Viewing Study NCT06625151



Ignite Creation Date: 2024-10-26 @ 3:41 PM
Last Modification Date: 2024-10-26 @ 3:41 PM
Study NCT ID: NCT06625151
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-10-01

Brief Title: Perfectionism and Daily Coping and Emotion Regulation Processes a Trial of Two Explanatory Feedback Interventions
Sponsor: None
Organization: None

Study Overview

Official Title: Perfectionism and Daily Stress Coping and Well-Being Testing an Explanatory Feedback Intervention
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Over the past three decades perfectionism has received increasing theoretical and empirical attention as a cognitive-personality factor that increases vulnerability to a wide range of psychological problems including depression and anxiety Although mediators and moderators of the link between perfectionism and well-being have been identified the direct clinical utility of these findings has not been a focus The Perfectionism and Coping Processes Model - Explanatory Feedback Intervention PCPM-EFI draws on previous findings and individually analyzes participant responses to perfectionism measures and online daily questionnaires of stress coping and mood over 7 days The EFI provides an individualized slideshow presentation that is delivered in a single 45-60 minute session by a student research assistant to address how stress and coping patterns trigger and maintain negative affect and lower positive affect in the participants daily life A recent waitlist controlled feasibility trial compared the PCPM-EFI condition with a waitlist control condition over 4 weeks in 176 university students with higher SC perfectionism with individualized feedback delivered one-on-one by student trainees in-person or remotely through videoconferencing The feasibility of the individualized analyses of each participants daily data was supported by identifying daily trigger patterns maintenance tendencies strengths common triggers and best targets for reducing negative mood and increasing positive mood across several stressors for each participant Participant ratings indicated that the comprehensive feedback was coherent and functional Participants in the EFI condition compared to those in the control condition reported increases in empowerment coping self-efficacy and problem-focused coping as well as decreases in depressive and anxious symptoms Between-group effect sizes were moderate-to-large There were reliable improvements in empowerment and depressive symptoms for 56 and 36 respectively of participants in the EFI condition These findings demonstrate the broad applicability conceptual utility and effectiveness of the PCPM-EFI for self-critical perfectionistic individuals Given these promising findings research is needed to examine the utility of customizing daily emotion regulation findings and the complementary effects of providing meaningful feedback on well-being

The present study will build on the promising findings of the PCPM-EFI by using a 7-day daily diary methodology to test a complementary EFI on perfectionism and emotion regulation processes eg self-compassion mindfulness experiential avoidance rumination reappraisal delivered online through videoconferencing in a sample of university students with higher self-critical perfectionism Based on the Perfectionism and Emotion Regulation Processes Model PERPM the PERPM-EFI follows the same structure as the PCPM-EFI to provide individualized analyses drawn from previous findings The results of a pilot study of 12 university students with higher SC perfectionism suggest that the PERPM-EFI is broadly applicable conceptually useful and effective Specifically despite the small sample size participants reported increases in empowerment mindfulness self-compassion and emotional self-awareness as well as decreases in depressive and anxious symptoms The present study will use a randomized control design to examine whether the PCPM-EFI plus PERPM-EFI can better improve well-being relative to providing no feedback the PERPM-EFI alone or PCPM-EFI alone in the context of a 4-week longitudinal study with three time points in a sample of 180 university students The four conditions will be a waitlist control condition b PCPM-EFI c PERPM-EFI and d PCPM-EFI plus PERPM-EFI It is hypothesized that all three EFI conditions will yield better outcomes than the waitlist control condition It is also hypothesized that the combined PCPM-EFI plus PERPM-EFI condition will be superior to the PCPM-EFI condition and PERPM-EFI condition on empowerment primary outcome and secondary symptom outcomes ie depressive symptoms anxious symptoms negative affect positive affect It is also expected that participants in the PCPM-EFI plus PERPM-EFI condition and PCPM-EFI condition will exhibit larger increases in coping self-efficacy and problem-focused coping than participants in the PERPM-EFI condition On the other hand it is hypothesized that participants in the PCPM-EFI plus PERPM-EFI condition and PERPM-EFI condition will exhibit larger increases in self-compassion mindfulness and emotional self-awareness than participants in the PCPM-EFI condition If the feedback interventions are shown to be efficacious the interventions could be offered to universities work places clinical settings and other organizations
Detailed Description: 1 Rationale for Study Over the past three decades perfectionism has received increasing theoretical and empirical attention as a cognitive-personality factor that increases vulnerability to several psychological problems including depression and anxiety In Canada the United States and the United Kingdom young adults are experiencing higher levels of depression anxiety and suicide ideation as well as significantly higher levels of self-critical perfectionism than a decade ago Although the self-criticism SC dimension of perfectionism has been consistently associated with lower well-being little longitudinal research has examined the mechanisms through which SC is related to well-being over time

