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Clinical Trials/NCT01935050
NCT01935050
Completed
Not Applicable

A Guided Cognitive-Behavioral Self-Help Treatment for Depression in Parkinson's Disease

Rutgers, The State University of New Jersey1 site in 1 country34 target enrollmentApril 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Rutgers, The State University of New Jersey
Enrollment
34
Locations
1
Primary Endpoint
The Hamilton Depression Rating Scale
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this project is to develop and pilot-test a guided cognitive-behavioral self-help program for mild-to-moderate depression in Parkinson's disease (dPD). We will pilot-test the guided self-help treatment on 20 people with PD and their caregivers. The manual will be revised based on participant feedback. Several feasibility measures regarding the guided self-help program (i.e., recruitment, retention, enjoyment, helpfulness, adherence) will also be assessed. Moreover, preliminary estimates of effect size for this guided self-help program will be calculated and used in future research. We hypothesize that people with PD will report decreases in depression, anxiety, and negative thoughts and improvements in quality life and sleep and that caregivers will report decreases in burden after participating in the guided self-help program

Detailed Description

To our knowledge, Cognitive-Behavioral self-help interventions remain unexplored for depression in PD to date. The results of this study will be used to support future treatment development efforts for depression and other psychiatric complications in PD that may improve the access to and quality of mental health care in this medical population.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
April 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Roseanne D Dobkin, PhD

Associate Professor of Psychiatry

Rutgers, The State University of New Jersey

Eligibility Criteria

Inclusion Criteria

  • Previous diagnosis of Parkinson's disease by a general neurologist or Movement Disorders Specialist
  • Clinically significant depression as determined by study staff
  • 35-85 years old
  • Stable medication regimen ≥ 6 weeks
  • No change in mental health treatment in past 2 months _

Exclusion Criteria

  • Severe depressive symptoms
  • Suicidal plans or intent
  • Significant cognitive impairment
  • Significant motor fluctuations (i.e., ≥ 50% of the day)
  • Unstable medical conditions
  • Receiving CBT elsewhere

Outcomes

Primary Outcomes

The Hamilton Depression Rating Scale

Time Frame: 14 weeks

A clinician-administered rating scale for depression

Secondary Outcomes

  • Inference Questionnaire(14 weeks)
  • Beck Depression Inventory(14 weeks)
  • Insomnia Severity Index(14 weeks)
  • Medical Outcomes Short Form(14 weeks)
  • Clinical Global Impression-Improvement Scale(14 weeks)
  • Feasibility and adherence measures(10 weeks)
  • Hamilton Anxiety Rating Scale(14 weeks)
  • Caregiver Distress Scale(14 weeks)

Study Sites (1)

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