Fibromyalgia Clinical Trial
Official title:
Resilience Factors and Selective Learning in Patients With Fibromyalgia
NCT number | NCT04889300 |
Other study ID # | BRF0421 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 8, 2021 |
Est. completion date | August 2, 2021 |
Verified date | October 2022 |
Source | Philipps University Marburg Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Learning impairments (such as reduced selective learning or excessive generalization) in the context of pain can lead to disability. Learning deficits have been found in experimental studies in various pain populations. In current scientific discussions, the activation of resilience factors (in particular positive affect and optimism) is being considered to optimize learning experiences and to make therapeutic procedures more effective. Positive affect could promote selective learning since positive emotions broaden attention and focus and thus possibly improve inhibitory learning. There is first scientific evidence for improved safety learning through positive affect in non-clinical samples in the context of pain. In this research project, the influence of positive affect and optimism on selective learning will be investigated in a clinical sample of fibromyalgia patients. Data will be collected online and standardized questionnaires will be used. The authors expect that (1) There will be a larger increase in positive affect and positive future expectations in the Best Possible Self condition than in the Typical Day condition. (2) Patients in the Best Possible Self condition will show elevated positive affect and positive future expectations after the intervention compared to patients in the Typical Day condition. (3) And crucially, patients in the Best Possible Self condition will show better selective learning than patients in the Typical Day group. Thus the investigators hypothesize that the blocking effect will be higher for patients with higher degrees of positive affect and optimism.
Status | Completed |
Enrollment | 189 |
Est. completion date | August 2, 2021 |
Est. primary completion date | August 2, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - self-reported fibromyalgia diagnosis - access to a computer or laptop with audio output Exclusion Criteria: - dyslexia - other impairments that affect cognitive performance (e.g. stroke or brain damages) |
Country | Name | City | State |
---|---|---|---|
Germany | Philipps University Marburg Medical Center | Marburg |
Lead Sponsor | Collaborator |
---|---|
Philipps University Marburg Medical Center |
Germany,
Boselie JJ, Vancleef LM, Peters ML. Increasing Optimism Protects Against Pain-Induced Impairment in Task-Shifting Performance. J Pain. 2017 Apr;18(4):446-455. doi: 10.1016/j.jpain.2016.12.007. Epub 2016 Dec 27. — View Citation
Boselie JJLM, Vancleef LMG, Smeets T, Peters ML. Increasing optimism abolishes pain-induced impairments in executive task performance. Pain. 2014 Feb;155(2):334-340. doi: 10.1016/j.pain.2013.10.014. Epub 2013 Oct 19. — View Citation
Flink IK, Reme S, Jacobsen HB, Glombiewski J, Vlaeyen JWS, Nicholas MK, Main CJ, Peters M, Williams ACC, Schrooten MGS, Shaw W, Boersma K. Pain psychology in the 21st century: lessons learned and moving forward. Scand J Pain. 2020 Apr 28;20(2):229-238. doi: 10.1515/sjpain-2019-0180. Review. — View Citation
Flink IK, Smeets E, Bergboma S, Peters ML. Happy despite pain: Pilot study of a positive psychology intervention for patients with chronic pain. Scand J Pain. 2015 Apr 1;7(1):71-79. doi: 10.1016/j.sjpain.2015.01.005. — View Citation
Geschwind N, Meulders M, Peters ML, Vlaeyen JW, Meulders A. Can experimentally induced positive affect attenuate generalization of fear of movement-related pain? J Pain. 2015 Mar;16(3):258-69. doi: 10.1016/j.jpain.2014.12.003. Epub 2014 Dec 20. — View Citation
Harvie DS, Weermeijer JD, Olthof NA, Meulders A. Learning to predict pain: differences in people with persistent neck pain and pain-free controls. PeerJ. 2020 Jun 23;8:e9345. doi: 10.7717/peerj.9345. eCollection 2020. — View Citation
Meevissen YM, Peters ML, Alberts HJ. Become more optimistic by imagining a best possible self: effects of a two week intervention. J Behav Ther Exp Psychiatry. 2011 Sep;42(3):371-8. doi: 10.1016/j.jbtep.2011.02.012. Epub 2011 Mar 2. — View Citation
