Major DepressionCATCH-ITNCT01893749
Primary Care Internet Based Depression Prevention for Adolescents (CATCH-IT) Also Known as Promoting AdolescenT Health
A study testing CATCH-IT in people with Major Depression and Depressive Episodes, run by Benjamin Van Voorhees, MD, MPH at 7 sites in United States.
Trial summary
The purpose of this randomized multiple-site clinical study is to determine whether a revised CATCH-IT (Internet-based depression prevention program) is more effective than a general health education Internet intervention (Health Education)on teens ages 13-18 (inclusive). Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression, Depressive Episodes
- What is being tested?
- CATCH-IT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,142 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2012to Jul 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents:
- Youth ages 13 through 18 who are English speaking. (B) Youth must be experiencing elevated level of depressive symptoms on the Center for Epidemiologic Studies Depression (CES-D) scale (score >/= 16). (C) Youth will be included if they have a past history of depression, anxiety, externalizing symptoms, or substance abuse. Youth presenting in partial remission from a major depressive episode at Baseline will be rescreened after 2 months utilizing the phone screen to ensure episode is fully remitted prior to randomization or access to study intervention. Those who do not fully remit after two months will be excluded.
- Parents:
- Parent of eligible adolescents
- Physicians (PCP) or NP:
- Physician in any of the study sites
- Healthcare Professionals:
- Primary care practice for a minimum of 6 months
Who cannot join
- Adolescents:
- Current DSM-IV diagnosis 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;
Show all 17Show fewer
- 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 suicide 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).
- Parents:
- Ineligible child
- Non-English speaking
- Physicians:
- None
- Healthcare Professionals:
- None
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
ACCESS Healthcare Systems
Chicago, Illinois, 60606
University of Illinois
Chicago, Illinois, 60612
Franciscan St. Margaret Health
Dyer, Indiana, 46311
Northshore Healthcare Systems
Evanston, Illinois, 60201
Advocate Health Care
Oak Lawn, Illinois, 60453
Children's Clinic
Oak Park, Illinois, 60302
Wellesley Center for Women
Wellesley, Massachusetts, 02481-8203
About this study
Official title: Primary Care Internet Based Depression Prevention for Adolescents (Promoting AdolescenT Health-PATH)
The purpose of this randomized multiple-site clinical study is to determine whether a revised CATCH-IT (Internet-based depression prevention program) is more effective than a general health education Internet intervention (Health Education)on teens ages 13-18 (inclusive). It is hypothesized that teens in CATCH-IT will exhibit lower levels of depressed mood and/or maintain lower depressive scores over 2 years long-term follow up as compared to teens in Health Education group.
Read the detailed description
Additional aims and hypothesis are provided below:
-Aim 1: To determine whether the CATCH-IT depression prevention intervention prevents or delays major depressive episodes, as well as non-affective disorder episodes, compared to HEALTH EDUCATION.
Hypothesis 1: Compared to youth in the HEALTH EDUCATION condition, youth assigned to CATCH-IT will have a lower hazard ratio of major depressive episodes and non-affective disorder episodes over 2 years.
-Aim 2: To determine if participants in the CATCH-IT group exhibit more rapid favorable changes of depressive symptoms/and or vulnerability/protective factors compared to the HEALTH EDUCATION group.
Hypothesis 2: Compared to youth in the HEALTH EDUCATION condition, youth in the CATCH-IT program will demonstrate a steeper slope of improved symptoms and fewer depressed days over 2 years.
-Aim 3: To determine if participants in the CATCH-IT 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) as compared to participants in HEALTH EDUCATION.
Hypothesis 3: Compared to youth in the HEALTH EDUCATION group, youth in the CATCH-IT program will demonstrate more rapid benefits in reduced educational impairment, improved quality of life, and fewer disorders over 2 years.
-Aim 4: To determine for whom (moderators)among 13-18 year old (inclusive) and how (mediators) the CATCH-IT program works.
Hypothesis 4.1: CATCH-IT effects will be moderated by six domains: (1) demographic/cultural factors, (2) vulnerability factors/adverse events,(3) motivation,(4) physician relationship, (5) parent/child co-morbid psychopathology, and (6) treatment.
Hypothesis 4.2: The relation between CATCH-IT participation and reduction in depressive episodes will be mediated by adherence to the Internet, motivational interview fidelity as they alter vulnerability factors (e.g. motivation, cognition and social support) and responses to adverse events, which in turn impact the likelihood of episodes.
Exploratory Aim 1: To determine the implementation feasibility of the intervention from the physician/nurse practitioner and office nurse/medical assistant perspective as well as to describe the practices in relationship to the medical home model.
