FibromyalgiaNCT04889300
Resilience Factors and Selective Learning in Patients With Fibromyalgia
A study testing Best Possible Self and Typical Day in people with Fibromyalgia, run by Philipps University Marburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Best Possible Self and Typical Day
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteGermany
- Study dates
- 8 Apr 2021to 2 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- self-reported fibromyalgia diagnosis
- access to a computer or laptop with audio output
Who cannot join
- dyslexia
- other impairments that affect cognitive performance (e.g. stroke or brain damages)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Best Possible Self, Typical Day
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Possible SelfBehavioural
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.
Typical DayBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Typical Day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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-.
Measured: 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-.
Measured: 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-.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: immediately after the blocking procedure
Secondary outcomes (8)
Trait Optimism
Trait Optimism will be measured with the revised version of the life-orientation-test (LOT-R; Scheier \& Carver 1985).
Measured: pre-intervention (baseline)
chronic pain
Pain will be measured with the revised graded chronic pain scale (GCPS-R, von Korff et al., 2020).
Measured: immediately after the blocking procedure
Depression
Depression will be measured with the Patient Health Questionnaire (PHQ-9, Spitzer, Kroenke \& Williams, 1999).
Measured: immediately after the blocking procedure
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).
Measured: immediately after the blocking procedure
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.
Measured: post-intervention (immediately after the intervention)
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.
Measured: immediately after the blocking procedure
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.
Measured: immediately after the blocking procedure
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.
Measured: post-intervention (immediately after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start8 Apr 2021
- Primary completion2 Aug 2021
- Study completion2 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Riecke, Philipps University Marburg
- Investigators
- Winfried Rief, Professor, Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889300
- Sponsor's protocol ID
- BRF0421
- Status last verified
- Oct 2022
- First submitted
- 21 Apr 2021
- Last updated
- 6 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28039101Boselie 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.
PubMed 24145210Flink 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.
PubMed 32242835Flink 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.
PubMed 29911605Geschwind 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.
PubMed 25536535Harvie 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.
PubMed 32612886Meevissen 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.
PubMed 21450262Meulders 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.
PubMed 32417719Meulders 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.
PubMed 29533384Meulders 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.
PubMed 25068487Meulders 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.
PubMed 24650796Vlaeyen 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.
PubMed 10781906Vlaeyen 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.
PubMed 22321917Zbozinek 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience Factors and Selective Learning in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT04889300
- Acronym / sponsor ID
- BRF0421
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 2 Aug 2021 (actual)
- Study completion
- 2 Aug 2021 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Best Possible Self | Experimental | Behavioral: Best Possible SelfPositive 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. |
| Typical Day | Active comparator | Behavioral: Typical DayIn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- self-reported fibromyalgia diagnosis
- access to a computer or laptop with audio output
Key exclusion criteria (2 listed)
- dyslexia
- other impairments that affect cognitive performance (e.g. stroke or brain damages)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best Possible SelfParticipants 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. | Behavioural | Best Possible Self |
| Typical DayParticipants 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. | Behavioural | Typical Day |
Primary outcome
Positive Affect
Time frame: post-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.
State Optimism/Positive Future Expectancies
Time frame: post-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 phase
Time frame: Pain-expectancy will be measured in the pre-rating phase before 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 different stimuli which are used in the experiment (A, B, X, Z).
Pain expectancy/contingency awareness elemental acquisition phase
Time frame: Pain-expectancy will be measured in the practice phase before 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 reminder of acquisition phase
Time frame: post-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 phase
Time frame: post-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 phase
Time frame: post-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 Affect
Time frame: immediately after the blocking procedure
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.
State Optimism/Positive Future Expectancies
Time frame: immediately after the blocking procedure
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.
8 secondary outcomes
Trait Optimism
Time frame: pre-intervention (baseline)
chronic pain
Time frame: immediately after the blocking procedure
Depression
Time frame: immediately after the blocking procedure
Pain Catastrophizing
Time frame: immediately after the blocking procedure
Negative Affect
Time frame: post-intervention (immediately after the intervention)
Negative Affect
Time frame: immediately after the blocking procedure
Negative Future Expectancies
Time frame: immediately after the blocking procedure
Negative Future Expectancies
Time frame: post-intervention (immediately after the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Background: PubMed 28039101Boselie 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.
- Background: PubMed 24145210Boselie 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.
- Background: PubMed 32242835Flink 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.
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- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried Rief, Professor principal investigator
Philipps University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Possible Self and Typical Day in people with Fibromyalgia, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Affect (time frame: post-intervention (immediately after the intervention)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04889300, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.