跳至主要内容
临床试验/NCT03390218
NCT03390218Unknown不适用

Comparison of Treatment for Anxiety and Depression Augmented With TAO to Treatment as Usual (TAU) in the Weber Human Services

TAO Connect, Inc.2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
Outcome Questionnaire-45

研究概览

简要总结

Access to effective treatment resources is a ubiquitous problem in behavioral health. There is a need for effective interventions that are more easily accessed at a lower cost. This study will compare outcomes for two models of treatment: 1) The experimental group, Therapy Assistance Online (TAO), and 2) the comparison group, treatment as usual.

详细描述

Access to effective treatment resources is a ubiquitous problem in behavioral health. There is a need for effective interventions that are more easily accessed at a lower cost. This stud will compare outcomes for two models of treatment: 1) The experimental group, Therapy Assistance Online (TAO), and 2) the comparison group, treatment as usual.

TAO group TAO is a suite of tools for providing patient education, support, and accountability delivered digitally. Educational materials are organized in an evidence based-protocolled treatment for anxiety or depression. TAO participants will attend a once weekly group in a computer lab. Each participant will complete an interactive educational module and have a brief session with the group leader to discuss application of the content. Participants will have access to a companion app they may use between sessions to practice skills and reinforce learning.

Treatment as Usual Group - After the completion of a psychosocial assessment, and development of a treatment plan, clients are offered individual and group therapy sessions, case management services, and medication management services depending on the diagnoses. Individual and group therapy is often generic in nature as well, although some structured, evidence-based treatments are offered such as Psycho-Education Multi-Family Group and Illness Management Recovery.

Potential participants will receive an initial evaluation and screening to determine diagnosis, appropriateness for the study, and level of care required. Informed consent will include a statement indicating that agreement to participate will not affect access to treatment. Those who do not wish to participate will receive care as usual. Patients who agree to participate will be randomly assigned to either treatment as usual or treatment augmented with TAO.

Referral and Randomization Process -

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

入选标准

  • Clients in their first month of treatment with any primary or secondary diagnosis of depression or anxiety. This includes all forms of depression and/or anxiety disorder.

排除标准

  • Chronic depression with a Likely Utilization of Services Instrument (LUSI) designation of "high" or "consistent user" of services. These clients should be referred to Illness Management Recovery.
  • Clients with schizophrenia, or any other form of active psychosis.
  • Clients with substance dependence disorder.
  • Clients with personality disorders.
  • Clients whose intellectual functioning would prevent understanding the TAO system and materials.
  • Client must not have been in treatment for anxiety and depression in the past three months.

研究组 & 干预措施

TAO (Therapy Assisted Online)

Experimental

TAO participants will attend a once weekly group in a computer lab. Each participant will complete an interactive educational module using an evidence based protocoled treatment for anxiety and/or depression, and have a brief session with the group leader to discuss application of the content. Participants will have access to a companion app they may use between sessions to practice skills and reinforce learning.

干预措施: Therapy Assistance Online (Behavioral)

Treatment as usual

Active Comparator

After the completion of a psychosocial assessment, and development of a treatment plan, clients are offered individual and group therapy sessions, case management services, and medication management services depending on the diagnoses. Individual and group therapy is often generic in nature as well, although some structured, evidence-based treatments are offered such as Psycho-Education Multi-Family Group and Illness Management Recovery.

干预措施: Treatment as usual (Behavioral)

结局指标

主要结局

Outcome Questionnaire-45

时间窗: At intake, 8 weeks, 12 weeks- change in scores

45 question survey, assessing symptom change, the OQ-45 is the most commonly used measure of change in psychotherapy. The OQ-45 has one general scale and 3 sub-scales. 1. The symptom distress scale scores range from 0-100 with a clinical cut-off of 36. Reliable change is indicated when a client's score changes by 10 points or more. 2. The Interpersonal relations scale scores range from 0-44, the clinical cut-off is 15, reliable change when a client's score changes by 8 points or more. 3. Social role scale, scores range from 0-36, clinical cut-off is 12 or more, reliable change is a change of 7 points or more

次要结局

未报告次要终点

研究者

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

Sherry Benton

Chief Science Officer

TAO Connect, Inc.

研究点 (2)

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