- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02505737
Telephone-Based Counseling for Depression in Parkinson's Disease (TH-CBT)
Improving Access to Depression Care in Parkinson's Disease: A Telehealth Approach
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All study procedures, including the initial evaluation, study treatment sessions, and follow-up study assessments, take place over the phone and no travel is required. All PWP across the USA may participate.
All participants will continue to receive their routine medical treatment under the supervision of their personal doctors (e.g., neurologists, psychiatrists, primary care physicians, therapists) while participating in the study. In addition to usual care, half of the participants in the study will receive the experimental telehealth treatment (TH-CBT; intervention group), immediately after enrolling in the research program. The other half will only receive usual care (control group) and will have the option to receive TH-CBT, after completing all study related assessments (9 months after the initial evaluation). Group assignment will be decided randomly (i.e., by chance).
Study eligibility will be determined by a qualified professional. Those who qualify for participation will be randomly assigned (e.g., flip of a coin) to either the intervention (TH-CBT) or the control group (enhanced usual care).
Participants assigned to the TH-CBT group will receive a 10-chapter CBT self-help treatment workbook, tailored to the unique needs of people with PD, immediately following enrollment. Participants will read and complete one treatment module per week (approximately 60 minutes per module plus practice exercises throughout the week). The treatment materials will review different coping skills for the effective management of depression. Study therapists will call participants to review the treatment material over the phone every week (after every chapter) or every other week (after ever 2 chapters), based on participant needs. These telephone-based counseling sessions will last 60 minutes. It will take approximately 10 weeks to complete the study treatment materials.
A family member or friend (carepartner) will also be asked to participate in 3-4 separate educational sessions (30-60 minutes each), evenly dispersed throughout the 10 week TH-CBT treatment period. The study treatment provided to the care-partner will teach the care-partner how to best support the participant with PD as he/she tries to incorporate the information learned during the study treatment, in day-to-day life.
Participants will be re-evaluated 6, 11, 15, and 35 weeks after the initial evaluation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
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Piscataway, New Jersey, United States, 08854
- Rutgers University-Robert Wood Johnson Medical School
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Confirmed diagnosis of Parkinson's disease.
- Clinically significant depressive symptoms (e.g., symptoms are pervasive, distressing, and make life harder). The presence of a formal depressive disorder will be determined by study staff based on standardized criteria (e.g., SCID).
- 35-85 years old
- Stable medication regimen ≥ 6 weeks
- No change in mental health treatment in the past 2 months
- Family member or friend willing to participate
- Access to a telephone
- Live in the United States of America (USA)
Exclusion Criteria:
- Suicidal plans or intent
- Probable Dementia or Significant Cognitive Impairment
- Significant motor fluctuations (i.e., ≥ 50% of the day)
- Unstable medical conditions
- Bipolar, Psychotic Spectrum, or Substance Abuse Disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TH-CBT
The treatment works by teaching people with PD (PWP) the coping skills needed to manage their emotional reactions to the numerous challenges posed by the disease.
Specifically, the treatment targets maladaptive thought patterns (e.g., I have no control; I am helpless) and behaviors (e.g., social isolation, lack of exercise, poor sleep habits, excessive worry), and critically, provides caregivers with the tools needed to encourage the PWPs' practice of their newly acquired coping skills.
Treatment is administered over the phone and no travel is required.
|
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
All participants will continue to receive their routine medical treatment under the supervision of their personal doctors (e.g., neurologists, psychiatrists, primary care physicians, therapists) while participating in the study.
This routine treatment (e.g., usual care) will be further enhanced with the provision of written educational materials for effective coping with PD, the close clinical monitoring of depressive symptoms by study staff, and the provision of counseling resources in the local community.
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Community-based treatment as usual and supplemental reading material
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression on the Hamilton Depression Rating Scale
Time Frame: 9 months
|
clinician-administered scale- depression
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Response on the Clinical Global Impression- Improvement Scale
Time Frame: 9- months
|
clinician-administered scale- treatment response
|
9- months
|
Anxiety on the Hamilton Anxiety Rating Scale
Time Frame: 9-months
|
clinician administered scale-anxiety
|
9-months
|
Quality of life on the SF-36
Time Frame: 9-months
|
self-report scale- quality of life
|
9-months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Roseanne D Dobkin, PhD, Rutgers Robert Wood Johnson Medical School
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20150001714
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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