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. 2019 May 14;2019(5):CD012533. doi: 10.1002/14651858.CD012533.pub2

NCT02505737.

Trial name or title Telephone‐based counselling for depression in Parkinson's disease (TH‐CBT)
Methods Parallel randomised trial
Participants Caregiver: A family member or friend (care‐partner) of a person with Parkinson's Disease (PD). Age ranged from 35 to 85 years (confirmed by author via email).
Care‐recipients: 35 to 85 years (adult, senior), all sexes eligible for the study, 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 standardised criteria, 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).
Interventions Title of the intervention: Telephone‐guided cognitive behavioural self‐help program (TH‐CBT) plus enhanced usual care
Aim: To evaluate a 10‐session telephone‐guided cognitive behavioural self‐help program (TH‐CBT) for depression in PD (dPD).
Interventionist(s): no details provided. Author confirmed they were licensed Clinical Psychologists and Masters level therapists.
Mode of delivery: Telephone
Duration: 3‐4 separate educational sessions (30‐60 minutes each), evenly dispersed throughout the 10‐week TH‐CBT treatment period.
Content: TH‐CBT will be delivered to the participant with PD and 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 behaviours (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.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. The care‐partner will be asked to participate in separate sessions.
Standardisation: no details provided
Comparison group: enhanced usual care (routine medical treatment 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 counselling resources in the local community). 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).
Outcomes Caregiver distress inventory (confirmed by author via email)
Starting date July 2015
Contact information Roseanne D Dobkin, PhD email: dobkinro@rwjms.rutgers.edu
Notes Roseanne Dobkin contacted and confirmed that no data are available to share for this review.