MBCT for People With Parkinson's Disease and Caregivers (MBCT-PD-2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04469049|
Recruitment Status : Not yet recruiting
First Posted : July 13, 2020
Last Update Posted : September 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Anxiety Depression||Behavioral: Mindfulness-based cognitive therapy (MBCT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants will receive the MBCT intervention, however they will be separated in several distinct groups over time, due to MBCT protocol limitations.|
|Masking:||None (Open Label)|
|Official Title:||Mindfulness-based Cognitive Therapy for People With Parkinson's Disease and Caregivers|
|Estimated Study Start Date :||November 15, 2020|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Experimental: Mindfulness-based cognitive therapy (MBCT)
All participants will receive the MBCT intervention, consisting of 8 90-minute weekly group sessions.
Behavioral: Mindfulness-based cognitive therapy (MBCT)
MBCT is an evidence-based psychotherapy which combines mindfulness skills with cognitive therapy strategies.
- Change in anxiety symptom severity [ Time Frame: 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 [ Time Frame: 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.
- Change in mindfulness levels [ Time Frame: 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.
- Change in caregiver burden score (caregivers only) [ Time Frame: From pre- to post-MBCT 8 weeks later ]Change in AMA Caregiver Self-Assessment Questionnaire score. The scale score range is 0-16, with higher scores indicating higher caregiver burden.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04469049
|Contact: Sarah Wang, PhDemail@example.com|
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Contact: Sarah Wang, PhD 415-353-7885 firstname.lastname@example.org|
|Principal Investigator: Andreea L Seritan, MD|
|Principal Investigator:||Andreea L. Seritan, MD||University of California, San Francisco|