Trial Outcomes & Findings for Adapting Behavioral Activation to Technology Platform (NCT NCT03783533)

Last Updated: 2022-09-16

Results Overview

Measures symptoms of adolescent depression; Scores range from 0 to 24 with higher scores indicating higher depression symptoms.

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

Measured within 3-weeks post BA App User Testing

Results posted on

2022-09-16

Participant Flow

To recruit teens between February and March 2020, we advertised our study in online groups, sent messages and flyers to clinicians, and a mailing list of parents with teenagers. Interested participants filled out a screener with contact information and the PHQ-8. If the teen was experiencing PHQ-8 \>15, we required that they had a current therapist. Participants were paid $10 for each week's activity and $20 for exit interviews. All study activities were conducted between May and August 2020.

Participant milestones

Participant milestones
Measure	Adolescents Adolescents with PHQ-9 scores between 5 and 20 who do not report current suicidality (Pine et al., 1999) will be recruited from clinician target users' practice settings. The investigators will recruit new adolescents for each Aim to decrease bias in feedback and outcomes. Behavioral Activation: Intervention: Behavioral Activation (BA) therapy is based on a functional analytic model of depression that highlights the need for increased positive reinforcement (rewards) and decreased anhedonia, or diminished motivation to seek rewards, to maintain normal mood. BA is significantly more effective than Cognitive Behavioral Therapy and comparable to antidepressant medication in reducing depressive symptoms among depressed adults (Dimidjian et al., 2006). McCauley (senior mentor) et al. (2016) adapted BA for adolescents to target anhedonia, effective problem solving and avoidant behaviors with peers, family, and school. McCauley's findings and others show BA is a promising intervention for adolescent MDD (Chu et al., 2009; Cuijpers et al.,, 2007; McCauley et al., 2015; Ritschel et al., 2011). BA focuses on targeting ideographically identified avoidant behaviors and rewarding experiences that affect mood.
Overall Study STARTED	11
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adapting Behavioral Activation to Technology Platform

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adolescents n=11 Participants Adolescents with PHQ-9 scores between 5 and 12 (Mild Range) who do not report current suicidality (Pine et al., 1999) will be recruited from clinician target users' practice settings. The investigators will recruit new adolescents for each Aim to decrease bias in feedback and outcomes. Behavioral Activation: Intervention: Behavioral Activation (BA) therapy is based on a functional analytic model of depression that highlights the need for increased positive reinforcement (rewards) and decreased anhedonia, or diminished motivation to seek rewards, to maintain normal mood. BA is significantly more effective than Cognitive Behavioral Therapy and comparable to antidepressant medication in reducing depressive symptoms among depressed adults (Dimidjian et al., 2006). McCauley (senior mentor) et al. (2016) adapted BA for adolescents to target anhedonia, effective problem solving and avoidant behaviors with peers, family, and school. McCauley's findings and others show BA is a promising intervention for adolescent MDD (Chu et al., 2009; Cuijpers et al.,, 2007; McCauley et al., 2015; Ritschel et al., 2011). BA focuses on targeting ideographically identified avoidant behaviors and rewarding experiences that affect mood.
Age, Categorical <=18 years	11 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	15.83 years STANDARD_DEVIATION 2.14 • n=5 Participants
Sex/Gender, Customized Female	4 Participants n=5 Participants
Sex/Gender, Customized Male	4 Participants n=5 Participants
Sex/Gender, Customized Non-binary/Transgender	1 Participants n=5 Participants
Sex/Gender, Customized Unknown	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants
Patient Health Questionnaire-8	14.44 units on a scale STANDARD_DEVIATION 3.94 • n=5 Participants

PRIMARY outcome

Timeframe: Measured within 3-weeks post BA App User Testing

Measures symptoms of adolescent depression; Scores range from 0 to 24 with higher scores indicating higher depression symptoms.

