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Guided Self-Help for Depression in Parkinson's Disease

Primary Purpose

Depression, Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided Cognitive-Behavioral Self-Help
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Parkinson's disease, Cognitive-Behavioral Treatment

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rutgers University-Robert Wood Johnson Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Guided Cognitive-Behavioral Self-Help

Arm Description

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).

Outcomes

Primary Outcome Measures

The Hamilton Depression Rating Scale
A clinician-administered rating scale for depression

Secondary Outcome Measures

Beck Depression Inventory
A self-report measure of depression
Hamilton Anxiety Rating Scale
A clinician-administered rating scale of anxiety
Inference Questionnaire
Self-report measure of negative thoughts
Caregiver Distress Scale
Self-report measure of caregiver stress
Insomnia Severity Index
Self-report sleep scale
Medical Outcomes Short Form
Self-report quality of life scale
Feasibility and adherence measures
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]
Clinical Global Impression-Improvement Scale
Clinician-rated scale of depression improvement

Full Information

First Posted
May 29, 2013
Last Updated
December 10, 2017
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT01935050
Brief Title
Guided Self-Help for Depression in Parkinson's Disease
Official Title
A Guided Cognitive-Behavioral Self-Help Treatment for Depression in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Parkinson's Disease
Keywords
Depression, Parkinson's disease, Cognitive-Behavioral Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided Cognitive-Behavioral Self-Help
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Guided Cognitive-Behavioral Self-Help
Intervention Description
Participants will complete the study treatment at home. Bi-weekly telephone support will be provided by study staff.
Primary Outcome Measure Information:
Title
The Hamilton Depression Rating Scale
Description
A clinician-administered rating scale for depression
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Description
A self-report measure of depression
Time Frame
14 weeks
Title
Hamilton Anxiety Rating Scale
Description
A clinician-administered rating scale of anxiety
Time Frame
14 weeks
Title
Inference Questionnaire
Description
Self-report measure of negative thoughts
Time Frame
14 weeks
Title
Caregiver Distress Scale
Description
Self-report measure of caregiver stress
Time Frame
14 weeks
Title
Insomnia Severity Index
Description
Self-report sleep scale
Time Frame
14 weeks
Title
Medical Outcomes Short Form
Description
Self-report quality of life scale
Time Frame
14 weeks
Title
Feasibility and adherence measures
Description
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]
Time Frame
10 weeks
Title
Clinical Global Impression-Improvement Scale
Description
Clinician-rated scale of depression improvement
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roseanne D Dobkin, PhD
Organizational Affiliation
Rutgers Robert Wood Johnson Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University-Robert Wood Johnson Medical School
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States

12. IPD Sharing Statement

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Guided Self-Help for Depression in Parkinson's Disease

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