Telehealth Psychotherapy for Depression in Parkinson's Disease

August 5, 2022 updated by: Alice Cronin-Golomb, Boston University Charles River Campus
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Vision & Cognition Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cognitive-behavioral therapy (CBT)
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)
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.
ACTIVE_COMPARATOR: Waitlist Control
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety and Related Disorders Interview Schedule for DSM-5
Time Frame: Change in diagnosis of depression from baseline to post-treatment (approximately 12 weeks after baseline) and 6-week follow-up.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University Charles River Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2019

Primary Completion (ACTUAL)

April 30, 2021

Study Completion (ACTUAL)

April 30, 2021

Study Registration Dates

First Submitted

June 16, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (ACTUAL)

June 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 5, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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