Brain mechanisms of acceptance and commitment therapy for nerve pain

INTERVENTION: Patients will be randomised to either the ACT condition (66%) or waiting list condition (33%) using a secure (24‐hour) web‐based randomisation programme controlled centrally by the Liverpool Clinical Trials Centre (LCTC). Randomisation will take place per patient after the second diagnostic visit with the researcher or during a phone call with the researcher. Patients randomised to the intervention group will start treatment directly and will be treated with ACT for PDN. Patients will be offered seven 2‐3 hour group sessions of ACT, delivered at weekly to fortnightly intervals within a time frame of around 3 months. A valued ACTion intervention programme is a brief ACT‐based group treatment programme aiming to train patients with PDN how to develop more acceptance, mindfulness, commitment and behaviour change strategies to increase psychological flexibility in order to clarify patients’ values so that they can return to a rich, full life. All patients will be informed that randomization to the waitlist condition implies that treatment would be offered after the final research visit (at 6 months follow up), either (a) access the intervention’s resources (such as audio sessions to listen to in their own time and a therapy workbook) or (b) take part in the full ACT intervention in person. CONDITION: Painful diabetic neuropathy (PDN) ; Nervous System Diseases PRIMARY OUTCOME: ; 1. Feasibility‐related outcomes will include the following: number of referrals, the number of interviews with researchers, time taken to fill in questionnaires, missing data, and follow‐up response rates, measured at T2 (post‐treatment periods); 2. Acceptability of the treatment assessed using qualitative methods to provide a better insight into the following: a barrier screening evaluation, burden for not taking part/discontinuation?or dropping out, sessions attended rates, homework completion, time dedicated to homework practice, experience (satisfaction, perceptions), acceptability of the protocol to the Aintree Diabetes Centre, measured at T2 (post‐treatment periods); 3. The means and standard deviations (SDs) of the SF36 scale and its subscales in the neuropathic pain population are estimated in order to compute a more robust estimate of the sample size and effect size required for future efficacy trials; INCLUSION CRITERIA: 1. Age 18 years or older, who have normal or corrected to normal vision and hearing by having a visual acuity of at least decimal 0.5 (6/12) measured on the Snellen scale (e.g., without metal‐rimmed glasses or hearing aids) 2. Willing to participate in the study and complete the scientific protocol 3. People with type 1 or type 2 diabetes, with a glycated hemoglobin (HbA1c) level =11% at the screening visit, will be considered eligible to participate in the study SECONDARY OUTCOME: ; 1. Neuroimaging outcomes: brain plasticity in relation to the neural substrates of pain modulation measured using high‐resolution anatomical images obtained using T1‐ and T2‐weighted scans for grey matter anatomy assessments and DTI for white matter assessment. Comparison of functional information will use Blood Oxygen Level Dependent (BOLD) echo‐planar imaging in response to painful stimuli and emotional conflicts, and in the resting‐state, measured at T1 (pre‐treatment periods), T2 (post‐treatment periods).; 2. Computer‐based/neuropsychological tests: neurocognitive functioning measured using Cambridge Neuropsychological Test Automated Battery (CANTAB®) at T1 (pre‐treatment periods), T2 (post‐treatment periods), T3 (2‐month follow‐up); 3. Self‐report questionnaires:; 3.1. Catastrophic thinking measured using the Pain Catastrophizing Scale (PCS) at T1 (pre‐treatment periods), T2 (post‐treatment periods), T3 (2‐month follow‐up); 3.2. Perceived control over pain, and Medical utilisation measured using the Survey of Pain Attitudes (SOPA) at T1 (pre‐treatment periods), T2 (post‐treatment periods), T3 (2‐month follow‐up); 3.3. Patients' readiness to adopt a self‐management approach to their chronic pain and in monitoring their progress in rehabilitation measured using the Pain Stages of Change questionnaire (PSOCQ) at T1 (pre‐treatment periods), T2 (post‐treatment periods), T3 (2‐month follow‐up); 3.4. Quality of life (QOL) measured using the SF‐36 Health Survey and the General health: EQ‐5D‐5L at T1 (pre‐treatment periods), T2 (post‐treatment periods), T3 (2‐month follow‐up); 3.5. Self‐care activity associated with glycaemic control measured using the Diabetes Self‐Management Questionnaire (DSMQ) at T1 (pre‐treatment periods), T2 (post‐treatment periods), T3 (2‐month follow‐up); 3.6. Fatigue measured using the Single‐item Rhoten Fatigue Scale at T1 (pre‐treatment periods), T2 (post‐treatment periods), T3 (2‐month follow‐up); 3.7. Patient's perception of how treatment has affected their level of activity, symptoms, emotions, and overall quality of life measured using the Patient Global Impression of Change (PICQ) at T2 (post‐treatment periods), T3 (2‐month follow‐up); 3.8. The acceptability and experience of treatment measured using the Client Satisfaction Questionnaire‐8 (CSQ‐8) at T1 (pre‐treatment periods), T2 (post‐treatment periods), T3 (2‐month follow‐up); 3.9. Emotional functioning measured using the SF‐36 Health Survey (emotional subtest) and the Profile of Mood States at T1 (pre‐treatment periods), T2 (post‐treatment periods), T3 (2‐month follow‐up);