CompletedNot Applicable

Transdiagnostic Behavioral Activation Therapy for Youth Anxiety and Depression

United States895 participantsStarted 2009-09

Plain-language summary

Psychological therapies for depression have demonstrated efficacy, but outcomes are still unsatisfactory, especially in cases with high comorbidity. Depression and anxiety co-occur in up to 69-75% of teens and intensify functional impairment and service use. This study will develop treatment materials for a transdiagnostic Group Behavioral Activation Therapy (GBAT) and conduct a pilot waitlist-controlled school-based study with 35 7th and 8th grade boys and girls with co-occurring depression and anxiety. Multi-reporter, multi-domain assessments will be conducted at initial screening, pre- and post-treatment, and 4-month follow-up. BA is a straightforward, but flexible and robust, therapy that has demonstrated strong results in adults. Current formulations of BA highlight the specific role of avoidance in depressotypic behavior. It presumes that anhedonia, isolation, and negative behaviors associated with depression function to avoid imminent distress even as it blocks access to otherwise available positive reinforcement. This study will therefore employ novel electronic diary technology to obtain Ecological Momentary Assessment and evaluate: (a) the function of avoidance in distinguishing youth with depression (n=35) from a non-clinical comparison group (n=18), and (b) the role of avoidance in mediating treatment gains in participants in the GBAT intervention.

Who can participate

Age range

11 Years – 15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * clinical (ADIS CSR ≥ 4) or subclinical (ADIS CSR = 2-3) principal diagnosis of either a DSM-IV-TR unipolar depression disorder (Major Depressive Disorder (\[MDD\], Minor Depression \[MinD\], or Dysthymia \[Dys\]) or * an anxiety disorder (Generalized Anxiety Disorder \[GAD\], Social Phobia \[SOP\], Separation Anxiety \[SAD\]). Exclusion Criteria: * any principal diagnosis other than anxiety or depression or parent report of mental retardation, * pervasive developmental disorder, * schizophrenia, or * bipolar disorder, or * report of past-year hospitalization for a suicide attempt. Concurrent use of antidepressant or anxiolytic medications was permitted as long as dosage was stable for at least four weeks and the family intended to maintain the dose.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Diagnosis via the Anxiety Disorders Interview Schedule-IV-TR (ADIS-IV-TR)

Timeframe: Change from baseline (pretreatment) diagnosis at 15 weeks

Trial details

NCT IDNCT01829100

SponsorRutgers University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-12

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