Clinical trial NCT01935050: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Parkinson's Disease
Keywords: Depression
Parkinson's disease
Cognitive-Behavioral Treatment
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 34
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Hamilton Depression Rating Scale
timeFrame: 14 weeks
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: 14 weeks
measure: Hamilton Anxiety Rating Scale
timeFrame: 14 weeks
measure: Inference Questionnaire
timeFrame: 14 weeks
measure: Caregiver Distress Scale
timeFrame: 14 weeks
measure: Insomnia Severity Index
timeFrame: 14 weeks
measure: Medical Outcomes Short Form
timeFrame: 14 weeks
measure: Feasibility and adherence measures
timeFrame: 10 weeks
measure: Clinical Global Impression-Improvement Scale
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers University-Robert Wood Johnson Medical School
state: New Jersey
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Roseanne D Dobkin, PhD
role: PRINCIPAL_INVESTIGATOR
References: