DepressionNCT00938873
Understanding the Impact of Meditative Homework on Metacognitive Processes in the Context of Mindfulness Based Cognitive Therapy (MBCT)
An observational study of Depression, run by Lahtinen, Marika at 1 site in United Kingdom.
Trial summary
Mindfulness based cognitive therapy (MBCT) is a group psycho-educational treatment designed to reduce the risk of recurrent depression by integrating mindfulness based meditation practices with cognitive therapy techniques. MBCT comprises eight weekly two-hour group sessions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Mindfulness Based Cognitive Therapy (MBCT)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2009to Apr 2011
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eight participants will be recruited from South London and Maudsley NHS Trust, which is a national health service site offering Mindfulness Based Cognitive Therapy (MBCT).
Who may be able to join
- Participants will be 18 to 65 years of age and recruited through an NHS Trust offering MBCT.
- At present I am uncertain of the exact inclusion and exclusion criteria as the relevant NHS trust is yet to be determined, so the guidelines recommended by Teasdale et al., (2000) and Ma and Teasdale (2004) will be used.
- These authors suggest that MBCT has no significant effect on reducing the relapse rates of depression in patients with ≤ 2 episodes of depression.
- Therefore the present study will use participants who have experienced more than three episodes of depression as judged by the relevant NHS Trust.
- No restrictions are placed in terms of participants' use of antidepressant medication.
Who cannot join
- Exclusion criteria consists of disorders where the participant would have difficulties understanding and/or applying mindfulness techniques, including current alcohol or substance dependence, borderline personality disorder, organic mental disorder or pervasive developmental delay, schizoaffective disorder, schizophrenia, schizophreniform disorder, delusional disorder and psychotic disorder not otherwise specified.
- Potential participants engaging in yoga or Buddhist meditation more than twice a week are excluded as these practices significantly overlap with the MBCT program.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South London & Maudsley NHS Trust
London, London, SE5 8AZ
About this study
Mindfulness based cognitive therapy (MBCT) is a group psycho-educational treatment designed to reduce the risk of recurrent depression by integrating mindfulness based meditation practices with cognitive therapy techniques. MBCT comprises eight weekly two-hour group sessions. Additionally, participants are required to commit to one hour per day of between sessions meditative homework assignments six days per week. Existing quantitative research suggest that MBCT is an effective intervention for preventing depressive relapse in patients with three or more episodes of depression (Teasdale et al.2000, Ma \& Teasdale, 2004). The focus of qualitative research has been on evaluating the acceptability of MBCT for various clinical populations; participants' accounts have been positive indicating MBCT may be a potential therapeutic tool for treating older adults (Graham \& Senthinathan, 2007), psychosis (Abba, Chadwick, \& Stevenson, 2008), Parkinson's disease (Fitzpatrick, Simpson, \& Smith, 2010) as well as acute depression (Mason \& Hargreaves, 2001).
The benefits of undertaking meditative mindfulness practice in the context of MBCT have been linked to changes in metacognitive processes. Two distinct multi-level information processing frameworks dealing with how thoughts are processed from a metacognitive perspective have been proposed: The Interacting Cognitive Subsystems (ICS; Teasdale, 1999a, 1999b) and the Self Regulatory Executive Function (S-REF; Wells, 2000) theory. The ICS framework forms a rationale for meditative aspects of the MBCT programme. The S-REF model differs from the ICS theory in its conceptualisation of the object or 'being' mode of metacognitive processing.
Read more
Regular daily practice of mindfulness meditation has been regarded as among the most essential aspects of mindfulness programmes (Kabat-Zinn, 1990; Mason \& Hargreaves, 2001). Existing studies, with their focus on effectiveness or acceptability of MBCT as an intervention, have thus far excluded an important aspect of the course involving the experience of meditative homework assignments. Therefore, the aim of this study was to explore subjective accounts of the meaning of carrying out meditative homework assignments in the context of a National Health Service (NHS) run MBCT course. The research questions focused on the impact of meditative homework on thought processes as well as an exploration of barriers and facilitating factors from a participant's perspective.Six individual in-depth interviews were conducted with participants all of whom had completed the full MBCT programme. Interpretive phenomenological Analysis (IPA) was used as the methodology for analysing interview transcripts. Data analysis began with a detailed examination of one case until a thorough analysis was completed after which subsequent cases were analysed. Finally a cross case analysis was carried out where individual themes were interrogated for similarities and differences (Smith, et al., 2009).
