Major Depression Clinical Trial
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.
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.
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