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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH112872 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Seattle Children's Hospital | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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National data indicate over 650,000 children and adolescents are exposed to physical, sexual, or emotional abuse or physical or emotional neglect each year. Moreover, youth with a history of childhood maltreatment (CM) are at least twice as likely to develop depression and are at substantial risk for nonresponse to current best practice depression interventions (i.e., cognitive behavioral therapy and antidepressants) compared to non-maltreated peers. Research suggests that CM increases risk for depression through disruptions in the positive valence system, such as reward processing, and Behavioral Activation (BA) may be an alternative depression intervention that targets these deficits. This proposal will examine whether BA intervention reduces depression and anhedonia in a sample of depressed adolescents, aged 13-18, with variable histories of CM exposure (BA Group). A total of 30 depressed adolescents will be recruited to undergo a 12-week course of BA. All participants will undergo clinical assessment to measure depression symptoms and anhedonia at baseline (Week 0) and post- (Week 12) treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Activation Arm | Experimental | See treatment description for information on Behavioral Activation. Participants will receive 12 weekly sessions of Behavioral Activation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation | Behavioral | The Adolescent Behavioral Activation Program (ABAP) will be used as the BA protocol. ABAP was developed and validated by McCauley, Dimidjian et al. to adapt BA to adolescents. ABAP is a 12-week protocol that utilizes an idiographic approach to foster rewarding experiences, effective problem solving, and goal attainment, and decrease avoidance, barriers to activation, and depressive rumination that may be contributing to depression severity and maintenance. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | Changes in depression symptoms will be measured with self-report on the Patient Health Questionnaire-9 (PHQ-9). Total score will be reported with a range of 0 to 27 with higher scores indicating greater symptoms of depression. Higher symptoms of depression are considered a worse outcome. | Week 12 (post-treatment) |
| Anhedonia/Activation | Changes in feelings of loss of pleasure and interest (i.e., Anhedonia) will be measured via self-report on the Behavioral Activation for Depression Scale (BADS) total score. The range on the BADS is 0 to 150, with higher scores representing less activation. Higher scores are considered a worse outcome on this measure. | Week 12 |
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| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Changes in anxiety symptoms and diagnoses with diagnostic interviews and self-report (SCARED). | Symptoms will be measured at baseline, post-treatment, and 3-month follow-up. |
| Behavioral Problems |
Inclusion Criteria Behavioral Activation Group:
- current diagnosis of clinical depression (minor or major) will be recruited as study participants in the Behavioral Activation (BA) Group
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica L Jenness, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
We did not assign to groups. This was a single-arm, open pilot trial
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Activation Arm | See treatment description for information on Behavioral Activation. Participants will receive 12 weekly sessions of Behavioral Activation. Behavioral Activation: The Adolescent Behavioral Activation Program (ABAP) will be used as the BA protocol. ABAP was developed and validated by McCauley, Dimidjian et al. to adapt BA to adolescents. ABAP is a 12-week protocol that utilizes an idiographic approach to foster rewarding experiences, effective problem solving, and goal attainment, and decrease avoidance, barriers to activation, and depressive rumination that may be contributing to depression severity and maintenance. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Activation Arm | See treatment description for information on Behavioral Activation. Participants will receive 12 weekly sessions of Behavioral Activation. Behavioral Activation: The Adolescent Behavioral Activation Program (ABAP) will be used as the BA protocol. ABAP was developed and validated by McCauley, Dimidjian et al. to adapt BA to adolescents. ABAP is a 12-week protocol that utilizes an idiographic approach to foster rewarding experiences, effective problem solving, and goal attainment, and decrease avoidance, barriers to activation, and depressive rumination that may be contributing to depression severity and maintenance. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depression | Changes in depression symptoms will be measured with self-report on the Patient Health Questionnaire-9 (PHQ-9). Total score will be reported with a range of 0 to 27 with higher scores indicating greater symptoms of depression. Higher symptoms of depression are considered a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | Week 12 (post-treatment) |
|
Adverse events were measured across 6-months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Activation Arm | See treatment description for information on Behavioral Activation. Participants will receive 12 weekly sessions of Behavioral Activation. Behavioral Activation: The Adolescent Behavioral Activation Program (ABAP) will be used as the BA protocol. ABAP was developed and validated by McCauley, Dimidjian et al. to adapt BA to adolescents. ABAP is a 12-week protocol that utilizes an idiographic approach to foster rewarding experiences, effective problem solving, and goal attainment, and decrease avoidance, barriers to activation, and depressive rumination that may be contributing to depression severity and maintenance. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assistant Professor | University of Washington | 414-331-4871 | jennessj@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2021 | Mar 13, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 2, 2020 | Apr 10, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Changes in commonly co-morbid behavioral problems with depression (i.e., attention deficit/hyperactivity disorder, conduct problems, oppositionality) and diagnoses will be measured.
