Depression
Conditions
Keywords
Depression, Childhood adversity, Behavioral Activation, Reward Processing
Brief summary
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.
Interventions
BEHAVIORALBehavioral 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.
Sponsors
Seattle Children's Hospital
National Institute of Mental Health (NIMH)
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes
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
* IQ \< 80; * non-English speaking youth or parent; * current PTSD diagnosis; * lifetime history of a developmental (e.g., autism), neurological (e.g., epilepsy), psychotic, bipolar, or substance disorder; * current psychiatric (e.g., antidepressants) or other mood altering medication (e.g., steroids) other than AD/HD medication; * requiring a higher level of care (i.e., inpatient hospitalization) due to suicidality or other mental or physical health related problem. * Any youths who are currently being maltreated will not be enrolled to ensure that participants do not have active safety concerns. * Full course of other evidence-based depression intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | Week 12 (post-treatment) | 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. |
| Anhedonia/Activation | Week 12 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hopelessness | Pre- (Week 0) and post-treatment (Week 12) | 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. |
| Anxiety | Symptoms will be measured at baseline, post-treatment, and 3-month follow-up. | Changes in anxiety symptoms and diagnoses with diagnostic interviews and self-report (SCARED). |
| Ecological Momentary Assessment (EMA) | Questionnaires delivered 3x/day, 2 days/week from Weeks 0 to 12 | Changes in self-reported activity engagement and mood will be delivered through a mobile application. |
| Suicidality | Weekly throughout treatment (Weeks 0-12) and at a 3-month follow-up (24 Week) | Changes in suicidal ideation, plans, and behaviors and self-harm thoughts and behaviors will be measured on a semi-structured interview and self-report. |
| Behavioral Problems | Pre- (Week 0) and post-treatment (Week 12) | Changes in commonly co-morbid behavioral problems with depression (i.e., attention deficit/hyperactivity disorder, conduct problems, oppositionality) and diagnoses will be measured. |
Countries
United States
Participant flow
Pre-assignment details
We did not assign to groups. This was a single-arm, open pilot trial
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Behavioral Activation Arm |
|---|---|
| Age, Categorical <=18 years | 32 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 14.88 years STANDARD_DEVIATION 1.39 |
| Anhedonia | 73.53 units on a scale STANDARD_DEVIATION 22.18 |
| Childhood Trauma Questionnaire | 40.63 units on a scale STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Patient Health Questionnaire-9 | 13.94 units on a scale STANDARD_DEVIATION 6.51 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 32 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
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.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation Arm | Anhedonia/Activation | 61.80 score on a scale | Standard Deviation 22.19 |
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.
Time frame: Week 12 (post-treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation Arm | Depression | 9.63 score on a scale | Standard Deviation 5.49 |
Other Pre-specified
Anxiety
Changes in anxiety symptoms and diagnoses with diagnostic interviews and self-report (SCARED).
Time frame: Symptoms will be measured at baseline, post-treatment, and 3-month follow-up.
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.
Time frame: Pre- (Week 0) and post-treatment (Week 12)
Other Pre-specified
Ecological Momentary Assessment (EMA)
Changes in self-reported activity engagement and mood will be delivered through a mobile application.
Time frame: Questionnaires delivered 3x/day, 2 days/week from Weeks 0 to 12
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.
Time frame: Pre- (Week 0) and post-treatment (Week 12)
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.
Time frame: Weekly throughout treatment (Weeks 0-12) and at a 3-month follow-up (24 Week)