Telephone-Based Counseling for Depression in Parkinson's Disease

NCT02505737 | Completed

• 1 other identifier: 20150001714
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Depression on the Hamilton Depression Rating Scale

  clinician-administered scale- depression

  9 months

Secondary Outcomes (3)

• Treatment Response on the Clinical Global Impression- Improvement Scale

  9- months

• Anxiety on the Hamilton Anxiety Rating Scale

  9-months

• Quality of life on the SF-36

  9-months

Study Arms (2)

TH-CBT

EXPERIMENTAL

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.

Behavioral: TH-CBT

Enhanced Usual Care

OTHER

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

Interventions

TH-CBT BEHAVIORAL

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

TH-CBT

Enhanced Usual Care OTHER

Community-based treatment as usual and supplemental reading material

Enhanced Usual Care

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

Rutgers University-Robert Wood Johnson Medical School

Piscataway, New Jersey, 08854, United States

Location

Related Publications (1)

• 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.

  PMID: 32238507 DERIVED

MeSH Terms

Conditions

Depression; Parkinson Disease

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Roseanne D Dobkin, PhD

  Rutgers Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 22, 2015
• Study Start: July 1, 2015
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: February 19, 2019

Record last verified: 2019-02

Locations

US (1)