induction study
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2021 ◽  
Author(s):  
◽  
Bryony Harrison

<p>Guilt induction is a behaviour involving exaggeration of hurt feelings to elicit guilt in an intimate partner, and thus elicit a reassuring and loving response. This thesis investigates whether greater depressive symptoms are linked with use of low level, everyday guilt induction. We also examine the possibility that guilt induction elicits commitment-driven maintenance behaviour from partners, including accommodation (e.g., smiling, providing encouragement) but also increased tolerance for intimate partner violence. We tested a mediation model in which higher depressive symptoms predicted greater of guilt induction, which in turn predicted greater partner accommodation (Study 1) and tolerance of intimate partner violence (Study 2). We assessed observer-coded guilt induction behaviours in a dyadic study (Study 1; 152 couples) and experiences of partner guilt induction in self-report questionnaires (Study 2; 217 individuals). Depressive symptoms predicted greater use of guilt induction (Study 1), and perceptions of partner’s depressive symptoms predicted more experiences of partner guilt induction (Study 2), suggesting that individuals higher in depressive symptoms experience insecurities consistent with motivations to guilt induce. Guilt induction predicted greater use of immediate partner accommodation (Study 1), and experiences of guilt induction predicted greater tolerance for one of four forms of intimate partner violence (Study 2). This suggests that guilt induction elicits accommodation of negative behaviours, including tolerance of certain types of intimate partner violence. An additional analysis highlighted a change in partner behaviour from increased accommodation when guilt induction initially occurred, to relatively decreased accommodation at the following time point, 30 seconds later (Study 1). This research supports and expands on prior theory suggesting people higher in depressive symptomology tend to use strategies to gain reassurance and care that can ultimately backfire.</p>


2021 ◽  
Author(s):  
◽  
Bryony Harrison

<p>Guilt induction is a behaviour involving exaggeration of hurt feelings to elicit guilt in an intimate partner, and thus elicit a reassuring and loving response. This thesis investigates whether greater depressive symptoms are linked with use of low level, everyday guilt induction. We also examine the possibility that guilt induction elicits commitment-driven maintenance behaviour from partners, including accommodation (e.g., smiling, providing encouragement) but also increased tolerance for intimate partner violence. We tested a mediation model in which higher depressive symptoms predicted greater of guilt induction, which in turn predicted greater partner accommodation (Study 1) and tolerance of intimate partner violence (Study 2). We assessed observer-coded guilt induction behaviours in a dyadic study (Study 1; 152 couples) and experiences of partner guilt induction in self-report questionnaires (Study 2; 217 individuals). Depressive symptoms predicted greater use of guilt induction (Study 1), and perceptions of partner’s depressive symptoms predicted more experiences of partner guilt induction (Study 2), suggesting that individuals higher in depressive symptoms experience insecurities consistent with motivations to guilt induce. Guilt induction predicted greater use of immediate partner accommodation (Study 1), and experiences of guilt induction predicted greater tolerance for one of four forms of intimate partner violence (Study 2). This suggests that guilt induction elicits accommodation of negative behaviours, including tolerance of certain types of intimate partner violence. An additional analysis highlighted a change in partner behaviour from increased accommodation when guilt induction initially occurred, to relatively decreased accommodation at the following time point, 30 seconds later (Study 1). This research supports and expands on prior theory suggesting people higher in depressive symptomology tend to use strategies to gain reassurance and care that can ultimately backfire.</p>


PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0259424
Author(s):  
Tessa R. Mazachowsky ◽  
Katarina McKenzie ◽  
Michael A. Busseri ◽  
Caitlin E. V. Mahy

The ability to consider the future under the influence of an induced current state is known as induced-state episodic foresight. One study to date has examined adults’ induced episodic foresight and found that adults’ (like children’s) preferences for the future are related to their current state such that they predicted wanting water (vs. pretzels) in the future when experiencing a current state of thirst [1]. We attempted to replicate these findings in adults. In Study 1, adults (N = 198) in a laboratory selected pretzels for tomorrow at the same rate (around 20%) in an experimental condition (thirst induced) and a control condition (thirst not induced). In a lecture, 32% of adults preferred pretzels for tomorrow without thirst induction (Study 2, N = 63). Partially replicating Kramer et al. [1], we found that a minority of adults preferred pretzels (vs. water) when experiencing a current state of thirst. However, in contrast to their findings, our results showed that when thirst was not induced, a minority of adults also preferred pretzels for tomorrow. Thus, adults’ future preference was similar regardless of thirst induction. We also tested thirst as a mechanism for adults’ preference for the future and found that across conditions adults’ thirst predicted their choice of water (vs. pretzels) for the future. In sum, our results partially replicated Kramer et al. [1] by showing the current state, regardless of thirst induction, predicts adults’ choices for the future.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S112-S113
Author(s):  
E Loftus ◽  
S Vermeire ◽  
B Feagan ◽  
C Yun ◽  
J Hsieh ◽  
...  

