Primary Care Internet Based Depression Prevention for Adolescents (CATCH-IT) Also Known as Promoting AdolescenT Health

Major Depression Clinical Trial

— CATCH-IT  

Official title:

Primary Care Internet Based Depression Prevention for Adolescents (Promoting AdolescenT Health-PATH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893749
• Other study ID #: 2011-0505
• Secondary ID: 1R01MH090035-01A
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: July 2016

Study information

• Verified date: August 2019
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1142
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

Adolescents:

(A) 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

Exclusion Criteria:

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;

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Episodes
• Major Depression

Intervention

Behavioral:
• CATCH-IT
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.

Locations

Country	Name	City	State
United States	ACCESS Healthcare Systems	Chicago	Illinois
United States	University of Illinois	Chicago	Illinois
United States	Franciscan St. Margaret Health	Dyer	Indiana
United States	Northshore Healthcare Systems	Evanston	Illinois
United States	Advocate Health Care	Oak Lawn	Illinois
United States	Children's Clinic	Oak Park	Illinois
United States	Wellesley Center for Women	Wellesley	Massachusetts

Sponsors (9)

Lead Sponsor	Collaborator
Benjamin Van Voorhees, MD, MPH	Access Healthcare Systems, Advocate Health Care, Franciscan St. Margaret Health - Franciscan Alliance, Harvard Vanguard Medical Associates, Infant Welfare Society, NorthShore University HealthSystem, Northwestern University, Wellesley College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to Internet Use	Counting the number of logs/subject (over 2 years), number of characters typed, number of clicks in each page, time spent on each session and total time spent online and Socio-cultural Relevance Scale.	continous measure
Other	Implementation	Changes in perceived feasibility and implementation of the study from the healthcare professionals (physicians, nurse and leaders)from baseline to the completion of the study at 24 months.	0, 2, 24 months
Other	Motivation (adolescent)	Theory of Planned Behavior Scale, Trans-Theoretical Model Scale	0,2,12 months
Other	Demographic Information	assesses age, height, weight, contact information, race, ethnicity, home demographics, educational level of parents.	0,2,6,12,24 months
Primary	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.	0, 2, 6, 12, 18 and 24 months
Secondary	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	0, 2, 6, 12, 24 months
Secondary	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)	0, 2, 6, 12, 18, 24 months
Secondary	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).	0, 2, 6, 12, 18, 24 months

External Links

•   Infant Welfare Society Link