NCT05700786

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

October 5, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

12 months

First QC Date

March 11, 2022

Last Update Submit

April 16, 2024

Conditions

Keywords

perfectionismmindfulnessself-criticismgroup psychotherapy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Withing-group effectiveness (perfectionism)

    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).

Study Arms (3)

Control Group

NO INTERVENTION

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.

Experimental Group 1 - Online Format

ACTIVE COMPARATOR

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

Experimental Group 2 - Online Format

ACTIVE COMPARATOR

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

Interventions

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.

Experimental Group 1 - Online FormatExperimental Group 2 - Online Format

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Being diagnosed with neurodevelopmental or schizophrenia/psychosis spetrum disoders;
  • Being under either psychiatric or psychological treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro di Psicologia e Psicoterapia Tages Onlus - Firenze

Florence, FI, 50137, Italy

Location

Related Publications (11)

  • Cheli S, Cavalletti V, Flett GL, Hewitt PL. Mindful compassion for perfectionism in personality disorders: A pilot acceptability and feasibility study. BPA - Applied Psychology Bulletin (Bollettino di Psicologia Applicata). 2020; 68(287): 55-65. https://doi.org/10.26387/bpa.287.5

    BACKGROUND
  • Hewitt PL, Mikail SF, Dang SS, Kealy D, Flett GL. Dynamic-relational treatment of perfectionism: An illustrative case study. J Clin Psychol. 2020 Nov;76(11):2028-2040. doi: 10.1002/jclp.23040. Epub 2020 Aug 15.

    PMID: 33245562BACKGROUND
  • Hewitt PL, Qiu T, Flynn CA, Flett GL, Wiebe SA, Tasca GA, Mikail SF. Dynamic-relational group treatment for perfectionism: Informant ratings of patient change. Psychotherapy (Chic). 2020 Jun;57(2):197-205. doi: 10.1037/pst0000229. Epub 2019 May 20.

    PMID: 31107049BACKGROUND
  • Hewitt PL, Smith MM, Deng X, Chen C, Ko A, Flett GL, Paterson RJ. The perniciousness of perfectionism in group therapy for depression: A test of the perfectionism social disconnection model. Psychotherapy (Chic). 2020 Jun;57(2):206-218. doi: 10.1037/pst0000281. Epub 2020 Jan 30.

    PMID: 31999191BACKGROUND
  • Smith MM, Sherry SB, Ray C, Hewitt PL, Flett GL. Is perfectionism a vulnerability factor for depressive symptoms, a complication of depressive symptoms, or both? A meta-analytic test of 67 longitudinal studies. Clin Psychol Rev. 2021 Mar;84:101982. doi: 10.1016/j.cpr.2021.101982. Epub 2021 Jan 26.

    PMID: 33556805BACKGROUND
  • Gilbert P. Compassion: From Its Evolution to a Psychotherapy. Front Psychol. 2020 Dec 9;11:586161. doi: 10.3389/fpsyg.2020.586161. eCollection 2020.

    PMID: 33362650BACKGROUND
  • Gilbert P. Evolution and depression: issues and implications. Psychol Med. 2006 Mar;36(3):287-97. doi: 10.1017/S0033291705006112. Epub 2005 Oct 20.

    PMID: 16236231BACKGROUND
  • Petrocchi N, Dentale F, Gilbert P. Self-reassurance, not self-esteem, serves as a buffer between self-criticism and depressive symptoms. Psychol Psychother. 2019 Sep;92(3):394-406. doi: 10.1111/papt.12186. Epub 2018 Jun 15.

    PMID: 29907988BACKGROUND
  • McEwan K, Gilbert P. A pilot feasibility study exploring the practising of compassionate imagery exercises in a nonclinical population. Psychol Psychother. 2016 Jun;89(2):239-43. doi: 10.1111/papt.12078. Epub 2015 Oct 10.

    PMID: 26454144BACKGROUND
  • GILBERT, P. & CHODEN, K. (2014). Mindful compassion: How the science of compassion can help you understand your emotions, live in the present, and connect deeply with others. New Harbinger Publications.

    BACKGROUND
  • HEWITT, P.L., FLETT, G.L. & MIKAIL, S.F. (2017). Perfectionism: A relational approach to conceptualization, assessment, and treatment. New York:The Guilford Press.

    BACKGROUND

Study Officials

  • Simone Cheli, PhD

    Tages Onlus

    PRINCIPAL INVESTIGATOR
  • Paul L Hewitt, PhD

    British Columbia University

    STUDY CHAIR
  • Gil Goldzweig, PhD

    The Academic College of Tel-Aviv Yaffo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The study design reflects an external, third-party evaluation. The evaluation team (i.e. the researcers conducting the analysis) will be independent from both the application vendor (i.e. the therapists conducting the intervention) and the recruitment team (i.e. the researchers recruiting and randomly allocating the participants).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pragmatic waiting-list randomized controlled trial with blinded outcome assessment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2022

First Posted

January 26, 2023

Study Start

October 5, 2022

Primary Completion

September 30, 2023

Study Completion

December 15, 2023

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The study protocol, SAP, ICF and CSR will be available before the end of February 2023
Access Criteria
All material will be freely accessible to anyone on the Open Science Foundation (see link below).
More information

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