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
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.
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)
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