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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH126985-01A1 | U.S. NIH Grant/Contract | View source | |
| 2025P011729 | Other Identifier | Emory IRB |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDD patients | Experimental | Participants will be seen for a maximum of 16 sessions over 16 weeks. Two extra sessions will be allowed during treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, weekly therapy visits 1-16 post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wade E Craighead, PhD | Contact | 4047273287 | ecraigh@emory.edu | |
| Michael Treadway, PhD | Contact | mtreadway@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Treadway, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
De-identified data (including access and additional documents) will be shared through the NIMH NDA and in accordance with NIMH NDA data-sharing policy.
As soon as possible after data collection.
In accordance with NIMH NDA data-sharing policy.
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 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. |
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| Facility for Education and Research in Neuroscience (FERN) | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Child and Adolescent Mood Program (CAMP) | Recruiting | Atlanta | Georgia | 30329 | United States |
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