID
- 077/2016
- Conditions
- Substance Dependence
- Keywords
- cognitive bias modification, interpretation bias, suicidal ideation, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 22 Dec 2016 (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.
The purpose of this study is to determine whether computer bias modification for interpretation bias (CBM-I) is effective in the reduction of suicidal ideation in substance use disorders.
Detailed description
Eighty-eight adult inpatients completing residential treatment in the Addictions Services at the Centre for Addiction and Mental Health (CAMH) will be randomized to receive CBM-I daily for one week, adjunct to the residential psychosocial treatment or to an assessment-only control condition. Participants will complete clinical measures consisting of interviews and questionnaires measuring suicidal ideation, hopelessness, depression, negative affect, and interpretation biases before, during and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Bias Modification | Experimental | Behavioral: Cognitive Bias Modification64 training paragraphs, approximately 10-20 seconds each, digitally recorded and presented stereophonically through headphones, delivered over the course of one week. |
| Assessment-Only Control | No intervention | –No training will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Exhibit moderate suicide risk or greater
- Be enrolled in the Addictions Services inpatient program
- Fluent in reading English
- Capacity to give informed consent
Key exclusion criteria (3 listed)
- A lifetime diagnosis of a psychotic or bipolar disorder
- Significant neurological disorder or psychical illness likely to interfere with participation
- Psychotropic medication changes within the past two weeks
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 |
|---|---|---|
| Cognitive Bias ModificationTraining paragraphs describe scenarios designed to be ambiguous at the outset and to resolve in a positive direction, with the intention of establishing a learning contingency between the ambiguity at the beginning of the scenario and the positive resolution that becomes clear towards the end of the statement. | Behavioural | Cognitive Bias Modification |
Primary outcome
Columbia-Suicide Severity Rating Scale, Screen Version (C-SSRS)
Time frame: Seven days
This scale quantifies the severity of suicidal ideation and behaviour.
4 secondary outcomes
Beck Hopelessness Scale (BHS)
Time frame: Seven days
Beck Depression Inventory II (BDI-II)
Time frame: Seven days
Positive and Negative Affect Schedule (PANAS)
Time frame: Seven days
Scrambled Sentences Tests
Time frame: Seven days
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 30 Jan 2019.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Lena C Quilty, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Bias Modification in people with Substance Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 4 inclusion and 3 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 30 Jan 2019. 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 Canada. 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?
Columbia-Suicide Severity Rating Scale, Screen Version (C-SSRS) (time frame: Seven days). 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 30 Jan 2019.