| Pre- (Week 0) and post-treatment (Week 12) |
| Hopelessness | Changes in feelings of hopelessness (i.e., feeling like nothing is good, everything is bad, nothing can change it) will be measured by self-report. | Pre- (Week 0) and post-treatment (Week 12) |
| Suicidality | Changes in suicidal ideation, plans, and behaviors and self-harm thoughts and behaviors will be measured on a semi-structured interview and self-report. | Weekly throughout treatment (Weeks 0-12) and at a 3-month follow-up (24 Week) |
| Ecological Momentary Assessment (EMA) | Changes in self-reported activity engagement and mood will be delivered through a mobile application. | Questionnaires delivered 3x/day, 2 days/week from Weeks 0 to 12 |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Patient Health Questionnaire-9 | Changes in depression symptoms will be measured with self-report on the Patient Health Questionnaire-9 (PHQ-9). Total score will be reported with a range of 0 to 27 with higher scores indicating greater symptoms of depression. Higher symptoms of depression are considered a worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Childhood Trauma Questionnaire | The Childhood Trauma Questionnaire (CTQ) measures lifetime experiences of sexual, physical, and emotional abuse as well as emotional neglect. The total score ranges from 5 to 125 with higher scores indicating more experiences of abuse or neglect. | Mean | Standard Deviation | units on a scale |
|
| Anhedonia | Changes in feelings of loss of pleasure and interest (i.e., Anhedonia) will be measured via self-report on the Behavioral Activation for Depression Scale (BADS) total score. The range on the BADS is 0 to 150, with higher scores representing less activation. Higher scores are considered a worse outcome on this measure. | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Anhedonia/Activation | Changes in feelings of loss of pleasure and interest (i.e., Anhedonia) will be measured via self-report on the Behavioral Activation for Depression Scale (BADS) total score. The range on the BADS is 0 to 150, with higher scores representing less activation. Higher scores are considered a worse outcome on this measure. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
|
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| Other Pre-specified | Anxiety | Changes in anxiety symptoms and diagnoses with diagnostic interviews and self-report (SCARED). | Not Posted | Mar 2024 | Symptoms will be measured at baseline, post-treatment, and 3-month follow-up. | Participants |
| Other Pre-specified | Behavioral Problems | Changes in commonly co-morbid behavioral problems with depression (i.e., attention deficit/hyperactivity disorder, conduct problems, oppositionality) and diagnoses will be measured. | Not Posted | Mar 2024 | Pre- (Week 0) and post-treatment (Week 12) | Participants |
| Other Pre-specified | Hopelessness | Changes in feelings of hopelessness (i.e., feeling like nothing is good, everything is bad, nothing can change it) will be measured by self-report. | Not Posted | Mar 2024 | Pre- (Week 0) and post-treatment (Week 12) | Participants |
| Other Pre-specified | Suicidality | Changes in suicidal ideation, plans, and behaviors and self-harm thoughts and behaviors will be measured on a semi-structured interview and self-report. | Not Posted | Mar 2024 | Weekly throughout treatment (Weeks 0-12) and at a 3-month follow-up (24 Week) | Participants |
| Other Pre-specified | Ecological Momentary Assessment (EMA) | Changes in self-reported activity engagement and mood will be delivered through a mobile application. | Not Posted | Mar 2024 | Questionnaires delivered 3x/day, 2 days/week from Weeks 0 to 12 | Participants |
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| 32 |
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| 32 |
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