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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
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Roseanne D Dobkin, PhD, Rutgers, The State University of New Jersey

Tracking Information
First Submitted Date  ICMJE July 21, 2015
First Posted Date  ICMJE July 22, 2015
Last Update Posted Date February 19, 2019
Actual Study Start Date  ICMJE July 2015
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2015)
Depression on the Hamilton Depression Rating Scale [ Time Frame: 9 months ]
clinician-administered scale- depression
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2015)
Hamilton Depression Rating Scale [ Time Frame: 9 months ]
clinician-administered scale- depression
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2015)
  • Clinical Global Impression- Improvement Scale [ Time Frame: 9- months ]
    clinician-administered scale- treatment response
  • Hamilton Anxiety Rating Scale [ Time Frame: 9-months ]
    clinician administered scale-anxiety
  • SF-36 [ Time Frame: 9-months ]
    self-report scale- quality of life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telephone-Based Counseling for Depression in Parkinson's Disease
Official Title  ICMJE Improving Access to Depression Care in Parkinson's Disease: A Telehealth Approach
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Parkinson's Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: TH-CBT
  • 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.
    Intervention: Other: Enhanced Usual Care
Publications * Dobkin RD, Mann SL, Gara MA, Interian A, Rodriguez KM, Menza M. Telephone-based cognitive behavioral therapy for depression in Parkinson disease: A randomized controlled trial. Neurology. 2020 Apr 21;94(16):e1764-e1773. doi: 10.1212/WNL.0000000000009292. Epub 2020 Apr 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2019)
72
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2015)
144
Actual Study Completion Date  ICMJE June 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Confirmed diagnosis of Parkinson's disease.
  2. 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).
  3. 35-85 years old
  4. Stable medication regimen ≥ 6 weeks
  5. No change in mental health treatment in the past 2 months
  6. Family member or friend willing to participate
  7. Access to a telephone
  8. Live in the United States of America (USA)

Exclusion Criteria:

  1. Suicidal plans or intent
  2. Probable Dementia or Significant Cognitive Impairment
  3. Significant motor fluctuations (i.e., ≥ 50% of the day)
  4. Unstable medical conditions
  5. Bipolar, Psychotic Spectrum, or Substance Abuse Disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02505737
Other Study ID Numbers  ICMJE 20150001714
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roseanne D Dobkin, PhD, Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE Michael J. Fox Foundation for Parkinson's Research
Investigators  ICMJE
Principal Investigator: Roseanne D Dobkin, PhD Rutgers Robert Wood Johnson Medical School
PRS Account Rutgers, The State University of New Jersey
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP