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Attentional Re-training for Chronic Pain Patients (ABCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04150419
Recruitment Status : Not yet recruiting
First Posted : November 4, 2019
Last Update Posted : April 13, 2020
Sponsor:
Collaborator:
Fondation Apicil
Information provided by (Responsible Party):
Nantes University Hospital

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
Chronic Pelvic Perinal Pain Other: Group 1 Other: Group 2 Other: Group 3 (control group) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : June 15, 2020
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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).




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. [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 > 10)
  • Patient under guardianship, curatorship or judicial protection
  • Pregnant or breastfeeding woman

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04150419


Contacts
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Contact: Virginie Quistrebert-Davanne, PhD +33 2 40 76 80 36 virginie.quistrebertdavanne@chu-nantes.fr

Sponsors and Collaborators
Nantes University Hospital
Fondation Apicil
Investigators
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Principal Investigator: Virginie Quistrebert-Davanne, PhD Nantes University Hospital Nantes
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04150419    
Other Study ID Numbers: RC18_0361
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Attentional bias modification training
chronic pelvi-perinal pain.
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms