DepressionPhase 3CATCH-ITNCT01228890
Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)
A Phase 3 study testing CATCH-IT and AMPE in people with Depression and Anxiety, run by University of Chicago at 4 sites in United States.
Trial summary
In this 5-year, two-site randomized clinical trial, we propose to test the efficacy of the CATCH-IT primary care/Internet based depression prevention intervention against Attention Monitoring Psychoeducation (AMPE) in preventing the onset of depressive episodes in an intermediate to high risk group of adolescents aged… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Depression, Anxiety, Externalizing Symptoms
- What is being tested?
- CATCH-IT and AMPE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2010to Apr 2011
- Phase
- Phase 3
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Youth ages 13 through 17.
- Youth must be experiencing elevated level of depressive symptoms on the Center for Epidemiologic Studies Depression46 (CES-D) scale (score >/= 16) and have at least two core symptoms of Major Depression on the Patient Health Questionnaire, Adolescents.
- Youth will be included if they have a past history of depression, anxiety, externalizing symptoms, or substance abuse.
Who cannot join
- Current DSM-IV diagnosis (Kiddie Schedule of Affective Disorders) of Major Depressive Disorder, current therapy for depression, or be taking antidepressants (e.g., SSRIs, TCAs, MAOIs, bupropion, nefazodone, mirtazapine, venlafaxine).
- Current CES-D score >35
- DSM-IV diagnosis of schizophrenia (current or past) or bipolar affective disorder
- Current serious medical illness that causes significant disability or dysfunction
- Significant reading impairment (a minimum sixth-grade reading level based on parental report), mental retardation, or developmental disabilities
- Serious imminent suicidal risk (as determined by endorsement of current suicidality on CES-D or in KSADS interview) or other conditions that may require immediate psychiatric hospitalization
- Psychotic features or disorders, or currently be receiving psychotropic medication
- Extreme, current drug/alcohol abuse (greater than or equal to 2 on the CRAFFT).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Harvard Vanguard Medical Associates
Boston, Massachusetts
University of Chicago
Chicago, Illinois, 60637
Access Community Health Network
Chicago, Illinois
Northshore University Health Systems
Evanston, Illinois
About this study
In this 5-year, two-site randomized clinical trial, we propose to test the efficacy of the CATCH-IT primary care/Internet based depression prevention intervention against Attention Monitoring Psychoeducation (AMPE) in preventing the onset of depressive episodes in an intermediate to high risk group of adolescents aged 13-17. We plan to (a) identify high risk adolescents based on elevated scores on the PHQ-A, a screening measure of depressive symptoms; (b) recruit 400 (200 per site) of these at-risk adolescents to be randomized into either the CATCH-IT or the AMPE group; (c) assess outcomes at 2, 8, 12, 18, and 24 months post intake on measures of depressive symptoms, depressive diagnoses, other mental disorders, and on measures of role impairment in education, quality of life, attainment of educational milestones, and family functioning; and (d) conduct exploratory analyses to examine the effectiveness of this intervention program, moderators of protection, and potential ethnic and cultural differences in intervention response.
- Conditions
- Depression, Anxiety, Externalizing Symptoms, Substance Abuse
- Being tested
- CATCH-IT, AMPE
- Medical subject headings
- Depression, Anxiety Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CATCH-ITBehavioural
The CATCH-IT 2-R intervention has a motivational (3 PCP motivational interviews at time 0, 1.5 months and 12 months and 3 coaching phone calls at 2 and 4 weeks and 18 months) and an Internet component (with separate adolescent [14 modules] and parent [5 modules] programs). This revised and expanded intervention will include a comprehensive approach to reducing modifiable risk factors and enhancing resiliency factors associated with increased or decreased risk of depression, respectively, proposed by Spence and Reinecke.148 The revised CATCH-IT "Tracker" will monitor time in study and deploy elements of the intervention based on time since enrollment, including computer and human elements (e.g. calls, doctor visits).
AMPEBehavioural
The AMPE components are similar to those employed in previous primary care based quality improvement/Chronic Care Model Interventions (patient education [psycho-education described below], provider training [described in Case Finding and Recruitment], active monitoring and referral [case management, discussed under assessments], physician and nurse education and routine contact with PCP [study design rationale]). This Internet site will focus on assisting parents and adolescents in early identification of need for treatment and will also target stigma and negative attitudes toward treatment of mental disorders we have previously identified as barriers to seeking and adhering to treatment.
| Study group | Role | What they receive |
|---|---|---|
| CATCH-IT 2-R Arm | Experimental | Primary care/Internet based depression prevention intervention (CATCH-IT 2-R) with a family component. Receives: Behavioral: CATCH-IT |
| Attention Monitoring Psycho-education (AMPE) Arm | Active comparator | Not described Receives: Behavioral: AMPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether the CATCH-IT 2-R depression prevention intervention prevents or delays major depressive episodes, as well as non-affective disorder episodes, compared to AMPE.
Measured: 49-60 months from beginning of trial
Secondary outcomes (3)
To determine if participants in the CATCH-IT 2-R group exhibit more rapid favorable changes of depressive symptoms/and or vulnerability/protective factors compared with the AMPE group.
Measured: 49-60 months from beginning of the trial
To determine if participants in the CATCH-IT 2-R program report lower perceived educational impairment, greater quality of life, greater health-related quality of life, and lower incidence of other mental disorders (anxiety, substance/alcohol use).
Measured: 49-60 months from beginning of trial
To determine for whom (moderators) and how (mediators) the CATCH-IT 2-R program works in this population.
