ABCD: Attentional Re-training for Chronic Pain Patients

Sponsor
Nantes University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04150419
Collaborator
Fondation Apicil (Other)
90
1
3
12
7.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Group 1
  • Other: Group 2
  • Other: Group 3 (control group)
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Evaluation of the Effectiveness of a Therapeutic Program for the Attentional Re-training of Chronic Pain Patients: Feasibility of E-care
Actual Study Start Date :
Oct 15, 2021
Anticipated Primary Completion Date :
Oct 15, 2022
Anticipated Study Completion Date :
Oct 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: G1

Other: Group 1
Attentional training to avoid threatening, negative or pain-related information.

Experimental: G2

Other: Group 2
Attention training for vigilance for positive emotional information.

Active Comparator: G3

Other: Group 3 (control group)
Neutral attentional training (control group).

Outcome Measures

Primary Outcome Measures

  1. To evaluate the effectiveness of a therapeutic program for attentional re-training on the painful feelings of patients with chronic pelvic-perineal pain. [3 months]

    Variation in pain assessed from the numerical scale. The Numerical Pain Rating Scale measures the perception of pain intensity with an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Nantes Nantes France 44400

Sponsors and Collaborators

  • Nantes University Hospital
  • Fondation Apicil

Investigators

  • Principal Investigator: Virginie Quistrebert-Davanne, PhD, Nantes University Hospital Nantes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT04150419
Other Study ID Numbers:
  • RC18_0361
First Posted:
Nov 4, 2019
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nantes University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2022