Guided Self-Help for Depression in Parkinson's Disease

December 10, 2017 updated by: Roseanne D Dobkin, PhD, Rutgers, The State University of New Jersey

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Rutgers University-Robert Wood Johnson Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Previous diagnosis of Parkinson's disease by a general neurologist or Movement Disorders Specialist
  2. Clinically significant depression as determined by study staff
  3. 35-85 years old
  4. Stable medication regimen ≥ 6 weeks
  5. No change in mental health treatment in past 2 months _

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guided Cognitive-Behavioral Self-Help
All participants will receive the experimental intervention: Guided Cognitive-Behavioral Self-Help. The 10 patient treatment modules will incorporate exercise, behavioral activation, thought monitoring and restructuring, relaxation training, worry control, and sleep hygiene. The four caregiver educational modules will provide caregivers with the skills needed to facilitate patients' practice of treatment techniques learned in session. For example, caregivers will be taught to help patients identify negative thoughts and replace them with more balanced alternatives and will be given tools to assist patients complete therapy goals (i.e., exercise, socializing).
Behavioral: Guided Cognitive-Behavioral Self-Help
Participants will complete the study treatment at home. Bi-weekly telephone support will be provided by study staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Hamilton Depression Rating Scale
Time Frame: 14 weeks
A clinician-administered rating scale for depression
14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory
Time Frame: 14 weeks
A self-report measure of depression
14 weeks
Hamilton Anxiety Rating Scale
Time Frame: 14 weeks
A clinician-administered rating scale of anxiety
14 weeks
Inference Questionnaire
Time Frame: 14 weeks
Self-report measure of negative thoughts
14 weeks
Caregiver Distress Scale
Time Frame: 14 weeks
Self-report measure of caregiver stress
14 weeks
Insomnia Severity Index
Time Frame: 14 weeks
Self-report sleep scale
14 weeks
Medical Outcomes Short Form
Time Frame: 14 weeks
Self-report quality of life scale
14 weeks
Feasibility and adherence measures
Time Frame: 10 weeks
Feasibility [Likert ratings (0-10) on the dimensions of readability, clarity, effort, enjoyment, fatigue, helpfulness, and progress regarding treatment materials] and adherence measures [a numerical rating regarding the % of recommended activities accomplished]
10 weeks
Clinical Global Impression-Improvement Scale
Time Frame: 14 weeks
Clinician-rated scale of depression improvement
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Investigators

  • Principal Investigator: Roseanne D Dobkin, PhD, Rutgers Robert Wood Johnson Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimate)

September 4, 2013

Study Record Updates

Last Update Posted (Actual)

December 12, 2017

Last Update Submitted That Met QC Criteria

December 10, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013002798

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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