Comparing Mindfulness Based Cognitive Therapy and Mindfulness Based Self-compassion Therapy in a Psoriasis Sample
1 other identifier
interventional
94
1 country
1
Brief Summary
Increasing research evidence supports the effectiveness of mindfulness based interventions; however, the exact mechanisms of change are poorly understood. Some evidence proposes that self-compassion is an important mechanism of change in the effectiveness of mindfulness based interventions. The current research will evaluate and compare the effectiveness of two mindfulness meditation approaches; Mindfulness Based Cognitive Therapy (MBCT) and Mindfulness based Self-compassion Therapy (MBSCT), for individuals with psoriasis, a skin condition commonly associated with stress. Blood analyses will be conducted to assess and compare the impact of the interventions on the immune system. Self-report questionnaires will explore participants' psychological functioning (e.g. self-compassion, depression, anxiety, worry). This study will also examine whether a relationship exists between immune functioning and psychological factors. An audio-guided MBSCT programme will be piloted, with a view to trialling as a more cost-effective alternative to traditional mindfulness interventions. Findings will enable us to design more effective interventions in the future, and yield clear results regarding the existence of a definite link between immunological functioning and psychological functioning. The main research hypothesis is that participants who complete a mindfulness based intervention will experience significantly greater psychological well-being, symptom reduction, and greater changes in telomerase and cytokine activity than individuals who only receive treatment as usual for their psoriasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 23, 2014
CompletedFirst Posted
Study publicly available on registry
April 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedApril 25, 2014
April 1, 2014
1.5 years
April 23, 2014
April 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in immunological markers
Telomerase, Cytokines, C Reactive Protein will be measured in blood at 4 time points.
14 months
Psoriasis symptom control
Measured by Psoriasis Area \& Severity Index (PASI) and drug dose reduction (if applicable)
14 months
Psychological Well-Being
As measured by: Hospital Anxiety and Depression Scale Penn State Worry Questionnaire Fears of Compassion Scales Five Facets of Mindfulness Questionnaire
14 months
Quality of Life
Measured by WHO QoL index and Dermatology Life Quality Index.
14 months
Study Arms (3)
Mindfulness Based Cognitive Therapy
ACTIVE COMPARATORMindfulness Based Cognitive Therapy
MBSCT 8 week course
EXPERIMENTALMindfulness Based Self Compassion Therapy
Mindfulness Based Self-Compassion - Audio guided
ACTIVE COMPARATORMBSC - minimal contact
Interventions
MBCT 8 week course delivered by trained facilitator
8 week course in Mindfulness Based Self Compassion delivered remotely by audio guided MP3
Mindfulness Based Self Compassion Therapy - 8 wee course delivered by trained facilitator
Eligibility Criteria
You may qualify if:
- adults over 18 years
- diagnosis of mild to severe psoriasis
You may not qualify if:
- extraneous health issues which may influence immunological activity
- Participants deemed unsuitable for MBCT or MBSCT after a psychological assessment
- previous participation in a formal 8-week mindfulness programme (e.g., MBCT, MBSR).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Vincent's University Hospital
Dublin, Dublin, 4, Ireland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Paul D'Alton
Study Record Dates
First Submitted
April 23, 2014
First Posted
April 25, 2014
Study Start
November 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
April 25, 2014
Record last verified: 2014-04