Telephone-Based Counseling for Depression in Parkinson's Disease (TH-CBT)
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|ClinicalTrials.gov Identifier: NCT02505737|
Recruitment Status : Completed
First Posted : July 22, 2015
Last Update Posted : February 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression Parkinson's Disease||Behavioral: TH-CBT Other: Enhanced Usual Care||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Improving Access to Depression Care in Parkinson's Disease: A Telehealth Approach|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||June 30, 2018|
|Actual Study Completion Date :||June 30, 2018|
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
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.
Other: Enhanced Usual Care
Community-based treatment as usual and supplemental reading material
- Depression on the Hamilton Depression Rating Scale [ Time Frame: 9 months ]clinician-administered scale- depression
- Treatment Response on the Clinical Global Impression- Improvement Scale [ Time Frame: 9- months ]clinician-administered scale- treatment response
- Anxiety on the Hamilton Anxiety Rating Scale [ Time Frame: 9-months ]clinician administered scale-anxiety
- Quality of life on the SF-36 [ Time Frame: 9-months ]self-report scale- quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505737
|United States, New Jersey|
|Rutgers University-Robert Wood Johnson Medical School|
|Piscataway, New Jersey, United States, 08854|
|Principal Investigator:||Roseanne D Dobkin, PhD||Rutgers Robert Wood Johnson Medical School|