The treatment of co-morbid emotional problems in people with diabetes type 2: Evaluation of a mindfulness-based psychological intervention

A considerable proportion of the patients with type 2 diabetes experience
emotional problems, varying from disease-specific worries to general symptoms
of anxiety and depression. This emotional well-being is related to other
unfavourable outcomes, like reduced quality of life, worse self-care, reduced
glycemic control, complications, and mortality. A mindfulness-based
psychological intervention may increase the emotional well-being in patients
with diabetes, since the intervention has proven to be successful in various
other patient populations earlier.

1. To test the effectivity of a mindfulness-based psychological intervention
(MBSR) aimed at increasing the emotional well-being and quality of life of
patients with type 2 diabetes; 2. To examine which group of patients, with
which characteristics (like the extent of complications and personality) will
benefit most from the intervention; 3. To investigate the effect of the
intervention on self-care, health care consumption behaviour, glycemic control,
and blood pressure.

The study is a randomized controlled trial (RCT). For the intervention there
are four measurements for the experimental group and seven measurements for the
wait-list control group: both groups are measured before the intervention of
the experimental group (T1), at week 4 of the intervention (T2), immediately
after the intervention (T3), one month after the end of the intervention of the
experimental group (T4) and six months after the end of the intervention of the
experimental group (T5). In addition, the T5 measurement is the pre-measurement
of the control group, who will get another three measurements during and after
their intervention.

MBSR: the group mindfulness-based intervention will be given in eight weekly
sessions (including one booster session) to groups of eight to ten persons. The
intervention will be based on a combination of existing protocols. Besides
education about the mechanisms of stress, coping, and relaxation, there will be
much emphasis on practicing mindfulness (e.i. breathing, moving, and observing
and letting-go thoughts with non-judgemental attention) and there will be group
discussions about relevant matters concerning the exercises and daily living.
Wait-list control group: the wait-list control group will continue to receive
regular care (care-as-usual) and will be placed on a wait-list to receive the
MBSR intervention six months later. Both interventions will be given by a
psychologist.

MBSR is a widely applied and investigated intervention, for which no risks are
known. Participants join eight sessions of two-and-a-half hours and at several
occasions questionnaires (15 - 45 min.) are completed. In addition, no invasive
treatments are performed, except two standard venipunctures. Risk is therefore
minimal.