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临床试验/NCT05386329
NCT05386329已完成不适用

Development and Preliminary Testing of a Non-regulated Digital Service That Supports Cognitive Behavioral Therapy for Depressive Symptoms Under Clinical Supervision

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 28 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
入组人数
28
试验地点
2
主要终点
Drop-Out Rates

研究概览

简要总结

We are testing a smartphone app that provides therapy for depression. Participants will also receive short weekly virtual appointments with a therapist. Researchers want to know if this new treatment is usable, whether participants are satisfied with it, and whether it can help lower symptoms.

详细描述

The purpose of this project is to conduct an open trial to test the feasibility, acceptability, and preliminary efficacy of a new therapist-guided smartphone-delivered cognitive behavioral therapy (CBT) for major depressive disorder (MDD). This treatment will include unlimited access to the mobile CBT for depression app over 8 weeks plus 8 virtual visits with a doctoral-level psychologist or psychology intern with their master's degree. The therapist will be assigned once eligibility is determined. All virtual sessions will be no longer than 16-25 min. The combined CBT app plus virtual treatment will be tested in 28 patients. Clinical assessments will occur at baseline, mid-treatment (week 4), end-of-treatment (week 8), and 3 month follow-up. The investigators hypothesize that this treatment will be feasible, acceptable to participants, and lead to reductions in depression symptoms and functional impairment as well as improvements in quality of life from baseline to end-of-treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Living in Massachusetts
  • Current primary diagnosis of depression
  • at least moderately severe current symptoms of depression

排除标准

  • Recent or anticipated changes in psychotropic medication use
  • Past participation in a course of CBT for depression
  • Current severe substance use disorder
  • Lifetime bipolar disorder or psychosis
  • Acute, active suicidal ideation
  • Concurrent psychological treatment
  • Does not own a supported mobile Smartphone with a data plan
  • Lack of technology literacy that would interfere with ability to engage with smartphone treatment

结局指标

主要结局

Drop-Out Rates

时间窗: assessed at end-of-treatment (week 8)

To determine feasibility, we will report rates of and reasons for participant dropout from the trial.

Change in Patient Satisfaction (as Measured by the CSQ-8)

时间窗: Measured at midpoint (week 4) and end-of-treatment (week 8)

The Client Satisfaction Questionnaire (CSQ) is an 8-item self-report questionnaire which assesses the satisfaction with clinical services received. Each item uses a 4-point Likert scale. Items are summed for a total score ranging from 8 to 32, with higher scores indicating greater satisfaction.

Change in Treatment Credibility (as Measured by the CEQ)

时间窗: Change in credibility from baseline (week 0) to midpoint (week 4)

The Credibility/Expectancy Questionnaire (CEQ) is a 6-item, self-report questionnaire. Items 1-3 assess clients' impressions of the treatment credibility; they are scored on Likert scales ranging from 1 to 9 (e.g., from 1='not at all' to 9='very much'). Items are summed for a total score that can range from 3 to 27, where higher scores mean greater treatment credibility.

Change in Outcome Expectancy (as Measured by the CEQ)

时间窗: Measured at baseline (week 0) and midpoint (week 4)

The Credibility/Expectancy Questionnaire (CEQ) is a 6-item, self-report questionnaire. Items 4-6 are used to assess clients' outcome expectancy. Item 5 is scored on a Likert scale ranging from 1 to 9 (where 1='not at all' to 9='very much'). Items 4 and 6 are scored on a scale from 0% to 100% (in 10-point increments); their scores are then converted linearly on a Likert scale from 1 to 9. Items are summed together for a total outcome expectancy score that can range from 3 to 27, where higher scores mean a higher outcome expectancy.

App Rating (as Measured by the uMARS)

时间窗: Measured at endpoint (week 8)

The Mobile Application Rating Scale user version (uMARS) is a self-report form with 26 items that assess participant's evaluations of various app features. Dimensions of this measure include engagement (5 items), functionality (4 items), aesthetics (3 items), information quality (4 items); other items about app subjectivity quality (4 items) and perceived impact (6 items) are also available but do not contribute to the overall score (and are not reported here). Items are rated on differently worded 5-point Likert scales ranging from 1 (Inadequate) to 5 (Excellent). An overall app rating score can be calculated as the mean score of the first four subscales (engagement, functionality, aesthetics, and information quality; range of 1-5), where higher scores indicate higher overall perceived app quality.

Change in Treatment Utilization

时间窗: Measured at midpoint (week 4) and end-of-treatment (week 8)

Treatment utilization was assessed with a single question: "On average, how much time (in minutes) do you spend using the app or practicing skills from the app in total, per week?" Answers were collected as number of minutes in integer format, where more time spent on and off the app was interpreted as greater treatment utilization.

次要结局

  • Change in MDD Symptom Severity (as Measured by the HAM-D)(Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up))
  • Change in Functional Impairment (as Measured by the WSAS)(Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up))
  • Change in Quality of Life (as Measured by the Q-LES-Q-SF)(Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up))

研究者

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

Sabine Wilhelm, PhD

Chief of Psychology

Massachusetts General Hospital

研究点 (2)

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