Mindful Compassion for Perfectionism

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to confirm the feasibility of an integrative form of group psychotherapy in treating perfectionism. In a previous pilot study we suggested that this new treatment is safe and feasible, also reporting a significant reduction of perfectionism at final assessment. The intervention integrates the Paul Hewitt relational model of perfectionism and the Paul Gilbert Compassion Focused Therapy. We will explore the feasibility of the proposed group therapy through a three-arm waiting-list randomized controlled trial. Our hypothesis is that those in the treatment groups (either online or in presence format) will show at the end of the intervention a lower level of perfectionsm than those in the control group.

Detailed Description
-----------------
After being informed about the study and potential risks, all partecipants giving written informed consent will undergo a psychological assessment so as to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1 ratio to (i) new integrative group psychotherapy through an in presence format, (ii) the same integrative group psychotherapy through an online format, (iii) a waiting-list control group. At the end of active experimental groups treatment (2 months), all the partecipants will have access to the final follow-up assessment.

Official Title
-----------------
Mindful Compassion for Perfectionism: A Waiting-list Randomized Controlled Trial

Conditions
-----------------
Perfectionism

Intervention / Treatment
-----------------
* Behavioral: Mindful compassion for perfectionism


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being aged between 18 and 30 Reporting at least a clinically significant value at Multidimensional Perfectionsm Scale (at least one of the dimensions must have scores equal to or greater than the clinical population mean of the questionnaire manual) Exclusion Criteria: Being diagnosed with neurodevelopmental or schizophrenia/psychosis spetrum disoders; Being under either psychiatric or psychological treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic waiting-list randomized controlled trial with blinded outcome assessment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>The control group is made up of participants who are eligible but not assigned to the treatment. For ethical reasons they will be able to access the intervention once the experimental group has concluded the study. During the waiting-list phase, participants can access a mental health intervention, but in this case they are excluded from the study. Participants are told that there is only one possible active group and therefore a waiting-list is created. This explanation is given to reduce a worsening symptom bias for feeling excluded from treatment. | |
| Active Comparator: Experimental Group 1 - Online Format<br>The experimental intervention is an integrative mindful compassion group therapy as manualized by Cheli, Cavalletti, Flett & Hewitt (2020). The structure was outlined on the base of standard mindfulness-based interventions, comprising eight 2-hour online group sessions and one day of silence lasting 4 hours. The contents and the phases of the intervention were rooted in two different frameworks. On the one hand, the sequence of and the types of practices were defined in accordance with the mindful compassion protocol (Gilbert & Choden, 2014). On the other hand, the shared conceptualization of perfectionism and its role in triggering, maintaining, and inducing relapses in personality disoders was proposed through the relational model by Hewitt and colleagues (2017). The hybrid format (online weekly sessions plus an in presence half-day of silence) has been developed in accordance with existing COViD-19 emergency and rules. | Behavioral: Mindful compassion for perfectionism<br>* The intervention is a 8-week group psychotherapy in a hybrid format: 8 weekly online sessions lasting 2 hours plus an in presence half-day of silence lasting 4 hours.<br>|
| Active Comparator: Experimental Group 2 - Online Format<br>The experimental intervention is an integrative mindful compassion group therapy as manualized by Cheli, Cavalletti, Flett & Hewitt (2020). The structure was outlined on the base of standard mindfulness-based interventions, comprising eight 2-hour in presence group sessions and one day of silence lasting 4 hours in presence. The contents and the phases of the intervention were rooted in two different frameworks. On the one hand, the sequence of and the types of practices were defined in accordance with the mindful compassion protocol (Gilbert & Choden, 2014). On the other hand, the shared conceptualization of perfectionism and its role in triggering, maintaining, and inducing relapses in personality disoders was proposed through the relational model by Hewitt and colleagues (2017). | Behavioral: Mindful compassion for perfectionism<br>* The intervention is a 8-week group psychotherapy in a hybrid format: 8 weekly online sessions lasting 2 hours plus an in presence half-day of silence lasting 4 hours.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility (adverse events; adherence) | Feasibility is defined on the basis of two criteria: absence of adverse events (i.e. dropouts; hospitalization; etc.) and adequate adherence (i.e. maximum 1 skipped session per participant) | 2 measurements: one at baseline assessment; one at final assessment. Initial assessment will be 1 month priori the intervention, the final assessment at the end of the intervention (2 months after the beginning of the intervention). | 
| Betwen-groups effectiveness (perfectionism) | At the final assessment, the experimental group's Perfectionistic Cognitions Inventory (PCI) scores are significantly lower than those of the control group (the differences in the initial assessment must be insignificant). Higher scores of PCI (ranging between 0 to 100) are indicative of higher perfectionistic worry | 2 measurements: one at baseline assessment; one at final assessment. Initial assessment will be 1 month priori the intervention, the final assessment at the end of the intervention (2 months after the beginning of the intervention). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Withing-group effectiveness (perfectionism) | In the experimental group the scores on the Perfectionistic Cognitions Inventory (PCI) must show a significant difference between initial and final assessment. Higher scores of PCI (ranging between 0 to 100) are indicative of higher perfectionistic worry | 2 measurements: one at baseline assessment; one at final assessment. Initial assessment will be 1 month priori the intervention, the final assessment at the end of the intervention (2 months after the beginning of the intervention). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perfectionism, mindfulness, self-criticism, group psychotherapy