Guided Self-Help for Depression in Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-04-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Depression Parkinson's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Guided Cognitive-Behavioral Self-Help

Intervention Type BEHAVIORAL

Participants will complete the study treatment at home. Bi-weekly telephone support will be provided by study staff.

Interventions

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Guided Cognitive-Behavioral Self-Help

Participants will complete the study treatment at home. Bi-weekly telephone support will be provided by study staff.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No