DepressionNCT05548244
Mechanisms of Behavioral Activation (BA)
A study testing Behavioral Activation Therapy and Baseline assessment procedures in people with Depression, run by Emory University at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Behavioral Activation Therapy and Baseline assessment procedures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jan 2023to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Michael Treadway, PhD contact
United States3 sites, 3 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Wade E Craighead, PhD, ecraigh@emory.edu
- Recruiting
Facility for Education and Research in Neuroscience (FERN)
Atlanta, Georgia, 30322
Michael Treadway, PhD, mtreadway@emory.edu
- Recruiting
Child and Adolescent Mood Program (CAMP)
Atlanta, Georgia, 30329
Wade E Craighead, PhD, ecraigh@Emory.edu
About this study
Official title: Multi-level Mechanisms of Behavioral Activation Therapy for Adolescent Depression
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.
Read the detailed description
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
- Depression
- Being tested
- Behavioral Activation Therapy, Baseline assessment procedures
- Keywords
- Behavioral Activation, fMRI
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation TherapyBehavioural
Also called BA 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.
Baseline assessment proceduresBehavioural
Completion of the K-SADS and CDRS-R to assess MDD, and the Wechsler Abbreviated Scale of Intelligence - 2nd Edition to assess IQ.
| Study group | Role | What they receive |
|---|---|---|
| MDD patients | Experimental | Participants will be seen for a maximum of 16 sessions over 16 weeks. Two extra sessions will be allowed during treatment. Receives: Behavioral: Behavioral Activation Therapy; Behavioral: Baseline assessment procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Week 8 post intervention (Midpoint), week 16 post intervention
Secondary outcomes (1)
Change in Beck Depression Inventory (BDI-II)
BDI-II is a 21-self report assessment of the level of depressive symptoms over 2-week period. The minimum and maximum values for the BDI-II are (0-63). The higher the scores, the greater the severity of depression.
Measured: Baseline, weekly therapy visits 1-16 post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start30 Jan 2023
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Michael Treadway, Emory University
- Investigators
- Michael Treadway, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548244
- Sponsor's protocol ID
- IRB00078545
- Other IDs
- 1R01MH126985-01A1, 2025P011729
- Status last verified
- May 2026
- First submitted
- 15 Sep 2022
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data (including access and additional documents) will be shared through the NIMH NDA and in accordance with NIMH NDA data-sharing policy.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-level Mechanisms of Behavioral Activation Therapy for Adolescent Depression
- ClinicalTrials.gov ID
- NCT05548244
- Acronym / sponsor ID
- IRB00078545
- Conditions
- Depression
- Keywords
- Behavioral Activation, fMRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDD patients | Experimental | Behavioral: Behavioral Activation Therapy, Behavioral: Baseline assessment proceduresParticipants will be seen for a maximum of 16 sessions over 16 weeks. Two extra sessions will be allowed during treatment. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Activation TherapyAlso: BA TherapyParticipants 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. | Behavioural | MDD patients |
| Baseline assessment proceduresCompletion of the K-SADS and CDRS-R to assess MDD, and the Wechsler Abbreviated Scale of Intelligence - 2nd Edition to assess IQ. | Behavioural | MDD patients |
Primary outcome
Change in Diagnostic Interview Status (CDRS-R) total score from baseline
Time frame: Baseline, week 16 post intervention
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.
Change in Adolescent Longitudinal Interval Follow-Up Evaluation (A-LIFE)
Time frame: Week 8 post intervention (Midpoint), week 16 post intervention
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).
1 secondary outcome
Change in Beck Depression Inventory (BDI-II)
Time frame: Baseline, weekly therapy visits 1-16 post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified data (including access and additional documents) will be shared through the NIMH NDA and in accordance with NIMH NDA data-sharing policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Treadway, PhD contact
Michael Treadway, PhD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation Therapy and Baseline assessment procedures in people with Depression, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wade E Craighead, PhD (4047273287, ecraigh@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diagnostic Interview Status (CDRS-R) total score from baseline (time frame: Baseline, week 16 post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.