跳至主要内容
临床试验/NCT02505737
NCT02505737已完成不适用

Improving Access to Depression Care in Parkinson's Disease: A Telehealth Approach

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
2
主要终点
Depression on the Hamilton Depression Rating Scale

研究概览

简要总结

There is a critical need for treatments that address depression and barriers to mental health care in Parkinson's disease (PD). This randomized-controlled trial will evaluate a 10-session telephone-guided cognitive behavioral self-help program (TH-CBT) for depression in PD (dPD). 72 people with dPD (and their caregivers) will receive either TH-CBT plus enhanced usual care (INTERVENTION GROUP) or enhanced usual care only (CONTROL GROUP). Groups will be compared at baseline, midpoint, endpoint, and 1 and 6 months post-treatment. Participants assigned to the control group with have the opportunity to receive the experimental intervention (TH-CBT) after the data collection period (e.g., after the 6-month follow-up evaluation). Given the public health impact of improved depression treatment in PD, the knowledge to be gained may be significant and the project could directly impact clinical practice.

详细描述

All study procedures, including the initial evaluation, study treatment sessions, and follow-up study assessments, take place over the phone and no travel is required. All PWP across the USA may participate.

All participants will continue to receive their routine medical treatment under the supervision of their personal doctors (e.g., neurologists, psychiatrists, primary care physicians, therapists) while participating in the study. In addition to usual care, half of the participants in the study will receive the experimental telehealth treatment (TH-CBT; intervention group), immediately after enrolling in the research program. The other half will only receive usual care (control group) and will have the option to receive TH-CBT, after completing all study related assessments (9 months after the initial evaluation). Group assignment will be decided randomly (i.e., by chance).

Study eligibility will be determined by a qualified professional. Those who qualify for participation will be randomly assigned (e.g., flip of a coin) to either the intervention (TH-CBT) or the control group (enhanced usual care).

Participants assigned to the TH-CBT group will receive a 10-chapter CBT self-help treatment workbook, tailored to the unique needs of people with PD, immediately following enrollment. Participants will read and complete one treatment module per week (approximately 60 minutes per module plus practice exercises throughout the week). The treatment materials will review different coping skills for the effective management of depression. Study therapists will call participants to review the treatment material over the phone every week (after every chapter) or every other week (after ever 2 chapters), based on participant needs. These telephone-based counseling sessions will last 60 minutes. It will take approximately 10 weeks to complete the study treatment materials.

A family member or friend (carepartner) will also be asked to participate in 3-4 separate educational sessions (30-60 minutes each), evenly dispersed throughout the 10 week TH-CBT treatment period. The study treatment provided to the care-partner will teach the care-partner how to best support the participant with PD as he/she tries to incorporate the information learned during the study treatment, in day-to-day life.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Confirmed diagnosis of Parkinson's disease.
  • Clinically significant depressive symptoms (e.g., symptoms are pervasive, distressing, and make life harder). The presence of a formal depressive disorder will be determined by study staff based on standardized criteria (e.g., SCID).
  • 35-85 years old
  • Stable medication regimen ≥ 6 weeks
  • No change in mental health treatment in the past 2 months
  • Family member or friend willing to participate
  • Access to a telephone
  • Live in the United States of America (USA)

排除标准

  • Suicidal plans or intent
  • Probable Dementia or Significant Cognitive Impairment
  • Significant motor fluctuations (i.e., ≥ 50% of the day)
  • Unstable medical conditions
  • Bipolar, Psychotic Spectrum, or Substance Abuse Disorders

结局指标

主要结局

Depression on the Hamilton Depression Rating Scale

时间窗: 9 months

clinician-administered scale- depression

次要结局

  • Quality of life on the SF-36(9-months)
  • Anxiety on the Hamilton Anxiety Rating Scale(9-months)
  • Treatment Response on the Clinical Global Impression- Improvement Scale(9- months)

研究者

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

Roseanne D Dobkin, PhD

Associate Professor of Psychiatry

Rutgers, The State University of New Jersey

研究点 (2)

Loading locations...

相似试验

Telephone-Based Counseling for Depression in... | 临床试验