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Mechanisms of Behavioral Activation (BA)

Multi-level Mechanisms of Behavioral Activation Therapy for Adolescent Depression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
15 Years to 17 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The investigators will be comparing brain (neural) activation of depressed adolescent patients before, during and after a course of Behavioral Activation (BA) therapy using functional magnetic resonance imaging (fMRI)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at brain activity before, during, and after Behavioral Activation (BA) therapy for teens ages 15–17 with depression. It tests whether BA affects avoiding activities due to low motivation differently from avoiding threats. Healthy teens will also have brain scans, called fMRI scans, for comparison.

The investigators will be comparing brain (neural) activation of depressed adolescent patients before, during and after a course of Behavioral Activation (BA) therapy using functional magnetic resonance imaging (fMRI). In particular, the project seeks to determine whether BA targets different neural mechanisms for behavioral avoidance associated with low motivation as compared to threat avoidance. A group of healthy controls will also be scanned as a comparator group for behavioral and imaging measures.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 15–17 years old.
  • For the depression group: have major depression confirmed by a study interview and a depression score above 45 (T-score above 65).
  • Have an estimated IQ above 80 on the study test.
  • Be able to get care without staying in a hospital.
  • Be willing to avoid other counseling or similar treatments during the study.
  • Have taken no mental health medicines for 2 weeks before consent, or 4 weeks for fluoxetine. Prescribed stimulant medicine for ADHD is an exception.
  • For the depression group: have access to a smartphone, tablet, or computer to complete study check-ins.
  • For the healthy group: have no major depression and a depression score below 28 (T-score below 52).

Who can't join

  • Have ever had bipolar disorder, schizophrenia, related disorders, or psychosis (trouble knowing what is real). Currently have a developmental disorder, severe conduct disorder, life-threatening anorexia, OCD, or autism.
  • Take mental health medicines before entry, subject to the ADHD exception above; have an estimated IQ below 80; or have had alcohol or drug abuse or dependence in the past 3 months.
  • Have a possible or confirmed brain or nerve disorder, epilepsy, or a past traumatic brain injury; or have been unconscious for more than 30 minutes.
  • Fear tight spaces, have a health condition that prevents an fMRI scan, be pregnant, or be left-handed.
  • Have a serious, immediate risk of suicide or a medical condition that needs care before depression treatment.
  • Use substances other than nicotine within 2 weeks of the scan, or use nicotine within 3 hours of the scan.
  • Have changed your ADHD stimulant treatment within 30 days of the scan.
  • Be unable to complete the 3 study check-in periods, including because you lack a smartphone, or complete less than 70% of the check-ins.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Male and female adolescents ages 15-17; * current MDD diagnosis as determined by K-SADS-PL, * CDRS-R raw score \> 45 (T-score \> 65) at baseline; * estimated full scale IQ \> 80 as determined by the WASI-II; * able to receive outpatient care; * willing to not partake in other psychosocial treatments; * not taking psychotropic medications in the two weeks (four weeks for fluoxetine) prior to consent, with the exception of psychostimulant medication prescribed for the treatment of ADHD. * Additionally, depressed patients must have access to required technology (e.g. smart phone, tablet, or desktop computer) to complete the EMA portion of the study. * Healthy controls cannot not meet criteria for MDD and their CDRS-R raw score must be below 28; T-score \< 52). Exclusion Criteria: * Current or past diagnosis of bipolar, schizophrenia, schizophreniform, schizoaffective disorders, or psychosis NOS; * current diagnosis of developmental disorder, severe conduct disorder, life-threatening anorexia, OCD, or autism-spectrum disorders; * taking psychotropic medications prior to entry; * estimated IQ \< 80; alcohol/drug dependence or abuse within the last 3 months; * potential/confirmed neurological disorder or epilepsy; * claustrophobia; * presence of a medical condition that precludes fMRI; * endorsement of imminent and serious suicidality; * medical conditions that take precedence over the presence of MDD; * pregnancy; * substance use (excluding nicotine) within two weeks of the fMRI scan; * left-handedness; * nicotine use within 3 hours of the fMRI scan; * history of traumatic brain injury or of being unconscious for more than 30 minutes; * a stimulant regime for ADHD which has changed within 30 days of the fMRI scan. * Non-compliance (i.e. \<70% completion) or inability (i.e. lack of smartphone device) to complete the 3 assessment periods of EMA.

Study sites (3)

GA