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CompletedNCT01893749

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
1,142 (actual)
Sponsor
Benjamin Van Voorhees, MD, MPH · Academic / Other
Sex
All
Age
13 Years – 18 Years
Healthy volunteers
Accepted

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.

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

Interventions

TypeNameDescription
BEHAVIORALCATCH-ITIt 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.

Timeline

Start date
2012-02-01
Primary completion
2016-07-01
Completion
2016-07-01
First posted
2013-07-09
Last updated
2019-08-22

Locations

7 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01893749. Inclusion in this directory is not an endorsement.