Abstract Background Filgotinib (FIL) is a once-daily, oral, preferential Janus kinase 1 inhibitor in development for the treatment of inflammatory bowel disease. FIL for the treatment of moderately to severely active ulcerative colitis (UC) was evaluated in the phase 2b/3 randomized, double-blind, placebo (PBO)-controlled SELECTION study (NCT02914522). Long-term use of corticosteroids (CS) is associated with significant side effects. The aim of this post hoc analysis was to assess the CS-sparing effects of FIL in the SELECTION study. Methods Patients (18–75 years old) with moderately to severely active UC were randomized (2:2:1) to receive FIL 100 mg (n = 564), FIL 200 mg (n = 507) or PBO (n = 280) once daily orally for up to 11 weeks (induction study). At week 11, FIL induction responders were rerandomized 2:1 to continue their induction FIL dose or to receive PBO (maintenance study). CS use was kept stable up to week 14, at which point mandatory CS tapering occurred. CS could be resumed during the maintenance study; however, if the baseline CS dose was exceeded this was considered treatment failure. In this post hoc analysis, CS-free remission was defined as remission at week 58 (endoscopic subscore ≤ 1, rectal bleeding subscore = 0 and ≥ 1-point decrease in stool frequency subscore to achieve 0 or 1) without systemic or localized CS use that was indicated for UC in the previous 1, 3, 6 or 8 months. Results The baseline characteristics of patients in the maintenance study were similar across treatment groups (Table 1). Of the 92 patients receiving CS at maintenance baseline (week 11; maintenance week 0) who received FIL 200 mg during the maintenance study, 25 (27%) were in remission at week 58 and had been continuously CS-free for at least the previous 6 months (Table 2). The proportion of CS-free remitters in the FIL 200 mg group was consistently higher than with PBO (Table 2). In patients taking CS at maintenance baseline who had continued CS-use post baseline, lower median prednisone dosing was observed with FIL 200 mg than with PBO throughout the maintenance study (maximum difference at week 34 [maintenance week 23]: 5.0 mg vs 13.8 mg) (Figure 1). In SELECTION, a total of 199 patients received FIL 200 mg in the maintenance study, of whom 74 (37.2%) were in remission at week 58; of these 74 patients, 69 (93.2%) were continuously CS-free for at least the previous 6 months (Figure 2). Conclusion In this post hoc analysis of SELECTION maintenance study data, FIL 200 mg was effective in reducing and eliminating CS use through to week 58 in patients with moderately to severely active UC. The vast majority of patients taking FIL 200 mg who were in remission at week 58 had not taken CS in the previous 6 months.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S096-S097
Author(s):  
W J Sandborn ◽  
M C Dubinsky ◽  
J Torres ◽  
S Vermeire ◽  
P G Kotze ◽  
...  

Abstract Background Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). RIVETING (NCT03281304) is an ongoing, double-blind, randomised, parallel-group study designed to evaluate the efficacy and safety of dose reduction to tofacitinib 5 mg twice daily (BID) vs remaining on 10 mg BID in patients (pts) with UC in stable remission on tofacitinib 10 mg BID maintenance therapy. Eligible pts had received tofacitinib 10 mg BID for ≥2 consecutive years in an open-label, long-term extension (OLE) study (NCT01470612), and had been in stable remission for ≥6 months (M) and corticosteroid (CS)-free for ≥4 weeks prior to enrolment.1 We aimed to evaluate tofacitinib efficacy outcomes by the number of prior tumour necrosis factor inhibitors (TNFi) failed and by prior CS use. Methods We evaluated the efficacy of tofacitinib 5 mg BID at Month 6 of RIVETING, based on the number of prior TNFi failed (0, 1 or &gt;1), CS use (yes/no) and CS dose (&lt;15 mg/day and ≥15 mg/day) at baseline (BL) of OCTAVE Induction 1&2 and at OLE study BL. CS were prohibited in RIVETING. Results Of the 70 pts randomised to dose-reduce to tofacitinib 5 mg BID, 43 pts had no prior TNFi failure, 17 pts had previous failure with 1 TNFi and 10 pts had previous failure with &gt;1 TNFi. At Month 6, modified Mayo (mMayo) score remission was maintained in 79.1%, 70.6% and 80.0% of pts who had previous failure with 0, 1 and &gt;1 TNFi, respectively. At Month 6, the change from RIVETING BL total Mayo score, mMayo score, partial Mayo score (PMS) and modified PMS was similar across TNFi subgroups (Table 1). Of pts who enrolled into RIVETING, 26 pts were receiving CS (9 received &lt;15 mg/day and 17 received ≥15 mg/day) at induction study BL, and 7 pts were receiving CS at OLE study BL. At Month 6, rates of mMayo score remission were numerically higher in pts with CS use at induction study BL (84.6%) vs those without CS use (72.7%). The rate of mMayo score remission was numerically higher in pts without CS use (77.8%) vs pts with CS use at OLE BL (71.4%), although pt numbers were very low in the CS-use group. These trends were also observed for other efficacy endpoints (Table 2). The Month 6 change from RIVETING BL mMayo score and total Mayo score was numerically higher in pts with vs pts without CS use at induction BL (0.7 and 1.1 vs 0.6 and 0.9, respectively) and OLE BL (1.0 and 1.3 vs 0.6 and 0.9, respectively) (Table 2). Conclusion In pts who were in stable remission for &gt;6M, efficacy endpoints were maintained following dose reduction to tofacitinib 5 mg BID, regardless of the number of prior TNFi failures or prior CS use. These analyses are post hoc and limited by the small sample size. Reference