1a Perfectionism Dimensions and Daily Stress Reactivity and Coping Ineffectiveness

Previous longitudinal studies of university students community adults and depressed patients have used 7-day and 14-day daily diary designs to obtain several assessments of appraisals coping and affect for each individual in the individuals natural everyday environments Based on the Perfectionism Coping Processes Model PCPM multilevel structural equation modeling MSEMSEM between-persons results have demonstrated that SC perfectionists maintain lower well-being eg negative affect lower positive affect over time because these individuals have a tendency to a generate daily stress for themselves by magnifying the negative aspects of events such that mundane difficulties can be interpreted as threatening stressors b engage in avoidant coping which stems from helplessness thinking that the individual is unable to cope with stressors to the individuals own and others satisfaction and c perceive that others are unwilling or unavailable to help the individual in times of stress and thereby lack an important resource ie perceived social support to make stressors seem less overwhelming On the other hand the adaptive potential of PS has been exhibited by an indirect relation with positive affect through maintenance of higher daily problem-focused coping when individuals with higher PS are not depressed MSEM within-person results have shown that several distinct appraisals eg event stress and coping strategies eg avoidant coping commonly operate together across many different stressors when the typical individual experiences daily increases in negative affect and drops in positive affect In parallel constructive social eg perceived social support and self eg perceived control appraisals and engagement coping strategies eg positive reinterpretation problem-focused coping commonly facilitate one another which is linked to within-person increases in daily positive affect for the typical individual

1b Perfectionism Dimensions and Daily Emotion Dysregulation Given the pervasive and enduring stress management problems that generate persistent distress for perfectionistic individuals it is important to better understand how certain emotion regulation strategies might make emotional reactions worse or serve a protective role A recent SSHRC-funded study extends this previous research by using 14-day daily diaries and MSEMmultilevel modeling to examine the impact of SC and PS dimensions of perfectionism on emotion regulation eg mindfulness self-compassion experiential avoidance rumination and well-being in a sample of 154 community adults over two years Based on the Perfectionism and Emotion Regulation Processes Model PERPM MSEM between-persons results demonstrated that SC perfectionism maintains higher negative affect and lower positive affect over 14 days because these individuals have a tendency to generate daily stress for themselves and engage in experiential avoidance and rumination and tend less to engage in mindfulness self-compassion and reappraisal Within-person mediation results showed that when the typical individual perceives more stress than usual the individual responds with less mindfulness self-compassion and reappraisal than usual and engages in more experiential avoidance and rumination than usual and this was connected to decreases in daily well-being Further multilevel modeling results demonstrated that individuals with higher SC perfectionism relative to those with lower SC experience stronger within-person decreases in well-being eg higher negative affect lower positive affect when the individual reports more stress than usual and less self-compassion and mindfulness than usual

1 c Feedback Interventions for Perfectionists Although mediators and moderators of the link between perfectionism and well-being have been identified the direct clinical utility of these findings has not been a focus Few studies have involved participants in a role beyond the completion of study questionnairesdiaries An exception was a study in which a total of 60 young adults assessed to be maladaptive perfectionists were randomized to a control group or a single-session feedback intervention in which the participants perfectionism results were discussed Findings revealed that providing feedback to maladaptive perfectionists about the individuals perfectionism reduced self-reported global symptomatic distress as well as emotional reactivity Although the findings suggest that a brief individualized feedback intervention is effective one important limitation of extant studies employing feedback interventions is that the feedback did not describe the actions to be taken to make change According to feedback intervention theory and the model of actionable feedback feedback will have an optimal effect on performance when information is focused on helping the recipient see how hisher behaviour should change to improve functioning This entails customizability of feedback that engages the individual with hisher own data making himher an active participant in the sense-making process rather than a passive recipient of information

