Adapting Behavioral Activation to Technology Platform

NCT03783533 | Completed Results

• 2 other identifiers: STUDY00002824P50MH115837
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (5)

• Patient Health Questionnaire-Adolescent (PHQ-8)

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

  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

  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.

  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.

  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.

  Measured within 3-week post BA App User Testing

Secondary Outcomes (1)

• Platform Engagement

  Measuring platform engagement across 35 days of platform use.

Study Arms (1)

Adolescent Target Users of Behavioral Activation (BA) App

EXPERIMENTAL

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

Interventions

Behavioral Activation BEHAVIORAL

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.

Adolescent Target Users of Behavioral Activation (BA) App

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents with PHQ-9 scores between 5 and 15 (Mild to Moderate Range) who do not report current suicidality (Pine et al., 1999) will be recruited from clinician target users' practice settings.

You may not qualify if:

• Current suicidal ideation or PHQ-9 scores that are below or above the cutoff described above for adolescents.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98115, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Jessica Jenness
• Organization: University of Washington

jennessj@uw.edu

206-616-7967

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Assistant Professor

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 21, 2018
• Study Start: August 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 16, 2022
• Results First Posted: September 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)