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临床试验/NCT05122429
NCT05122429已完成不适用

Asynchronous Techniques for the Delivery of Empirically Supported Psychotherapies

Stony Brook University1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2017年11月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
145
试验地点
1
主要终点
Functional impairment in work/school, social life, and family life change

研究概览

简要总结

The aim of this study is to test the feasibility, acceptability and efficacy of methods for delivering mental health support when real-time communication is not possible (e.g. on long duration space flights where communication lags of up to 45 minutes are anticipated). The investigators hypothesize that the two enhanced treatment conditions (i.e., those with therapist support) will outperform the online self-management program without support. The investigators also predict that outcomes for the two enhanced conditions will be comparable to those reported in the literature for in-person psychotherapy programs.

详细描述

The aim of this study is to test the feasibility, acceptability and efficacy of methods for delivering mental health support when real-time communication is not possible (e.g. on long duration space flights where communication lags of up to 45 minutes are anticipated). Participants will be healthy, high functioning adults (e.g., medical residents, postdoctoral fellows in the sciences, math, and engineering) who report elevated psychological distress, mood or anxiety symptoms. Participants will complete a self-guided online therapy program (MyCompass) and will be randomized to receive one of the following: (1) online therapy without therapist support, 2) online therapy plus therapist support via electronic text-based messaging (i.e., secure email), or 3) online therapy plus therapist support via video messaging. Outcomes will be evaluated weekly via online self-report measures of psychological distress, mood, anxiety, number of hours and quality of sleep, fatigue, and resiliency indicators (i.e., coping and mindfulness). The investigators will examine changes over time in outcomes across all three groups. The investigators hypothesize that the two enhanced treatment conditions (i.e., those with therapist support) will outperform the online self-management program without support. The investigators also predict that outcomes for the two enhanced conditions will be comparable to those reported in the literature for in-person psychotherapy programs.

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • •18+years old;
  • •Masters of Art degree or higher in social/biomedical(medicine)/physical science, engineering or mathematics
  • •current elevated distress as measured by the Depression Anxiety and Stress Scale, 21 item version(≥ 5 on DASS Depression Subscale OR ≥ 4 on DASS Anxiety Subscale OR ≥ 8 on DASS Stress Subscale) (DASS, Lovibond & Lovibond, 1995); and, (5) ≥ 5 on any subscale of the Sheehan Disability Scale (SDS, Sheehan 1983).

排除标准

  • •Any current or recent (i.e. past month) suicide ideation
  • •any history of suicide attempt (within past 5 years)
  • •serious mental illness (i.e., psychosis, mania)
  • •alcohol or substance dependency during the past 6 months
  • •serious medical problems (e.g., seizures, cancer)
  • •current participation in psychotherapy
  • •new use of psychoactive medications (i.e., benzodiazepines for less than 1 month or selective serotonin reuptake inhibitors [SSRIs], tricyclics, or serotonin-norepinephrine reuptake inhibitors [SNRIs] for less than 3 months).

研究组 & 干预措施

myCompass Only

Experimental

Self-guided e-health treatment

干预措施: e-Health Treatment (Behavioral)

myCompass + Delayed Text Therapy Support

Experimental

Self-guided e-health treatment with delayed (44min) text support from a therapist.

干预措施: e-Health Treatment (Behavioral)

myCompass + Delayed Video Therapy Support

Experimental

Self-guided e-health treatment with delayed (44min) video support from a therapist.

干预措施: e-Health Treatment (Behavioral)

结局指标

主要结局

Functional impairment in work/school, social life, and family life change

时间窗: Change from baseline at 6-weeks assessments, 1-weeks post treatment, and 1-month post treatment

Sheehan Disability Scale is a 3 item measure to assess functional impairment in work/school, social life, and family life.

Symptoms of Depression, Stress, and Anxiety Change

时间窗: Change from baseline at 6-weeks assessments, 1-week post treatment, and 1-month post treatment

Depression Anxiety and Stress Scale is a 21-item measure to assess the severity of Depression, Stress, and Anxiety.

次要结局

  • Sleep Quality Change(Change from baseline at 1-week post treatment and 1-month post treatment)
  • Fatigue Severity Change(Change from baseline at 1-week post treatment and 1-month post treatment)
  • Treatment Satisfaction(1-week post treatment)

研究者

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

Adam Gonzalez

Associate Professor

Stony Brook University

研究点 (1)

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