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

B

Benjamin Van Voorhees, MD, MPH

Status

Completed

Conditions

Major Depression
Depressive Episodes

Treatments

Behavioral: CATCH-IT

Study type

Interventional

Funder types

Other

Identifiers

NCT01893749
1R01MH090035-01A1 (U.S. NIH Grant/Contract)
2011-0505

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,142 patients

Sex

All

Ages

13 to 18 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,142 participants in 2 patient groups

CATCH-IT
Experimental group
Description:
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.
Treatment:
Behavioral: CATCH-IT
Health Education
No Intervention group
Description:
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.

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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