Diabetes Mellitus Clinical Trial
Official title:
The Development of Contextual Cognitive Behavioural Approach to Painful Diabetic Neuropathy: A Feasibility Trial
Diabetes mellitus (DM) is highly prevalent, and a significant public health problem.
Approximately 25-30% of all individuals with DM develop painful diabetic neuropathy (PDN).
PDN is considered a complex, multi-dimensional condition, possibly affecting the physical and
mental health of the individual. PDN is usually described as a sense of burning, stabbing,
aching and/or pricking mainly affecting areas like toes, legs, and feet and physically
interfering with mobility, sleep, mood, and overall quality of life. This condition
represents both a significant problem in its own right and a useful condition in which to
test treatments that may offer wider benefits for neuropathic pain conditions in general.
A relatively new and promising approach to chronic pain, within the wider range of cognitive
and behavioural approaches, is Acceptance and Commitment Therapy (ACT). ACT is a form of
Cognitive Behavioural Therapy (CBT) that focuses specifically on increasing psychological
flexibility. Psychological flexibility is the capacity to change or continue with a
behaviour, depending on which is more effective, according to one's goals and what the
current situation affords. Psychological flexibility in turn includes processes of
acceptance, values-based action, and other processes related to mindfulness. There are no
published studies of ACT for individuals with PDN, and the limited available evidence
indicates that a CBT-based intervention like ACT has the potential to reduce pain in people
with PDN. People with PDN have clear treatment needs. While ACT may help them, little is
known directly about the relevance of different components of ACT for this condition or about
how to customise it for them. The proposed research aims to conduct a small feasibility trial
which will pilot test a psychological treatment for PDN and assess the feasibility,
acceptability and effectiveness of such a treatment.
People with diabetes often experience a type of pain called Painful Diabetic Neuropathy
(PDN). PDN is described as a stabbing, burning, pricking, or aching sensation affecting the
toes, feet, and legs. This type of pain can interfere with walking, sleep, mood and overall
quality of life. Although medication may offer some short-term improvement in this pain, this
is a chronic condition for the majority of the patients and the pain typically remains a
problem. Our research team aims to assess the acceptability and potential benefits of a
psychological treatment for people with PDN.
The intervention is a tailored ACT-based self-management intervention which will be delivered
online. The purpose of this intervention is to improve participant daily functioning via
increased psychological flexibility. The development of the PDN ACT-based intervention
involved a multidisciplinary team of psychologists, health professionals and diabetes
specialists.
The ACT treatment package will embrace the core treatment processes of acceptance, cognitive
defusion, mindfulness, and values-based action. Methods will include practice in contacting
painful experiences, experiential cognitive methods to promote awareness, exercises similar
to mindfulness, methods to increase one's the role of goals and values in patient choice, and
to help people flexibly stick to commitments.
The process will involve, two brief direct one-to-one contact sessions, one at the beginning
and one at the end of the intervention, with convenient means according to each participant,
as for example Skype, phone or face to face. Following the first one-to-one session there
will be 8 short online sessions, with a duration of 20-30 minutes each. In accordance with
ACT principles, participants will be encouraged to complete tasks between the online
sessions. Particularly, they will be asked to write on a diary weekly, which will include
ratings for openness, awareness and engagement. Within the diary we will also ask
participants to note changes, in medication, if any, and if the data is sufficient and
relevant we will include them in the final analysis. The completion of these tasks has been
found to be predictive of CBT outcomes.
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