DepressionNCT06786247
Evaluation of an Asynchronous Remote Communities Approach to Behavioral Activation for Depressed Adolescents
A study testing ActivaTeen and Behavioral Activation in people with Depression and Adolescent Behavior, run by University of Washington.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Depression, Adolescent Behavior
- What is being tested?
- ActivaTeen and Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- English-speaking
- Access to a smartphone device
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
- 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
- Conditions
- Depression, Adolescent Behavior
- Being tested
- ActivaTeen, Behavioral Activation
- Keywords
- depression, adolescence, asynchronous remote community, behavioral activation, digital health
- Medical subject headings
- Depression, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActivaTeenBehavioural
The 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 ActivationBehavioural
Also called BA
Behavioral 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.
| Study group | Role | What they receive |
|---|---|---|
| ActivaTeen + BA | Experimental | Receives access to ActivaTeen app along with individual behavioral activation therapy Receives: Behavioral: ActivaTeen; Behavioral: Behavioral Activation |
| BA Only | Active comparator | Receives individual behavioral activation therapy alone Receives: Behavioral: Behavioral Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
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.
Measured: Week 12
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)
Measured: Week 12
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)
Measured: Week 12
Intervention Appropriateness Measure
The Intervention Appropriateness Measure assesses the appropriateness 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 appropriateness (range: 4 - 20)
Measured: Week 12
Feasibility Of Intervention Measure
The Feasibility of Intervention Measure assesses the feasibility 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 feasibility (range: 4 - 20)
Measured: Week 12
Secondary outcomes (2)
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.
Measured: Baseline to Week 24
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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study startApr 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jessica Jenness, University of Washington
- Investigators
- Jessica Jenness, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786247
- Sponsor's protocol ID
- STUDY00018887
- Other IDs
- 5R34MH128387-02
- Status last verified
- Jan 2025
- First submitted
- 20 Dec 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Asynchronous Remote Communities Approach to Behavioral Activation for Depressed Adolescents
- ClinicalTrials.gov ID
- NCT06786247
- Acronym / sponsor ID
- STUDY00018887
- Conditions
- Depression, Adolescent Behavior
- Keywords
- depression, adolescence, asynchronous remote community, behavioral activation, digital health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ActivaTeen + BA | Experimental | Behavioral: ActivaTeen, Behavioral: Behavioral ActivationReceives access to ActivaTeen app along with individual behavioral activation therapy |
| BA Only | Active comparator | Behavioral: Behavioral ActivationReceives individual behavioral activation therapy alone |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
- English-speaking
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActivaTeenThe 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. | Behavioural | ActivaTeen + BA |
| Behavioral ActivationAlso: BABehavioral 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. | Behavioural | ActivaTeen + BA, BA Only |
Primary outcome
Intervention Usability Scale
Time frame: Week 12
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.
User Burden Scale
Time frame: Week 12
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.
Client Satisfaction Questionnaire - 8
Time frame: Week 12
The CSQ-8 is an 8-item, unidimensional measure assessing general satisfaction with mental health services. Higher scores indicate greater satisfaction (range: 8 - 32)
Acceptability Of Intervention Measure
Time frame: Week 12
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)
Intervention Appropriateness Measure
Time frame: Week 12
The Intervention Appropriateness Measure assesses the appropriateness 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 appropriateness (range: 4 - 20)
Feasibility Of Intervention Measure
Time frame: Week 12
The Feasibility of Intervention Measure assesses the feasibility 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 feasibility (range: 4 - 20)
2 secondary outcomes
Loneliness
Time frame: Baseline to Week 24
Therapeutic Alliance
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Jenness, PhD principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing ActivaTeen and Behavioral Activation in people with Depression and Adolescent Behavior, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Warren Szewczyk (206-543-5080, activateen@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Usability Scale (time frame: Week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.