Trial Outcomes & Findings for Activating and Connecting Teens (ACT) Study (NCT NCT03438656)
NCT ID: NCT03438656
Last Updated: 2024-05-02
Results Overview
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.
COMPLETED
NA
32 participants
Week 12 (post-treatment)
2024-05-02
Participant Flow
We did not assign to groups. This was a single-arm, open pilot trial
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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32
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Overall Study
COMPLETED
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30
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
Lost to Follow-up
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2
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Baseline Characteristics
Activating and Connecting Teens (ACT) Study
Baseline characteristics by cohort
| Measure |
Behavioral Activation Arm
n=32 Participants
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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|---|---|
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Age, Categorical
<=18 years
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32 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Age, Continuous
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14.88 years
STANDARD_DEVIATION 1.39 • n=5 Participants
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Sex: Female, Male
Female
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17 Participants
n=5 Participants
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Sex: Female, Male
Male
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15 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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3 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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29 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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2 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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2 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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3 Participants
n=5 Participants
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Race (NIH/OMB)
White
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12 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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9 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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3 Participants
n=5 Participants
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Region of Enrollment
United States
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32 Participants
n=5 Participants
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Patient Health Questionnaire-9
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13.94 units on a scale
STANDARD_DEVIATION 6.51 • n=5 Participants
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Childhood Trauma Questionnaire
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40.63 units on a scale
STANDARD_DEVIATION 9.00 • n=5 Participants
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Anhedonia
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73.53 units on a scale
STANDARD_DEVIATION 22.18 • n=5 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Behavioral Activation Arm
n=32 Participants
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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Depression
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9.63 score on a scale
Standard Deviation 5.49
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PRIMARY outcome
Timeframe: Week 12Changes 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.
Outcome measures
| Measure |
Behavioral Activation Arm
n=32 Participants
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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|---|---|
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Anhedonia/Activation
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61.80 score on a scale
Standard Deviation 22.19
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OTHER_PRE_SPECIFIED outcome
Timeframe: 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).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Questionnaires delivered 3x/day, 2 days/week from Weeks 0 to 12Changes in self-reported activity engagement and mood will be delivered through a mobile application.
Outcome measures
Outcome data not reported
Adverse Events
Behavioral Activation Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place