(Cost-)Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Cancer Patients

Depression Clinical Trial

— BeMind  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138513
• Other study ID #: 2012.WO14.C153
• Secondary ID: NL46338.091.13
• Status: Completed
• Phase: N/A
• First received: May 6, 2014
• Last updated: September 18, 2017
• Start date: April 2014
• Est. completion date: May 1, 2017

Study information

• Verified date: February 2016
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: May 1, 2017
• Est. primary completion date: July 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• severe psychiatric morbidity as psychoses, suicidal ideation

• previous mindfulness-based treatment.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Distress

Intervention

Behavioral:
• Mindfulness Based Cognitive Therapy
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.

Locations

Country	Name	City	State
Netherlands	Helen Dowling Institute	Bilthoven	Utrecht
Netherlands	Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Secondary	DSM-IV Axis I mood or anxiety disorders	DSM IV Axis I psychiatric disorder as diagnosed by a structured interview	0, 3 (post intervention), 12 months (9mo follow-up)
Secondary	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.	0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Secondary	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.	0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Secondary	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).	0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Secondary	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).	0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Secondary	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.	0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Secondary	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).	0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Secondary	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.	0 (baseline) and 12 months (9mo follow-up)
Secondary	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	week 2,3,4,5,6,7,8 and 9 of intervention
Secondary	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).	week 4 and week 9 during intervention
Secondary	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.	week 4 and week 9 during intervention
Secondary	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).	week 2,3,4,5,6,7,8 and 9 of intervention
Secondary	Change from baseline in anxiety and depressive symptoms - follow up	Hospital Anxiety and Depression Scale - anxiety and depressive symptoms at follow up.	0, (baseline) 6 (3mo follow-up) and 12 months (9mo follow-up)

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