Clinical trial NCT03993041: Telehealth Psychotherapy for Depression in Parkinson's Disease
Official title: Telehealth Psychotherapy for Depression in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Parkinson's Disease
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Depression is a prevalent non-motor symptom of Parkinson's disease (PD). Cognitive-behavioral therapy (CBT) has been shown to be an effective treatment for depression in PD. CBT is usually administered in-person in weekly sessions, but PD motor disability, stigma, and transportation issues may prevent attending such therapy sessions. CBT administered via live videoconference technology may allow the treatment of depression, while circumventing the barriers that deter those with PD from seeking psychological services. The investigators propose that videoconference CBT will improve mood in individuals with PD who have depression.

Detailed description: The investigators plan to conduct a randomized control trial with 12 participants. Six (PD-early) will receive three assessments: baseline, immediately post-treatment (post1), and 6 weeks after treatment (post2). The other six (PD-waitlist) will have an additional assessment (Baseline 2; 12 weeks after Baseline 1) to examine practice effects before beginning treatment, and then will have the post1 and post2 assessments (four assessments).

Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson's disease (PD), any subtype
* Depression
* Internet access and a webcam
* For psychotropic and dopaminergic medications, participants may enroll only if they are stable for at least 6 weeks and 2 weeks, respectively, before beginning the study
* The investigators will enroll only depressed individuals with PD who are not already receiving or are willing to stop other ongoing psychotherapy before beginning this treatment study

Exclusion Criteria:

* Serious chronic medical or neurological illness, other than PD
* History of traumatic brain injury
* Mental retardation
* Current or recent (past 90 days) history of substance abuse or drug dependence, with the exception of nicotine, marijuana, and caffeine
* Active suicidal or homicidal ideation or intent
* Dementia
* Current DSM-5 diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or substance/medication-induced disorder
* Previous experience with an adequate trial of cognitive-behavioral therapy (8 sessions within the past 5 years
* Concurrent psychosocial treatment (i.e., therapy) focused on depression, anxiety, or other related disorders, or are not willing to refrain from initiating additional therapy during the study
* Concurrent psychotropic medications if not stabilized or not willing to maintain a stable dosage of psychotropic medications, such as medications for depression or anxiety, during study participation

Primary outcomes:
measure: Anxiety and Related Disorders Interview Schedule for DSM-5
timeFrame: Change in diagnosis of depression from baseline to post-treatment (approximately 12 weeks after baseline) and 6-week follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Vision & Cognition Laboratory
state: Massachusetts
Study officials:
affiliation: Boston University
name: Alice Cronin-Golomb, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: