DepressionNCT03783533
Adapting Behavioral Activation to Technology Platform
A study testing Behavioral Activation in people with Depression, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Depression
- What is being tested?
- Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Current suicidal ideation or PHQ-9 scores that are below or above the cutoff described above for adolescents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Designing and Evaluating an Asynchronous Remote Communication Approach to Behavioral Activation With Clinicians and Adolescents At Risk for Depression
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.
Read the detailed description
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.
- Conditions
- Depression
- Being tested
- Behavioral Activation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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: Measured within 3-week post BA App User Testing
Secondary outcomes (1)
Platform Engagement
Platform mood-activity logging across 35 days of possible logging 3x/day
Measured: Measuring platform engagement across 35 days of platform use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start1 Aug 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783533
- Sponsor's protocol ID
- STUDY00002824
- Other IDs
- P50MH115837
- Status last verified
- Aug 2022
- First submitted
- 29 Nov 2018
- Last updated
- 16 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing and Evaluating an Asynchronous Remote Communication Approach to Behavioral Activation With Clinicians and Adolescents At Risk for Depression
- ClinicalTrials.gov ID
- NCT03783533
- Acronym / sponsor ID
- STUDY00002824
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 21 Dec 2018 (actual)
- Results
- Posted 16 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent Target Users of Behavioral Activation (BA) App | Experimental | Behavioral: Behavioral ActivationAdolescents 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Current suicidal ideation or PHQ-9 scores that are below or above the cutoff described above for adolescents.
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 |
|---|---|---|
| Behavioral ActivationIntervention: 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. | Behavioural | Adolescent Target Users of Behavioral Activation (BA) App |
Primary outcome
Patient Health Questionnaire-Adolescent (PHQ-8)
Time frame: 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.
User Burden Scale
Time frame: 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
Acceptability of Intervention Measure
Time frame: 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.
Appropriateness of Intervention Measure
Time frame: 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.
Feasibility of Intervention Measure
Time frame: 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.
1 secondary outcome
Platform Engagement
Time frame: Measuring platform engagement across 35 days of platform use.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation in people with Depression, run by University of Washington at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 16 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-Adolescent (PHQ-8) (time frame: Measured within 3-weeks post BA App User Testing). The study lists 5 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 16 Sep 2022.