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MindfulnessNCT05154266

Effectiveness of 'Taking it Further' (TiF) Programme

A study testing Taking it Further in people with Mindfulness, run by University of Oxford at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Meta-analyses have demonstrated that mindfulness-based programmes are more effective than no treatment across different populations and desired outcomes yet there is limited evidence on how to sustain these benefits beyond the traditional eight-week courses. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mindfulness
What is being tested?
Taking it Further
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
1 siteUnited Kingdom
Study dates
28 Jun 2021to 21 Dec 2021
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • English-speaking
  • Has access to computer for online mindfulness sessions and assessments
  • Participants who have completed an MBSR and/or MBCT course in the past

Who cannot join

  • Has taken TiF programme prior to the start of the study
  • Has completed a mindfulness programme that does not fit within the parameters of a formal mindfulness-based programme.
  • Those that have recently experienced a traumatic event or bereavement and/or has been abusing substances to manage stress and/or has been harming themselves recently
  • Participants on mindfulness teacher training pathway

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University of Oxford

    Oxford, Oxfordshire, OX3 7JX

Other trials in United Kingdom

About this study

Official title: Effectiveness of 'Taking it Further' (TiF) Programme Compared to Waitlist Control in the Promotion of Well-being and Mental Health: A Randomised Controlled Trial With Graduates of MBCT and MBSR

Meta-analyses have demonstrated that mindfulness-based programmes are more effective than no treatment across different populations and desired outcomes yet there is limited evidence on how to sustain these benefits beyond the traditional eight-week courses. The 'Taking it Further' (TiF) programme was developed by the University of Oxford Mindfulness Centre to help reinforce and deepen one's mindfulness practice to promote well-being and mental health for life. The proposed study aims to evaluate the effectiveness of this programme in graduates of MBCT/MBSR on well-being and mental health outcomes and explore the mediators (i.e. mindfulness, decentring, and self-compassion) through which this programme has an effect over the course of twelve weeks using a randomised controlled trial with a waitlist control. The planned research is part of an overall effort to optimize treatment effects and the long-term effectiveness of mindfulness-based programmes.

Read the detailed description

Participants that expressed an interest in taking part in the study were screened for research inclusion/exclusion criteria and for course suitability. Research inclusion/exclusion was assessed by the lead researcher whereas course suitability was assessed jointly by the lead researcher and a trained mindfulness teacher at the Oxford Mindfulness Centre (OMC). Eligible participants were invited to complete baseline measures that assessed the primary outcome and mediator (well-being and mindfulness respectively) around two weeks before the start date and then again around one week before the start date to establish a stable baseline. For one of these online questionnaires, participants were instructed to complete an online orientation video to ensure continued eligibility. Within a few days of the start date, participants were randomised to the treatment (online TiF programme) or wait-list control group. One day before the start date, all participants were invited to complete a battery of questionnaires which assessed the outcome measures (well-being, psychological quality of life, depression, anxiety), mediator measures (mindfulness, self-compassion, decentring), and an additional measure regarding perceived expectations about the mindfulness course. Participants were then invited to complete a battery of questionnaires at weeks 4, 8, and 12 (post-intervention). For the battery of questionnaires for weeks 4 and 8, participants completed the same measures assessed at baseline with additional questions that assessed: the amount of practice, quality of practice, side effects of practice, and overall experience. For week 12 (post-intervention), participants completed the same measures as weeks 4 and 8 with additional questions that assessed the perceived credibility of the mindfulness programme, perceived quality of mindfulness teaching, and potential harm. Data collection was divided into two phases, with the first phase running from June-September and the second phase running from October-December 2021. The TiF courses were run online and the surveys themselves were also administered online.

Conditions
Mindfulness
Being tested
Taking it Further
Keywords
Mindfulness-Based Cognitive Therapy, Mechanism, Mediator, Well-being, Mental health
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Taking it FurtherBehavioural

    This programme is offered to individuals who have already completed a Mindfulness-Based Cognitive Therapy (MBCT) or Mindfulness-Based Stress Reduction Programme (MBSR). In this programme, participants explore weekly themes (i.e. 'Responding not reacting' and 'Taking care of ourselves, taking care of others'). These themes reinforce the learning from the eight-week MBCT/MBSR courses whilst also providing new learning opportunities. The programme makes some of the dimensions that are implicit in MBCT/MBSR more explicit; for example, the cultivation of attitudes of mindfulness (such as equanimity, joy, and kindness). These attitudes of mindfulness require a foundational mindfulness practice and thus this is an additive learning theme from traditional MBCT/MBSR programmes.