Outcome measures

Outcome measures
Measure	Adolescents n=5 Participants Adolescents with PHQ-9 scores between 5 and 20 who do not report current suicidality (Pine et al., 1999) will be recruited from clinician target users' practice settings. The investigators will recruit new adolescents for each Aim to decrease bias in feedback and outcomes. Behavioral Activation: Intervention: Behavioral Activation (BA) therapy is based on a functional analytic model of depression that highlights the need for increased positive reinforcement (rewards) and decreased anhedonia, or diminished motivation to seek rewards, to maintain normal mood. BA is significantly more effective than Cognitive Behavioral Therapy and comparable to antidepressant medication in reducing depressive symptoms among depressed adults (Dimidjian et al., 2006). McCauley (senior mentor) et al. (2016) adapted BA for adolescents to target anhedonia, effective problem solving and avoidant behaviors with peers, family, and school. McCauley's findings and others show BA is a promising intervention for adolescent MDD (Chu et al., 2009; Cuijpers et al.,, 2007; McCauley et al., 2015; Ritschel et al., 2011). BA focuses on targeting ideographically identified avoidant behaviors and rewarding experiences that affect mood.
Patient Health Questionnaire-Adolescent (PHQ-8)	9.60 units on a scale Standard Deviation 6.27

PRIMARY outcome

Timeframe: Measured within 3-weeks post BA App User Testing

Assesses the burden of the intervention adaptation with both clinician and adolescent participants across several domains and ranges from 0 to 80 for a total score with higher scores indicating higher burden. Scores were averaged across subscales including: * Access Burden * Emotional Burden * Financial Burden * Mental Burden * Physical Burden * Privacy Burden * Social Burden * Time Burden

Outcome measures

Outcome measures
Measure	Adolescents n=5 Participants Adolescents with PHQ-9 scores between 5 and 20 who do not report current suicidality (Pine et al., 1999) will be recruited from clinician target users' practice settings. The investigators will recruit new adolescents for each Aim to decrease bias in feedback and outcomes. Behavioral Activation: Intervention: Behavioral Activation (BA) therapy is based on a functional analytic model of depression that highlights the need for increased positive reinforcement (rewards) and decreased anhedonia, or diminished motivation to seek rewards, to maintain normal mood. BA is significantly more effective than Cognitive Behavioral Therapy and comparable to antidepressant medication in reducing depressive symptoms among depressed adults (Dimidjian et al., 2006). McCauley (senior mentor) et al. (2016) adapted BA for adolescents to target anhedonia, effective problem solving and avoidant behaviors with peers, family, and school. McCauley's findings and others show BA is a promising intervention for adolescent MDD (Chu et al., 2009; Cuijpers et al.,, 2007; McCauley et al., 2015; Ritschel et al., 2011). BA focuses on targeting ideographically identified avoidant behaviors and rewarding experiences that affect mood.
User Burden Scale	.60 units on a scale Standard Deviation .21

PRIMARY outcome

Timeframe: Measured within 3-weeks post BA App User Testing

This is a survey measure that assesses the acceptability of the intervention adaptation with both clinician and adolescent participants. Scores range from 4 to 20 with higher scores indicating higher acceptability.

Outcome measures

Outcome measures
Measure	Adolescents n=5 Participants Adolescents with PHQ-9 scores between 5 and 20 who do not report current suicidality (Pine et al., 1999) will be recruited from clinician target users' practice settings. The investigators will recruit new adolescents for each Aim to decrease bias in feedback and outcomes. Behavioral Activation: Intervention: Behavioral Activation (BA) therapy is based on a functional analytic model of depression that highlights the need for increased positive reinforcement (rewards) and decreased anhedonia, or diminished motivation to seek rewards, to maintain normal mood. BA is significantly more effective than Cognitive Behavioral Therapy and comparable to antidepressant medication in reducing depressive symptoms among depressed adults (Dimidjian et al., 2006). McCauley (senior mentor) et al. (2016) adapted BA for adolescents to target anhedonia, effective problem solving and avoidant behaviors with peers, family, and school. McCauley's findings and others show BA is a promising intervention for adolescent MDD (Chu et al., 2009; Cuijpers et al.,, 2007; McCauley et al., 2015; Ritschel et al., 2011). BA focuses on targeting ideographically identified avoidant behaviors and rewarding experiences that affect mood.
Acceptability of Intervention Measure	3.55 units on a scale Standard Deviation .51

PRIMARY outcome

Timeframe: Measured within 3-week post BA App User Testing

This is a survey measure that assesses the appropriateness of the intervention adaptation with both clinician and adolescent participants. Scores range from 4 to 20 with higher scores indicating higher appropriateness.