Two master themes were presented: 'The relationship of meditative homework to metacognitive experience' and 'Motivating and discouraging factors for engagement in meditative practice'. Results reveal a transformation in metacognitive processes as a result of undertaking meditative homework. The subjective experience of metacognitive processes is examined in the context of existing psychological theories including the ICS (Teasdale, 1999a, 1999b) as well as the S-REF (Wells, 2000) theory involving metacognitions. A model for perceived facilitating factors and difficulties experienced in carrying out meditative homework is constructed based on the Integrated Theoretical Foundations Model for CBT homework assignment (Kazantzis, et al., 2005). The model explores participants' motivation in three stages of the homework process: firstly during assignment of the meditative homework task, secondly in completing the planned task and finally carrying out review of the task in question. Implications of the present study are discussed in relation to psychological literature, homework assignment and the practise of MBCT.
- Conditions
- Depression
- Being tested
- Mindfulness Based Cognitive Therapy (MBCT)
- Keywords
- MBCT, identity, depression, recurrent, homework
- Medical subject headings
- Depression, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive Therapy (MBCT)Behavioural
Also called MBCT
Mindfulness based cognitive therapy (MBCT) is a group psycho-educational treatment designed to reduce the risk of recurrent depression by integrating mindfulness based meditation practices with cognitive therapy techniques. MBCT comprises eight weekly two-hour group sessions with an additional one hour daily 6 days a week for meditative homework practice.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Cognitive Therapy | The present study will use participants who have experienced more than three episodes of depression as judged by South London and Maudsley NHS Trust. No restrictions are placed in terms of participants' use of antidepressant medication. Participants will be 18 to 65 years old and would have participated in an MBCT course run by South London and Maudsley NHS Trust. Receives: Behavioral: Mindfulness Based Cognitive Therapy (MBCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The project involves one 60-minute interview per participant aiming to evaluate lived experience of having taken part in an MBCT programme. The specific focus is on MBCT programme's possible impact on personal identity, barriers and facilitating factors.
Measured: Interviews are conducted upon completion of MBCT course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startDec 2009
- Primary completionApr 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahtinen, Marika
- Sponsor type
- University, hospital or other
- Collaborators
- University of East London, South London and Maudsley NHS Foundation Trust
- Responsible party
- Principal investigator, Marika Lahtinen, University of East London
- Investigators
- Marika Lahtinen, Principal investigator, University of East London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938873
- Sponsor's protocol ID
- 1-Lahtinen
- Status last verified
- Feb 2012
- First submitted
- 13 Jul 2009
- Last updated
- 29 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Impact of Meditative Homework on Metacognitive Processes in the Context of Mindfulness Based Cognitive Therapy (MBCT)
- ClinicalTrials.gov ID
- NCT00938873
- Acronym / sponsor ID
- 1-Lahtinen
- Conditions
- Depression
- Keywords
- MBCT, identity, depression, recurrent, homework
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Lahtinen, MarikaUniversity, hospital or other
- Collaborators
- University of East London, South London and Maudsley NHS Foundation Trust
- Study start
- Dec 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 14 Jul 2009 (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.
Mindfulness based cognitive therapy (MBCT) is a group psycho-educational treatment designed to reduce the risk of recurrent depression by integrating mindfulness based meditation practices with cognitive therapy techniques. MBCT comprises eight weekly two-hour group sessions. Additionally, participants are required to commit to one hour per day of between sessions meditative homework assignments six days per week. Existing quantitative research suggest that MBCT is an effective intervention for preventing depressive relapse in patients with three or more episodes of depression (Teasdale et al.2000, Ma \& Teasdale, 2004). The focus of qualitative research has been on evaluating the acceptability of MBCT for various clinical populations; participants' accounts have been positive indicating MBCT may be a potential therapeutic tool for treating older adults (Graham \& Senthinathan, 2007), psychosis (Abba, Chadwick, \& Stevenson, 2008), Parkinson's disease (Fitzpatrick, Simpson, \& Smith, 2010) as well as acute depression (Mason \& Hargreaves, 2001).
The benefits of undertaking meditative mindfulness practice in the context of MBCT have been linked to changes in metacognitive processes. Two distinct multi-level information processing frameworks dealing with how thoughts are processed from a metacognitive perspective have been proposed: The Interacting Cognitive Subsystems (ICS; Teasdale, 1999a, 1999b) and the Self Regulatory Executive Function (S-REF; Wells, 2000) theory. The ICS framework forms a rationale for meditative aspects of the MBCT programme. The S-REF model differs from the ICS theory in its conceptualisation of the object or 'being' mode of metacognitive processing.
