Attentional Re-training for Chronic Pain Patients

NCT ID: NCT04150419

Last Updated: 2022-12-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-15
• Study Completion Date: 2022-12-06

Brief Summary

Hyper-vigilance, focusing, avoidance are part of the vocabulary used by the clinician who deals with chronic pain. These notions refer to the functioning and dysfunction of so-called "selective" attention. These "selective attentional biases" are believed to be responsible, in part, for the development and maintenance of negative pain-related thoughts (such as catastrophic thoughts), inappropriate behaviours (such as inactivity and fear of movement) and unpleasant emotions (such as stress or anger). In addition, they would also be a powerful indicator of the onset of post-operative pain and could limit the effectiveness of therapeutic management. Therapeutically, attention bias can be "managed" through attentional re-training techniques (ABMs) that teach patients to direct their attention differently. These techniques have been widely validated in anxious or addictive populations but have never been used to date in chronic pain patients. This home-based attention bias management (e-retraining) would represent, for chronic pain patients, an additional tool aimed not only at reducing their pain but also at achieving other associated factors such as anxiety, stress, catastrophic thoughts, avoidance behaviours and quality of life.

Detailed Description

After obtaining the patients' agreement, they will be randomized in one of the 3 experimental groups:

• G1: Attentional training to avoid threatening, negative or pain-related information.
• G2: Attention training for vigilance for positive emotional information.
• G3: neutral attentional training (control group).

The study will be conducted from the patient's home via a connection to the protected site of the Nantes University Hospital. The various questionnaires will be completed from the secure site of the Nantes University Hospital and the computerized experimental tasks will be carried out using the Inquisit software (WEB version at home).

The study will begin with an evaluation of the patients' attention and psychological processes (completion of questionnaires + 2 attention tasks), during a follow-up visit to the urology department of the University Hospital of Nantes.

Then, an 8-week attentional re-training program (2 training sessions per week) will be proposed.

At the end of the 8 weeks, an evaluation (Questionnaires + attention tasks) will be offered to patients always from home.

Finally, a final evaluation, 4 weeks after the end of the re-training, will always be proposed from the patient's home.

Conditions

Chronic Pelvic Perinal Pain

Keywords

Attentional bias modification training; chronic pelvi-perinal pain.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

G1

Group Type: EXPERIMENTAL

Group 1

Intervention Type: OTHER

Attentional training to avoid threatening, negative or pain-related information.

G2

Group Type: EXPERIMENTAL

Group 2

Intervention Type: OTHER

Attention training for vigilance for positive emotional information.

G3

Group Type: ACTIVE_COMPARATOR

Group 3 (control group)

Intervention Type: OTHER

Neutral attentional training (control group).

Interventions

Group 1

Attentional training to avoid threatening, negative or pain-related information.

Intervention Type: OTHER

Group 2

Attention training for vigilance for positive emotional information.

Intervention Type: OTHER

Group 3 (control group)

Neutral attentional training (control group).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Chronic pain patients, i.e., chronic pain that has been ongoing for more than 3 months.
• Patient follow-up in the urology department of the University Hospital of Nantes
• Age between 18 and 65
• Good understanding of French, able to read and write.
• Serve correctly and painlessly with both hands
• Affiliated with a social security system
• Signed consent
• With internet access.

Exclusion Criteria

• Current and unstable psychiatric (mood disorders, anxiety disorders) and addictive (substance use disorders, alcoholic or otherwise, excluding nicotine) disorders.
• Does not use both hands properly and painlessly
• Depression (BDI-II ≤18)
• Patient under guardianship, curatorship or judicial protection
• Pregnant or breastfeeding woman

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Apicil

OTHER

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Virginie Quistrebert-Davanne, PhD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital Nantes

Locations

CHU Nantes

Nantes, , France

Countries

France

Other Identifiers

RC18_0361

Identifier Type: -

Identifier Source: org_study_id