The current study aims at investigating whether individual mindfulness-based cogntiive therapy (MBCT) online and MBCT offered face-to-face in groups are superior to a waiting list-control group in terms of improvement of depression and anxiety,…
ID
Source
Brief title
Condition
- Other condition
- Anxiety disorders and symptoms
Synonym
Health condition
depressieve stemmingstoornissen en -afwijkingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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).
Secondary outcome
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.
Background summary
During the past 20 years the survival rate of cancer has increased due to
advancements in the diagnosis and treatment of cancer. Therefore, cancer is
increasingly approached as a chronic illness. After diagnosis the 5 year
survival rate is about 70% (Mitchell, Ferugson, Gill, Paul & Symonds, 2013). In
the coming years the incidence and surival rates will increase even further. As
a consequence, more people will receive a cancer diagnosis and more people will
have to deal with the consequences of cancer. The Dutch Cancer Foundation, by
means of illustration, expects an increase of the absolute 10-year prevalence
of cancer from 420.000 people in 2009 to 660.000 in 2020 (Signaleringscommissie
KWF Kankerbestrijding, 2011).
A significant share of the cancer patients suffers from psychological
complaints. Recent figures show that the mean prevalence of depression in
cancer patients is estimated between 8 and 24% depending on the diagnostic
instrument used.
This process of ilness has different stages, the diagnostic phase, treatment
phase, post treatment phase and revalidation afterwards. Sometimes it means
living in fear of cancer recurrence. About 15% of the breast cancer patients
has psychological complaints during the diagnostic phase, and 15 % of them
develop psychological symptoms after treatment (Henselmans et.al., 2010)
Since the absolute prevalence of cancer is rising, the request for
psychological help for cancer patients will rise too in the upcoming years.
Therefore, we are in need of effective and broadly available psychological
services.
Study objective
The current study aims at investigating whether individual mindfulness-based
cogntiive therapy (MBCT) online and MBCT offered face-to-face in groups are
superior to a waiting list-control group in terms of improvement of depression
and anxiety, fatigue, psychological health, quality of life, mindfulness skills
and cost-effectiveness. We will also examine the predictors and mediators of
treatment effect in both individual MBCT online and MBCT group training. With
regard to prediction of treatment effect, we will investigate socio-demographic
variables such as age and education level. With regard to mediation, we will
look at mindfulness skills, working alliance between client and professional
and group cohesion.
Study design
A three-armed (group/online/TAU) randomized, waiting-list-controlled study
Intervention
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 minutes, 6 days a week. They will
receive CD sets with exercises to support this. The individual online MBCT
programme will have the same content as the face-to-face MBCT.
In the individual online condition, clients will practise exercises at home
guided by audio files and written instructions that are included in a reader.
For example, clients will start the intervention by studying the reader*s
chapter for that first week and by downloading an MP3 file with the body scan
exercise, which they are asked to practice every day for 45 minutes. They
register their experiences in their homework logs during the week. The
therapist will react to the homework logs with a written reply, sent to the
patient on a predetermined day of the week. Patients continue with the next
week by downloading a new chapter of the reader and new mindfulness exercises
for that week, and so on for all nine weeks. Clients can only continue with the
next session after they have recorded their homework experiences of the
previous week. Clients complete the programme in 9-12 weeks.
Study burden and risks
This study involves capacitated adults and therapeutic research. Participation
is free of charge. There are no indications that there are risks related to the
intervention. Participating in this study can be time consuming, as
participants will be interviewed on several occasions, they will fill out
several questionnaires at different time points. These questionnaires contain
questions that might be confronting for the participant, as they confront the
participant with her current situation. However, we do not expect this to be
harmful.
Reinier Postlaan 10
Nijmegen 6525GC
NL
Reinier Postlaan 10
Nijmegen 6525GC
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46338.091.13 |