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

NCT ID: NCT03904654

Last Updated: 2020-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-26

Study Completion Date

2020-04-06

Brief Summary

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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

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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.

Conditions

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Parkinson Disease Anxiety Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will receive the MBCT intervention, however they will be separated in 2 distinct groups over time, due to MBCT protocol limitations.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness-based cognitive therapy (MBCT)

All participants will receive the MBCT intervention, consisting of 8 60-minute consecutive weekly MBCT group sessions.

Group Type EXPERIMENTAL

Mindfulness-based cognitive therapy (MBCT)

Intervention Type BEHAVIORAL

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

Interventions

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Mindfulness-based cognitive therapy (MBCT)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Parkinson Foundation

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreea L. Seritan, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16488379 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27125963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17987654 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27431515 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 25881019 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 26101690 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27144052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19843353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30654854 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10965637 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17765453 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26808973 (View on PubMed)

Other Identifiers

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PF-CGP_19123

Identifier Type: -

Identifier Source: org_study_id

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