PerfectionismMCPNCT05700786
Mindful Compassion for Perfectionism
A study testing Mindful compassion for perfectionism in people with Perfectionism, run by Tages Onlus at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Perfectionism
- What is being tested?
- Mindful compassion for perfectionism
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteItaly
- Study dates
- 5 Oct 2022to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Being diagnosed with neurodevelopmental or schizophrenia/psychosis spetrum disoders;
- Being under either psychiatric or psychological treatment
Trial locations and contacts
1 site in 1 country.
Italy1 site
Centro di Psicologia e Psicoterapia Tages Onlus - Firenze
Florence, FI, 50137
About this study
Official title: 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.
Read the 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.
- Conditions
- Perfectionism
- Being tested
- Mindful compassion for perfectionism
- Keywords
- perfectionism, mindfulness, self-criticism, group psychotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful compassion for perfectionismBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Mindful compassion for perfectionism |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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)
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
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start5 Oct 2022
- Primary completion30 Sep 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for PerfectionismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic waiting-list randomized controlled trial with blinded outcome assessment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tages Onlus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone Cheli, PhD, Principal investigator, Tages OnlusPaul L Hewitt, PhD, Study chair, British Columbia UniversityGil Goldzweig, PhD, Study chair, The Academic College of Tel-Aviv Yaffo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700786
- Sponsor's protocol ID
- MCP-2022
- Acronym
- MCP
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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
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.
PubMed 33245562Hewitt 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.
PubMed 31107049Hewitt 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.
PubMed 31999191Smith 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.
PubMed 33556805Gilbert P. Compassion: From Its Evolution to a Psychotherapy. Front Psychol. 2020 Dec 9;11:586161. doi: 10.3389/fpsyg.2020.586161. eCollection 2020.
PubMed 33362650Gilbert P. Evolution and depression: issues and implications. Psychol Med. 2006 Mar;36(3):287-97. doi: 10.1017/S0033291705006112. Epub 2005 Oct 20.
PubMed 16236231Petrocchi 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.
PubMed 29907988McEwan 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.
PubMed 26454144GILBERT, 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.
HEWITT, P.L., FLETT, G.L. & MIKAIL, S.F. (2017). Perfectionism: A relational approach to conceptualization, assessment, and treatment. New York:The Guilford Press.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Compassion for Perfectionism: A Waiting-list Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05700786
- Acronym / sponsor ID
- MCP / MCP-2022
- Conditions
- Perfectionism
- Keywords
- perfectionism, mindfulness, self-criticism, group psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Tages OnlusUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Pragmatic waiting-list randomized controlled trial with blinded outcome assessment
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Mindful compassion for perfectionismThe 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. |
| Experimental Group 2 - Online Format | Active comparator | Behavioral: Mindful compassion for perfectionismThe 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). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Being diagnosed with neurodevelopmental or schizophrenia/psychosis spetrum disoders;
- Being under either psychiatric or psychological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful compassion for perfectionismThe 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. | Behavioural | Experimental Group 1 - Online Format, Experimental Group 2 - Online Format |
Primary outcome
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)
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
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- BackgroundCheli 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: PubMed 33245562Hewitt 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.
- Background: PubMed 31107049Hewitt 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.
- Background: PubMed 31999191Hewitt 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.
- Background: PubMed 33556805Smith 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.
- Background: PubMed 33362650Gilbert P. Compassion: From Its Evolution to a Psychotherapy. Front Psychol. 2020 Dec 9;11:586161. doi: 10.3389/fpsyg.2020.586161. eCollection 2020.
- Background: PubMed 16236231Gilbert P. Evolution and depression: issues and implications. Psychol Med. 2006 Mar;36(3):287-97. doi: 10.1017/S0033291705006112. Epub 2005 Oct 20.
- Background: PubMed 29907988Petrocchi 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.
- Background: PubMed 26454144McEwan 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.
- BackgroundGILBERT, 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.
- BackgroundHEWITT, P.L., FLETT, G.L. & MIKAIL, S.F. (2017). Perfectionism: A relational approach to conceptualization, assessment, and treatment. New York:The Guilford Press.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Cheli, PhD principal investigator
Tages Onlus
Paul L Hewitt, PhD study chair
British Columbia University
Gil Goldzweig, PhD study chair
The Academic College of Tel-Aviv Yaffo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful compassion for perfectionism in people with Perfectionism, run by Tages Onlus at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05700786, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.