Exploratory Aim 2: To determine whether CATCH-IT has a favorable cost-benefit ratio and/or cost effectiveness of <$50,000/disability adjusted life year compared to the HEALTH EDUCATION group.
- Conditions
- Major Depression, Depressive Episodes
- Being tested
- CATCH-IT
- Keywords
- depression, prevention, teen, at risk, internet
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CATCH-ITBehavioural
Also called CATCH-IT 2, CATCH-IT 3
It contains 14 modules focused on behavioral activation, cognitive behavioral therapy, interpersonal therapy and a resiliency building model, including elements such as narratives, video diaries, skill building exercises and a booster program (not yet initiated) with 6 modules that involves interaction with a live therapist. It also includes three 15-minute meetings with the primary care provider at baseline, 2 months and 12 months post intervention. These meetings are focused on the motivational interview approach where the patient and the doctor talk about the mental/physical health goals of the patient and determine the best approach for the patient by allowing the patient to have full input into the plan.
| Study group | Role | What they receive |
|---|---|---|
| CATCH-IT | Experimental | 200 randomized teens 13-18 year old (inclusive) will be enrolled into the online program that contains 14 modules focused various therapeutic techniques, a booster session of 6 modules at the end of the online program and three 15 minute visits with their primary care doctor to discuss the benefits and disadvantages of the program.
Parents will also be invited to participant in a partnering online program involving 4 modules online and 1 optional module. They will be asked to then participate in three 15 minute interviews with a member of the study team to discuss the benefits and disadvantages of the program. Receives: Behavioral: CATCH-IT |
| Health Education | No intervention | 200 randomized teens, ages 13-18 year old (inclusive) receiving an online program with 14 modules that focus on general health education, depression, diet, exercise, hygiene and safety. Parents will also be invited to participate in an online program with 4 modules that also focus on general health education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Depressive Episode (major and sub-threshold)
Kiddie Schedule of Affective Disorders Scale (KSADS) used to evaluate for current and past depressive episode at each time point (interval between time points). Occurrence of first depressive episode was determined by the Depression Symptom Rating (DSR). We considered a score indicating at least sub-threshold major depression (a DSR of ≥3+) to be a depressive episode. DSR 4 and above and 5 alone will also be assessed.
Measured: 0, 2, 6, 12, 18 and 24 months
Secondary outcomes (3)
Depressed mood
The Center for Epidemiological Studies of Depression(CES-D)Scale -Change in CES-D score between groups (CATCH-IT \& HEALTHED) across the duration of the study and for each assessment point
Measured: 0, 2, 6, 12, 24 months
Vulnerability Factors
Sibling Inventory of Differential Experience, (SIDE), Child/Parent Report of Parental Behavior Inventory (CRPBI - teen and parent), Conflict Behavior Questionnaire (CBQ - teen and parent), Beck Hopelessness Scale, Adolescent Life Events Questionnaire (ALEQ) (not all measures at all time points)
Measured: 0, 2, 6, 12, 18, 24 months
Quality of Life, educational impairment and other mental disorder symptoms or episodes
Masten's Status Questionnaire,World Health Organization (WHO) Quality of Life Scale , Educational Impairment Scale, Change in scales of SCARED, Disruptive Behavior Disorder Scale (DBD - teen and parent), CRAFFT (substance abuse), SCARED (anxiety), Global Assessment Scale (GAS, assessor scores from KSADS responses) scores (not all measures at all time points).
Measured: 0, 2, 6, 12, 18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startFeb 2012
- Primary completionJul 2016
- Study completionJul 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 Major DepressionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benjamin Van Voorhees, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- Wellesley College, Northwestern University, Harvard Vanguard Medical Associates, Access Healthcare Systems, Endeavor Health, Infant Welfare Society, Wake Forest University Health Sciences, Franciscan St. Margaret Health - Franciscan Alliance
- Responsible party
- Sponsor-investigator, Benjamin Van Voorhees, MD, MPH, University of Illinois Chicago
- Investigators
- Benjamin Van Voorhees, MD, MPH, Principal investigator, UICTracy Gladstone, PHD, Principal investigator, Wellesley Center for Women
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893749
- Sponsor's protocol ID
- 2011-0505
- Other IDs
- 1R01MH090035-01A1
- Acronym
- CATCH-IT
- Status last verified
- Aug 2019
- First submitted
- 5 Jun 2012
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Van Voorhees B, Gladstone TRG, Sobowale K, Brown CH, Aaby DA, Terrizzi DA, Canel J, Ching E, Berry AD, Cantorna J, Eder M, Beardslee W, Fitzgibbon M, Marko-Holguin M, Schiffer L, Lee M, de Forest SA, Sykes EE, Suor JH, Crawford TJ, Burkhouse KL, Goodwin BC, Bell C. 24-Month Outcomes of Primary Care Web-Based Depression Prevention Intervention in Adolescents: Randomized Clinical Trial. J Med Internet Res. 2020 Oct 28;22(10):e16802. doi: 10.2196/16802.
PubMed 33112254Gladstone T, Buchholz KR, Fitzgibbon M, Schiffer L, Lee M, Voorhees BWV. Randomized Clinical Trial of an Internet-Based Adolescent Depression Prevention Intervention in Primary Care: Internalizing Symptom Outcomes. Int J Environ Res Public Health. 2020 Oct 22;17(21):7736. doi: 10.3390/ijerph17217736.
PubMed 33105889Gladstone TG, Marko-Holguin M, Rothberg P, Nidetz J, Diehl A, DeFrino DT, Harris M, Ching E, Eder M, Canel J, Bell C, Beardslee WR, Brown CH, Griffiths K, Van Voorhees BW. An internet-based adolescent depression preventive intervention: study protocol for a randomized control trial. Trials. 2015 May 1;16:203. doi: 10.1186/s13063-015-0705-2.
PubMed 25927539
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Internet Based Depression Prevention for Adolescents (Promoting AdolescenT Health-PATH)
- ClinicalTrials.gov ID
- NCT01893749
- Acronym / sponsor ID
- CATCH-IT / 2011-0505
- Conditions
- Major Depression, Depressive Episodes
- Keywords
- depression, prevention, teen, at risk, internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,142 participants (actual)
- Lead sponsor
- Benjamin Van Voorhees, MD, MPHUniversity, hospital or other
- Collaborators
- Wellesley College, Northwestern University, Harvard Vanguard Medical Associates, Access Healthcare Systems, Endeavor Health, Infant Welfare Society, Wake Forest University Health Sciences, Franciscan St. Margaret Health - Franciscan Alliance
- Study start
- Feb 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 Jul 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.
The purpose of this randomized multiple-site clinical study is to determine whether a revised CATCH-IT (Internet-based depression prevention program) is more effective than a general health education Internet intervention (Health Education)on teens ages 13-18 (inclusive). It is hypothesized that teens in CATCH-IT will exhibit lower levels of depressed mood and/or maintain lower depressive scores over 2 years long-term follow up as compared to teens in Health Education group.
Detailed description
Additional aims and hypothesis are provided below:
-Aim 1: To determine whether the CATCH-IT depression prevention intervention prevents or delays major depressive episodes, as well as non-affective disorder episodes, compared to HEALTH EDUCATION.
Hypothesis 1: Compared to youth in the HEALTH EDUCATION condition, youth assigned to CATCH-IT will have a lower hazard ratio of major depressive episodes and non-affective disorder episodes over 2 years.
-Aim 2: To determine if participants in the CATCH-IT group exhibit more rapid favorable changes of depressive symptoms/and or vulnerability/protective factors compared to the HEALTH EDUCATION group.
Hypothesis 2: Compared to youth in the HEALTH EDUCATION condition, youth in the CATCH-IT program will demonstrate a steeper slope of improved symptoms and fewer depressed days over 2 years.
-Aim 3: To determine if participants in the CATCH-IT 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) as compared to participants in HEALTH EDUCATION.
Hypothesis 3: Compared to youth in the HEALTH EDUCATION group, youth in the CATCH-IT program will demonstrate more rapid benefits in reduced educational impairment, improved quality of life, and fewer disorders over 2 years.
-Aim 4: To determine for whom (moderators)among 13-18 year old (inclusive) and how (mediators) the CATCH-IT program works.
Hypothesis 4.1: CATCH-IT effects will be moderated by six domains: (1) demographic/cultural factors, (2) vulnerability factors/adverse events,(3) motivation,(4) physician relationship, (5) parent/child co-morbid psychopathology, and (6) treatment.
Hypothesis 4.2: The relation between CATCH-IT participation and reduction in depressive episodes will be mediated by adherence to the Internet, motivational interview fidelity as they alter vulnerability factors (e.g. motivation, cognition and social support) and responses to adverse events, which in turn impact the likelihood of episodes.
Exploratory Aim 1: To determine the implementation feasibility of the intervention from the physician/nurse practitioner and office nurse/medical assistant perspective as well as to describe the practices in relationship to the medical home model.
