Evaluation of an Asynchronous Remote Communities Approach to Behavioral Activation for Depressed Adolescents
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-19
SponsorUniversity of Washington
About this trial
The goal of this clinical trial is to learn if a digital health intervention, called "ActivaTeen," improves depression treatment for teenagers with depression. The investigators also want to know if ActivaTeen is easy to use for both teenagers and mental health clinicians who help deliver treatment through ActivaTeen. All teenagers in the study will receive an individual depression therapy called Behavioral Activation or "BA" and about half will also use ActivaTeen.
The main questions this trial aims to answer are:
* Does ActivaTeen improve depression treatment for teenagers? * Do teenagers and clinicians find ActivaTeen to be acceptable?
Researchers will compare teenagers using ActivaTeen along with BA to teenagers who are only doing BA to see the effects of ActivaTeen.
Participants in the study will:
* Fill out surveys online several times during the study, which lasts about 6 months * Receive individual BA therapy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 13 - 19
Referred for MDD treatment
Clinically assessed diagnosis of current MDD based on caregiver or patient report or a PHQ-8 total of 8 or greater (moderate MDD)
MDD clinically determined to be the primary diagnosis
Disqualifiers
Developmental disability (e.g., intellectual disability, autism spectrum disorder)
Severe psychiatric comorbidity (e.g., active suicidality requiring higher level of care; psychosis or substance use, bipolar, or conduct disorder)
Previously completed a full course of evidence based psychosocial intervention for depression
Trial design
Design model
Parallel
Treatments tested in this trial
ActivaTeen
BehavioralThe ActivaTeen app is built on HIPAA-compliant instance of a popular messaging software. Participants in the treatment group can access the app at any time via desktop or mobile, where they can find features designed to enhance their receipt of BA therapy. These features include: weekly BA skills and homework completion support, in-app messaging with their BA therapist, mood and activity tracking and data visualizations, chatbot check-ins on progress and guided problem-solving around barriers, and moderated peer support using the ActivaTeen app. The app will have a moderator, who is part of the study team, to manage peer-to-peer interactions within ActivaTeen.
Behavioral Activation
BehavioralBehavioral activation therapy involves individual weekly sessions with a trained therapist for 12 weeks. The sessions are completed either in-person or via telehealth. The treatment focuses on behavioral manifestations of depression such as isolating, and how these behaviors are interconnected with low mood and depressive emotions. BA helps patients find ways to engage in behaviors that are meaningful to them based on their values, priorities, and goals, with the aim of creating positive loops between doing meaningful activities and improved mood. The therapist provides structure and problem-solving for activating these behaviors and keeping track of changes over time.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: ActivaTeen + BAExperimental treatment 2 interventions
Group B: BA OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Intervention Usability Scale
The IUS was adapted from the System Usability Scale, with the word "system" replaced with "intervention platform" for each item. Items are rated on a Likert-type scale from 0 (strongly disagree) to 4 (strongly agree) and half of the items are reverse-scored. The total score is calculated by multiplying the sum of these scores by 2.5 (possible range: 0-100), with higher scores indicating greater usability.
Time frame
Week 122
User Burden Scale
The User Burden Scale (UBS) is a widely used and reliable scale that includes 20-items that capture user burden of computing systems across 6 subscales1) difficulty of use, 2) physical, 3) time and social, 4) mental and emotional, 5) privacy, and 6) financial. Items are rated on a 5-point Likert scale from 0 (Never/Not at all) to 4 (All of the time/Extremely). Higher scale scores indicate greater user burden.
Time frame
Week 123
Client Satisfaction Questionnaire - 8
The CSQ-8 is an 8-item, unidimensional measure assessing general satisfaction with mental health services. Higher scores indicate greater satisfaction (range: 8 - 32)
Time frame
Week 124
Acceptability Of Intervention Measure
The Acceptability of Intervention Measure assesses the acceptability of a particular intervention. The measure has 4 items each and responses are coded on a 1 - 5 Likert scale (Completely Disagree to Completely Agree). Higher scores indicate greater acceptability (range: 4 - 20)
Time frame
Week 12Secondary outcomes
1
Loneliness
The self-report NIH Loneliness Toolbox assesses perceptions of loneliness in the past month using a 7-item survey for ages 8 to 17 scored on a 5-point Likert scale from 1 (Never) to 5 (Always). Higher total scores indicate greater loneliness. Age-adjusted scale scores will be generated for each participant.
Time frame
Baseline to Week 242
Therapeutic Alliance
The Working Alliance Inventory, Short Form (WAI-S) will be used to assess the therapeutic alliance between clients and therapists. The WAI-S comprises 12 items designed to evaluate the quality of the working relationship, agreement on goals, and agreement on tasks between the client and therapist. Each item is scored on a 1 to 7 Likert scale, where higher scores indicate stronger therapeutic alliance. The total score ranges from 12 to 84, with higher scores indicating a more positive and effective therapeutic alliance.
Time frame
Week 12Other outcomes
1
Enrollment Rate
The enrollment rate (those enrolled / those screened) will be used as a measure of trial design feasibility. The number of participants enrolled will be divided by the number of candidates screened.
Time frame
Baseline2
Loss to Follow Up Rate
The loss-to-follow-up rate (participants who do not complete Week 24 / randomized participants) will be used as a measure of trial design feasibility. The number of participants who do not complete the Week 24 visit will be divided by the number of participants who complete randomization.
Time frame
Baseline to Week 243
Behavioral Activation Attendance
Attendance at BA sessions will be used as a measure of engagement in treatment (both study arms receive BA). The number of attended sessions will be divided by the total possible (12).
Time frame
Baseline to Week 124
Behavioral Activation Homework Completion
Completion of BA homework will be used as a measure of engagement in treatment (both study arms receive BA). The number of completed homeworks will be divided by the total possible.
Time frame
Baseline to Week 12Locations
Sponsors and contacts
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University of Washington
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov
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