Guided Self-Help for Depression in Parkinson's Disease

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Completed

CT.gov ID

NCT01935050

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Depression Parkinson's Disease	Behavioral: Guided Cognitive-Behavioral Self-Help	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The Hamilton Depression Rating Scale [14 weeks]
A clinician-administered rating scale for depression

Secondary Outcome Measures

Beck Depression Inventory [14 weeks]
A self-report measure of depression
Hamilton Anxiety Rating Scale [14 weeks]
A clinician-administered rating scale of anxiety
Inference Questionnaire [14 weeks]
Self-report measure of negative thoughts
Caregiver Distress Scale [14 weeks]
Self-report measure of caregiver stress
Insomnia Severity Index [14 weeks]
Self-report sleep scale
Medical Outcomes Short Form [14 weeks]
Self-report quality of life scale
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]
Clinical Global Impression-Improvement Scale [14 weeks]
Clinician-rated scale of depression improvement

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 _