Meulders A, Boddez Y, Blanco F, Van Den Houte M, Vlaeyen JWS. Reduced selective learning in patients with fibromyalgia vs healthy controls. Pain. 2018 Jul;159(7):1268-1276. doi: 10.1097/j.pain.0000000000001207. — View Citation
Meulders A, Harvie DS, Bowering JK, Caragianis S, Vlaeyen JW, Moseley GL. Contingency learning deficits and generalization in chronic unilateral hand pain patients. J Pain. 2014 Oct;15(10):1046-56. doi: 10.1016/j.jpain.2014.07.005. Epub 2014 Jul 25. — View Citation
Meulders A, Meulders M, Vlaeyen JW. Positive affect protects against deficient safety learning during extinction of fear of movement-related pain in healthy individuals scoring relatively high on trait anxiety. J Pain. 2014 Jun;15(6):632-44. doi: 10.1016/j.jpain.2014.02.009. Epub 2014 Mar 17. — View Citation
Meulders A. Fear in the context of pain: Lessons learned from 100 years of fear conditioning research. Behav Res Ther. 2020 Aug;131:103635. doi: 10.1016/j.brat.2020.103635. Epub 2020 Apr 30. Review. — View Citation
Vlaeyen JWS, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000 Apr;85(3):317-332. doi: 10.1016/S0304-3959(99)00242-0. Review. — View Citation
Vlaeyen JWS, Linton SJ. Fear-avoidance model of chronic musculoskeletal pain: 12 years on. Pain. 2012 Jun;153(6):1144-1147. doi: 10.1016/j.pain.2011.12.009. Epub 2012 Feb 8. — View Citation
Zbozinek TD, Craske MG. The Role of Positive Affect in Enhancing Extinction Learning and Exposure Therapy for Anxiety Disorders. Journal of Experimental Psychopathology. April 2017:13-39. doi:10.5127/jep.052615
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pain expectancy/contingency awareness practice phase | Participants can train to give pain expectancy ratings for the stimuli C+ und D-, which are only used in the practice phase. | Pain-expectancy will be measured in the practice phase before the intervention | |
Other | Positive Affect | Positive Affect will be measured with the Positive and Negative Affect Schedule (PANAS; Breyer & Bluemke, 2016). It will be tested if there are baseline differences between the BPS and TD group. Further, this outcome might be used as covariate. | pre-intervention (baseline) | |
Other | State Optimism/Positive Future Expectancies | State Optimism/Positive Future Expectancies will be measured with the future expectancies scale (FEX; Hanssen et al., 2013; Peters, Vieler, & Lautenbacher, 2016). It will be tested if there are baseline differences between the BPS and TD group. Further, this outcome might be used as a covariate. |
pre-intervention | |
Other | Negative Future Expectancies | Negative Future Expectancies will be measured with the future expectancies scale (FEX; Hanssen et al., 2013; Peters, Vieler, & Lautenbacher, 2016).It will be tested if participants´ score in Negative Future Expectancies are influenced by the intervention. | pre-intervention (baseline) | |
Other | Negative Affect | Negative Affect will be measured with the Positive and Negative Affect Schedule (PANAS; Breyer & Bluemke, 2016). It will be tested if there are baseline differences between the BPS and TD group. | pre-intervention | |
Primary | Positive Affect | Positive Affect will be measured with the Positive and Negative Affect Schedule (PANAS; Breyer & Bluemke, 2016). It will be tested if participants of the BPS group score higher in Positive Affect after the intervention than at baseline. Further, we will test if participants in the BPS condition score higher in Positive Affect than participants in the TD group. | post-intervention (immediately after the intervention) | |
Primary | State Optimism/Positive Future Expectancies | State Optimism/Positive Future Expectancies will be measured with the future expectancies scale (FEX; Hanssen et al., 2013; Peters, Vieler, & Lautenbacher, 2016). It will be tested if participants of the BPS group score higher in Optimism after the intervention than at baseline. Further, we will test if participants in the BPS condition score higher in Optimism than participants in the TD group. |
post-intervention (immediately after the intervention) | |
Primary | Pain expectancy/contingency awareness pre-rating phase | Numerical Rating Scale (NRS; 0-100; 0 = expect not all, 100 = expect very much) It will be tested to which extent participants expect pain for the different stimuli which are used in the experiment (A, B, X, Z). | Pain-expectancy will be measured in the pre-rating phase before the intervention | |
