MBCT for People With Parkinson's Disease and Caregivers

NCT04469049 | Completed

• 1 other identifier: MZHF_20200962
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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 (PD) and caregivers of people with PD.

Conditions

Parkinson Disease; Anxiety; Depression

Keywords

Parkinson's disease; Mindfulness-based intervention; Mindfulness-based cognitive therapy (MBCT)

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Change in mindfulness levels

  From pre- to post-MBCT 8 weeks later

• Change in caregiver burden score (caregivers only)

  From pre- to post-MBCT 8 weeks later

Study Arms (1)

Mindfulness-based cognitive therapy (MBCT)

EXPERIMENTAL

All participants will receive the MBCT intervention, consisting of 8 90-minute weekly group sessions.

Behavioral: Mindfulness-based cognitive therapy (MBCT)

Interventions

Mindfulness-based cognitive therapy (MBCT) BEHAVIORAL

MBCT is an evidence-based psychotherapy which combines mindfulness skills with cognitive therapy strategies.

Mindfulness-based cognitive therapy (MBCT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Mount Zion Health Fund: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (15)

• 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. doi: 10.1016/S1474-4422(06)70373-8.

  PMID: 16488379 BACKGROUND

• 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.

  PMID: 27125963 BACKGROUND

• 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. doi: 10.1002/mds.21803.

  PMID: 17987654 BACKGROUND

• Martinez-Fernandez 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.

  PMID: 27431515 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25881019 BACKGROUND

• 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

  BACKGROUND

• Pickut B, Vanneste S, Hirsch MA, Van Hecke W, Kerckhofs E, Marien 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.

  PMID: 26101690 BACKGROUND

• 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.

  PMID: 27144052 BACKGROUND

• 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.

  PMID: 19843353 BACKGROUND

• Rodgers SH, Schutze 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.

  PMID: 30654854 BACKGROUND

• 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. doi: 10.1037//0022-006x.68.4.615.

  PMID: 10965637 BACKGROUND

• 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. doi: 10.1016/j.janxdis.2007.07.005. Epub 2007 Jul 22.

  PMID: 17765453 BACKGROUND

• 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.

  PMID: 26808973 BACKGROUND

• Seritan AL, Iosif AM, Prakash P, Wang SS, Eisendrath S. Online Mindfulness-Based Cognitive Therapy for People with Parkinson's Disease and Their Caregivers: a Pilot Study. J Technol Behav Sci. 2022;7(3):381-395. doi: 10.1007/s41347-022-00261-7. Epub 2022 May 2.

  PMID: 35527798 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Anxiety Disorders; Depression

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Andreea L. Seritan, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive the MBCT intervention, however they will be separated in several distinct groups over time, due to MBCT protocol limitations.

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 13, 2020
• Study Start: November 11, 2020
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)