Measured: 49-60 months from beginning of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: no one enrolled; PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Vanguard Medical Associates
- Responsible party
- Sponsor
- Investigators
- Benjamin Van Voorhees, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228890
- Sponsor's protocol ID
- 10-464-A
- Acronym
- CATCH-IT
- Status last verified
- Dec 2012
- First submitted
- 25 Oct 2010
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)
- ClinicalTrials.gov ID
- NCT01228890
- Acronym / sponsor ID
- CATCH-IT / 10-464-A
- Conditions
- Depression, Anxiety, Externalizing Symptoms, Substance Abuse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no one enrolled; PI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Harvard Vanguard Medical Associates
- Study start
- Sep 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 27 Oct 2010 (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.
In this 5-year, two-site randomized clinical trial, we propose to test the efficacy of the CATCH-IT primary care/Internet based depression prevention intervention against Attention Monitoring Psychoeducation (AMPE) in preventing the onset of depressive episodes in an intermediate to high risk group of adolescents aged 13-17. We plan to (a) identify high risk adolescents based on elevated scores on the PHQ-A, a screening measure of depressive symptoms; (b) recruit 400 (200 per site) of these at-risk adolescents to be randomized into either the CATCH-IT or the AMPE group; (c) assess outcomes at 2, 8, 12, 18, and 24 months post intake on measures of depressive symptoms, depressive diagnoses, other mental disorders, and on measures of role impairment in education, quality of life, attainment of educational milestones, and family functioning; and (d) conduct exploratory analyses to examine the effectiveness of this intervention program, moderators of protection, and potential ethnic and cultural differences in intervention response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CATCH-IT 2-R Arm | Experimental | Behavioral: CATCH-ITPrimary care/Internet based depression prevention intervention (CATCH-IT 2-R) with a family component. |
| Attention Monitoring Psycho-education (AMPE) Arm | Active comparator | Behavioral: AMPE |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Youth ages 13 through 17.
- Youth must be experiencing elevated level of depressive symptoms on the Center for Epidemiologic Studies Depression46 (CES-D) scale (score >/= 16) and have at least two core symptoms of Major Depression on the Patient Health Questionnaire, Adolescents.
- Youth will be included if they have a past history of depression, anxiety, externalizing symptoms, or substance abuse.
Key exclusion criteria (8 listed)
- Current DSM-IV diagnosis (Kiddie Schedule of Affective Disorders) of Major Depressive Disorder, current therapy for depression, or be taking antidepressants (e.g., SSRIs, TCAs, MAOIs, bupropion, nefazodone, mirtazapine, venlafaxine).
- Current CES-D score >35
- DSM-IV diagnosis of schizophrenia (current or past) or bipolar affective disorder
- Current serious medical illness that causes significant disability or dysfunction
- Significant reading impairment (a minimum sixth-grade reading level based on parental report), mental retardation, or developmental disabilities
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 |
|---|---|---|
| CATCH-ITThe CATCH-IT 2-R intervention has a motivational (3 PCP motivational interviews at time 0, 1.5 months and 12 months and 3 coaching phone calls at 2 and 4 weeks and 18 months) and an Internet component (with separate adolescent [14 modules] and parent [5 modules] programs). This revised and expanded intervention will include a comprehensive approach to reducing modifiable risk factors and enhancing resiliency factors associated with increased or decreased risk of depression, respectively, proposed by Spence and Reinecke.148 The revised CATCH-IT "Tracker" will monitor time in study and deploy elements of the intervention based on time since enrollment, including computer and human elements (e.g. calls, doctor visits). | Behavioural | CATCH-IT 2-R Arm |
| AMPEThe AMPE components are similar to those employed in previous primary care based quality improvement/Chronic Care Model Interventions (patient education [psycho-education described below], provider training [described in Case Finding and Recruitment], active monitoring and referral [case management, discussed under assessments], physician and nurse education and routine contact with PCP [study design rationale]). This Internet site will focus on assisting parents and adolescents in early identification of need for treatment and will also target stigma and negative attitudes toward treatment of mental disorders we have previously identified as barriers to seeking and adhering to treatment. | Behavioural | Attention Monitoring Psycho-education (AMPE) Arm |
Primary outcome
To determine whether the CATCH-IT 2-R depression prevention intervention prevents or delays major depressive episodes, as well as non-affective disorder episodes, compared to AMPE.
Time frame: 49-60 months from beginning of trial
3 secondary outcomes
To determine if participants in the CATCH-IT 2-R group exhibit more rapid favorable changes of depressive symptoms/and or vulnerability/protective factors compared with the AMPE group.
Time frame: 49-60 months from beginning of the trial
To determine if participants in the CATCH-IT 2-R program report lower perceived educational impairment, greater quality of life, greater health-related quality of life, and lower incidence of other mental disorders (anxiety, substance/alcohol use).
Time frame: 49-60 months from beginning of trial
To determine for whom (moderators) and how (mediators) the CATCH-IT 2-R program works in this population.
Time frame: 49-60 months from beginning of trial
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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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.
Benjamin Van Voorhees, MD principal investigator
University of Chicago
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CATCH-IT and AMPE in people with Depression and Anxiety, run by University of Chicago at 4 sites in United States.
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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
To determine whether the CATCH-IT 2-R depression prevention intervention prevents or delays major depressive episodes, as well as non-affective disorder episodes, compared to AMPE. (time frame: 49-60 months from beginning of trial). 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 17 Dec 2012; AzTrials last refreshed its copy on 1 Nov 2026.