Effectiveness of 'Taking it Further' (TiF) Programme

January 11, 2022 updated by: ProfessorWillemKuyken, University of Oxford

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7JX
        • University of Oxford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindfulness Programme
Participants randomized to the mindfulness programme were invited to complete a twelve-week programme called 'Taking it Further'.
Behavioral: Taking it Further
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.
No Intervention: Waitlist Control
Participants 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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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.
Pre-intervention (~2 weeks and 1 week before Week 0), Week 0, Week 4, Week 8, Week 12 (Post-intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Mindfulness
Time Frame: Pre-intervention (~2 weeks and 1 week before Week 0), Week 0, Week 4, Week 8, Week 12 (Post-intervention)
To explore the effects of the TiF programme on mindfulness over time, the Five Facet Mindfulness Questionnaire Short-Form (FFMQ-15) will be used.
Pre-intervention (~2 weeks and 1 week before Week 0), Week 0, Week 4, Week 8, Week 12 (Post-intervention)
Change in Psychological Quality of Life
Time Frame: Week 0, Week 4, Week 8, Week 12 (Post-intervention)
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.
Week 0, Week 4, Week 8, Week 12 (Post-intervention)
Change in Depression
Time Frame: Week 0, Week 4, Week 8, Week 12 (Post-intervention)
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.
Week 0, Week 4, Week 8, Week 12 (Post-intervention)
Change in Anxiety
Time Frame: Week 0, Week 4, Week 8, Week 12 (Post-intervention)
To investigate the effects of the TiF programme on anxiety over time, the 7-item Generalized Anxiety Disorder (GAD-7) will be used.
Week 0, Week 4, Week 8, Week 12 (Post-intervention)
Change in Self-compassion
Time Frame: Week 0, Week 4, Week 8, Week 12 (Post-intervention)
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.
Week 0, Week 4, Week 8, Week 12 (Post-intervention)
Change in Decentring
Time Frame: Week 0, Week 4, Week 8, Week 12 (Post-intervention)
To explore the effects of the TiF programme on decentring over time, the 11-item Experiences Questionnaire (EQ) will be used.
Week 0, Week 4, Week 8, Week 12 (Post-intervention)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Amount of mindfulness practice
Time Frame: Week 4, Week 8, Week 12 (Post-intervention)
The amount of mindfulness practice will be meausured using daily journal logs and participants will be asked about the amount of practice every four weeks retrospectively.
Week 4, Week 8, Week 12 (Post-intervention)
Change in quality of mindfulness practice
Time Frame: Week 4, Week 8, Week 12 (Post-intervention)
To assess the quality of mindfulness practice, the Practice Quality-Mindfulness (PQ-M) questionnaire will be used.
Week 4, Week 8, Week 12 (Post-intervention)
Change in side effects of mindfulness practice
Time Frame: Week 4, Week 8, Week 12 (Post-intervention)
Participants will be asked about their experience (including potential side effects of mindfulness practice) across a twelve-week period using open-ended questions.
Week 4, Week 8, Week 12 (Post-intervention)
Perceived expectations
Time Frame: Week 0
Participants will be asked about perceived expectations about the TiF programme before they took part.
Week 0
Perceived credibility
Time Frame: Week 12 (Post-intervention)
Participants will be asked about perceived credibility of the TiF programme after they completed the programme.
Week 12 (Post-intervention)
Perceived quality of teaching
Time Frame: Week 12 (Post-intervention)
Participants allocated to treatment will be asked about perceived quality of teaching received during the TiF programme.
Week 12 (Post-intervention)
Potential harm
Time Frame: Week 12 (Post-intervention)
Participants will be asked about perceived harm over the course of twelve weeks.
Week 12 (Post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oxford

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mind and Life Europe

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Willem Kuyken, University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TiF2021
  • 2020EVA-Maloney, Shannon (Other Grant/Funding Number: Mind and Life Europe)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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