DistressBeMindNCT02138513
(Cost-)Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Cancer Patients
A study testing Mindfulness Based Cognitive Therapy in people with Distress and Anxiety, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
Mindfulness-based cognitive therapy has been demonstrated to be effective in reducing anxiety, depression and fatigue in cancer patients. As this intervention can be offered in groups, costs are relatively low. In addition, delivering MBCT online might make the intervention more accessible and cost-effectiveness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distress, Anxiety, Depression
- What is being tested?
- Mindfulness Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 2 sitesNetherlands
- Study dates
- Apr 2014to 1 May 2017
- 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
- HADS ≥ 11
- Cancer diagnosis (at present or past)
- Stable dose if using psychopharmacological medication for at least 3 months
- computer literacy and acces to internet
- capable of filling out questionnaires in Dutch
Who cannot join
- severe psychiatric morbidity as psychoses, suicidal ideation
- previous mindfulness-based treatment.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Helen Dowling Institute
Bilthoven, Utrecht, 3723 MB
Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500HB
About this study
Official title: (Cost-) Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) in Cancer Patients: a Superiority Trial of Online and Face-to-face Treatment Versus Treatment as Usual (TAU).
Mindfulness-based cognitive therapy has been demonstrated to be effective in reducing anxiety, depression and fatigue in cancer patients. As this intervention can be offered in groups, costs are relatively low. In addition, delivering MBCT online might make the intervention more accessible and cost-effectiveness. However, more information is needed about what treatment works best for which patient.
Therefore, the aim of this study is to investigate clinical and cost-effectiveness of both individual MBCT online and MBCT offered as a group training compared to TAU .
Read more
Study design: The design of the study will be a multi-centre, randomised, superiority trial, comparing MBCT online and MBCT offered as a group training with TAU. Participants in the TAU condition will be randomised to one of the treatment conditions after 3 months. Main assessments will take place at baseline (T0), post-treatment (T1), and 3 (T2) and 9 months after post-treatment (T3).
We expect the MBCT conditions to be superior to TAU in terms of improving mindfulness skills, anxiety and depressive compants, psychological well-being, rumination and fear of cancer recurrence. We also expect the MBCT to result in patients returning to work earlier, have a higher work ability and have lower medical care costs, thereby being more cost-effective than TAU.
- Conditions
- Distress, Anxiety, Depression
- Being tested
- Mindfulness Based Cognitive Therapy
- Keywords
- Mindfulness, MBCT, Cancer, Oncology, E-health, Cost-effectiveness
- Medical subject headings
- Anxiety Disorders, Depression, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive TherapyBehavioural
This MBCT protocol consists of 8 weekly sessions of 2,5 hours each and a silent day of 6 hours of meditation practice. Similar to group MBCT, in the online MBCT group, participants will be asked to practice at home for 45 minutes, 6 days a week. They will receive files with meditation and yoga exercises to support this.
| Study group | Role | What they receive |
|---|---|---|
| Online MBCT | Experimental | Not described Receives: Behavioral: Mindfulness Based Cognitive Therapy |
| group MBCT | Experimental | Not described Receives: Behavioral: Mindfulness Based Cognitive Therapy |
| Treatment as usual | No intervention | 3 months waiting list, subsequent assignment to group or online MBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in anxiety and depressive symptoms
Anxiety and depressive symptoms as assessed by the Hospital Anxiety and Depression-scale (HADS). The HADS is a self-report questionnaire that comprises 14 items measuring feelings of generalized fear and depressive symptoms. The HADS is considered a reliable and valid instrument for assessing anxiety and depression in medical patients and is sensitive to change (Herrmann, 1997; Bjelland et al., 2002). This instrument was also validated in a palliative cancer population (Akechi, 2006).
Measured: 0 (baseline), 3 months (post intervention)
Secondary outcomes (14)
Change from baseline in fear of cancer recurrence
Fear of cancer recurrence will be assessed with the Fear of Cancer Recurrence Inventory (FCRI; Simard \& Savard, 2009a; van der Lee et al., 2012).
Measured: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
DSM-IV Axis I mood or anxiety disorders
DSM IV Axis I psychiatric disorder as diagnosed by a structured interview
Measured: 0, 3 (post intervention), 12 months (9mo follow-up)
Change from baseline in positive mental health
The Mental Health Continuum-Short Form (MHC-SF) measures positive mental health and comprises 14 items, representing various feelings of well-being. Respondents rate the frequency of every feeling in the past month on a 6-point Likert scale (never, once or twice a month, about once a week, two or three times a week, almost every day, every day). The MHC-SF contains three subscales: emotional, psychological and social well-being. MHC-SF has shown high internal and moderate test-retest reliability, convergent and discriminant validity.
Measured: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in healthcare consumption
The TIC-P generates quantitative data about direct medical costs and indirect societal costs as a consequence of psychological/psychiatric illnesses.
Measured: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in health-related quality of life
To measure the quality of the health status of cancer patients a validated health-related quality of life (HRQoL) instrument will be used, the EuroQol-5D (EQ-5D). This HRQoL instrument will be completed by the patient together with a researcher and is available in a validated Dutch translation (Lamers, 2005). The EQ-5D is a generic HRQoL instrument comprising five domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D index is obtained by applying predetermined weights to the five domains. This index gives a societal-based global quantification of the participant's health status on a scale ranging from 0 (death) to 1 (perfect health). Participants will also be asked to rate their overall HRQoL on a visual analogue scale (EQ- 5D VAS) consisting of a vertical line ranging from 0 (worst imaginable health status) to 100 (best imaginable).
Measured: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in health-related quality of life
In addition to the EQ-5D, the SF-12 will be administered for explorative purposes for there are indications that the SF-12 is more sensitive for changes in HRQol in populations with less severe morbidity (Johnson and Coons, 1998).
Measured: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in mindfulness skills
The 39-item Five Facet Mindfulness Questionnaire has been developed as a reliable and valid comprehensive instrument for assessing different aspects of mindfulness. A Dutch 24-item short form of the FFMQ (FFMQ-SF) was developed and assessed in a sample of 376 adults with clinically relevant symptoms of depression and anxiety and cross-validated in an independent sample of patients with fibromyalgia. Confirmatory factor analyses showed good model fit for the five-factor structure of the FFMQ-SF: observing, describing, acting with awareness, nonjudging, and nonreactivity. The FFMQ-SF was related to measures of psychological symptoms, well-being, experiential avoidance, and the personality factors neuroticism and openness to experience.
Measured: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in rumination
The rumination subscale of the RRQ assesses a neurotic self-attentiveness (i.e. recurrent, primarily past-oriented thinking about the self), which is prompted by threats, losses, of injustices to the self. Subjects rate their level of agreement of disagreement on a five-point rating scale (e.g., "I always seem to be rehashing in my mind recent things I've said or done"). There is evidence of good internal consistency (.90) and stability over a 10-month period and convergent validity. The measure in the current study was translated into Dutch using the guidelines of the International Test Commission (Hambleton, 1994). Cronbach's alphas were .88 and .90 in Sample 1, and .90 and .91 in Sample 2, respectively (Luyckx et al., 2008).
Measured: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in personality assessment
Personality is measured with the NEO Five Factor Inventory (NEO-FFI, Costa \& McCrae, 1992) which consists of five domains: neuroticism, extraversion, openness, altruism, and conscientiousness.
Measured: 0 (baseline) and 12 months (9mo follow-up)
Change in mindfulness skills during intervention
The Mindful Attention Awareness Scale (MAAS) will be administered before each MBCT session to assess mindful attention in daily life
Measured: week 2,3,4,5,6,7,8 and 9 of intervention
Group cohesion during intervention
We will examine self-reported individual group cohesion ratings during the MBCT training with a Dutch Group Cohesion Questionnaire that has been used in cancer patients before (May et al., 2008). The GCQ-23 uses 22 items across four scales: the bond with the group as whole, the bond with other members, cooperation within the group and the instrumental value. Each item is rated from 1 (totally disagree) to 6 (totally agree). Internal consistency of all scales was reported to range from adequate to good (0.66-0.88).
Measured: week 4 and week 9 during intervention
Working alliance during intervention
The Working Alliance Inventory (WAI) is most often used to assess working alliance between participant and healthcare professional. We will use the Dutch translation of the short form (WAI-S, Vervaeke \& Vertommen, 1996), which is closely related to the original scale and also has good psychometric and predictive quality (Busseri \& Tyler, 2003). The WAI-S is a 12 item, self report questionnaire, rated on a 7-point Likert scale (1 = never to 7 = always) with three subscales: 1) agreement between participant and therapist on the goals of the therapy; 2) agreement on the rationale of the therapy addressing the problems of the participant; and 3) the quality of the interpersonal bond between the participant and the therapist.
Measured: week 4 and week 9 during intervention
Change in mood during intervention
In the current study, positive and negative affect is assessed before each MBCT session using the International Positive and Negative Affect Scale - Short Form. The cross-sample stability, internal reliability, temporal stability, crosscultural factorial invariance, and convergent and criterion-related validities of the I-PANAS-SF were examined and found to be psychometrically acceptable (Thompson, 2007).
Measured: week 2,3,4,5,6,7,8 and 9 of intervention
Change from baseline in anxiety and depressive symptoms - follow up
Hospital Anxiety and Depression Scale - anxiety and depressive symptoms at follow up.
Measured: 0, (baseline) 6 (3mo follow-up) and 12 months (9mo follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startApr 2014
- Primary completion20 Jul 2016
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DistressStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne EM Speckens, MD, PhD, Principal investigator, Radboud University Medical Centre Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138513
- Sponsor's protocol ID
- 2012.WO14.C153
- Other IDs
- NL46338.091.13
- Acronym
- BeMind
- Status last verified
- Feb 2016
- First submitted
- 6 May 2014
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bisseling EM, Compen FR, Schellekens MPJ, Thewes B, Speckens AEM, van der Lee ML. Exploring Fear of Cancer Recurrence in a Sample of Heterogeneous Distressed Cancer Patients with and Without a Psychiatric Disorder. J Clin Psychol Med Settings. 2021 Sep;28(3):419-426. doi: 10.1007/s10880-021-09776-2. Epub 2021 Jun 17.
PubMed 34138447Bisseling E, Cillessen L, Spinhoven P, Schellekens M, Compen F, van der Lee M, Speckens A. Development of the Therapeutic Alliance and its Association With Internet-Based Mindfulness-Based Cognitive Therapy for Distressed Cancer Patients: Secondary Analysis of a Multicenter Randomized Controlled Trial. J Med Internet Res. 2019 Oct 18;21(10):e14065. doi: 10.2196/14065.
PubMed 31628791Compen F, Bisseling E, Schellekens M, Donders R, Carlson L, van der Lee M, Speckens A. Face-to-Face and Internet-Based Mindfulness-Based Cognitive Therapy Compared With Treatment as Usual in Reducing Psychological Distress in Patients With Cancer: A Multicenter Randomized Controlled Trial. J Clin Oncol. 2018 Aug 10;36(23):2413-2421. doi: 10.1200/JCO.2017.76.5669. Epub 2018 Jun 28.
PubMed 29953304Compen FR, Bisseling EM, Van der Lee ML, Adang EM, Donders AR, Speckens AE. Study protocol of a multicenter randomized controlled trial comparing the effectiveness of group and individual internet-based Mindfulness-Based Cognitive Therapy with treatment as usual in reducing psychological distress in cancer patients: the BeMind study. BMC Psychol. 2015 Aug 13;3(1):27. doi: 10.1186/s40359-015-0084-1. eCollection 2015.
PubMed 26273472
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Cost-) Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) in Cancer Patients: a Superiority Trial of Online and Face-to-face Treatment Versus Treatment as Usual (TAU).
- ClinicalTrials.gov ID
- NCT02138513
- Acronym / sponsor ID
- BeMind / 2012.WO14.C153
- Conditions
- Distress, Anxiety, Depression
- Keywords
- Mindfulness, MBCT, Cancer, Oncology, E-health, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 20 Jul 2016 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 14 May 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.
Mindfulness-based cognitive therapy has been demonstrated to be effective in reducing anxiety, depression and fatigue in cancer patients. As this intervention can be offered in groups, costs are relatively low. In addition, delivering MBCT online might make the intervention more accessible and cost-effectiveness. However, more information is needed about what treatment works best for which patient.
Therefore, the aim of this study is to investigate clinical and cost-effectiveness of both individual MBCT online and MBCT offered as a group training compared to TAU .
Study design: The design of the study will be a multi-centre, randomised, superiority trial, comparing MBCT online and MBCT offered as a group training with TAU. Participants in the TAU condition will be randomised to one of the treatment conditions after 3 months. Main assessments will take place at baseline (T0), post-treatment (T1), and 3 (T2) and 9 months after post-treatment (T3).
We expect the MBCT conditions to be superior to TAU in terms of improving mindfulness skills, anxiety and depressive compants, psychological well-being, rumination and fear of cancer recurrence. We also expect the MBCT to result in patients returning to work earlier, have a higher work ability and have lower medical care costs, thereby being more cost-effective than TAU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Online MBCT | Experimental | Behavioral: Mindfulness Based Cognitive Therapy |
| group MBCT | Experimental | Behavioral: Mindfulness Based Cognitive Therapy |
| Treatment as usual | No intervention | –3 months waiting list, subsequent assignment to group or online MBCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HADS ≥ 11
- Cancer diagnosis (at present or past)
- Stable dose if using psychopharmacological medication for at least 3 months
- computer literacy and acces to internet
- capable of filling out questionnaires in Dutch
Key exclusion criteria (2 listed)
- severe psychiatric morbidity as psychoses, suicidal ideation
- previous mindfulness-based treatment.
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 TherapyThis MBCT protocol consists of 8 weekly sessions of 2,5 hours each and a silent day of 6 hours of meditation practice. Similar to group MBCT, in the online MBCT group, participants will be asked to practice at home for 45 minutes, 6 days a week. They will receive files with meditation and yoga exercises to support this. | Behavioural | Online MBCT, group MBCT |
Primary outcome
Change from baseline in anxiety and depressive symptoms
Time frame: 0 (baseline), 3 months (post intervention)
Anxiety and depressive symptoms as assessed by the Hospital Anxiety and Depression-scale (HADS). The HADS is a self-report questionnaire that comprises 14 items measuring feelings of generalized fear and depressive symptoms. The HADS is considered a reliable and valid instrument for assessing anxiety and depression in medical patients and is sensitive to change (Herrmann, 1997; Bjelland et al., 2002). This instrument was also validated in a palliative cancer population (Akechi, 2006).
14 secondary outcomes
Change from baseline in fear of cancer recurrence
Time frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
DSM-IV Axis I mood or anxiety disorders
Time frame: 0, 3 (post intervention), 12 months (9mo follow-up)
Change from baseline in positive mental health
Time frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in healthcare consumption
Time frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in health-related quality of life
Time frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in health-related quality of life
Time frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in mindfulness skills
Time frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in rumination
Time frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in personality assessment
Time frame: 0 (baseline) and 12 months (9mo follow-up)
Change in mindfulness skills during intervention
Time frame: week 2,3,4,5,6,7,8 and 9 of intervention
Group cohesion during intervention
Time frame: week 4 and week 9 during intervention
Working alliance during intervention
Time frame: week 4 and week 9 during intervention
Change in mood during intervention
Time frame: week 2,3,4,5,6,7,8 and 9 of intervention
Change from baseline in anxiety and depressive symptoms - follow up
Time frame: 0, (baseline) 6 (3mo follow-up) and 12 months (9mo follow-up)
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 19 Sep 2017.
- Derived from this study: PubMed 34138447Bisseling EM, Compen FR, Schellekens MPJ, Thewes B, Speckens AEM, van der Lee ML. Exploring Fear of Cancer Recurrence in a Sample of Heterogeneous Distressed Cancer Patients with and Without a Psychiatric Disorder. J Clin Psychol Med Settings. 2021 Sep;28(3):419-426. doi: 10.1007/s10880-021-09776-2. Epub 2021 Jun 17.
- Derived from this study: PubMed 31628791Bisseling E, Cillessen L, Spinhoven P, Schellekens M, Compen F, van der Lee M, Speckens A. Development of the Therapeutic Alliance and its Association With Internet-Based Mindfulness-Based Cognitive Therapy for Distressed Cancer Patients: Secondary Analysis of a Multicenter Randomized Controlled Trial. J Med Internet Res. 2019 Oct 18;21(10):e14065. doi: 10.2196/14065.
- Derived from this study: PubMed 29953304Compen F, Bisseling E, Schellekens M, Donders R, Carlson L, van der Lee M, Speckens A. Face-to-Face and Internet-Based Mindfulness-Based Cognitive Therapy Compared With Treatment as Usual in Reducing Psychological Distress in Patients With Cancer: A Multicenter Randomized Controlled Trial. J Clin Oncol. 2018 Aug 10;36(23):2413-2421. doi: 10.1200/JCO.2017.76.5669. Epub 2018 Jun 28.
- Derived from this study: PubMed 26273472Compen FR, Bisseling EM, Van der Lee ML, Adang EM, Donders AR, Speckens AE. Study protocol of a multicenter randomized controlled trial comparing the effectiveness of group and individual internet-based Mindfulness-Based Cognitive Therapy with treatment as usual in reducing psychological distress in cancer patients: the BeMind study. BMC Psychol. 2015 Aug 13;3(1):27. doi: 10.1186/s40359-015-0084-1. eCollection 2015.
- Related InfoLink 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.
Anne EM Speckens, MD, PhD principal investigator
Radboud University Medical Centre Nijmegen
2 sites 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 in people with Distress and Anxiety, run by Radboud University Medical Center at 2 sites in Netherlands.
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 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 from baseline in anxiety and depressive symptoms (time frame: 0 (baseline), 3 months (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 NCT02138513, which also lists 4 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 19 Sep 2017.