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临床试验/NCT05672745
NCT05672745已完成不适用

An Open-label Pilot Study to Learn How the Phenotypical Characteristics of Woebot Users Are Related to Clinical Outcomes

Woebot Health2 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2022年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
256
试验地点
2
主要终点
Patient Health Questionnaire

研究概览

简要总结

The goal of this observational study is to understand the characteristics of Woebot users as they relate to clinical outcomes.

The objectives it aims to address are:

  1. To assess Woebot usage patterns, satisfaction ratings, self-efficacy, stress, resilience, work productivity and activity impairment, alexthymia, and bond over time based on demographic, clinical baseline levels, and attitudinal characteristics
  2. Among users who present with clinical levels of anxiety or depression, to assess the contribution of demographic characteristics, attitudinal characteristics, and patterns of engagement on clinical outcomes of interest over time
  3. To collect and explore attitudinal characteristics of Woebot users regarding their experiences with mental health care and perceived value of digital tools for emotional support
  4. Explore meaningful subgroups of Woebot users based on demographic and attitudinal characteristics, clinical outcomes, and patterns of engagement

Participants who meet study eligibility requirements will be:

  • invited to engage with the Woebot Life program for 8 weeks
  • complete survey assessments at day 3, week 4 (mid-intervention), and week 8 (end of intervention)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18+ years old
  • US resident
  • English literacy
  • Availability to complete survey assessments
  • Ownership or regular access to a smartphone with WiFi and sufficient data access for the duration of the study.

排除标准

  • Current suicidal ideation with a plan or intent or a suicide attempt within the past 12 months
  • A reported lifetime diagnosis of a psychotic disorder (including schizophrenia or schizoaffective disorder) or bipolar disorder
  • Previous use of the Woebot application

结局指标

主要结局

Patient Health Questionnaire

时间窗: Change from Baseline to Mid-Intervention at Week 4; change from Baseline to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8

Measure of depression. An 8-item self-report questionnaire where total scores range from 0 to 24, with higher scores indicating greater levels of depression

Client Satisfaction Questionnaire (CSQ-8)

时间窗: Post-intervention at Week 8

An 8-item measure used to assess client's satisfaction with treatment.Total scores range from 8-32, with high scores indicating greater satisfaction with the treatment.

Working Alliance Inventory (WAI)

时间窗: Change from Day 3 to Mid-Intervention at Week 4; change from Day 3 to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8

Measure of working alliance. A measure of therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Total scores range from 12-60, with higher scores indicating greater alliance. The present study utilized the validated 12-item Short-Revised version (WAI-SR) with minor changes to language, replacing "therapist" with "Woebot".

Mental Health Self-Efficacy Scale (MHSES)

时间窗: Change from Baseline to Mid-Intervention at Week 4; change from Baseline to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8

Six items assess confidence in managing stress, depression, and anxiety, and are scored on a 10 point Likert scale (from 1, not at all confident to 10, very confident). Ratings across the 6 items are summed for an overall measure of MHSES (range 10 to 60), with higher scores indicating more self-efficacy. This measure is included as a way to capture an individual's confidence that they can successfully manage their mental health concerns.

Patient-Reported Outcomes Measurement Information System Global Health (PROMIS)

时间窗: Change from Baseline to Mid-Intervention at Week 4; change from Baseline to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8

Ten items used to assess five core domains of health (physical function, pain, fatigue, emotional distress, and social). Total scores range from 5-50, where greater scores represent the best health and functioning.

Work Productivity and Activity Impairment (WPAI)

时间窗: Change from Baseline to Mid-Intervention at Week 4; change from Baseline to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8

The WPAI measures presenteeism, absenteeism, work productivity loss for the currently employed, and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity

App engagement metrics

时间窗: Baseline to Post-intervention at Week 8

Data tracking mobile application use, including conversational interactions with Woebot and patterns of engagement over time, will be collected throughout the duration of treatment (8-weeks).

Brief Resilience Questionnaire (BRS)

时间窗: Change from Baseline to Mid-Intervention at Week 4; change from Baseline to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8

The BRS is a measure used to assess a person's ability to bounce back or recover after experiencing a stressor. Total scores range from 1 (low resilience) to 5 (high resilience).

Perceived Stress Scale (PSS)

时间窗: Change from Baseline to Mid-Intervention at Week 4; change from Baseline to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8

The PSS is a 10-item tool to assess individual levels of stress in the past month. Total scores range from 0 (no stress) to 40 (very high levels of stress).

Toronto Alexithymia Scale (TAS)

时间窗: Change from Baseline to Mid-Intervention at Week 4; change from Baseline to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8

The TAS-20 is an instrument that measures alexithymia, or difficulty with identifying and describing emotions and focusing attention externally. Total scores range from 20-100, with with low levels of alexithymia indicative of high levels of emotional self-awareness and vice versa.

Burnout

时间窗: Change from Baseline to Mid-Intervention at Week 4; change from Baseline to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8

Single-item question to measure burnout on a scale from 1-5, where 5 is feeling completely burned out to the point change is needed.

Generalized Anxiety Disorder Questionnaire

时间窗: Change from Baseline to Mid-Intervention at Week 4; change from Baseline to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8

Measure of anxiety. A 7-item brief self-report questionnaire, where total score range is between 0-21, with higher scores indicate greater levels of anxiety.

次要结局

  • Perceived Barriers to Care (PBC)(Day 3 of Intervention)
  • Woebot Attitudinal Survey (WAS)(Post-intervention at Week 8)

研究者

发起方
Woebot Health
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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