Regular daily practice of mindfulness meditation has been regarded as among the most essential aspects of mindfulness programmes (Kabat-Zinn, 1990; Mason \& Hargreaves, 2001). Existing studies, with their focus on effectiveness or acceptability of MBCT as an intervention, have thus far excluded an important aspect of the course involving the experience of meditative homework assignments. Therefore, the aim of this study was to explore subjective accounts of the meaning of carrying out meditative homework assignments in the context of a National Health Service (NHS) run MBCT course. The research questions focused on the impact of meditative homework on thought processes as well as an exploration of barriers and facilitating factors from a participant's perspective.Six individual in-depth interviews were conducted with participants all of whom had completed the full MBCT programme. Interpretive phenomenological Analysis (IPA) was used as the methodology for analysing interview transcripts. Data analysis began with a detailed examination of one case until a thorough analysis was completed after which subsequent cases were analysed. Finally a cross case analysis was carried out where individual themes were interrogated for similarities and differences (Smith, et al., 2009).
Two master themes were presented: 'The relationship of meditative homework to metacognitive experience' and 'Motivating and discouraging factors for engagement in meditative practice'. Results reveal a transformation in metacognitive processes as a result of undertaking meditative homework. The subjective experience of metacognitive processes is examined in the context of existing psychological theories including the ICS (Teasdale, 1999a, 1999b) as well as the S-REF (Wells, 2000) theory involving metacognitions. A model for perceived facilitating factors and difficulties experienced in carrying out meditative homework is constructed based on the Integrated Theoretical Foundations Model for CBT homework assignment (Kazantzis, et al., 2005). The model explores participants' motivation in three stages of the homework process: firstly during assignment of the meditative homework task, secondly in completing the planned task and finally carrying out review of the task in question. Implications of the present study are discussed in relation to psychological literature, homework assignment and the practise of MBCT.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Cognitive Therapy | – | Behavioral: Mindfulness Based Cognitive Therapy (MBCT)The present study will use participants who have experienced more than three episodes of depression as judged by South London and Maudsley NHS Trust. No restrictions are placed in terms of participants' use of antidepressant medication. Participants will be 18 to 65 years old and would have participated in an MBCT course run by South London and Maudsley NHS Trust. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eight participants will be recruited from South London and Maudsley NHS Trust, which is a national health service site offering Mindfulness Based Cognitive Therapy (MBCT).
Key inclusion criteria (5 listed)
- Participants will be 18 to 65 years of age and recruited through an NHS Trust offering MBCT.
- At present I am uncertain of the exact inclusion and exclusion criteria as the relevant NHS trust is yet to be determined, so the guidelines recommended by Teasdale et al., (2000) and Ma and Teasdale (2004) will be used.
- These authors suggest that MBCT has no significant effect on reducing the relapse rates of depression in patients with ≤ 2 episodes of depression.
- Therefore the present study will use participants who have experienced more than three episodes of depression as judged by the relevant NHS Trust.
- No restrictions are placed in terms of participants' use of antidepressant medication.
Key exclusion criteria (2 listed)
- Exclusion criteria consists of disorders where the participant would have difficulties understanding and/or applying mindfulness techniques, including current alcohol or substance dependence, borderline personality disorder, organic mental disorder or pervasive developmental delay, schizoaffective disorder, schizophrenia, schizophreniform disorder, delusional disorder and psychotic disorder not otherwise specified.
- Potential participants engaging in yoga or Buddhist meditation more than twice a week are excluded as these practices significantly overlap with the MBCT program.
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 Therapy (MBCT)Also: MBCTMindfulness based cognitive therapy (MBCT) is a group psycho-educational treatment designed to reduce the risk of recurrent depression by integrating mindfulness based meditation practices with cognitive therapy techniques. MBCT comprises eight weekly two-hour group sessions with an additional one hour daily 6 days a week for meditative homework practice. | Behavioural | Mindfulness Based Cognitive Therapy |
Primary outcome
The project involves one 60-minute interview per participant aiming to evaluate lived experience of having taken part in an MBCT programme. The specific focus is on MBCT programme's possible impact on personal identity, barriers and facilitating factors.
Time frame: Interviews are conducted upon completion of MBCT course
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2012.
- Resources for Mindfulness Based Cognitive Therapy (MBCT)Link provided by the sponsor.
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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.
Marika Lahtinen principal investigator
University of East London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Lahtinen, Marika at 1 site in United Kingdom.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 29 Feb 2012. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The project involves one 60-minute interview per participant aiming to evaluate lived experience of having taken part in an MBCT programme. The specific focus is on MBCT programme's possible impact on personal identity, barriers and facilitating factors. (time frame: Interviews are conducted upon completion of MBCT course). 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 29 Feb 2012.