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Guided Self-Help for Depression in Parkinson's Disease

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01935050
Enrollment
34
Registered
2013-09-04
Start date
2013-04-30
Completion date
2016-04-30
Last updated
2017-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Parkinson's Disease

Keywords

Depression, Parkinson's disease, Cognitive-Behavioral 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.

Interventions

BEHAVIORALGuided Cognitive-Behavioral Self-Help

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

Sponsors

Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Hamilton Depression Rating Scale14 weeksA clinician-administered rating scale for depression

Secondary

MeasureTime frameDescription
Hamilton Anxiety Rating Scale14 weeksA clinician-administered rating scale of anxiety
Inference Questionnaire14 weeksSelf-report measure of negative thoughts
Caregiver Distress Scale14 weeksSelf-report measure of caregiver stress
Beck Depression Inventory14 weeksA self-report measure of depression
Medical Outcomes Short Form14 weeksSelf-report quality of life scale
Feasibility and adherence measures10 weeksFeasibility \[Likert ratings (0-10) on the dimensions of readability, clarity, effort, enjoyment, fatigue, helpfulness, and progress regarding treatment materials\] and adherence measures \[a numerical rating regarding the % of recommended activities accomplished\]
Clinical Global Impression-Improvement Scale14 weeksClinician-rated scale of depression improvement
Insomnia Severity Index14 weeksSelf-report sleep scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026