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S024-S026
Author(s):  
L Peyrin-Biroulet ◽  
I Dotan ◽  
T Hibi ◽  
V Taliadouros ◽  
A Oortwijn ◽  
...  

Abstract Background Patients with ulcerative colitis (UC) often do not respond to treatment or lose response over time, and thus switch between therapies with various mechanisms of action (MoAs).1 Filgotinib (FIL) is a once-daily, oral, Janus kinase 1 preferential inhibitor in development as a UC treatment. We assessed the efficacy of FIL in biologic (bio)-naïve and bio-experienced patients with UC, and in bio-experienced patients with failure of 1 or ≥2 biologics or 1 or 2 MoAs. Methods SELECTION (NCT02914522) was a phase 2b/3 double-blind, randomised, placebo-controlled trial comprising two induction studies and a maintenance study. Adults (18–75 years) with moderately to severely active UC were randomised 2:2:1 to FIL 200 mg, FIL 100 mg or placebo (PBO) once daily for 11 weeks in Induction Study A (bio-naïve) and B (bio-experienced). Patients in either clinical remission or Mayo Clinic Score (MCS) response at week 10 (responders) could enter the Maintenance Study. Responders who received induction FIL were re-randomised 2:1 to continue their induction regimen or PBO through week 58. Responders who received induction PBO continued PBO. We assessed clinical remission and MCS response at weeks 10 and 58 in bio-naïve patients and bio-experienced patients with failure of 1 or ≥2 biologics and 1 or 2 MoAs (TNF antagonists and vedolizumab). All p values for subgroup analyses are nominal. Results At week 10, clinical remission was achieved by a significantly higher proportion of bio-naïve and -experienced patients treated with FIL 200 mg than PBO (Figure 1a). A higher proportion of bio-experienced patients with 1 biologic or MoA failure treated with FIL 200 mg than PBO achieved clinical remission at week 10 (p&lt;0.05); a smaller treatment effect was seen in patients with ≥2 biologic or 2 MoA failures (Figure 1b). None of these comparisons reached p&lt;0.05 for FIL 100 mg. Higher proportions of patients treated with either dose of FIL than PBO achieved MCS response at week 10 in all (sub)groups (Figure 2). At week 58, higher proportions of bio-naïve and -experienced responders, and bio-experienced responders with ≥2 biologic or 2 MoA failures treated with maintenance FIL 200 mg than PBO achieved clinical remission (p&lt;0.05) (Table 1). Higher proportions of responders treated with maintenance FIL 200 mg than PBO achieved MCS response at week 58 in all (sub)groups. Conclusion FIL 200 mg was effective in inducing and maintaining clinical remission in bio-naïve and -experienced patients. Induction results suggest FIL 200 mg is most effective in bio-naïve patients, and those who switch after failure of 1 biologic or MoA. Interpretation of week 58 data is limited by low patient numbers. Reference


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S034-S035
Author(s):  
S Danese ◽  
T Hibi ◽  
T E Ritter ◽  
J B Dinoso ◽  
J Hsieh ◽  
...  

