Telephone-Based Counseling for Depression in Parkinson's Disease
Condition: Depression; Parkinson's Disease
MeSH terms: Parkinson Disease; Depression; Depressive Disorder
Study type: Interventional

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.
    

Intervention name(s): TH-CBT; Enhanced Usual Care
Intervention type(s): Behavioral; Other
Intervention description(s): 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; Community-based treatment as usual and supplemental reading material
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment