(Cost) effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in cancer patients: a superiority trial of online versus face-to-face treatment versus treatment as usual (TAU).

(Cost) effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in cancer patients: a superiority trial of online versus face-to-face treatment versus treatment as usual (TAU). - (Online) Mindfulness-Based Cognitive Therapy in cancer patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40225

Enrollment

245

Registered

2014-02-21

Start date

2015-04-24

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depressieve stemmingstoornissen en -afwijkingen Fear and depression psychological wellbeing

Interventions

The face-to-face group MBCT training will consists of 8 weekly sessions of 2,5 hours each and a silent day of 6 hours of meditation practice. Participants will be asked to practice at home for 45 mi

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Included are all patients:;-with a diagnosis of cancer (any stage) -who are suffering from psychological distress (total HADS score >=11), -who, if using psychopharmacological medication, have been on a stable dose for at least three months -who have access to internet and are computer literate -who are capable of filling out questionnaires in Dutch. .

Exclusion criteria

Exclusion criteria: Excluded are all patients with;- Previous experience with mindfulness - severe psychiatric comorbidity such as psychoses and suicidal ideation

Design outcomes

Primary

Measure	Time frame
Anxiety and depression 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).	—

Measure

Time frame

Anxiety and depression 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).

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Secondary

Measure	Time frame
Fear of cancer recurrence (FRCI), mental health (MHC-SF), cost-effectiveness (as assessed by health-related quality of life (EQ-5D + SF-12) and health care consumption (TIC-P)), mindfulness skills (FFMQ-SF), rumination (RRQ), patient-health care professional working alliance (WAI-S), group cohesion (GCQ-22), trainer competence and perceived trainer competence (MBI-TAC), personality (NEO-FFI), qualitative semi-structured interviews. Weekly measurements will be done by the MAAS and the PANAS.	—

Measure

Time frame

Fear of cancer recurrence (FRCI), mental health (MHC-SF), cost-effectiveness (as assessed by health-related quality of life (EQ-5D + SF-12) and health care consumption (TIC-P)), mindfulness skills (FFMQ-SF), rumination (RRQ), patient-health care professional working alliance (WAI-S), group cohesion (GCQ-22), trainer competence and perceived trainer competence (MBI-TAC), personality (NEO-FFI), qualitative semi-structured interviews. Weekly measurements will be done by the MAAS and the PANAS.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)