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Resilience Factors and Selective Learning in Patients With Fibromyalgia

Resilience Factors and Selective Learning in Patients With Fibromyalgia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04889300
Enrollment
189
Registered
2021-05-17
Start date
2021-04-08
Completion date
2021-08-02
Last updated
2022-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

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.

Detailed description

Selective learning will be experimentally investigated by using the blocking procedure. The blocking effect is one mechanism that can provide information about selective learning. In this procedure, one event (A+) will be first paired with pain. Participants should learn the relation between this event and the occurrence of pain. After, another event (x), i.e. the blocking stimulus, is displayed with the first event A (AX+). The combination of both events will also be associated with pain. It will be tested, to which extent participants expect pain for the blocking stimulus alone. In case of blocked, i.e. reduced pain expectation for X we can assume adaptive, selective learning. In the planned study a fictitious diary of a fibromyalgia patient will be used as cover story. Different events and the words pain or no pain will be visually presented together, indicating in which situation pain occurs and in which not. Participants will be asked to imagine that they are the practitioner trying to learn which situations are associated with pain. This learning experiment is based on a former study by Meulders and colleagues, in which selective learning was investigated by presenting fictitious diary entries, such as Kim was walking her dog or the weather was bad today (CS) and pairing the sentences in terms of the blocking procedure (see above). In the central test phase, in which events were presented without pain report, participants were asked to give their pain expectations for the different situations. Deficits in selective learning were found in fibromyalgia patients compared to healthy control. For the planned study this learning paradigm will be used with minor adaptations (translated to German, minor instruction adaptations, renamed scale ends, higher scale resolution). The learning experiment will take about 15 minutes. Positive affect and optimism will be induced through the Best Possible Self (BPS) Intervention. Subjects will be randomly assigned to either the optimism condition or a control condition. The whole study will be conducted online. Participants will be asked to switch from the experimental platform to the questionnaire platform at various times. In order to recreate the laboratory situation and to keep participants engaged, we implemented several videos in which the virtual investigator guides participants throughout the experiment. The sample size should include 164 participants, assuming a small effect. A priori power analyses were calculated with the software program G\*Power for ANOVA with repeated measures, within-between interaction with a small effect (f=0.1, Power 0.8, α=0.05). Patients with fibromyalgia will be recruited via social media platforms like Facebook and Instagram, but also through advertisement in magazines, self-help groups as well as via flyers in medical offices and clinics. Mainly ANOVA´s with repeated measures and t-tests are planned to be calculated. There will be four separate repeated measures (RM) ANOVA´s on positive and negative Affect and on positive and negative future expectations with Group (BPS/TD) as between-factor and Time (Pre/Post) as within-subjects factor. Planned contrasts will also be used to check whether the increase in a) positive affect and b) positive future expectations (and not a decrease in a) negative affect and b) negative future expectations) will be larger in the BPS group compared with the TD group. Further, we will calculate ANOVA´s to test acquisition of pain expectancy in the different phases. The central analysis will be a 2 x 3 RM ANOVA with Group (BPS/TD) as between-subjects variable and Stimulus Type (B/Z/X) as within-subjects variable on pain expectancy ratings in the test phase of the learning experiment. Further, following the literature, the investigators might do responder analyses and use the change in a) positive affect and b) positive future expectations as predictors for selective learning (in order to have more power in statistical analyses, if necessary). Transformations: Transformations of not normally distributed variables will be done. Inference criteria: We will use the standard p \< .05 criteria. Data exclusion: Participants will be excluded from analyses, if they give Z\>X ratings in the test phase or if they give the same rating throughout the whole experiment. Participants, who did not complete the BPS/TD writing exercise properly will be excluded from ANOVA´s with group factors.

Interventions

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.

BEHAVIORALTypical Day

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.

Sponsors

Philipps University Marburg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
State Optimism/Positive Future Expectanciespost-intervention (immediately after the intervention)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.
Pain expectancy/contingency awareness pre-rating phasePain-expectancy will be measured in the pre-rating phase before the interventionNumerical 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/contingency awareness elemental acquisition phasePain-expectancy will be measured in the practice phase before the interventionNumerical 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/contingency awareness reminder of acquisition phasepost-intervention (immediately after the intervention)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/contingency awareness compound acquisition phasepost-intervention (immediately after the intervention)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-.
Pain expectancy/contingency awareness test phasepost-intervention (immediately after the intervention)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.
Positive Affectpost-intervention (immediately after the intervention)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.

Secondary

MeasureTime frameDescription
Trait Optimismpre-intervention (baseline)Trait Optimism will be measured with the revised version of the life-orientation-test (LOT-R; Scheier & Carver 1985).
chronic painimmediately after the blocking procedurePain will be measured with the revised graded chronic pain scale (GCPS-R, von Korff et al., 2020).
Depressionimmediately after the blocking procedureDepression will be measured with the Patient Health Questionnaire (PHQ-9, Spitzer, Kroenke & Williams, 1999).
Pain Catastrophizingimmediately after the blocking procedurePain 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).
Negative Affectpost-intervention (immediately after the intervention)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.
Negative Future Expectanciesimmediately after the blocking procedureNegative 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.

Other

MeasureTime frameDescription
Pain expectancy/contingency awareness practice phasePain-expectancy will be measured in the practice phase before the interventionParticipants can train to give pain expectancy ratings for the stimuli C+ und D-, which are only used in the practice phase.
Positive Affectpre-intervention (baseline)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.
State Optimism/Positive Future Expectanciespre-interventionState 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.
Negative Future Expectanciespre-intervention (baseline)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.
Negative Affectpre-interventionNegative 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026