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Adapting Behavioral Activation to Technology Platform

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ClinicalTrials.gov Identifier: NCT03783533
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : December 24, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jessica Jenness, University of Washington

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Behavioral Activation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Designing and Evaluating an Asynchronous Remote Communication Approach to Behavioral Activation With Clinicians and Adolescents At Risk for Depression
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adolescents
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.




Primary Outcome Measures :
  1. Patient Health Questionnaire-Adolescent (PHQ-A) [ Time Frame: Change across pilot intervention completion, approximately 4-12 weeks ]
    Measures symptoms of adolescent depression; Scores range from 0 to 27 with higher scores indicating higher depression symptoms.

  2. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Change across pilot intervention completion, approximately 4-12 weeks ]
    Measures symptoms of adolescent anxiety; Scores range from 0 to 21 with higher scores indicating higher anxiety symptoms.

  3. User Burden Scale [ Time Frame: Within 3 weeks Post-pilot intervention ]

    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:

    • Access Burden: The system does not fit with the abilities or cultural background of the user.
    • Emotional Burden: The system makes the user feel bad or unnecessarily worry.
    • Financial Burden: The system costs a significant amount of money for the user to initially purchase or to maintain use.
    • Mental Burden: The system requires significant attention, concentration, or is distracting.
    • Physical Burden: The system makes the user physically uncomfortable.
    • Privacy Burden: The system risks revealing information about a user that he or she would prefer not to share.
    • Social Burden: The system may disrupt the user's ability to create and sustain social relationships.
    • Time Burden: The system requires frequent use or a significant amount of time to use.

  4. System Usability Scale [ Time Frame: Within 3 weeks post-pilot intervention ]
    Assesses the usability of the intervention adaptation with both clinician and adolescent participants. There is a total score from 0 to 40 with higher scores indicating better usability.

  5. Acceptability of Intervention Measure [ Time Frame: Within 3 weeks post-pilot intervention ]
    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.

  6. Appropriateness of Intervention Measure [ Time Frame: Within 3 weeks post-pilot intervention ]
    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.

  7. Feasibility of Intervention Measure [ Time Frame: Within 3 weeks post-pilot intervention ]
    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.


Secondary Outcome Measures :
  1. Behavioral Activation for Depression Scale [ Time Frame: Change across pilot intervention completion, approximately 4-12 weeks ]
    Assesses the adolescent's motivation and behavioral activation in multiple functional domains of their life. The BADS consists of 25 questions, each rated on a seven point scale ranging from 0 (not at all) to 6 (completely). There are subscales including activation, avoidance/rumination, work/school impairment, and social impairment with higher scores indicating higher levels of each of these constructs.

  2. Platform Engagement [ Time Frame: Changes in use measured across study completion (approximately 4-12 weeks). ]
    The investigators will use the built-in analytics tools for the technology application to identify the number of logins and posts per day per participant (both clinician and adolescent)

  3. Behavioral Activation/Inhibition Scale [ Time Frame: Change across pilot intervention completion, approximately 4-12 weeks ]

    Measures approach motivation/inhibition in adolescents. 20 items using 4 point scales (1 = strongly disagree to 4 = strongly agree).

    2 sub-scales (higher scores indicating higher levels of each construct): Behavioral Inhibition System (BIS) - 7 items about anticipation of punishment

    Behavioral Action System (BAS), which has 3 sub-scales of its own:

    Reward Responsiveness (RR) - 5 items about anticipation or occurrence of reward Drive (D) - 4 items about pursuit of desired goals Fun Seeking (FS) - 4 items about desire for new rewards and impulsive approach to potential rewards


  4. Snaith-Hamilton Pleasure Scale [ Time Frame: Change across pilot intervention completion, approximately 4-12 weeks ]
    pleasure seeking and anhedonia in adolescents.The 14-item Snaith-Hamilton Pleasure Scale (SHAPS).Each of the items has a set of four response categories--Definitely Agree, Agree, Disagree, and Strongly Disagree, with either of the Disagree responses receiving a score of 1 and either of the Agree responses receiving a score of 0. Thus, the SHAPS was scored as the sum of the 14 items so that total scores ranged from 0 to 14. A higher total SHAPS score indicated higher levels of present state of anhedonia.

  5. Shared Understanding Scale [ Time Frame: Within 3 weeks post-intervention ]
    Measures the level of shared understanding among group members for both adolescents and clinicians across all aims including the extent to which participants have shared values, norms, philosophy, problem-solving approaches, and prior experiences. This measure was developed by Ko et al (2005) and involves 12 yes/no items with a total score ranging from 0 to 12 with higher scores indicating greater shared understanding between the participant and another group member.

  6. Perceived Group Cohesion Scale [ Time Frame: Within 3 weeks post-intervention ]

    Measures whether individuals perceive the groups as cohesive across adolescents and clinicians. We measured intragroup cohesion using a five-item summative Likert type scale. In this scale, respondents rate questions from 1

    = never to 7 = always, and the item responses are summed. Items assessed group members' perception of group-wide trust; their perception of group-wide expectations of truthfulness, integrity, and living up to one's word; and their sense of shared respect for group members' competence.




Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783533


Contacts
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Contact: Jessica Jenness, PhD 206-616-7967 jennessj@uw.edu
Contact: Julie Kientz, PhD 206-221-0614 jkientz@uw.edu

Locations
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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98115
Contact: Jessica Jenness, PhD    206-616-7967    jennessj@uw.edu   
Principal Investigator: Jessica Jenness, PhD         
Principal Investigator: Julie Kientz, PhD         
Sponsors and Collaborators
University of Washington
National Institute of Mental Health (NIMH)

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Responsible Party: Jessica Jenness, Acting Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03783533     History of Changes
Other Study ID Numbers: STUDY00002824
P50MH115837 ( U.S. NIH Grant/Contract )
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders