Resilience Factors and Selective Learning in Patients With Fibromyalgia

NCT04889300 | Completed

• 1 other identifier: BRF0421
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (9)

• 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)

• 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)

• 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

• 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

• 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)

• 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)

• 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)

• 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

• 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 Outcomes (8)

• Trait Optimism

  pre-intervention (baseline)

• chronic pain

  immediately after the blocking procedure

• Depression

  immediately after the blocking procedure

• Pain Catastrophizing

  immediately after the blocking procedure

• Negative Affect

  post-intervention (immediately after the intervention)

Other Outcomes (5)

• Pain expectancy/contingency awareness practice phase

  Pain-expectancy will be measured in the practice phase before the intervention

• Positive Affect

  pre-intervention (baseline)

• State Optimism/Positive Future Expectancies

  pre-intervention

Study Arms (2)

Best Possible Self

EXPERIMENTAL

Positive affect and optimism will be induced through the Best Possible Self (BPS) Intervention. In the optimism intervention, participants will be asked to imagine a future in which everything went well and in which all their wishes are fulfilled. This procedure is known to reliably generate positive affect and positive future expectations (Carrillo et al., 2019). Orientated at Flink et al. (2015) the BPS condition was adapted for a pain population.

Behavioral: Best Possible Self

Typical Day

ACTIVE COMPARATOR

In the control condition, participants are asked to describe and visualize a typical day (TD). We adapted the TD condition in order to take possible changes in participants´ TD due to the COVID-19 pandemic into account.

Behavioral: Typical Day

Interventions

Best Possible Self BEHAVIORAL

Participants are asked to think about their Best Possible Self for one minute, then describe it for 15 minutes (in writing) and, subsequently, imagine it for another 5 minutes as vividly as possible.

Best Possible Self

Typical Day BEHAVIORAL

Participants are asked to think about their Typical Day for one minute, then describe it for 15 minutes (in writing) and, subsequently, imagine it for another 5 minutes as vividly as possible.

Typical Day

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• self-reported fibromyalgia diagnosis
• access to a computer or laptop with audio output

You may not qualify if:

• dyslexia
• other impairments that affect cognitive performance (e.g. stroke or brain damages)

Sponsors & Collaborators

• Philipps University Marburg: lead

Study Sites (1)

Philipps University Marburg Medical Center

Marburg, Germany

Location

Related Publications (14)

• 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.

  PMID: 28039101 BACKGROUND

• 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.

  PMID: 24145210 BACKGROUND

• 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.

  PMID: 32242835 BACKGROUND

• 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.

  PMID: 29911605 BACKGROUND

• 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.

  PMID: 25536535 BACKGROUND

• 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.

  PMID: 32612886 BACKGROUND

• 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.

  PMID: 21450262 BACKGROUND

• 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.

  PMID: 32417719 BACKGROUND

• 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.

  PMID: 29533384 BACKGROUND

• 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.

  PMID: 25068487 BACKGROUND

• 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.

  PMID: 24650796 BACKGROUND

• 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.

  PMID: 10781906 BACKGROUND

• 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. No abstract available.

  PMID: 22321917 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Winfried Rief, Professor

  Philipps University Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Jenny Riecke

Model Details: Positive affect and optimism will be induced through the Best Possible Self (BPS) Intervention. Subjects will be randomly assigned to either the optimism or the control condition. In the optimism intervention, participants will be asked to imagine a future in which everything went well and in which all their wishes are fulfilled. After, it will be tested if selective learning can be increased through higher degrees of positive affect/optimism.

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: May 17, 2021
• Study Start: April 8, 2021
• Primary Completion: August 2, 2021
• Study Completion: August 2, 2021
• Last Updated: October 6, 2022

Record last verified: 2022-10

Locations

DE (1)