Exploratory Aim 2: To determine whether CATCH-IT has a favorable cost-benefit ratio and/or cost effectiveness of <$50,000/disability adjusted life year compared to the HEALTH EDUCATION group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CATCH-IT | Experimental | Behavioral: CATCH-IT200 randomized teens 13-18 year old (inclusive) will be enrolled into the online program that contains 14 modules focused various therapeutic techniques, a booster session of 6 modules at the end of the online program and three 15 minute visits with their primary care doctor to discuss the benefits and disadvantages of the program. Parents will also be invited to participant in a partnering online program involving 4 modules online and 1 optional module. They will be asked to then participate in three 15 minute interviews with a member of the study team to discuss the benefits and disadvantages of the program. |
| Health Education | No intervention | –200 randomized teens, ages 13-18 year old (inclusive) receiving an online program with 14 modules that focus on general health education, depression, diet, exercise, hygiene and safety. Parents will also be invited to participate in an online program with 4 modules that also focus on general health education. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Youth ages 13 through 18 who are English speaking. (B) Youth must be experiencing elevated level of depressive symptoms on the Center for Epidemiologic Studies Depression (CES-D) scale (score >/= 16). (C) Youth will be included if they have a past history of depression, anxiety, externalizing symptoms, or substance abuse. Youth presenting in partial remission from a major depressive episode at Baseline will be rescreened after 2 months utilizing the phone screen to ensure episode is fully remitted prior to randomization or access to study intervention. Those who do not fully remit after two months will be excluded.
- Parent of eligible adolescents
- Physician in any of the study sites
- Primary care practice for a minimum of 6 months
Key exclusion criteria (17 listed)
- Current DSM-IV diagnosis 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;
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-ITAlso: CATCH-IT 2, CATCH-IT 3It contains 14 modules focused on behavioral activation, cognitive behavioral therapy, interpersonal therapy and a resiliency building model, including elements such as narratives, video diaries, skill building exercises and a booster program (not yet initiated) with 6 modules that involves interaction with a live therapist. It also includes three 15-minute meetings with the primary care provider at baseline, 2 months and 12 months post intervention. These meetings are focused on the motivational interview approach where the patient and the doctor talk about the mental/physical health goals of the patient and determine the best approach for the patient by allowing the patient to have full input into the plan. | Behavioural | CATCH-IT |
Primary outcome
Major Depressive Episode (major and sub-threshold)
Time frame: 0, 2, 6, 12, 18 and 24 months
Kiddie Schedule of Affective Disorders Scale (KSADS) used to evaluate for current and past depressive episode at each time point (interval between time points). Occurrence of first depressive episode was determined by the Depression Symptom Rating (DSR). We considered a score indicating at least sub-threshold major depression (a DSR of ≥3+) to be a depressive episode. DSR 4 and above and 5 alone will also be assessed.
3 secondary outcomes
Depressed mood
Time frame: 0, 2, 6, 12, 24 months
Vulnerability Factors
Time frame: 0, 2, 6, 12, 18, 24 months
Quality of Life, educational impairment and other mental disorder symptoms or episodes
Time frame: 0, 2, 6, 12, 18, 24 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 22 Aug 2019.
- Derived from this study: PubMed 33112254Van Voorhees B, Gladstone TRG, Sobowale K, Brown CH, Aaby DA, Terrizzi DA, Canel J, Ching E, Berry AD, Cantorna J, Eder M, Beardslee W, Fitzgibbon M, Marko-Holguin M, Schiffer L, Lee M, de Forest SA, Sykes EE, Suor JH, Crawford TJ, Burkhouse KL, Goodwin BC, Bell C. 24-Month Outcomes of Primary Care Web-Based Depression Prevention Intervention in Adolescents: Randomized Clinical Trial. J Med Internet Res. 2020 Oct 28;22(10):e16802. doi: 10.2196/16802.
- Derived from this study: PubMed 33105889Gladstone T, Buchholz KR, Fitzgibbon M, Schiffer L, Lee M, Voorhees BWV. Randomized Clinical Trial of an Internet-Based Adolescent Depression Prevention Intervention in Primary Care: Internalizing Symptom Outcomes. Int J Environ Res Public Health. 2020 Oct 22;17(21):7736. doi: 10.3390/ijerph17217736.
- Derived from this study: PubMed 25927539Gladstone TG, Marko-Holguin M, Rothberg P, Nidetz J, Diehl A, DeFrino DT, Harris M, Ching E, Eder M, Canel J, Bell C, Beardslee WR, Brown CH, Griffiths K, Van Voorhees BW. An internet-based adolescent depression preventive intervention: study protocol for a randomized control trial. Trials. 2015 May 1;16:203. doi: 10.1186/s13063-015-0705-2.
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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, MPH principal investigator
UIC
Tracy Gladstone, PHD principal investigator
Wellesley Center for Women
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CATCH-IT in people with Major Depression and Depressive Episodes, run by Benjamin Van Voorhees, MD, MPH at 7 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 8 inclusion and 17 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 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
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?
Major Depressive Episode (major and sub-threshold) (time frame: 0, 2, 6, 12, 18 and 24 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 NCT01893749, 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 22 Aug 2019.