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临床试验/NCT06786247
NCT06786247尚未招募不适用

Evaluation of an Asynchronous Remote Communities Approach to Behavioral Activation for Depressed Adolescents

University of Washington0 个研究点目标入组 70 人开始时间: 2025年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
主要终点
Intervention Usability Scale

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Intervention Usability Scale

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

次要结局

  • Loneliness(Baseline to Week 24)
  • Therapeutic Alliance(Week 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Jenness

Associate Professor: Department of Psychiatry and Behavioral Sciences

University of Washington

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