NCT02138513

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 19, 2017

Status Verified

February 1, 2016

Enrollment Period

2.3 years

First QC Date

May 6, 2014

Last Update Submit

September 18, 2017

Conditions

DistressAnxietyDepression

Keywords

MindfulnessMBCTCancerOncologyE-healthCost-effectiveness

Outcome Measures

Primary Outcomes (1)

  • 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).

    0 (baseline), 3 months (post intervention)

Secondary Outcomes (14)

  • Change from baseline in fear of cancer recurrence

    0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)

  • DSM-IV Axis I mood or anxiety disorders

    0, 3 (post intervention), 12 months (9mo follow-up)

  • Change from baseline in positive mental health

    0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)

  • Change from baseline in healthcare consumption

    0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)

  • Change from baseline in health-related quality of life

    0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)

  • +9 more secondary outcomes

Study Arms (3)

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

Interventions

Mindfulness Based Cognitive TherapyBEHAVIORAL

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.

Online MBCTgroup MBCT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • severe psychiatric morbidity as psychoses, suicidal ideation
  • previous mindfulness-based treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500HB, Netherlands

Location

Helen Dowling Institute

Bilthoven, Utrecht, 3723 MB, Netherlands

Location

Related Publications (4)

  • 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.

    PMID: 34138447DERIVED

  • Bisseling 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.

    PMID: 31628791DERIVED

  • Compen 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.

    PMID: 29953304DERIVED

  • Compen 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.

    PMID: 26273472DERIVED

MeSH Terms

Conditions

Anxiety DisordersDepressionNeoplasms

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Anne EM Speckens, MD, PhD

    Radboud University Medical Centre Nijmegen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 14, 2014

Study Start

April 1, 2014

Primary Completion

July 20, 2016

Study Completion

May 1, 2017

Last Updated

September 19, 2017

Record last verified: 2016-02

Locations

NL(2)