This trial is active, not recruiting.

Condition psoriasis
Treatments mindfulness based cognitive therapy, mbsc - minimal contact, mindfulness based self compassion therapy
Sponsor St Vincent's University Hospital, Ireland
Start date November 2013
End date May 2015
Trial size 94 participants
Trial identifier NCT02122978, 19/12/12 mind derm


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
(Active Comparator)
Mindfulness Based Cognitive Therapy
mindfulness based cognitive therapy MBCT
MBCT 8 week course delivered by trained facilitator
Mindfulness Based Self Compassion Therapy
mindfulness based self compassion therapy MBSCT
Mindfulness Based Self Compassion Therapy - 8 wee course delivered by trained facilitator
(Active Comparator)
MBSC - minimal contact
mbsc - minimal contact Mindfulness Based Self Compassion MP3
8 week course in Mindfulness Based Self Compassion delivered remotely by audio guided MP3

Primary Outcomes

Change in immunological markers
time frame: 14 months
Psoriasis symptom control
time frame: 14 months
Psychological Well-Being
time frame: 14 months
Quality of Life
time frame: 14 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - adults over 18 years - diagnosis of mild to severe psoriasis Exclusion Criteria: - 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).

Additional Information

Official title Comparing Mindfulness Based Cognitive Therapy and Mindfulness Based Self-compassion Therapy: Understanding What Works Psychologically and Physiologically in a Randomized Study in Dermatology
Description The proposed research is a randomized, multi-site, blinded comparative study of mindfulness-based cognitive therapy (MBCT), Mindfulness Based Self-compassion Therapy (MBSCT), minimal-contact MBSCT, and treatment as usual (TAU) in patients with psoriasis. Recruitment commenced in November 2013 and continued until March 2014. Participants were recruited via the Department of Dermatology in St. Vincent's University Hospital. During weekly dermatology clinics eligible participants were identified by medical members of the Dermatology team and on expression of interest were referred to an Assistant Psychologist for recruitment purposes. In addition participants were also recruited via an advertisement placed in a national newspaper. Eligible patients will be randomly assigned to TAU (n=25), MBCT (n=25), MBSCT (n=25), or audio-guided MBSCT (n=25). At Time 1 (pre intervention), participants will be required to give blood (a 50ml sample, i.e., roughly 10 teaspoons), and complete self-report measures on the same day as beginning the mindfulness programme. As it has previously been indicated that cells may be sensitive to sudden changes in stress, mood and time of day (Epel, 2012), blood samples will always be taken after completing the self-report measures and at a relatively standardized time, e.g., between 3-5pm. Care will be taken to ensure that conditions are relaxed across all participants, and a 10 minute rest period between completing the questionnaires and giving blood will be enforced. Bloods can be kept at room temperate for up to 24 hours and then prepared for storage below 60 degrees Celsius until PBMC analysis is to be conducted after all samples have been collected at Time 1 (post intervention). At Time 2, six-months and twelve-months follow-up, participants will again be required to give 50ml of blood and complete all self-report measures via an identical protocol, and analysis will be conducted again accordingly. Telomerase will be assessed using a TRAPeze EXCEL Telomerase Detection Kit. This will be complemented by flow cytometry analysis of telomere length. Serum cytokines before and after treatment will be examined by ELISA. This should give an indication of the effect of treatment on systemic inflammation. We will also examine the ability of PBMC from patients to produce proinflammatory cytokines, including IL-6, TNF, IL-1, and others associated with anxiety and depression. PBMC will be activated with innate stimulus such as LPS/zymosan. The production of cytokines will be determined by ELISA. Highly sensitive CRP is also a marker for psoriasis and will be assessed by ELISA to give an indication of overall inflammation. In regards to self-report measures, the following psychological scales will be used: 1. Hospital Anxiety and Depression Scale (HADS; Snaith & Zigmond, 1994) 2. Penn State Worry Questionnaire (PSWQ: Meyer, Miller, Metzger & Borkovec, 1990) 3 Fears of Compassion Scales (Gilbert, 2009) 4. Five Facets of Mindfulness Questionnaire (FFMQ: Baer, Smith, Hopkins, Krietemeyer & Toner, 2006) 5. World Health Organisation Quality of Life - BREF (WHO, 2004). 6. Dermatology Quality of Life Index Addressing our research question regarding the effectiveness of the mindfulness programs involves a repeated-measures comparative group intervention design. 4x4 mixed-methods ANOVAs will be used to assess pre, post and six/twelve month follow-up differences across the four experimental conditions, with group as the independent variable and psychological experience (e.g., depression, anxiety, worry, self compassion and mindfulness) or immunological activity (e.g., PBMC telomerase and cytokines) as the dependent variables. Number of hours per week practicing mindfulness during follow-up will be entered as a covariate. Effect sizes and confidence intervals will be calculated post-hoc using G*Power in order to facilitate ease of comparison between the study findings and other future studies and the relevant field of literature. Bivariate Spearman's Correlations will be conducted to examine the relationship between psychological variables and telomerase and cytokine activity on all four testing occasions, respectively. Spearman's Correlations are chosen as a suitable non-parametric correlation analysis given reports of telomerase as non-normally distributed (e.g., Epel et al., 2010; Wolkowitz et al., 2012) and inspection of our own preliminary data. Data will be collected on four occasions; pre and post intervention and at six and twelve months follow up.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by St Vincent's University Hospital, Ireland.