Mechanisms of Behavioral Activation (BA)

NCT05548244 | Recruiting DMC

• 2 other identifiers: IRB000785451R01MH126985-01A1
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Depression

Keywords

Behavioral Activation; fMRI

Outcome Measures

Primary Outcomes (2)

• Change in Diagnostic Interview Status (CDRS-R) total score from baseline

  Change from baseline on the Children's Depression Rating Scale-Revised (CDRS-R) total score. CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total sum of scores range from 17 to 113. Following on prior studies of adolescent MDD, a diagnosis of MDD and a CDRS-R score of 45 or greater is the criterion for admission to the study. A score of 27 or less at the end of the study is the criterion for remission of MDD.

  Baseline, week 16 post intervention

• Change in Adolescent Longitudinal Interval Follow-Up Evaluation (A-LIFE)

  The A-LIFE Interview, developed for use with adolescents, was based on the Longitudinal Interval Follow-up Evaluation scale (LIFE), a clinical interview for adults. The A-LIFE comprises three general sections, including psychopathology, psychosocial functioning, and general severity of the disorder (GSD). The psychopathology domain will be used in the current study because it provides information regarding whether the participant has met the criteria and symptoms of DSM-5 disorders. The A-LIFE measure of greatest interest in the current study is the 6-point rating of each identified psychiatric disorder. Each form of psychopathology is scored 1-6, and a depression score of 4, 5, or 6 yields a positive diagnosis of MDD. The primary outcome variable will be the number of MDD patients reaching remission status (\<4).

  Week 8 post intervention (Midpoint), week 16 post intervention

Secondary Outcomes (1)

• Change in Beck Depression Inventory (BDI-II)

  Baseline, weekly therapy visits 1-16 post intervention

Study Arms (1)

MDD patients

EXPERIMENTAL

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

Behavioral: Behavioral Activation Therapy; Behavioral: Baseline assessment procedures

Interventions

Behavioral Activation Therapy 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.

Also known as: BA Therapy

MDD patients

Baseline assessment procedures BEHAVIORAL

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

MDD patients

Eligibility Criteria

• Age: 15 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Facility for Education and Research in Neuroscience (FERN)

Atlanta, Georgia, 30322, United States

RECRUITING

Child and Adolescent Mood Program (CAMP)

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Wade E Craighead, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wade E Craighead, PhD

CONTACT

4047273287; ecraigh@emory.edu

Michael Treadway, PhD

CONTACT

mtreadway@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 21, 2022
• Study Start: January 30, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: As soon as possible after data collection.
• Access Criteria: In accordance with NIMH NDA data-sharing policy.

Locations

US (3)