PsoriasisNCT02122978
Comparing Mindfulness Based Cognitive Therapy and Mindfulness Based Self-compassion Therapy in a Psoriasis Sample
A study testing Mindfulness Based Cognitive Therapy, MBSC - minimal contact and Mindfulness Based Self Compassion Therapy in people with Psoriasis, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Mindfulness Based Cognitive Therapy, MBSC - minimal contact and Mindfulness Based Self Compassion Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteIreland
- Study dates
- Nov 2013to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults over 18 years
- diagnosis of mild to severe psoriasis
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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:
- Hospital Anxiety and Depression Scale (HADS; Snaith \& Zigmond, 1994)
- Penn State Worry Questionnaire (PSWQ: Meyer, Miller, Metzger \& Borkovec, 1990) 3 Fears of Compassion Scales (Gilbert, 2009)
- 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.
- Conditions
- Psoriasis
- Being tested
- Mindfulness Based Cognitive Therapy, MBSC - minimal contact, Mindfulness Based Self Compassion Therapy
- Keywords
- psoriasis, dermatology, mindfulness, self-compassion
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive TherapyBehavioural
Also called MBCT
MBCT 8 week course delivered by trained facilitator
MBSC - minimal contactBehavioural
Also called Mindfulness Based Self Compassion MP3
8 week course in Mindfulness Based Self Compassion delivered remotely by audio guided MP3
Mindfulness Based Self Compassion TherapyBehavioural
Also called MBSCT
Mindfulness Based Self Compassion Therapy - 8 wee course delivered by trained facilitator
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Cognitive Therapy | Active comparator | Mindfulness Based Cognitive Therapy Receives: Behavioral: Mindfulness Based Cognitive Therapy |
| MBSCT 8 week course | Experimental | Mindfulness Based Self Compassion Therapy Receives: Behavioral: Mindfulness Based Self Compassion Therapy |
| Mindfulness Based Self-Compassion - Audio guided | Active comparator | MBSC - minimal contact Receives: Behavioral: MBSC - minimal contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in immunological markers
Telomerase, Cytokines, C Reactive Protein will be measured in blood at 4 time points.
Measured: 14 months
Psoriasis symptom control
Measured by Psoriasis Area \& Severity Index (PASI) and drug dose reduction (if applicable)
Measured: 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
Measured: 14 months
Quality of Life
Measured by WHO QoL index and Dermatology Life Quality Index.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startNov 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Vincent's University Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Paul D'Alton, St Vincent's University Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122978
- Sponsor's protocol ID
- 19/12/12 mind derm
- Status last verified
- Apr 2014
- First submitted
- 23 Apr 2014
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02122978
- Acronym / sponsor ID
- 19/12/12 mind derm
- Conditions
- Psoriasis
- Keywords
- psoriasis, dermatology, mindfulness, self-compassion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (actual)
- Lead sponsor
- St Vincent's University Hospital, IrelandUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Hospital Anxiety and Depression Scale (HADS; Snaith \& Zigmond, 1994)
- Penn State Worry Questionnaire (PSWQ: Meyer, Miller, Metzger \& Borkovec, 1990) 3 Fears of Compassion Scales (Gilbert, 2009)
- 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Cognitive Therapy | Active comparator | Behavioral: Mindfulness Based Cognitive TherapyMindfulness Based Cognitive Therapy |
| MBSCT 8 week course | Experimental | Behavioral: Mindfulness Based Self Compassion TherapyMindfulness Based Self Compassion Therapy |
| Mindfulness Based Self-Compassion - Audio guided | Active comparator | Behavioral: MBSC - minimal contactMBSC - minimal contact |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults over 18 years
- diagnosis of mild to severe psoriasis
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Cognitive TherapyAlso: MBCTMBCT 8 week course delivered by trained facilitator | Behavioural | Mindfulness Based Cognitive Therapy |
| MBSC - minimal contactAlso: Mindfulness Based Self Compassion MP38 week course in Mindfulness Based Self Compassion delivered remotely by audio guided MP3 | Behavioural | Mindfulness Based Self-Compassion - Audio guided |
| Mindfulness Based Self Compassion TherapyAlso: MBSCTMindfulness Based Self Compassion Therapy - 8 wee course delivered by trained facilitator | Behavioural | MBSCT 8 week course |
Primary outcome
Change in immunological markers
Time frame: 14 months
Telomerase, Cytokines, C Reactive Protein will be measured in blood at 4 time points.
Psoriasis symptom control
Time frame: 14 months
Measured by Psoriasis Area \& Severity Index (PASI) and drug dose reduction (if applicable)
Psychological Well-Being
Time frame: 14 months
As measured by: Hospital Anxiety and Depression Scale Penn State Worry Questionnaire Fears of Compassion Scales Five Facets of Mindfulness Questionnaire
Quality of Life
Time frame: 14 months
Measured by WHO QoL index and Dermatology Life Quality Index.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
Related trials for Psoriasis
Active, not recruitingObservational study
Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden
Psoriasis, Moderate to Severe Psoriasis
RecruitingPhase 3
Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
Plaque Psoriasis
Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Psoriasis Vulgaris, Psoriasis
Active, not recruitingPhase 3
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)
Psoriatic Arthritis (PsA)
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Cognitive Therapy, MBSC - minimal contact and Mindfulness Based Self Compassion Therapy in people with Psoriasis, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in immunological markers (time frame: 14 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2014.