Mindful Compassion for Perfectionism (MCP)

April 16, 2024 updated by: Tages Onlus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • FI
      • Firenze, FI, Italy, 50137
        • Centro di Psicologia e Psicoterapia Tages Onlus - Firenze

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
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
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
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.
Active Comparator: Experimental Group 2 - Online Format
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility (adverse events; adherence)
Time Frame: 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).
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)
Time Frame: 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).
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)
Time Frame: 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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tages Onlus

Investigators

  • Principal Investigator: Simone Cheli, PhD, Tages Onlus
  • Study Chair: Paul L Hewitt, PhD, British Columbia University
  • Study Chair: Gil Goldzweig, PhD, The Academic College of Tel-Aviv Yaffo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2022

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MCP-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study protocol will be made available at the beginning of the active treatment phase and the raw data at the end of the study. All information will be uploaded to the Open Science Foundation.

IPD Sharing Time Frame

The study protocol, SAP, ICF and CSR will be available before the end of February 2023

IPD Sharing Access Criteria

All material will be freely accessible to anyone on the Open Science Foundation (see link below).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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