Effectiveness of 'Taking it Further' (TiF) Programme

Mindfulness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05154266
• Other study ID #: TiF2021
• Secondary ID: 2020EVA-Maloney,
• Status: Completed
• Phase: N/A
• Start date: June 28, 2021
• Est. completion date: December 21, 2021

Study information

• Verified date: January 2022
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: December 21, 2021
• Est. primary completion date: December 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mindfulness

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University of Oxford	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Mind and Life Europe

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Amount of mindfulness practice	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)
Other	Change in quality of mindfulness practice	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)
Other	Change in side effects of mindfulness practice	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)
Other	Perceived expectations	Participants will be asked about perceived expectations about the TiF programme before they took part.	Week 0
Other	Perceived credibility	Participants will be asked about perceived credibility of the TiF programme after they completed the programme.	Week 12 (Post-intervention)
Other	Perceived quality of teaching	Participants allocated to treatment will be asked about perceived quality of teaching received during the TiF programme.	Week 12 (Post-intervention)
Other	Potential harm	Participants will be asked about perceived harm over the course of twelve weeks.	Week 12 (Post-intervention)
Primary	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.	Pre-intervention (~2 weeks and 1 week before Week 0), Week 0, Week 4, Week 8, Week 12 (Post-intervention)
Secondary	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.	Pre-intervention (~2 weeks and 1 week before Week 0), Week 0, Week 4, Week 8, Week 12 (Post-intervention)
Secondary	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.	Week 0, Week 4, Week 8, Week 12 (Post-intervention)
Secondary	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.	Week 0, Week 4, Week 8, Week 12 (Post-intervention)
Secondary	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.	Week 0, Week 4, Week 8, Week 12 (Post-intervention)
Secondary	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.	Week 0, Week 4, Week 8, Week 12 (Post-intervention)
Secondary	Change in Decentring	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)