The Perfectionism and Coping Processes Model - Explanatory Feedback Intervention PCPM-EFI draws on previous findings and analyzes participant responses to perfectionism measures and online daily questionnaires of stress coping and mood over 7 days The PCPM-EFI provides an individualized slideshow presentation that is delivered in a single 45-60 minute session by a student research assistant to answer five questions about the participants perfectionism and daily stress coping and affect patterns Question 1 What increases the participants negative mood is addressed by contrasting scores from two days with a path diagram to demonstrate to the individual that when the individual perceives more criticism engages in more self-blame andor perceives less control than usual the individual uses more avoidant coping andor experiences higher event stress than usual and this is connected to daily increases in negative affect Question 2 What increases the participants positive mood is addressed by contrasting scores from two days with a path diagram to show to the individual that when the individual perceives more support from others uses more positive reinterpretation andor perceives more control than usual the individual engages in more problem-focused coping than usual and this is connected to daily increases in positive affect Question 3 Whats keeping the participant stuck is addressed by showing the individual how higher levels of SC maintained higher negative affect and lower positive affect averaged over seven days because of selected higher disengagement tendencies eg stress avoidant coping perceived criticism self-blame and selected lower engagement tendencies eg perceived social support positive reinterpretation perceived control problem-focused coping Question 4 What are the participants strengths is addressed by highlighting strengths to the individual including healthy striving ie PS without SC selected lower disengagement tendencies and selected higher engagement tendencies averaged over seven days Most important Question 5 What can the participant do to improve the participants mood is addressed with a summary slide to show what the person needs to do to manage and improve the individuals mood A given mechanism is designated as a best target when it is keeping the individual stuck and daily changes are connected to improvements in at least one other mechanism and mood

The investigators recently completed a waitlist controlled feasibility trial comparing the PCPM-EFI condition with a waitlist control condition over 4 weeks in 176 university students with higher SC perfectionism with individualized feedback delivered one-on-one by student trainees in-person or remotely through videoconferencing The feasibility of the individualized analyses of each participants daily data was supported by identifying daily trigger patterns maintenance tendencies strengths common triggers and best targets for reducing negative mood and increasing positive mood across several stressors for each participant Participant ratings indicated that the comprehensive feedback was coherent and functional Participants in the EFI condition compared to those in the control condition reported increases in empowerment coping self-efficacy and problem-focused coping as well as decreases in depressive and anxious symptoms Between-group effect sizes were moderate-to-large There were reliable improvements in empowerment and depressive symptoms for 56 and 36 respectively of participants in the EFI condition These findings demonstrate the broad applicability conceptual utility and effectiveness of the PCPM-EFI for self-critical perfectionistic individuals Given these promising findings research is needed to examine the utility of customizing daily emotion regulation findings and the complementary effects of providing meaningful feedback on well-being
2 The Present Study The present SSHRC-funded study will build on the promising findings of the PCPM-EFI by using a 7-day daily diary methodology to test a complementary EFI on perfectionism and emotion regulation processes eg self-compassion mindfulness experiential avoidance rumination reappraisal delivered online through videoconferencing in a sample of university students with higher self-critical perfectionism Based on the Perfectionism and Emotion Regulation Processes Model PERPM the PERPM-EFI follows the same structure as the PCPM-EFI to provide individualized analyses drawn from previous findings as well as findings from a current SSHRC-funded study The results of a pilot study of 12 university students with higher SC perfectionism suggest that the PERPM-EFI is broadly applicable conceptually useful and effective Specifically despite the small sample size participants reported increases in empowerment mindfulness self-compassion and emotional self-awareness as well as decreases in depressive and anxious symptoms The present study will use a randomized control design to examine whether the PCPM-EFI plus PERPM-EFI can better improve well-being relative to providing no feedback the PERPM-EFI alone or PCPM-EFI alone in the context of a 4-week longitudinal study with three time points in a sample of 180 university students The four conditions will be a waitlist control condition b PCPM-EFI c PERPM-EFI and d PCPM-EFI plus PERPM-EFI

Based on theory and previous findings it is expected that the EFIs will demonstrate three central features of the PCPM and PERPM as viable models of change Hayes Hofmann and Ciarrochi 2020 Hypothesis 1 will examine the feasibility of the individualized analyses of each participants daily questionnaire data to show that the PCPM-EFI and PERPM-EFI are broadly applicable across a wide array of stressors for most participants in predictable empirical ways For each participant it is expected that several appraisal coping emotion regulation and affect scores will change together on a daily basis in a manner consistent with the Disengagement Trigger Patterns Hypothesis 1a and Engagement Trigger Patterns Hypothesis 1b described above It is also expected that higherlower levels of aggregated daily disengagementengagement variables will differentiate each SC perfectionistic participant from the average person to fit the Explanatory Conceptualizations described above Hypothesis 1c It is also anticipated that many participants will exhibit some higher engagement andor lower disengagement tendencies to support a Resilience Conceptualization Hypothesis 1d consistent with previous findings demonstrating the heterogeneity of perfectionism Most important it is also expected that for most participants there will be at least one disengagement or engagement variable that is both a maintenance tendency and a common trigger for the Best Target Selection for each of the PCPM-EFI and PERPM-EFI Hypothesis 1e

Hypothesis 2 addresses the conceptual utility feasibility of the PCPM-EFI and PERPM-EFI steps derived from the individualized outputs of each participants daily diary data Participant ratings will indicate that the participant strongly agrees that the comprehensive feedback of the EFI steps as delivered by student research assistants helps the participant understand and make sense of the individuals mood and is functional in helping the participant understand how to improve the individuals mood

Finally Hypothesis 3 is that participants in the experimental conditions compared to those in the control condition will report primarily increases in empowerment ie being better informed improved acceptance of problems increased optimism and control over the future enhanced self-esteem Empowerment is the primary outcome because the EFI steps predominantly function to make complex processes seem less overwhelming and more manageable to the individual by showing that situations unfold in expected ways and helping understand how problems are maintained before the final step of selecting mechanisms for improving mood It is hypothesized that all three EFI conditions will yield better outcomes than the waitlist control condition It is also expected that the combined PCPM-EFI plus PERPM-EFI condition will be superior to the PCPM-EFI condition and PERPM-EFI condition on empowerment primary outcome and secondary symptom outcomes ie depressive symptoms anxious symptoms negative affect positive affect It is also expected that participants in the PCPM-EFI plus PERPM-EFI condition and PCPM-EFI condition will exhibit larger increases in coping self-efficacy and problem-focused coping than participants in the PERPM-EFI condition On the other hand it is hypothesized that participants in the PCPM-EFI plus PERPM-EFI condition and PERPM-EFI condition will exhibit larger increases in self-compassion mindfulness and emotional self-awareness than participants in the PCPM-EFI condition Reductions in SC perfectionism measures are not expected because the EFI does not directly target perfectionism itself and existing RCT data show that one session is insufficient for reducing perfectionism
3 Research Plan

3a Participants Participants will be students at McGill University including English- and French-speaking men and women between the ages of 18-65 Advertisements in student newspapers and bulletins placed around the McGill University campus and online advertisements will recruit university students Individuals potentially interested in participating will be sent a link to complete the screening consent form online through Qualtrics If a potential participant decides to take part in this study the individual will be asked to complete the screening questionnaire as well as perfectionism and current mood questionnaires online in a 5-10 minute session to determine whether the individual qualifies to participate in the study

