Mindfulness-based Cognitive Therapy (MBCT) for People With Parkinson's Disease

Not Applicable

Completed

• Conditions: Depression; Anxiety; Parkinson Disease

• Registration Number: NCT03904654
• Lead Sponsor: University of California, San Francisco

Brief Summary

This study aims to explore the feasibility and effectiveness of mindfulness-based cognitive therapy (MBCT) in reducing anxiety and/or depressive symptoms in people with Parkinson's disease.

Detailed Description

An adapted MBCT intervention will be offered to people with Parkinson's disease and mild-to-moderate depression and/or anxiety. Two 8-week long MBCT groups will be held between September 2019 and March 2020, based on the adapted protocol. Modifications will include shortening the traditional 120-minute to 90-minute format and performing mindful yoga from a chair, instead of a floor mat. Participants will be recruited from the community, according to the eligibility criteria detailed below. The participants' pre- and post-MBCT anxiety and/or depressive symptom severity and mindfulness levels (as measured with standardized, validated scales) will be compared, using a paired t-test.

Study Timeline

• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-03
• Study First Posted: 2019-04-05
• Study Start: 2019-08-26
• Primary Completion: 2020-04-06
• Study Completion: 2020-04-06
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Diagnosis of Parkinson's disease or parkinsonism (established by a neurologist)
2. Living in the San Francisco Bay Area
3. Being able and willing to attend 8 weekly 90-minute group sessions
4. Mild-to-moderate anxiety: GAD-7 score ≤ 16
5. Mild-to-moderate depression: PHQ-9 score ≤ 18

Exclusion Criteria

1. Severe anxiety: GAD-7 score > 16
2. Moderately severe-to-severe depression: PHQ-9 score > 18
3. Cognitive impairment: Montreal Cognitive Assessment (MoCA) score < 24
4. Heavy alcohol or drug use
5. Severe psychosis
6. Active suicidal or homicidal ideation
7. Severe motor fluctuations (less than 2 hours "on" time per day)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in anxiety symptom severity	From pre- to post-MBCT 8 weeks later	Change in Generalized Anxiety Disorder-7 item score (for participants with anxiety). The scale score range is 0-21, with higher scores indicating more severe anxiety.
Change in depressive symptom severity	From pre- to post-MBCT 8 weeks later	Change in Patient Health Questionnaire-9 score (for participants with depression). The scale score range is 0-27, with higher scores indicating more severe depression.

Secondary Outcome Measures

Name	Time	Method
Change in mindfulness levels	From pre- to post-MBCT 8 weeks later	Change in 15 item-Five Facet Mindfulness Questionnaire score. The scale score range is 0-75, with higher scores indicating higher mindfulness levels.
Time spent practicing mindfulness	During MBCT group (8 week-period)	Number of minutes per week spent practicing mindfulness exercises

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States