Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04889300
Status:
COMPLETED
Last Update Posted:
2022-10-06
First Post:
2021-04-21
Brief Title:
Resilience Factors and Selective Learning in Patients With Fibromyalgia
Sponsor:
Philipps University Marburg Medical Center
Organization:
Philipps University Marburg Medical Center
Study Overview
Official Title:
Resilience Factors and Selective Learning in Patients With Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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 ie 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 GPower for ANOVA with repeated measures within-between interaction with a small effect f01 Power 08 α005
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 ANOVAs with repeated measures and t-tests are planned to be calculated There will be four separate repeated measures RM ANOVAs on positive and negative Affect and on positive and negative future expectations with Group BPSTD as between-factor and Time PrePost 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 ANOVAs to test acquisition of pain expectancy in the different phases The central analysis will be a 2 x 3 RM ANOVA with Group BPSTD as between-subjects variable and Stimulus Type BZX 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 ZX ratings in the test phase or if they give the same rating throughout the whole experiment Participants who did not complete the BPSTD writing exercise properly will be excluded from ANOVAs with group factors
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 GPower for ANOVA with repeated measures within-between interaction with a small effect f01 Power 08 α005
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 ANOVAs with repeated measures and t-tests are planned to be calculated There will be four separate repeated measures RM ANOVAs on positive and negative Affect and on positive and negative future expectations with Group BPSTD as between-factor and Time PrePost 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 ANOVAs to test acquisition of pain expectancy in the different phases The central analysis will be a 2 x 3 RM ANOVA with Group BPSTD as between-subjects variable and Stimulus Type BZX 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 ZX ratings in the test phase or if they give the same rating throughout the whole experiment Participants who did not complete the BPSTD writing exercise properly will be excluded from ANOVAs with group factors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None