Clinical trial NCT04150419: Attentional Re-training for Chronic Pain Patients
Official title: Evaluation of the Effectiveness of a Therapeutic Program for the Attentional Re-training of Chronic Pain Patients: Feasibility of E-care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pelvic Perinal Pain
Keywords: Attentional bias modification training
chronic pelvi-perinal pain.
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Fondation Apicil
First posted: 2019-11-04
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: To evaluate the effectiveness of a therapeutic program for attentional re-training on the painful feelings of patients with chronic pelvic-perineal pain.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
Study officials:
affiliation: Nantes University Hospital Nantes
name: Virginie Quistrebert-Davanne, PhD
role: PRINCIPAL_INVESTIGATOR
References: