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Trial record 28 of 276 for:    personality AND therapy AND Personality | Recruiting, Not yet recruiting, Available Studies

Assessment of the Effectiveness of the NECT Program (NECT)

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ClinicalTrials.gov Identifier: NCT03972735
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborators:
Hôpital le Vinatier
University Hospital, Grenoble
Clinique du Dauphiné
Centre Hospitalier Annecy Genevois
University Hospital, Clermont-Ferrand
Centre Hospitalier Esquirol
Centre Hospitalier Universitaire de Nice
CHS LE VALMONT
University Hospital, Caen
University Hospital, Geneva
University Hospital, Montpellier
Information provided by (Responsible Party):
Dr Julien Dubreucq, Hospital Center Alpes-Isère

Brief Summary:

Self-stigma refers to the transformation process wherein a person's previously held social identity is progressively replaced by a devalued and stigmatized view of oneself termed "illness identity". Self-Stigma is a severe problem in Serious Mental Illness (SMI). Self-stigma prevalence is high (41.7% of the 1229 participants with SZ and 21.7% of the 1182 participants with mood disorders had moderate to high levels of IS in the GAMIAN-Europe study). Self-stigma was negatively associated with self-esteem, social function, wellbeing, quality of life or personal recovery and positively associated with psychiatric symptoms and depression. Several psychosocial interventions (mostly combinations of psychoeducation and cognitive behaviour therapy) have been designed to reduce self-stigma and its impact on clinical and functional outcomes, with preliminary effects on self-stigma, insight and self-efficacy.

Narrative Enhancement and Cognitive Therapy (NECT) is a manualized structured 20-session group-based intervention . Conducted by two trained facilitators the sessions combine psychoeducation, cognitive restructuring and story-telling exercises to reduce self-stigma. Developed in USA, NECT was adapted in Israel and Sweden. NECT showed effectiveness in reducing self-stigma and in improving self-esteem and quality of life. Despite being effective on changing coping strategies, NECT effectiveness on social function is still unclear.

The present study aims to validate NECT French adaptation and to evaluate its effectiveness on social function, self-stigma, psychiatric symptoms, self-esteem, wellbeing, quality of life and personal recovery in SMI participants (schizophrenia, bipolar disorder, borderline personality disorder)


Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar Disorder Borderline Personality Disorder Social Function Self-stigma Other: Psychiatric interview Other: Clinical, diagnostic and functional evaluation Other: neuropsychological assessment Other: NECT PROGRAM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: stepped-wedge
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study on the Efficacy of the NECT Program (Cognitive Therapy and Narrative Development) on Improving Social Functioning in People With Severe Psychic Disorders
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NECT + follow up
Narrative Development and Cognitive Therapy (NECT) is a 12 session group-based manualized intervention combining psychoeducation, cognitive restructuring and narrative enhancement. The 2 hours sessions are conducted by two trained facilitators.
Other: Psychiatric interview
PANSS, MADRS, PSP, YMRS

Other: Clinical, diagnostic and functional evaluation
ISMI, STORI, SERS, S-QOL, WEWMBS, BIRCHWOOD, MARS

Other: neuropsychological assessment
WAIS IV, BEM 144, TMT A, TMT B, D2-R, V-LIS

Other: NECT PROGRAM
Narrative Development and Cognitive Therapy (NECT) is a 12 session group-based manualized intervention combining psychoeducation, cognitive restructuring and narrative enhancement. The 2h sessions are conducted by two trained facilitators.

Placebo Comparator: TAU
  • Drug treatment (antipsychotic, mood stabilizing) for people with schizophrenia or with bipolar disorder
  • Support in day-care hospital
  • No intervention specifically targeting self-stigma reduction or improvements in social functioning (social cognitive remediation or social skills training)
Other: Psychiatric interview
PANSS, MADRS, PSP, YMRS

Other: Clinical, diagnostic and functional evaluation
ISMI, STORI, SERS, S-QOL, WEWMBS, BIRCHWOOD, MARS

Other: neuropsychological assessment
WAIS IV, BEM 144, TMT A, TMT B, D2-R, V-LIS

Other: NECT PROGRAM
Narrative Development and Cognitive Therapy (NECT) is a 12 session group-based manualized intervention combining psychoeducation, cognitive restructuring and narrative enhancement. The 2h sessions are conducted by two trained facilitators.




