Telephone-Based Counseling for Depression in Parkinson's Disease
NCT02505737 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2019-02-19
Summary
There is a critical need for treatments that address depression and barriers to mental health care in Parkinson's disease (PD). This randomized-controlled trial will evaluate a 10-session telephone-guided cognitive behavioral self-help program (TH-CBT) for depression in PD (dPD). 72 people with dPD (and their caregivers) will receive either TH-CBT plus enhanced usual care (INTERVENTION GROUP) or enhanced usual care only (CONTROL GROUP). Groups will be compared at baseline, midpoint, endpoint, and 1 and 6 months post-treatment. Participants assigned to the control group with have the opportunity to receive the experimental intervention (TH-CBT) after the data collection period (e.g., after the 6-month follow-up evaluation). Given the public health impact of improved depression treatment in PD, the knowledge to be gained may be significant and the project could directly impact clinical practice.
Conditions
Interventions
- BEHAVIORAL
-
TH-CBT
Telephone-Based Cognitive Behavioral Therapy (TH-CBT). A 10-session treatment protocol that incorporates behavioral activation, thought monitoring and restructuring, relaxation training, worry control, sleep hygiene, and caregiver psychoeducation and support
- OTHER
-
Enhanced Usual Care
Community-based treatment as usual and supplemental reading material
Sponsors & Collaborators
-
Michael J. Fox Foundation for Parkinson's Research
collaborator OTHER -
Rutgers, The State University of New Jersey
lead OTHER
Principal Investigators
-
Roseanne D Dobkin, PhD · Rutgers Robert Wood Johnson Medical School
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-07-31
- Primary Completion
- 2018-06-30
- Completion
- 2018-06-30
Countries
- United States
Study Locations
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