The Development of Contextual Cognitive Behavioural Approach to PDN

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus Painful Diabetic Neuropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The psychological treatment which we will use is called Acceptance and Commitment Therapy (ACT). The ACT treatment includes treatment processes of acceptance, cognitive defusion, mindfulness, and values-based action. Methods will include practice to deal with painful experiences, to improve awareness, to identify and work on goals, and to better stick to commitments.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

This is a single-cohort ACT based intervention.

Group Type EXPERIMENTAL

Acceptance and Commitment Therapy (ACT)

Intervention Type BEHAVIORAL

The process will involve, two, brief, one-to-one contact sessions, one at the beginning and one at the end of the intervention, in a way that is convenient for participants, including Skype, phone, or face to face in person. Following the first one-to-one session there will be eight short online sessions, about 20-30 minutes each. Participants will also be asked to complete some tasks between the sessions, in particular to record their progress briefly and any changes at their medication (i.e. type of drug, dose) in a diary weekly so that they can keep track of your developing skills.

Interventions

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Acceptance and Commitment Therapy (ACT)

The process will involve, two, brief, one-to-one contact sessions, one at the beginning and one at the end of the intervention, in a way that is convenient for participants, including Skype, phone, or face to face in person. Following the first one-to-one session there will be eight short online sessions, about 20-30 minutes each. Participants will also be asked to complete some tasks between the sessions, in particular to record their progress briefly and any changes at their medication (i.e. type of drug, dose) in a diary weekly so that they can keep track of your developing skills.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Aged at least 18 years.
* Confirmed diagnosis of diabetes.
* Presence of painful diabetic neuropathy.
* Have full verbal and written proficiency in English.
* Willingness and ability to take part.
* Have computer literacy.