Telehealth Psychotherapy for Depression in Parkinson's Disease

NCT03993041 | Completed

• 1 other identifier: 5222
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Anxiety and Related Disorders Interview Schedule for DSM-5

  Semi-structured diagnostic interview for assessment of mood and related disorders.

  Change in diagnosis of depression from baseline to post-treatment (approximately 12 weeks after baseline) and 6-week follow-up.

Study Arms (2)

Cognitive-behavioral therapy (CBT)

EXPERIMENTAL

Individuals in the CBT arm are expected to participate in a phone screen + baseline phase (one assessment) + 10-12 weeks of CBT intervention + post-intervention assessment + 6 week follow-up assessment.

Behavioral: Cognitive-behavioral therapy (CBT)

Waitlist Control

ACTIVE COMPARATOR

Individuals in the Waitlist Control arm are expected to participate in a phone screen + baseline phase (two assessments, 12 weeks apart) + 10-12 weeks of CBT intervention + post-intervention assessment + 6 week follow-up assessment.

Behavioral: Cognitive-behavioral therapy (CBT)

Interventions

Cognitive-behavioral therapy (CBT) BEHAVIORAL

Study therapists will deliver cognitive-behavioral therapy (CBT) based on an emotion-focused, transdiagnostic protocol. CBT targets problematic thoughts, feelings, and behaviors through goal-oriented, systematic procedures. The intervention used in this study is designed to target emotional processing with an emphasis on present-focused awareness, cognitive flexibility, emotional avoidance, awareness and tolerance of physical sensations, and situation-based emotion exposure. The intervention is designed to help individuals better understand emotional experiences in order to respond to intense emotions in a more adaptive way.

Cognitive-behavioral therapy (CBT); Waitlist Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Vision & Cognition Laboratory

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Depression; Parkinson Disease

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alice Cronin-Golomb, Ph.D.

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Vision & Cognition Laboratory

Study Record Dates

• First Submitted: June 16, 2019
• First Posted: June 20, 2019
• Study Start: August 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)