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.
BACKGROUND
Mindfulness-based interventions have shown to reduce psychological distress in cancer patients. The accessibility of mindfulness-based interventions for cancer patients could be further improved by providing mindfulness using an individual internet-based format. The aim of this study is to test the effectiveness of a Mindfulness-Based Cognitive Therapy (MBCT) group intervention for cancer patients in comparison with individual internet-based MBCT and treatment as usual (TAU).


METHODS
A three-armed multicenter randomized controlled trial comparing group-based MBCT to individual internet-based MBCT and TAU in cancer patients who suffer from at least mild psychological distress (Hospital Anxiety and Depression Scale (HADS) ≥ 11). Measurements will be conducted prior to randomization (baseline), post-treatment and at 3 months and 9 months post-treatment. Participants initially allocated to TAU are subsequently randomized to either group- or individual internet-based MBCT and will receive a second baseline measurement after 3 months. Thus, the three-armed comparison will have a time span of approximately 3 months. The two-armed intervention comparison includes a 9-month follow-up and will also consist of participants randomized to the intervention after TAU. Primary outcome will be post-treatment psychological distress (HADS). Secondary outcomes are fear of cancer recurrence (Fear of Cancer Recurrence Inventory), rumination (Rumination and Reflection Questionnaire), positive mental health (Mental Health Continuum - Short Form), and cost-effectiveness (health-related quality of life (EuroQol -5D and Short Form-12) and health care usage (Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness). Potential predictors: DSM-IV-TR mood/anxiety disorders (SCID-I) and neuroticism (NEO-Five Factor Inventory) will be measured. Mediators of treatment effect: mindfulness skills, (Five-Facets of Mindfulness Questionnaire- Short Form), working alliance (Working Alliance Inventory) and group cohesion (Group Cohesion Questionnaire) will also be measured.


CONCLUSIONS
This trial will provide valuable information on the clinical and cost-effectiveness of group versus internet-based MBCT versus TAU for distressed cancer patients.


BACKGROUND
Clinicaltrials.gov NCT02138513. Registered 6 May 2014.
Department of Psychiatry, Radboud University Nijmegen Medical Centre for Mindfulness, Postbus 9101, 6500 HB Nijmegen, The Netherlands.
F R
FR
Compen
Department of Psychiatry, Radboud University Nijmegen Medical Centre for Mindfulness, Postbus 9101, 6500 HB Nijmegen, The Netherlands ; Scientific Research Department, Helen Dowling Institute, Centre for Psycho-Oncology, Bilthoven, The Netherlands.
E M
EM
Bisseling
Scientific Research Department, Helen Dowling Institute, Centre for Psycho-Oncology, Bilthoven, The Netherlands.
M L
ML
Van der Lee
Department for Health Evidence, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
E M M
EM
Adang
Department for Health Evidence, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
A R T
AR
Donders
Department of Psychiatry, Radboud University Nijmegen Medical Centre for Mindfulness, Postbus 9101, 6500 HB Nijmegen, The Netherlands.
A E M
AE
Speckens
D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000379:methods; D003362:Cost-Benefit Analysis; D006801:Humans; D020407:Internet; D064866:Mindfulness; D009369:Neoplasms / Q000523:psychology*; D011569:Psychiatric Status Rating Scales; D011615:Psychotherapy, Group / Q000379:methods*; D011788:Quality of Life; D012107:Research Design; D013315:Stress, Psychological / Q000517:prevention & control*
Cancer; Distress; E-health; Internet-based; Mindfulness-based cognitive therapy; Randomized controlled trial