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Completed

NCT Number: NCT02505737

Telephone-Based Counseling for Depression in Parkinson's Disease

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.

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Key information

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University-Robert Wood Johnson Medical School

Piscataway, New Jersey, 08854, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Enhanced usual care

Other

Community-based treatment as usual and supplemental reading material

Primary outcomes

  1. Depression on the Hamilton Depression Rating Scale

    Time frame: 9 months

    clinician-administered scale- depression

Secondary outcomes

  1. Treatment Response on the Clinical Global Impression- Improvement Scale

    Time frame: 9- months

    clinician-administered scale- treatment response

  2. Anxiety on the Hamilton Anxiety Rating Scale

    Time frame: 9-months

    clinician administered scale-anxiety

  3. Quality of life on the SF-36

    Time frame: 9-months

    self-report scale- quality of life

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

Registry information

Official study title

Improving Access to Depression Care in Parkinson's Disease: A Telehealth Approach

Acronym: TH-CBT

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 22, 2015
Registry last updated
Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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