Outcome measures

Outcome measures
Measure	Adolescents n=5 Participants Adolescents with PHQ-9 scores between 5 and 20 who do not report current suicidality (Pine et al., 1999) will be recruited from clinician target users' practice settings. The investigators will recruit new adolescents for each Aim to decrease bias in feedback and outcomes. Behavioral Activation: Intervention: Behavioral Activation (BA) therapy is based on a functional analytic model of depression that highlights the need for increased positive reinforcement (rewards) and decreased anhedonia, or diminished motivation to seek rewards, to maintain normal mood. BA is significantly more effective than Cognitive Behavioral Therapy and comparable to antidepressant medication in reducing depressive symptoms among depressed adults (Dimidjian et al., 2006). McCauley (senior mentor) et al. (2016) adapted BA for adolescents to target anhedonia, effective problem solving and avoidant behaviors with peers, family, and school. McCauley's findings and others show BA is a promising intervention for adolescent MDD (Chu et al., 2009; Cuijpers et al.,, 2007; McCauley et al., 2015; Ritschel et al., 2011). BA focuses on targeting ideographically identified avoidant behaviors and rewarding experiences that affect mood.
Appropriateness of Intervention Measure	3.4 units on a scale Standard Deviation .55

PRIMARY outcome

Timeframe: Measured within 3-week post BA App User Testing

This is a survey measure that assesses the feasibility of the intervention adaptation with both clinician and adolescent participants. Scores range from 4 to 20 with higher scores indicating higher feasibility.

Outcome measures

Outcome measures
Measure	Adolescents n=5 Participants Adolescents with PHQ-9 scores between 5 and 20 who do not report current suicidality (Pine et al., 1999) will be recruited from clinician target users' practice settings. The investigators will recruit new adolescents for each Aim to decrease bias in feedback and outcomes. Behavioral Activation: Intervention: Behavioral Activation (BA) therapy is based on a functional analytic model of depression that highlights the need for increased positive reinforcement (rewards) and decreased anhedonia, or diminished motivation to seek rewards, to maintain normal mood. BA is significantly more effective than Cognitive Behavioral Therapy and comparable to antidepressant medication in reducing depressive symptoms among depressed adults (Dimidjian et al., 2006). McCauley (senior mentor) et al. (2016) adapted BA for adolescents to target anhedonia, effective problem solving and avoidant behaviors with peers, family, and school. McCauley's findings and others show BA is a promising intervention for adolescent MDD (Chu et al., 2009; Cuijpers et al.,, 2007; McCauley et al., 2015; Ritschel et al., 2011). BA focuses on targeting ideographically identified avoidant behaviors and rewarding experiences that affect mood.
Feasibility of Intervention Measure	3.50 units on a scale Standard Deviation .71

SECONDARY outcome

Timeframe: Measuring platform engagement across 35 days of platform use.

Platform mood-activity logging across 35 days of possible logging 3x/day

Outcome measures

Outcome measures
Measure	Adolescents n=5 Participants Adolescents with PHQ-9 scores between 5 and 20 who do not report current suicidality (Pine et al., 1999) will be recruited from clinician target users' practice settings. The investigators will recruit new adolescents for each Aim to decrease bias in feedback and outcomes. Behavioral Activation: Intervention: Behavioral Activation (BA) therapy is based on a functional analytic model of depression that highlights the need for increased positive reinforcement (rewards) and decreased anhedonia, or diminished motivation to seek rewards, to maintain normal mood. BA is significantly more effective than Cognitive Behavioral Therapy and comparable to antidepressant medication in reducing depressive symptoms among depressed adults (Dimidjian et al., 2006). McCauley (senior mentor) et al. (2016) adapted BA for adolescents to target anhedonia, effective problem solving and avoidant behaviors with peers, family, and school. McCauley's findings and others show BA is a promising intervention for adolescent MDD (Chu et al., 2009; Cuijpers et al.,, 2007; McCauley et al., 2015; Ritschel et al., 2011). BA focuses on targeting ideographically identified avoidant behaviors and rewarding experiences that affect mood.
Platform Engagement	52.13 Number of mood-activity logs Standard Deviation 45.53

Adverse Events

Adolescents

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jessica Jenness

University of Washington

Phone: 206-616-7967

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place