Primary | Pain expectancy/contingency awareness elemental acquisition phase | Numerical Rating Scale (NRS; 0-100; 0 = expect not all, 100 = expect very much) It will be tested to which extent participants expect pain for the stimuli A+ and Z-. | Pain-expectancy will be measured in the practice phase before the intervention | |
Primary | Pain expectancy/contingency awareness reminder of acquisition phase | Numerical Rating Scale (NRS; 0-100; 0 = expect not all, 100 = expect very much) It will be tested to which extent participants expect pain for the stimuli A+ and Z-. | post-intervention (immediately after the intervention) | |
Primary | Pain expectancy/contingency awareness compound acquisition phase | Numerical Rating Scale (NRS; 0-100; 0 = expect not all, 100 = expect very much) It will be tested to which extent participants expect pain for the stimuli B+, AX+ and Z-. | post-intervention (immediately after the intervention) | |
Primary | Pain expectancy/contingency awareness test phase | Numerical Rating Scale (NRS; 0-100; 0 = expect not all, 100 = expect very much) It will be tested to which extent participants expect pain for X, B, and Z. In case of "blocked", i.e. reduced pain expectation for X in the test phase we can assume adaptive, selective learning. | post-intervention (immediately after the intervention) | |
Primary | Positive Affect | Positive Affect will be measured with the Positive and Negative Affect Schedule (PANAS; Breyer & Bluemke, 2016). It will be tested if affect is stable from immediate postvisualization to end of the experiment. | immediately after the blocking procedure | |
Primary | State Optimism/Positive Future Expectancies | State Optimism/Positive Future Expectancies will be measured with the future expectancies scale (FEX; Hanssen et al., 2013; Peters, Vieler, & Lautenbacher, 2016). It will be tested if state optimism is stable from immediate postvisualization to end of the experiment. |
immediately after the blocking procedure | |
Secondary | Trait Optimism | Trait Optimism will be measured with the revised version of the life-orientation-test (LOT-R; Scheier & Carver 1985). | pre-intervention (baseline) | |
Secondary | chronic pain | Pain will be measured with the revised graded chronic pain scale (GCPS-R, von Korff et al., 2020). | immediately after the blocking procedure | |
Secondary | Depression | Depression will be measured with the Patient Health Questionnaire (PHQ-9, Spitzer, Kroenke & Williams, 1999). | immediately after the blocking procedure | |
Secondary | Pain Catastrophizing | Pain Catastrophizing will be measured with the Pain Catastrophizing Scale (PCS; Sullivan, Bishop, Pivik 1995). Answers are scored on a 5-point rating scale (0 = not at all; 4 = all the time). | immediately after the blocking procedure | |
Secondary | Negative Affect | Negative Affect will be measured with the Positive and Negative Affect Schedule (PANAS; Breyer & Bluemke, 2016). It will be tested if participants´ scores in Negative Affect are influenced by the intervention. | post-intervention (immediately after the intervention) | |
Secondary | Negative Affect | Negative Affect will be measured with the Positive and Negative Affect Schedule (PANAS; Breyer & Bluemke, 2016). It will be tested if Negative Affect is stable from immediate postvisualization to end of the experiment. | immediately after the blocking procedure | |
Secondary | Negative Future Expectancies | Negative Future Expectancies will be measured with the future expectancies scale (FEX; Hanssen et al., 2013; Peters, Vieler, & Lautenbacher, 2016).It will be tested if participants´ score in Negative Future Expectancies are influenced by the intervention. | immediately after the blocking procedure | |
Secondary | Negative Future Expectancies | Negative Future Expectancies will be measured with the future expectancies scale (FEX; Hanssen et al., 2013; Peters, Vieler, & Lautenbacher, 2016).It will be tested if participants´ score in Negative Future Expectancies are influenced by the intervention. | post-intervention (immediately after the intervention) |
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