Guided Self-Help for Depression in Parkinson's Disease

Not Applicable

Completed

• Conditions: Depression; Parkinson's Disease
• Interventions: Behavioral: Guided Cognitive-Behavioral Self-Help

• Registration Number: NCT01935050
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-08-29
• Study First Posted: 2013-09-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-10
• Last Update Posted: 2017-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Guided Cognitive-Behavioral Self-Help	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).

Primary Outcome Measures

Name	Time	Method
The Hamilton Depression Rating Scale	14 weeks	A clinician-administered rating scale for depression

Secondary Outcome Measures

Name	Time	Method
Inference Questionnaire	14 weeks	Self-report measure of negative thoughts
Beck Depression Inventory	14 weeks	A self-report measure of depression
Insomnia Severity Index	14 weeks	Self-report sleep scale
Medical Outcomes Short Form	14 weeks	Self-report quality of life scale
Clinical Global Impression-Improvement Scale	14 weeks	Clinician-rated scale of depression improvement
Feasibility and adherence measures	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 \[a numerical rating regarding the % of recommended activities accomplished\]
Hamilton Anxiety Rating Scale	14 weeks	A clinician-administered rating scale of anxiety
Caregiver Distress Scale	14 weeks	Self-report measure of caregiver stress

Trial Locations

Locations (1)

Rutgers University-Robert Wood Johnson Medical School; 🇺🇸 Piscataway, New Jersey, United States