3b Procedure Participants who meet prescreening criteria will be randomly assigned to one of four conditions using the randomization function in Excel to ensure the right amount in each condition at the end of the study At Time 1 participants will complete an online package of baseline measures at home to assess personality eg perfectionism and well-being ie depression anxiety negative affect positive affect Next participants will complete the online daily questionnaires once a day for seven consecutive days At Time 2 two weeks after baseline all participants will complete the brief perfectionism and well-being measures online The participants in the explanatory feedback conditions will receive personalized feedback about the individuals baseline questionnaire and daily diary results Participants in the three different explanatory feedback conditions will receive either a the PCPM-EFI in a 45-60 minute session b the PERPM-EFI in a 45-60 minute session or c the PCPM-EFI and PERP-EFI in a combined 90-120 minute session During this feedback session participants will also be asked to provide feedback on the feedback intervention itself by completing questionnaires and providing verbal feedback Selected outcome measures 5-10 minutes will be completed immediately after the intervention At Time 3 two weeks after Time 2 participants will complete online the brief perfectionism and well-being measures

After all assessments have been completed at Time 3 the participants in the waitlist control condition will be offered the PCPM-EFI and PERPM-EFI 90-120 minutes the participants in the PCPM-EFI condition will be offered the PERPM-EFI 45-60 minutes and the participants in the PERPM-EFI condition will be offered the PCPM-EFI 45-60 minutes after all assessments have been completed at Time 3 Selected outcome measures 5-10 minutes will be completed by the waitlist control PCPM-EFI condition and PERPM-EFI condition participants immediately after the intervention

3c EFI Daily Diary Procedure In this study participants will complete seven daily diaries online These portable electronic diaries have the capacity to present required items for questionnaires that are accessed by participants from a web link httpqualtricscom and to record store and export participant responses to statistical software SPSS Participants will be notified at 900pm to complete a daily self-report record at bedtime any time between 900pm and 300am It is also estimated that each recording will take participants approximately 14-18 minutes to complete First participants will rate on 5-point scales 26 items from the Positive and Negative Affect Scale PANAS to assess negative affect positive affect sadness and hostility today as in previous studies Second participants will rate on 9-point scales three items from the Test of Negative Social Interactions TENSE to indicate how frequently the participant had experienced different types of negative social interactions today as in previous studies Third participants will rate on 7-point scales three appraisals of the most bothersome event or issue of today unpleasantness duration and stressfulness As in previous studies these three appraisals will be combined to assess event stress Two additional items will assess perceived control and perceived criticism Fourth participants will rate on 4-point scales how the participant coped with the individuals most bothersome issue today using seven selected 4-item scales from the situational version of the COPE to assess avoidant coping behavioral disengagement self-distraction denial problem-focused coping active coping planning positive reinterpretation and self-blame consistent with previous studies Fifth participants will rate on 7-point scales three appraisals about the extent to which each of three social provisions were potentially available wanted and received in helping to handle the stressor today reliable alliance attachment and guidance As in previous studies these three appraisals will be combined to assess perceived social support Sixth participants will report the extent to which the participant ruminated in response to the most bothersome event of the day by rating five modified items from the brooding subscale of the Ruminative Responses Scale RRS Seventh participants will indicate the extent to which the participant engaged in emotion regulation behaviours with the most bothersome event or issue of the day by rating two items adapted from the Emotion Regulation Questionnaire ERQ to assess reappraisal and one additional modified item assessing reappraisal Eighth participants will indicate the extent to which the participant engaged in several experiential avoidance behaviours with the most bothersome event or issue of the day by rating eight items adapted from the Brief Experiential Avoidance Questionnaire BEAQ Ninth participants will report the degree to which the participant used self-compassion self-kindness vs self-judgment common humanity vs isolation mindfulness vs over-identification skills in response to the most bothersome event of the day by rating 26 modified items from the Self-Compassion Scale SCS Finally participants will report the degree to which the participant used mindfulness observe describe acting with awareness nonreactivity nonjudgmental acceptance skills in response to the most bothersome event of the day by rating 20 adapted items adapted from the Five Facet Mindfulness Questionnaire - Short Form FFMQ-SF

