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临床试验/NCT03712267
NCT03712267已完成不适用

Electronic Media and Its Application in Psychotherapy

Mclean Hospital2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年12月13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
110
试验地点
2
主要终点
Improvement in Mental Health Related Quality of Life/Functioning

研究概览

简要总结

This randomized control trial aims to establish whether viewing and discussing patients' electronic communication (texts, emails, Facebook direct messaging, etc) impacts clinical care and decision making across the lifespan.

详细描述

This study explores the usefulness and effectiveness of including electronic communication as part of standard clinical care. Participants will provide information and content from their electronic media to research assistants during in person interviews if they are in the intervention group. Research assistants will then give clinicians the information collected, so the clinicians can incorporate the data into the session as they see fit. Therapists will retain full clinical discretion of how they continue to conduct their therapy sessions. The investigators will compare the impact of receiving this electronic enhancement intervention versus only receiving treatment as usual care on mental health related functioning and therapeutic alliance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Study participants will be randomized to either the intervention group or the control group through an online computer randomizing generator. This is not a blinded randomized control trial.

入排标准

年龄范围
14 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Are currently receiving psychotherapy at McLean and have had at least 4 visits with their current therapy provider in outpatient clinics or 2 sessions with their therapy provider in partial hospitalization or residential settings
  • Age 18-85, and fluent in English
  • Have a primary diagnosis of anxiety or depression (as determined by self-report and review of medical records, which should list a primary depression or anxiety spectrum diagnosis). Symptomatology can be active or in remission.
  • Are actively using at least 1 platform for text messaging (i.e. they should have an account on each platform and have produced content within the month prior to beginning the study). This will be based on self report.
  • Use a mobile device for text messaging
  • Able to provide informed consent.

排除标准

  • Probable or diagnosed dementia or cognitive impairment, or neurodevelopmental disorder (such as an autism spectrum disorder) based on self report and review of medical records.
  • - Individuals with Attention-Deficit/Hyperactivity Disorder (ADHD) or Attention-Deficit Disorder (ADD) may be eligible provided symptoms have been stable for at least 6 months.
  • Active psychotic symptoms
  • - History of psychosis is allowable only if the patient has not had symptoms for at least a year
  • Are actively receiving ECT treatment
  • Current alcohol or drug abuse problem (based on self report and review of medical records)
  • - History of substance use is fine, provided there has been no relapse or withdrawal symptoms in the month leading up to enrollment
  • Are involuntarily admitted to McLean Hospital

结局指标

主要结局

Improvement in Mental Health Related Quality of Life/Functioning

时间窗: After final visit

Investigators will use the Short Form Health - 36 Item Survey (SF-36) to assess whether use of electronic media will lead to participants reporting improved functioning/quality of life. The SF-36 is a patient-administered scale and focuses on 8 domains including social functioning, perceptions of health, emotional well-being, role limitations due to physical or emotional concerns, and physical functioning.

Therapeutic Alliance

时间窗: After final visit

Investigators will use the Working Alliance Inventory - Short Revised (WAI-SR) scale to assess whether use of electronic media will lead to participants reporting an enhanced working alliance. The working alliance inventory is a 12 item measure of the client's/patient's perception of how comfortable they believe their alliance with their therapist is. Each item is rated on a scale of 1-5, and measures how frequently participants believe criteria has been achieved. A score of 1 typically represents that the specific item has been achieved least frequently and a sore of 5 indicates that the specific item is achieved at every session. The items are then summed up to compute a total score.

次要结局

  • Clinical Outcome - Improvement in scores of depression(Every 4 visits, up to 13 visits)
  • Clinical Outcome - Improvement in scores of anxiety(Every 4 visits, up to 13 visits)

研究者

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

Ipsit Vihang Vahia

Medical Director, Geriatric Psychiatry Outpatient Programs

Mclean Hospital

研究点 (2)

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