Abstract Background Filgotinib (FIL) is a preferential Janus kinase 1 inhibitor in development for the treatment of inflammatory bowel disease. SELECTION was a phase 2b/3 randomized, double-blind, placebo (PBO)-controlled trial to evaluate FIL for the treatment of moderately to severely active ulcerative colitis (UC) (NCT02914522). The aim of this post hoc analysis was to assess the speed of improvement in patient-reported outcomes (PROs) during FIL treatment. Methods Eligible patients who were biologic-naïve or -experienced were enrolled in induction study A or induction study B, respectively. In each study, patients were randomized 2:2:1 to receive FIL 100 mg, FIL 200 mg or PBO once daily orally for 10 weeks. In this post hoc analysis, data from daily patient diaries up to day 15 of induction, including Mayo stool frequency subscores (SF; range, 0 [normal] to 3 [≥5 stools/day more than normal]) and rectal bleeding subscores (RB; range, 0 [no blood] to 3 [passing blood alone]), were used to evaluate the proportion of patients achieving predefined subscores or subscore reductions. Results Induction studies A and B comprised 659 and 689 patients, respectively. Baseline characteristics were similar across treatment groups within induction study A and within induction study B. In induction study A, more patients treated with FIL 200 mg vs PBO reported a reduction in SF of ≥1 from baseline as early as day 6 (FIL 200 mg, 35.8%; PBO, 20.6%, p&lt;0.01) and every day from day 10 (Figure 1), and a reduction in RB of ≥1 from baseline as early as day 4 (FIL 200 mg, 36.9%; PBO, 23.7%; p&lt;0.01) and every day from day 7 (Figure 2). In induction study B, more patients treated with FIL 200 mg vs PBO reported a reduction in SF of ≥1 from baseline as early as day 2 (FIL 200 mg, 21.6%; PBO, 12.1%; p&lt;0.05) (Figure 3) and a reduction in RB of ≥1 from baseline as early as day 3 (FIL 200 mg, 29.5%; PBO, 17.6%; p&lt;0.01) (Figure 4). More patients receiving FIL 200 mg vs PBO achieved the composite score of RB=0 and SF≤1 as early as day 9 in induction study A (FIL 200 mg, 18.8%; PBO, 9.5%, p&lt;0.05). More patients receiving FIL 200 mg vs PBO achieved the composite score of RB=0 and SF≤1 as early as day 7 in induction study B (FIL 200 mg, 10.7%; PBO, 4.2%, p&lt;0.05). Conclusion In this post hoc analysis of induction study data from SELECTION, improvements in SF and RB were observed within the first week of therapy with FIL 200 mg, compared with PBO, in patients with moderately to severely active UC. These data demonstrate that FIL 200 mg has rapid onset of action, as assessed by PROs, in both biologic-naïve and biologic-experienced patients.


BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e042340
Author(s):  
Helena Nilvér ◽  
Anna Wessberg ◽  
Anna Dencker ◽  
Henrik Hagberg ◽  
Ulla-Britt Wennerholm ◽  
...  

ObjectiveTo compare childbirth experiences in women randomly assigned to either induction of labour at 41 weeks or to expectant management until 42 weeks, in the Swedish Post-term Induction Study.DesignA register-based, multicentre, randomised, controlled, superiority trial.SettingWomen were recruited at 14 hospitals in Sweden, 2016–2018.ParticipantsWomen with an uncomplicated singleton pregnancy were recruited at 41 gestational weeks.InterventionsThe women were randomly assigned to induction of labour at 41 weeks (induction group, n=1381) or expectant management until 42 weeks (expectant management group, n=1379).Outcome measuresAs main outcome, women’s childbirth experiences were measured using the Childbirth Experience Questionnaire version 2 (CEQ2), in 656 women, 3 months after the birth at three hospitals. As exploratory outcome, overall childbirth experience was measured in 1457 women using a Visual Analogue Scale (VAS 1–10) within 3 days after delivery at the remaining eleven hospitals.ResultsThe total response rate was 77% (2113/2760). There were no significant differences in childbirth experience measured with CEQ2 between the groups (induction group, n=354; expectant management group, n=302) in the subscales: own capacity (2.8 vs 2.7, p=0.09), perceived safety (3.3 vs 3.2, p=0.06) and professional support (3.6 vs 3.5, p=0.38) or in the total CEQ2 score (3.3 vs 3.2, p=0.07), respectively. Women in the induction group scored higher in the subscale participation (3.6 vs 3.4, p=0.02), although with a small effect size (0.19). No significant difference was observed in overall childbirth experience according to VAS (8.0 (n=735) vs 8.1 (n=735), p=0.22).ConclusionsThere were no differences in childbirth experience, according to CEQ2 or overall childbirth experience assessed with VAS, between women randomly assigned to induction of labour at 41 weeks or expectant management until 42 weeks. Overall, women rated their childbirth experiences high.Trial registration numberISRCTN26113652.


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