3d Data Analytics for the PCPM-EFI and PERPM-EFI The Excel scoring program that was successfully used in the waitlist controlled feasibility trial of the PCPM-EFI was adapted to perform individualized analyses of the perfectionism and daily stress emotion regulation ie mindfulness self-compassion experiential avoidance rumination and affect questionnaire responses based on recent PERPM findings in a sample of 154 community adults The PCPM-EFI script manual that was successfully used to deliver the individualized results to participants in the waitlist controlled trial of the PCPM-EFI was adapted to develop the PERPM-EFI script manual to deliver the individualized PERPM results to participants The PERPM-EFI addresses the same five within-person and between-persons questions of interest as the PCPM-EFI i What increases negative mood ii What increases positive mood iii What maintains negative mood iv What maintains positive mood and v What needs to be done to improve mood

3e EFI Delivery All participants will receive the feedback remotely through Zoom The feedback intervention will be scheduled for one meeting per participant that lasts 45-60 minutes the PCPM-EFI plus PERP-EFI session lasts 90-120 minutes The meeting will be one-on-one meaning that in each session one research assistant will deliver feedback to one participant The PCPM-EFI and PERPM-EFI are manualized and administered following a detailed script Participants will also receive by e-mail a PDF of the graphical summaries of the individuals personalized feedback for the individuals own reference Feedback sessions will be audio and visual recorded through Zoom The audio plus visual recording will be deleted and the audio only recording will be downloaded from Zoom The audiotape will be used for the purposes of providing feedback to the research assistants about the individuals delivery of the feedback intervention as well as for reviewing participants reactions to the feedback intervention

3f EFI Training The student research assistants will undergo 10 hours of feedback intervention training Under the supervision and tutelage of the primary investigator who is a licensed psychologist the research assistants will practice administering feedback using the PCPM-EFI and PERPM-EFI protocols and role plays based on case examples from previous studies If necessary the research assistants will complete additional role plays until procedural uniformity is established Differences will be measured by comparing participants usability and acceptability ratings between feedback providers

3g Conceptual Utility Questionnaire Participants will be asked to rate two to three statements on the perceived helpfulness of the explanatory feedback to make sense of clarify and understand EFI steps Disengagement Trigger Patterns Engagement Trigger Patterns Explanatory Conceptualization Resilience Conceptualization and Best Target Selection Participants will provide ratings on 5-point scales from strongly disagree to strongly agree immediately after receiving the feedback for each of the EFI steps After the Best Target Selection participants will rate three additional statements on the perceived function of the feedback to help improve the individuals mood

4 Data analyses Multilevel regression will be used to analyze the effects of feedback condition on the change processes ie empowerment coping self-efficacy coping self-compassion mindfulness emotional self-awareness and symptom outcomes ie depressive anxious stress Multilevel modeling analyses will allow separate regression coefficients to be estimated for each patients scores across time in order to examine the influence of feedback condition on each change process and well-being variable Group and Time main effects together with Group Time interactions will be examined in each model Between-group post hoc significance tests will be conducted Reliable change will also be used in order to determine the number of participants becoming more empowered primary outcome and the number of participants with mild depressive symptoms ie BDI scores of 10 or more having less depressive symptoms secondary outcome after undergoing each EFI condition Reliable change will also be used to determine the number of participants exhibiting less anxious symptoms less stress more coping self-efficacy more problem-focused coping more self-compassion more mindfulness and more emotional self-awareness after undergoing each EFI condition

5 Sample Size and Justification Out of 200 student participants it is expected that 180 students will successfully complete all of the study assessments estimated attrition rate of 10 Between-group effect sizes were moderate-to-large for empowerment d 089 coping self-efficacy d 059 problem-focused coping d 043 depressive symptoms d -068 and anxious symptoms d -046 for 176 participants in the previous study testing the effectiveness of the PCPM-EFI These anticipated effect sizes indicate that the expected sample of 45 participants per group will be sufficient to detect group differences in the present study Recruitment and follow-up of participants will occur over the academic year October 2024 to May 2026 and subsequent monthsyears will be spent analyzing and writing papers based on these findings If the feedback interventions are shown to be efficacious the interventions could be offered to universities work places clinical settings and other organizations

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None