An interventional study of Behavioral Activation in Depression, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-09-16.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
This project aims to use an asynchronous remote communities (ARC) approach both to discover the design requirements for adapting Behavioral Activation (BA) to ARC as well as design/build an ARC platform for administering BA. The investigators will test the feasibility of our approach in a small feasibility observational study with clinicians and adolescents.
An estimated 3.1 million adolescents are diagnosed with depression (MDD) each year (SAMHSA, 2016), and adolescent onset MDD is associated with chronic physical, mental and psychosocial disability (Birmaher et al., 1996). However, over 60% of adolescents with MDD do not receive mental health care, and, among those who do, treatment engagement is low (SAMHSA, 2016; Olfson et al., 2003). Behavioral Activation (BA) is an evidence-based psychosocial intervention (EBPI) for individuals with MDD (Dimidjian et al., 2006). While BA holds promise as an effective treatment with adolescents (McCauley et al., 2015, 2016), previous research approaches have found that adolescents may be better reached and engaged through social media, mobile technologies, and other technology platforms (Boyd, 2007; Park \& Calamaro, 2013). In addition, BA requires frequent interaction from patients over time, which can be difficult and costly for clinicians to administer directly. Thus, there is an opportunity to improve usability and engagement of EBPIs via new technology-based tools. Asynchronous Remote Communities (ARC) is a promising technology-based approach for engaging adolescents that capitalizes on the reach of technology while also providing support, social interactions, and motivation to engage. ARCs are technology-mediated groups that use private online platforms to deliver weekly tasks to participants and gather information about perceptions in a format that is lightweight, accessible, usable, and low burden. The investigators aim to use ARC both to discover the design requirements for adapting BA to ARC as well as design/build an ARC platform for administering BA. The investigators will test the feasibility of our approach in a small feasibility study with clinicians and adolescents. The investigators propose the following specific aims:
Aim 1: Use the ARC approach with adolescents, primary care physicians, and mental health specialists to discover target user needs, design constraints and to observe their experience with ARC: The investigators will first use ARC to collect target user (i.e., primary care providers (PCP) and mental health specialists, adolescents at risk for depression) data to understand their needs and the facilitators and barriers to adapting BA to ARC.
Aim 2: Design \& build an ARC platform for BA delivery with adolescents: Once the investigators have a strong understanding of the facilitators and barriers, the investigators will design a platform to use the ARC approach for BA delivery via Slack. The investigators will use an iterative design approach to understand the technical feasibility of the approach, whether and how to automate parts of the BA intervention using chatbots and other custom applications within Slack. The investigators will conduct small, informal usability testing with target users during this stage.
Aim 3: Test feasibility and usability with small pilot groups of adolescent and clinician target users: Once the investigators have a robust enough prototype of the ARC delivery platform for BA, the investigators will conduct a small pilot study with adolescents at-risk for depression and clinicians to assess the feasibility and usability of the approach. The investigators will collect data on the feasibility, usability, user burden, acceptability, and symptom outcomes.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 11 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Exclusion Criteria:
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: 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)
Measures symptoms of adolescent depression; Scores range from 0 to 24 with higher scores indicating higher depression symptoms.
Time frame: Measured within 3-weeks post BA App User Testing
User Burden Scale
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
Time frame: Measured within 3-weeks post BA App User Testing
Acceptability of Intervention Measure
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.
Time frame: Measured within 3-weeks post BA App User Testing
Appropriateness of Intervention Measure
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.
Time frame: Measured within 3-week post BA App User Testing
Feasibility of Intervention Measure
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.
Time frame: Measured within 3-week post BA App User Testing
Platform Engagement
Platform mood-activity logging across 35 days of possible logging 3x/day
Time frame: Measuring platform engagement across 35 days of platform use.
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.
| Milestone | Adolescents |
|---|---|
| Started | 11 |
| Completed | 7 |
| Not completed | 4 |
Measures symptoms of adolescent depression; Scores range from 0 to 24 with higher scores indicating higher depression symptoms.
| units on a scale | Adolescents |
|---|---|
| Patient Health Questionnaire-Adolescent (PHQ-8) | 9.60 ± 6.27 |
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
| units on a scale | Adolescents |
|---|---|
| User Burden Scale | .60 ± .21 |
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.
| units on a scale | Adolescents |
|---|---|
| Acceptability of Intervention Measure | 3.55 ± .51 |
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.
| units on a scale | Adolescents |
|---|---|
| Appropriateness of Intervention Measure | 3.4 ± .55 |
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.
| units on a scale | Adolescents |
|---|---|
| Feasibility of Intervention Measure | 3.50 ± .71 |
Platform mood-activity logging across 35 days of possible logging 3x/day
| Number of mood-activity logs | Adolescents |
|---|---|
| Platform Engagement | 52.13 ± 45.53 |
Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adolescents | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | Adolescents |
|---|---|
| <=18 years | 11 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Adolescents |
|---|---|
| Mean | 15.83 ± 2.14 |
| Sex/Gender, Customized(Participants) | Adolescents |
|---|---|
| Female | 4 |
| Male | 4 |
| Non-binary/Transgender | 1 |
| Unknown | 2 |
| Ethnicity (NIH/OMB)(Participants) | Adolescents |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 5 |
| Race (NIH/OMB)(Participants) | Adolescents |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 5 |
| More than one race | 1 |
| Unknown or Not Reported | 5 |
| Region of Enrollment(Participants) | Adolescents |
|---|---|
| United States | 11 |
| Patient Health Questionnaire-8(units on a scale) | Adolescents |
|---|---|
| Mean | 14.44 ± 3.94 |
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