(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).

Completed

Conditions: depressieve stemmingstoornissen en -afwijkingen
Fear and depression
psychological wellbeing
10002861

Registration Number: NL-OMON40225

Lead Sponsor: Radboudumc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 245

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Anxiety and depression as assessed by the Hospital Anxiety and Depression-scale<br /><br>(HADS). The HADS is a self-report questionnaire that comprises 14 items<br /><br>measuring feelings of generalized fear and depressive symptoms. The HADS is<br /><br>considered a reliable and valid instrument for assessing anxiety and depression<br /><br>in medical patients and is sensitive to change (Herrmann, 1997; Bjelland et<br /><br>al., 2002). This instrument was also validated in a palliative cancer<br /><br>population (Akechi, 2006). </p><br>

Secondary Outcome Measures

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