Mechanisms of Behavioral Activation (BA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-30

Study Completion Date

2027-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Brain Imaging of Psychotherapy for Depression

NCT00609453

Major Depressive Disorder

COMPLETED NA

Targeting Large-scale Networks in Depression With Real-time fMRI (Functional Magnetic Resonance Imaging) Neurofeedback

NCT05934604

Healthy Participants

COMPLETED NA

Real-time fMRI for the Treatment of Aggressive Behavior in Adolescents

NCT02563145

Aggression Conduct Disorder

COMPLETED NA

Using Functional MRI Neurofeedback to Modulate Self-blame in Major Depressive Disorder

NCT05455827

Depression

COMPLETED NA

Training of Neural Responding in BPD

NCT02866110

Borderline Personality Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary aim of this study is to investigate the behavioral and neurobiological factors predicting response to Behavior Activation (BA), a psychosocial treatment for Major Depressive Disorder (MDD), in adolescents.

The recruitment age pool will be adolescents ages 15-17. The investigators plan to recruit 40 healthy controls and 96 treatment-seeking adolescents for an overall sample of \~136 participants, Individuals who reach the age of majority (18) during the study will be re-consented as adults and allowed to continue participating in the study.

A healthy control group will be included to assess stability in behavioral and neuroimaging measures over the course of participation in the study.

The fMRI scan schedule will include three task-based sessions (baseline, after session 7, and after endpoint) and two (sessions 3 \& 9). "behavioral-scheduling-in-the-scanner" sessions Primary results will focus on symptom change within patients and their association to measures of low motivation and threat avoidance.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MDD patients

Participants will be seen for a maximum of 16 sessions over 16 weeks. Two extra sessions will be allowed during treatment.

Group Type EXPERIMENTAL

Behavioral Activation Therapy

Intervention Type BEHAVIORAL

Participants will be seen for a maximum of 16 sessions of therapy focused on increasing rewarding behaviors (16 individual therapy sessions of 1-hour, 2 of which include the BSIS component) over 16 weeks. BA intervention includes monthly booster sessions offered throughout 6-month follow up. If needed, two extra sessions will be allowed during treatment.

Baseline assessment procedures

Intervention Type BEHAVIORAL

Completion of the K-SADS and CDRS-R to assess MDD, and the Wechsler Abbreviated Scale of Intelligence - 2nd Edition to assess IQ.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Behavioral Activation Therapy

Participants will be seen for a maximum of 16 sessions of therapy focused on increasing rewarding behaviors (16 individual therapy sessions of 1-hour, 2 of which include the BSIS component) over 16 weeks. BA intervention includes monthly booster sessions offered throughout 6-month follow up. If needed, two extra sessions will be allowed during treatment.

Intervention Type BEHAVIORAL

Baseline assessment procedures

Completion of the K-SADS and CDRS-R to assess MDD, and the Wechsler Abbreviated Scale of Intelligence - 2nd Edition to assess IQ.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BA Therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes