Guided Self-Help for Depression in Parkinson's Disease

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935050
• Other study ID #: 2013002798
• Status: Completed
• Phase: N/A
• First received: May 29, 2013
• Last updated: December 10, 2017
• Start date: April 2013
• Est. completion date: April 2016

Study information

• Verified date: December 2017
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Guided Cognitive-Behavioral Self-Help
Participants will complete the study treatment at home. Bi-weekly telephone support will be provided by study staff.

Locations

Country	Name	City	State
United States	Rutgers University-Robert Wood Johnson Medical School	Piscataway	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Hamilton Depression Rating Scale	A clinician-administered rating scale for depression	14 weeks
Secondary	Beck Depression Inventory	A self-report measure of depression	14 weeks
Secondary	Hamilton Anxiety Rating Scale	A clinician-administered rating scale of anxiety	14 weeks
Secondary	Inference Questionnaire	Self-report measure of negative thoughts	14 weeks
Secondary	Caregiver Distress Scale	Self-report measure of caregiver stress	14 weeks
Secondary	Insomnia Severity Index	Self-report sleep scale	14 weeks
Secondary	Medical Outcomes Short Form	Self-report quality of life scale	14 weeks
Secondary	Feasibility and adherence measures	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]	10 weeks
Secondary	Clinical Global Impression-Improvement Scale	Clinician-rated scale of depression improvement	14 weeks