Evaluation of Cognitive Behavioral Therapy for Long-term Pain in Rheumatic Disease, Including Validation of AE-FS

NCT06413914 | Recruiting DMC

• 2 other identifiers: DS-00805656858
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Catastrophic thinking is a risk factor for a poor prognosis for pain in general and rheumatic disease in particular, which for many contributes to a behavioral pattern characterized by avoidance. Other people with long-term pain, on the other hand, have a pattern where they suppress thoughts and feelings of fear associated with pain, and push themselves to carry out activities. An inappropriate form of endurance can help maintain and intensify pain. The AE-FS is a short version of the Avoidance-Endurance Questionnaire with different subscales for maintaining activity despite pain. AE-FS can be of great clinical utility. The study of patients with rheumatic disease and long-term pain will validate a Norwegian version of the AE-FS as well as examine how the AE-FS seen in connection with other relevant questionnaires, including the Pain Catastrophizing Scale , reflects mechanisms for change in cognitive behavioral therapy for long-term pain. The effect of the intervention is evaluated with questionnaires at baseline/start of treatment, end of treatment, two months after end of treatment and after six months.

Conditions

Rheumatic Diseases; Pain, Chronic

Keywords

"Cognitive behavioral therapy"; Long-term pain; Avoidance-Endurance Questionnaire; Rheumatic disease

Outcome Measures

Primary Outcomes (5)

• Validation of AE-FS

  1\. The AE-FS questionnaire can be of great clinical value for mapping behavior and thoughts in mild and severe pain, both to predict long-term pain and as an educational tool in the treatment of patients. In the project, we will validate the form, by assessing its suitability for our patient group and compliance with other validated forms which, among other things, measure pain, depressive symptoms, anxiety symptoms and function.

  8 months

• Evaluation of cognitive behavioral therapy for long-term pain in rheumatic disease - Feasibility

  In the project, we also to evaluate the feasibility of the treatment:Feasibility and satisfaction, including attendance, dropouts, etc.

  8 months

• Evaluation of cognitive behavioral therapy for long-term pain in rheumatic disease - Pain

  Pain, measured by the Brief Pain Inventory questionnaire - short form

  8 months

• Evaluation of cognitive behavioral therapy for long-term pain in rheumatic disease - General symptoms

  General symptoms, measured by the PROMIS-29 questionnaire (Patient reported outcomes measurement information system).

  8 months

• Evaluation of cognitive behavioral therapy for long-term pain in rheumatic disease - Quality of life

  Quality of life/general health, measured by the EQ-5D-5L questionnaire (general health questionnaire).

  8 months

Secondary Outcomes (1)

• Analyses of predictors and mediators

  8 months

Study Arms (1)

Cognitive behavioral Therapy

EXPERIMENTAL

Cognitive behavioral therapy is the psychological approach in this study. It is associated with better outcomes of rehabilitation for long-term pain in general, reduced pain intensity and less use of medication and health services, sustaining factors that provide an understanding of how thoughts and feelings affect the experience of pain. An important aim is also a reduction in pain-related rumination and worry and changed metacognition that maintains inhibiting behavior and thought patterns. A workbook for pain has been developed. It contains knowledge about pain and pain management, describes measures and homework from session to session. The treatment consists of 8 sessions with 7 weekly sessions + 1 booster session 2 months after the end of treatment.

Behavioral: Cognitive behavioral Therapy

Interventions

Cognitive behavioral Therapy BEHAVIORAL

Cognitive behavioral therapy is the psychological approach in this study. It is associated with better outcomes of rehabilitation for long-term pain in general, reduced pain intensity and less use of medication and health services, sustaining factors that provide an understanding of how thoughts and feelings affect the experience of pain. An important aim is also a reduction in pain-related rumination and worry and changed metacognition that maintains inhibiting behavior and thought patterns. A workbook for pain has been developed. It contains knowledge about pain and pain management, describes measures and homework from session to session. The treatment consists of 8 sessions with 7 weekly sessions + 1 booster session 2 months after the end of treatment. .

Cognitive behavioral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A rheumatic disorder and a long term pain condition
• Written consent

You may not qualify if:

• Participation in another therapy during the study periode

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead

Study Sites (1)

Diakonhjemmet Sykehus

Oslo, 0319, Norway

RECRUITING

MeSH Terms

Conditions

Rheumatic Diseases; Chronic Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Erik Soegaard, PhD

  Diakonhjemmet Hospital

  STUDY CHAIR

Central Study Contacts

Kåre Osnes, PhD

CONTACT

+47 92833866; kare.osnes@diakonsyk.no

Torkil Berge, Psychologist

CONTACT

+47 22 02 98 00; torkil.berge@diakonsyk.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher PhD MD

Model Details: 200 patients with long-term pain and rheumtic disease, participate in cognitive behavioral therapy individually or in a group. The treatment consists of 8 sessions, 7 weekly sessions and a booster session 2 months after the end of treatment.

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: May 14, 2024
• Study Start: January 16, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)