Study groups in NCT05154266
Study groupRoleWhat they receive
Mindfulness ProgrammeExperimentalParticipants randomized to the mindfulness programme were invited to complete a twelve-week programme called 'Taking it Further'.
Receives: Behavioral: Taking it Further
Waitlist ControlNo interventionParticipants randomized to the waitlist control were asked to carry on as usual and were offered the Taking it Further course at a later time. No data was collected when the waitlist control group took part in the TiF programme.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Well-being

    To explore the effects of the TiF programme on well-being over time, the 14-item Warwick-Edinburgh Mental Well-being Scale (WEMWBS) will be used.

    Measured: Pre-intervention (~2 weeks and 1 week before Week 0), Week 0, Week 4, Week 8, Week 12 (Post-intervention)

Secondary outcomes (6)
  1. Change in Mindfulness

    To explore the effects of the TiF programme on mindfulness over time, the Five Facet Mindfulness Questionnaire Short-Form (FFMQ-15) will be used.

    Measured: Pre-intervention (~2 weeks and 1 week before Week 0), Week 0, Week 4, Week 8, Week 12 (Post-intervention)

  2. Change in Psychological Quality of Life

    To investigate the effects of the TiF programme on psychological quality of life over time, the 6-item psychological domain of the WHO-QOL-BREF questionnaire will be used.

    Measured: Week 0, Week 4, Week 8, Week 12 (Post-intervention)

  3. Change in Depression

    To evaluate the effects of the TiF programme on symptoms of depression over time, the 9-item Patient Health Questionnaire (PHQ-9) will be used.

    Measured: Week 0, Week 4, Week 8, Week 12 (Post-intervention)

  4. Change in Anxiety

    To investigate the effects of the TiF programme on anxiety over time, the 7-item Generalized Anxiety Disorder (GAD-7) will be used.

    Measured: Week 0, Week 4, Week 8, Week 12 (Post-intervention)

  5. Change in Self-compassion

    To explore the effects of the TiF programme on self-compassion over time, the 12-item Self-Compassion Scale Short-Form (SCS-SF) will be used.

    Measured: Week 0, Week 4, Week 8, Week 12 (Post-intervention)

  6. Change in Decentring

    To explore the effects of the TiF programme on decentring over time, the 11-item Experiences Questionnaire (EQ) will be used.

    Measured: Week 0, Week 4, Week 8, Week 12 (Post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2021
  2. Study start28 Jun 2021
  3. Primary completion21 Dec 2021
  4. Study completion21 Dec 2021

Resources

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
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Wait-list control
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05154266
Sponsor's protocol ID
TiF2021
Other IDs
2020EVA-Maloney, Shannon
Status last verified
Jan 2022
First submitted
29 Nov 2021
Last updated
13 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Montero-Marin J, Farley ER, Maloney S, Crane R, D'Alton P, Eldridge R, Giommi F, Griffith G, Hecht FM, Hinze V, Loucks EB, Strauss C, Taylor L, Baer R, Kuyken W. Participants' Perspective on the Competence of Mindfulness-Based Interventions Teaching: Development and Validation of the Mindfulness-Based Interventions-Participants' Assessment of Teaching (MBI:PAT) Questionnaire. Mindfulness (N Y). 2025;16(10):2825-2844. doi: 10.1007/s12671-025-02668-8. Epub 2025 Sep 3.

    PubMed 41322157
  • Maloney S, Montero-Marin J, Kuyken W. Mindfulness-Based Cognitive Therapy-Taking it Further (MBCT-TiF) compared to Ongoing Mindfulness Practice (OMP) in the promotion of well-being and mental health: A randomised controlled trial with graduates of MBCT and MBSR. Behav Res Ther. 2024 Feb;173:104478. doi: 10.1016/j.brat.2024.104478. Epub 2024 Jan 6.

    PubMed 38244384
  • Maloney S, Montero-Marin J, Kuyken W. Pathways to mental well-being for graduates of mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction (MBSR): A mediation analysis of an RCT. Psychother Res. 2024 Nov;34(8):1162-1173. doi: 10.1080/10503307.2023.2269299. Epub 2023 Nov 6.

    PubMed 37931304

Questions about this trial

What is this clinical trial studying?

A study testing Taking it Further in people with Mindfulness, run by University of Oxford 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 3 inclusion and 4 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 13 Jan 2022. 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?

Change in Well-being (time frame: Pre-intervention (~2 weeks and 1 week before Week 0), Week 0, Week 4, Week 8, Week 12 (Post-intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05154266, which also lists 3 linked publications.

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 13 Jan 2022.

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