MBCT for People With Parkinson's Disease and Caregivers

Depression Clinical Trial

— MBCT-PD-2  

Official title:

Mindfulness-based Cognitive Therapy for People With Parkinson's Disease and Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04469049
• Other study ID #: MZHF_20200962
• Status: Completed
• Phase: N/A
• Start date: November 11, 2020
• Est. completion date: June 11, 2021

Study information

• Verified date: October 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (PD) and caregivers of people with PD.

Description:

An adapted MBCT intervention will be offered to people with Parkinson's disease (PD) and mild-to-moderate depression and/or anxiety, as well as caregivers of people with PD. Several 8-week long MBCT groups will be held between September 2020 and May 2021, based on the adapted protocol. The MBCT intervention will consist of 90-minute weekly groups focused on teaching mindfulness techniques and ways to recognize cognitive patterns that can increase anxiety and/or depression. Participants will be recruited from the community, according to the eligibility criteria detailed below. For all participants, the 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. For caregivers, pre- and post-MBCT caregiver burden scores will be compared as well.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 11, 2021
• Est. primary completion date: June 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Having a diagnosis of Parkinson's disease (PD) or parkinsonism, established by a neurologist, or being a caregiver of a person with PD or parkinsonism

• Being able and willing to attend 8 weekly 90-minute online group sessions (5-6:30 pm PST)

• Mild-to-moderate anxiety: GAD-7 score = 16

• Mild-to-moderate depression: PHQ-9 score = 18

Exclusion Criteria:

• Severe anxiety: GAD-7 score > 16

• Moderately severe-to-severe depression: PHQ-9 score > 18

• Cognitive impairment: Montreal Cognitive Assessment (MoCA) score < 24

• Heavy alcohol or drug use

• Severe psychosis

• Active suicidal or homicidal ideation

• For people with PD: severe motor fluctuations (less than 2 hours "on" time per day)

• Pattern of engagement with health care that indicates low likelihood of completing an 8-week intervention.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Parkinson Disease

Intervention

Behavioral:
• Mindfulness-based cognitive therapy (MBCT)
MBCT is an evidence-based psychotherapy which combines mindfulness skills with cognitive therapy strategies.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Mount Zion Health Fund

Country where clinical trial is conducted

United States, 

References & Publications (14)

Broen MP, Narayen NE, Kuijf ML, Dissanayaka NN, Leentjens AF. Prevalence of anxiety in Parkinson's disease: A systematic review and meta-analysis. Mov Disord. 2016 Aug;31(8):1125-33. doi: 10.1002/mds.26643. Epub 2016 Apr 29. Review. — View Citation

Cash TV, Ekouevi VS, Kilbourn C, Lageman SK. Pilot study of a mindfulness-based group intervention for individuals with Parkinson's disease and their caregivers. Mindfulness 7: 361-371, 2016

Chaudhuri KR, Healy DG, Schapira AH; National Institute for Clinical Excellence. Non-motor symptoms of Parkinson's disease: diagnosis and management. Lancet Neurol. 2006 Mar;5(3):235-45. Review. — View Citation

Dissanayaka NN, Idu Jion F, Pachana NA, O'Sullivan JD, Marsh R, Byrne GJ, Harnett P. Mindfulness for Motor and Nonmotor Dysfunctions in Parkinson's Disease. Parkinsons Dis. 2016;2016:7109052. doi: 10.1155/2016/7109052. Epub 2016 Apr 10. — View Citation

Eisendrath SJ, Gillung E, Delucchi KL, Segal ZV, Nelson JC, McInnes LA, Mathalon DH, Feldman MD. A Randomized Controlled Trial of Mindfulness-Based Cognitive Therapy for Treatment-Resistant Depression. Psychother Psychosom. 2016;85(2):99-110. doi: 10.1159/000442260. Epub 2016 Jan 26. — View Citation

Evans S, Ferrando S, Findler M, Stowell C, Smart C, Haglin D. Mindfulness-based cognitive therapy for generalized anxiety disorder. J Anxiety Disord. 2008 May;22(4):716-21. Epub 2007 Jul 22. — View Citation

Fitzpatrick L, Simpson J, Smith A. A qualitative analysis of mindfulness-based cognitive therapy (MBCT) in Parkinson's disease. Psychol Psychother. 2010 Jun;83(Pt 2):179-92. doi: 10.1348/147608309X471514. Epub 2009 Oct 19. — View Citation

Gotink RA, Chu P, Busschbach JJ, Benson H, Fricchione GL, Hunink MG. Standardised mindfulness-based interventions in healthcare: an overview of systematic reviews and meta-analyses of RCTs. PLoS One. 2015 Apr 16;10(4):e0124344. doi: 10.1371/journal.pone.0124344. eCollection 2015. Review. Retraction in: PLoS One. 2019 Apr 12;14(4):e0215608. — View Citation

Martínez-Fernández R, Schmitt E, Martinez-Martin P, Krack P. The hidden sister of motor fluctuations in Parkinson's disease: A review on nonmotor fluctuations. Mov Disord. 2016 Aug;31(8):1080-94. doi: 10.1002/mds.26731. Epub 2016 Jul 19. Review. — View Citation

Pickut B, Vanneste S, Hirsch MA, Van Hecke W, Kerckhofs E, Mariën P, Parizel PM, Crosiers D, Cras P. Mindfulness Training among Individuals with Parkinson's Disease: Neurobehavioral Effects. Parkinsons Dis. 2015;2015:816404. doi: 10.1155/2015/816404. Epub 2015 May 26. — View Citation

Reijnders JS, Ehrt U, Weber WE, Aarsland D, Leentjens AF. A systematic review of prevalence studies of depression in Parkinson's disease. Mov Disord. 2008 Jan 30;23(2):183-9; quiz 313. Review. — View Citation

Rodgers SH, Schütze R, Gasson N, Anderson RA, Kane RT, Starkstein S, Morgan-Lowes K, Egan SJ. Modified Mindfulness-Based Cognitive Therapy for Depressive Symptoms in Parkinson's Disease: a Pilot Trial. Behav Cogn Psychother. 2019 Jul;47(4):446-461. doi: 10.1017/S135246581800070X. Epub 2019 Jan 18. — View Citation

Seritan AL, Ureste PJ, Duong T, Ostrem JL. Psychopharmacology for patients with Parkinson's disease and deep brain stimulation: Lessons learned in an academic center. Current Psychopharmacology 8(1):41-54, 2019 DOI: 10.2174/2211556007666180328142953

Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anxiety symptom severity	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.	From pre- to post-MBCT 8 weeks later
Primary	Change in depressive symptom severity	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.	From pre- to post-MBCT 8 weeks later
Secondary	Change in mindfulness levels	Change in 15 item-Five Facet Mindfulness Questionnaire score. The scale score range is 0-75, with higher scores indicating higher mindfulness levels.	From pre- to post-MBCT 8 weeks later
Secondary	Change in caregiver burden score (caregivers only)	Change in AMA Caregiver Self-Assessment Questionnaire score. The scale score range is 0-16, with higher scores indicating higher caregiver burden.	From pre- to post-MBCT 8 weeks later