The Development of Contextual Cognitive Behavioural Approach to PDN

NCT03700528 | Unknown

• 1 other identifier: IRAS ID 224386
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Diabetes Mellitus; Painful Diabetic Neuropathy

Outcome Measures

Primary Outcomes (1)

• Committed Action Questionnaire (CAQ-8)

  The CAQ-8 is an eight-item measure of committed action, a facet of PF. Committed action is the ability to persist with actions that are guided by goals, including when this runs into discouraging experiences and to change these actions when they are shown to be ineffective. Responses to the items were rated from 0 (never true) to 6 (always true). Out of the eight items four are positively keyed and four negatively keyed.

  8 weeks

Secondary Outcomes (7)

• Cognitive Fusion Questionnaire (CFQ-7)

  8 weeks

• Chronic Pain Acceptance Questionnaire (CPAQ-8)

  8 weeks

• Douleur neuropathique 4 (DN4)

  8 weeks

• Pain Scale

  8 weeks

• Patient Health Questionnaire (PHQ-9)

  8 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

This is a single-cohort ACT based intervention.

Behavioral: Acceptance and Commitment Therapy (ACT)

Interventions

Acceptance and Commitment Therapy (ACT) 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Not understanding verbal explanation or written information in English.
• Suffering from neuropathy due to other causes than diabetes.

Sponsors & Collaborators

• King's College London: lead
• Diabetes UK: collaborator

Study Sites (2)

St Thomas' NHS Foundation Trust (Diabetes Clinic)

London, SE1 7EH, United Kingdom

RECRUITING

Guy's hospital NHS Foundation Trust (Diabetes Clinic)

London, SE1 9RT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Neuropathies

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 9, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)