- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07834567
Clinical and Biological Correlates of Obsessive-Compulsive Disorder and Online Mindfulness-Based Cognitive Therapy (MIND-DOC)
Clinical and Biological Correlates of Obsessive-Compulsive Disorder and Implementation of an Integrated, Manualized Group Mindfulness-Based Cognitive Therapy Intervention
The study has two main objectives: (1) to evaluate the acceptability and feasibility of a specialized Mindfulness-Based Cognitive Therapy (MBCT) program for Obsessive-Compulsive Disorder (OCD), delivered via videoconference in a synchronous group format; and (2) to explore the associations between selected clinical and biological markers, OCD severity, and treatment response.
This is an interventional study involving outpatients with a diagnosis of OCD recruited at two participating centers in Italy: IRCCS Fatebenefratelli in Brescia (Center 1) and Centro Terapia Cognitiva e Mindfulness per il DOC in Vicenza (Center 2). Participants will take part in group-based treatment based on the MBCT program for OCD.
Participants recruited at Center 1 will undergo blood and saliva sampling for the molecular analyses planned as part of the study. A healthy control group, matched for age and sex, will also be recruited for comparison in the analyses related to the second objective.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Obsessive-Compulsive Disorder (OCD) is a common and potentially disabling psychiatric condition, characterized by intrusive and distressing thoughts (obsessions) and repetitive behaviors or mental acts (compulsions). Cognitive behavioral therapy, particularly exposure and response prevention, is considered a first-line treatment for OCD. However, a proportion of patients continue to experience clinically significant symptoms after treatment, highlighting the need for complementary therapeutic approaches.
Mindfulness-based interventions may help patients develop a less reactive and more accepting relationship with intrusive thoughts, emotions, and bodily sensations, potentially reducing the use of maladaptive strategies such as suppression, neutralization, and compulsions. Preliminary evidence suggests that mindfulness-based approaches may reduce OCD symptoms and may improve the acceptability of exposure-based treatment. However, evidence regarding synchronous, therapist-led online group interventions specifically adapted for OCD remains limited.
This study aims to evaluate the feasibility and acceptability of a specialized Mindfulness-Based Cognitive Therapy (MBCT) program for OCD, delivered online through synchronous videoconferencing. The manualized intervention (Didonna, 2022) integrates mindfulness practices with cognitive behavioral therapy, exposure and response prevention, acceptance, decentering, and self-compassion techniques.
The primary objective is to assess the feasibility and acceptability of the synchronous online intervention. Exploratory objectives are to evaluate changes in OCD symptoms and other clinical variables and to investigate associations between clinical characteristics, treatment response, and selected biological markers.
At least 42 adults aged 18-45 years with a diagnosis of OCD will be recruited at two participating centers in Italy. Participants will attend 11 weekly online group sessions conducted by trained therapists. The intervention may be provided alongside ongoing stable pharmacological treatment and other standard clinical care.
Clinical assessments: patients will undergo diagnostic and clinical assessment using the Structured Clinical Interview for DSM-5 (SCID-5-CV), including the personality disorders section (SCID-PD), and a medical and clinical history.
Clinical assessments will be performed at baseline, immediately after treatment, and at 3-month follow-up. Clinician-administered assessment will include the Yale-Brown Obsessive Compulsive Scale-2nd version (Y-BOCS-II) to assess OCD symptom severity. Self-report measures will assess depressive and anxiety symptoms, mindfulness, interoceptive awareness, dysfunctional obsessive beliefs, self-compassion, mind wandering, and general psychopathology.
Treatment acceptability and feasibility will be assessed through recruitment and dropout rates, treatment adherence, attendance, completion rates of assessment questionnaires, reasons for treatment discontinuation, treatment satisfaction, and home mindfulness practice. Participants will complete an ad hoc treatment satisfaction questionnaire at the end of treatment. Home practice time will be monitored during treatment and follow-up, and practice quality will be assessed using the Practice-Quality-Mindfulness (PQ-M) at predefined time points.
Biological assessments: patients recruited at Center 1 will provide blood and saliva samples before and after the intervention. Blood will be collected for RNA, DNA, plasma, and serum analyses; while saliva samples will be collected during the day to measure cortisol levels.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Mariangela Lanfredi
- Numero di telefono: 00390303501504
- Email: mlanfredi@fatebenefratelli.eu
Backup dei contatti dello studio
- Nome: Laura Pedrini, psychologist
- Numero di telefono: 00390303501504
- Email: lpedrini@fatebenefratelli.eu
Luoghi di studio
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Brescia, Italia
- Reclutamento
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
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Contatto:
- Laura Pedrini, psychologist
- Numero di telefono: 00390303501504
- Email: lpedrini@fatebenefratelli.eu
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Contatto:
- Mariangela Lanfredi, psychologist
- Numero di telefono: 00390303501504
- Email: mlanfredi@fatebenefratelli.eu
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Sub-investigatore:
- Evita Tomasoni, psychologist
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Sub-investigatore:
- Roberta Rossi, psychologist
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Patients with OCD.
Inclusion Criteria:
- Diagnosis of obsessive-compulsive disorder (OCD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Age between 18 and 45 years
- Stable pharmacological treatment for at least 3 months prior to the start of the experimental intervention
- No previous experience with mindfulness meditation, or previous mindfulness meditation experience with no practice during the 12 months prior to study enrollment
- Ability and willingness to provide written informed consent.
Exclusion Criteria:
- Diagnosis of schizophrenia spectrum or other psychotic disorders, including schizoaffective disorder
- Diagnosis of bipolar and related disorders
- Major depressive disorder in an acute phase
- Active substance use disorder or alcohol use disorder as the primary diagnosis
- Personality disorders of clinically significant severity
- Documented major neurocognitive disorder. Neurological conditions or medical conditions with a clinically significant impact on cognitive or mental functioning
- Previous mindfulness meditation practice within the 12 months prior to study enrollment
- Inability or unwillingness to provide informed consent
Healthy subjects.
Inclusion Criteria:
- Age between 18 and 45 years, with age matching within a maximum difference of ±3 years from the corresponding index patient. In all cases, control participants must be at least 18 years and no older than 48 years
- Voluntary participation in the study.
- Ability and willingness to provide written informed consent
Exclusion criteria:
- Age younger than 18 years
- History of psychiatric disorders, as assessed using the Structured Clinical Interview for DSM-5 Disorders - Clinician Version (SCID-CV)
- Intellectual developmental disorder.
- Current substance use disorder or alcohol use disorder
- Neurological disorders, including Parkinson's disease, major neurocognitive disorders, neurodegenerative syndromes, ataxias, multiple sclerosis, cerebrovascular events (stroke or transient ischemic attack [TIA]), central nervous system neoplasms, epilepsy, history of seizures, or clinically significant tremor
- Systemic medical conditions (e.g., diabetes mellitus, atherosclerosis, chronic arterial hypertension, or malignancies) requiring pharmacological treatment
- Current or previous mindfulness meditation practice within the 12 months prior to study enrollment
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Mindfulness-Based Cognitive Therapy (MBCT) for OCD
Participants will receive a manualized Mindfulness-Based Cognitive Therapy (MBCT) program for obsessive-compulsive disorder (OCD), integrating cognitive-behavioral therapy, exposure techniques, mindfulness, decentering, acceptance, and self-compassion practices. |
The intervention is a manualized Mindfulness-Based Cognitive Therapy (MBCT) program for OCD that integrates cognitive-behavioral therapy, exposure techniques, mindfulness, decentering, acceptance, and self-compassion practices (Didonna, 2022). The program aims to improve participants' ability to relate to internal experiences and reduce reactive patterns such as rituals and compulsions. Groups of 8-10 patients will receive the intervention online via synchronous videoconference. The program consists of 11 weekly sessions, including a 1.5-hour session involving family members and/or partners and a 6-hour intensive practice day. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from baseline in the Yale-Brown Obsessive Compulsive Scale 2nd version (Y-BOCS-II) total score.
Lasso di tempo: Baseline, post-treatment (11 weeks), and 3-month follow-up
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The Y-BOCS-II is a clinician-administered semi-structured interview used to assess the presence and severity of obsessive-compulsive disorder (OCD) symptoms. The scale consists of 10 severity items, each rated from 0 (no symptoms) to 5 (extreme symptoms). The total score ranges from 0 to 50, where higher scores indicate greater symptom severity. A decrease in the score reflects clinical improvement. |
Baseline, post-treatment (11 weeks), and 3-month follow-up
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Recruitment rate
Lasso di tempo: From study initiation to completion of recruitment.
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Recruitment rate will be calculated as the percentage of eligible participants who enroll in the study among all participants assessed for eligibility. |
From study initiation to completion of recruitment.
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Treatment dropout rate
Lasso di tempo: End of Treatment (Week 11).
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Treatment dropout rate will be calculated as the percentage of participants who discontinue treatment before completing the intervention.End of Treatment (Week 11). |
End of Treatment (Week 11).
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Treatment attendance rate
Lasso di tempo: End of Treatment (Week 11).
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Treatment attendance rate will be calculated as the percentage of scheduled treatment sessions attended by each participant. |
End of Treatment (Week 11).
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Assessment questionnaire completion rate
Lasso di tempo: Baseline (Week 0), End of Treatment (Week 11), and Post-Treatment Follow-Up (3 months after treatment completion).
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Assessment questionnaire completion rate will be calculated as the percentage of scheduled assessment questionnaires completed by participants. |
Baseline (Week 0), End of Treatment (Week 11), and Post-Treatment Follow-Up (3 months after treatment completion).
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Participant Satisfaction with the Group Treatment Program
Lasso di tempo: End of Treatment (Week 11).
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Participant satisfaction will be assessed using a study-specific 19-item questionnaire developed for this trial. Each item is rated on a 5-point Likert scale (1 = not at all; 5 = very much), yielding a total score ranging from 19 to 95. Higher total scores indicate a more favorable evaluation of the treatment program, including its perceived usefulness and acceptability, group experience, facilitators, and online treatment modality. |
End of Treatment (Week 11).
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Home mindfulness practice time
Lasso di tempo: During treatment (Weeks 1-11) and Post-Treatment Follow-Up (3 months after treatment completion).
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Home mindfulness practice time will be assessed as the total amount of time spent practicing mindfulness at home during the treatment and follow-up periods. |
During treatment (Weeks 1-11) and Post-Treatment Follow-Up (3 months after treatment completion).
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Quality of home mindfulness practice
Lasso di tempo: At Weeks 4, 8, 12, 20, and 24 from the start of the intervention.
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The quality of home mindfulness practice will be assessed using the Practice-Quality-Mindfulness (PQ-M) scale at predefined assessment time points. The PQ-M consists of six items rated on a visual analog percentage scale ranging from 0% to 100%. The total score is calculated as the mean of the six items, with higher scores indicating better quality of home mindfulness practice. |
At Weeks 4, 8, 12, 20, and 24 from the start of the intervention.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from baseline in the Beck Depression Inventory-II (BDI-II) total score.
Lasso di tempo: Baseline, post-treatment (11 weeks), and 3-month follow-up.
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The Beck Depression Inventory-II (BDI-II) is a self-report questionnaire designed to assess the severity of depressive symptoms. Each item is rated on a 4-point scale ranging from 0 to 3, reflecting increasing severity of the symptom. |
Baseline, post-treatment (11 weeks), and 3-month follow-up.
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Change from baseline in the Beck Anxiety Inventory (BAI) total score.
Lasso di tempo: Baseline, post-treatment (11 weeks), and 3-month follow-up.
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The Beck Anxiety Inventory (BAI) is a 21-item self-report questionnaire designed to measure the severity of anxiety symptoms over the past week. Each item is rated on a 4-point scale ranging from 0 (not at all) to 3 (severely). The total score ranges from 0 to 63, with higher scores indicating greater anxiety severity. |
Baseline, post-treatment (11 weeks), and 3-month follow-up.
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Change from baseline in the Five Facet Mindfulness Questionnaire-Short Form (FFMQ-SF) total score.
Lasso di tempo: Baseline, post-treatment (11 weeks), and 3-month follow-up.
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The Five Facet Mindfulness Questionnaire-Short Form (FFMQ-SF) is a 24-item self-report instrument used to assess five facets of mindfulness: Observing, Describing, Acting with Awareness, Non-judging of Inner Experience, and Non-reactivity to Inner Experience. Each item is scored on a 5-point Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true). The total score is calculated by summing all items and ranges from 24 to 120, with higher scores indicating higher levels of mindfulness. |
Baseline, post-treatment (11 weeks), and 3-month follow-up.
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Change from baseline in the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) subscale scores.
Lasso di tempo: Baseline, post-treatment (11 weeks), and 3-month follow-up.
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The Multidimensional Assessment of Interoceptive Awareness (MAIA-2) is a self-report questionnaire designed to evaluate multiple dimensions of individuals' awareness and perception of internal bodily sensations. The questionnaire assesses different aspects of interoceptive awareness, including noticing bodily sensations, emotional awareness, attention regulation, and the ability to respond to bodily sensations in an adaptive manner. Higher scores indicate greater adaptive interoceptive awareness. |
Baseline, post-treatment (11 weeks), and 3-month follow-up.
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Change from baseline in Obsessional Beliefs Questionnaire (OBQ-20) score.
Lasso di tempo: Baseline, post-treatment (11 weeks), and 3-month follow-up.
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The Obsessional Beliefs Questionnaire-20 (OBQ-20) is a 20-item self-report instrument designed to assess dysfunctional cognitive beliefs and attitudes critical to the development and maintenance of OCD. The scale evaluates four main domains: 1) Responsibility, 2) Threat Estimation, 3) Perfectionism, and 4) Importance/Control of Thoughts. Each item is rated on a 7-point Likert scale ranging from 1 (disagree very much) to 7 (agree very much). The total score is obtained by summing all 20 items and ranges from 20 to 140, with higher scores indicating a greater presence or severity of dysfunctional obsessional beliefs. |
Baseline, post-treatment (11 weeks), and 3-month follow-up.
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Change from baseline in the Self-Compassion Scale-Short Form (SCS-SF) total score.
Lasso di tempo: Baseline, post-treatment (11 weeks), and 3-month follow-up
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The Self-Compassion Scale-Short Form (SCS-SF) is a 12-item self-report questionnaire designed to assess an individual's level of self-compassion. Each item is rated on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). Higher scores indicate a greater level of self-compassion. |
Baseline, post-treatment (11 weeks), and 3-month follow-up
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Change from baseline in the Mind-Wandering Questionnaire (MWQ) total score.
Lasso di tempo: Baseline, post-treatment (11 weeks), and 3-month follow-up.
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The Mind-Wandering Questionnaire (MWQ) is a 5-item self-report instrument designed to measure trait levels of task-unrelated thought (mind-wandering). Each item is rated on a 6-point Likert scale ranging from 1 (almost never) to 6 (almost always). Higher total scores indicate a greater propensity or frequency of mind-wandering. |
Baseline, post-treatment (11 weeks), and 3-month follow-up.
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Change from baseline in the Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index (GSI)
Lasso di tempo: Baseline, post-treatment (11 weeks), and 3-month follow-up.
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The Global Severity Index (GSI) is the primary summary score of the Symptom Checklist-90-Revised (SCL-90-R), a 90-item self-report questionnaire designed to evaluate a broad range of psychological symptoms and psychopathology. Each of the 90 items is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The GSI raw score ranges from 0 to 4, with higher scores indicating a greater overall level of psychological distress and symptom severity. |
Baseline, post-treatment (11 weeks), and 3-month follow-up.
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Mariangela Lanfredi, psychologist, IRCCS Centro San Giovanni di Dio Fatebenefratelli
Pubblicazioni e link utili
Pubblicazioni generali
- Didonna F. (2022). Terapia Cognitiva Basata sulla Mindfulness per il Disturbo Ossessivo-Compulsivo. Edizioni Centro Studi Erickson: Trento.
- Zhang T, Lu L, Didonna F, Wang Z, Zhang H, Fan Q. Mindfulness-Based Cognitive Therapy for Unmedicated Obsessive-Compulsive Disorder: A Randomized Controlled Trial With 6-Month Follow-Up. Front Psychiatry. 2021 Aug 3;12:661807. doi: 10.3389/fpsyt.2021.661807. eCollection 2021.
- Lu L, Zhang T, Gao R, Zhang Z, Cao X, Chen Y, Liu Y, Zhang F, Zheng Y, Sun Y, Bai Y, Wang J, Didonna F, Zhang H, Fan Q. Mindfulness-based cognitive therapy for obsessive-compulsive disorder: Study protocol for a randomized controlled trial with functional magnetic resonance imaging and a 6-month follow-up. J Health Psychol. 2020 Nov-Dec;25(13-14):2072-2084. doi: 10.1177/1359105318780540. Epub 2018 Jul 5.
- Didonna F, Rossi R, Ferrari C, Iani L, Pedrini L, Rossi N, Xodo E, Lanfredi M. Relations of mindfulness facets with psychological symptoms among individuals with a diagnosis of obsessive-compulsive disorder, major depressive disorder, or borderline personality disorder. Psychol Psychother. 2019 Mar;92(1):112-130. doi: 10.1111/papt.12180. Epub 2018 Mar 25.
- Didonna F, Lanfredi M, Xodo E, Ferrari C, Rossi R, Pedrini L. Mindfulness-based Cognitive Therapy for Obsessive-Compulsive Disorder: A Pilot Study. J Psychiatr Pract. 2019 Mar;25(2):156-170. doi: 10.1097/PRA.0000000000000377.
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Termini relativi a questo studio
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- MIND-DOC
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