Primary Outcome Measures :
  1. Personal and Social Performance Scale [ Time Frame: Changes between baseline function, at 6, 12 and 18 months of follow-up ]
    Changes in the aggregates (average) of standardized performance levels : z-scores of social function (0 to 100) after NECT Program


Secondary Outcome Measures :
  1. Internalized Stigma of Mental Illness (ISMI) scale [ Time Frame: Changes between baseline function, at 6, 12 and 18 months of follow-up ]
    self-assessment of internalized stigma (mean score of total self-stigma ranging from 1 to 4)

  2. Positive and Negative Symptoms Scale for Schizophrenia (PANSS) [ Time Frame: Changes between baseline function, at 6, 12 and 18 months of follow-up ]
    Changes in the aggregates (average) of standardized performance levels : z-scores of positive and negative symptoms (minimum score 30- maximum score 210) of schizophrenia after NECT Program

  3. MADRS (Montgomery-Asberg Depression Rating) [ Time Frame: Changes between baseline function, at 6, 12 and 18 months of follow-up ]
    Changes in the aggregates (average) of standardized performance levels

  4. BIRCHWOOD INSIGHT SCALE [ Time Frame: Changes between baseline function, at 6, 12 and 18 months of follow-up ]
    Changes in the aggregates (average) of standardized performance levels

  5. MARS (Medication Adherence Rating Scale) [ Time Frame: Changes between baseline function, at 6, 12 and 18 months of follow-up ]
    self-assesment of adherence into treatment (minimum 1-maximum 10)

  6. WEMWBS (Warwick Edinburgh Mental Well Being Scale) ) [ Time Frame: Changes between baseline function, at 6, 12 and 18 months of follow-up ]
    self assessment of mental well being

  7. SERS (Self-Esteem Rating Scale) [ Time Frame: Changes between baseline function, at 6, 12 and 18 months of follow-up ]
    Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 10-maximum score 70) in self-assessment of self-esteem

  8. S-QOL (Subjective Quality of Life) [ Time Frame: Changes between baseline function, at 6, 12 and 18 months of follow-up ]
    sel-assessment of quality of life (minimum 0, maximum 100)

  9. STORI Stages of Recovery Instrument [ Time Frame: Changes between baseline function, at 6, 12 and 18 months of follow-up ]
    Self-assessment of personal recovery (maximum stage of recovery ranging from 0 to 5



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, bipolar I or II disorder, borderline personality disorder (DSM-V criteria, APA, 2013).
  • Clinical stability since 3 months (total PANSS score <120, MADRS score <15 and YMRS <12 for patients with schizophrenia and MADRS score <15 and YMRS <12 for patients with bipolar disorder).
  • Patients who gave informed consent to participate in the study.
  • Affiliated to a social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Criteria relating to the associated pathologies entailing particular risks:
  • Neurological disorders of vascular, infectious or neurodegenerative origin.
  • Taking somatic drugs with a cerebral or mental impact (eg corticosteroids).
  • Presence of an associated intellectual disability.
  • Prohibited treatments and procedures:
  • Subject in exclusion period of another study.
  • Simultaneous participation in other programs having an impact on social functioning or self-stigmatization: remediation of social cognition, individual and group care targeting self-stigmatization and training in social skills.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972735


Contacts
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Contact: Julien JD DUBREUCQ, MD +33 4 76 58 88 00 jdubreucq@ch-alpes-isere.fr
Contact: Thomas TC COHEN, CRA +33 4 76 58 88 13 tcohen@ch-alpes-isere.fr

Locations
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France
Ch Annecy-Genevois
Annecy, Aura, France, 74000
Ch Le Vinatier
Bron, Aura, France, 69678
CHU de CLERMONT-FERRAND
Clermont-Ferrand, Aura, France, 63000
University Hospital, Grenoble Not yet recruiting
Grenoble, Aura, France, 38043
Contact: Mircea MP POLOSAN, MD       mpolosan@chu-grenoble.Fr   
Principal Investigator: Mircea MP POLOSAN, MD         
CHS Esquirol Not yet recruiting
Limoges, Aura, France, 87000
Contact: Emilie EL LEGROS LAFARGE, MD         
Principal Investigator: Emilie EL LEGROS LAFARGE, MD         
Clinique du Dauphiné Not yet recruiting
Seyssins, Aura, France, 38180
Contact: Elisabeth EG GIRAUD BARO, MD       egiraudbaro@orange.fr   
Principal Investigator: Elisabeth EG GIRAUD BARO, MD         
Chs Le Valmont
Valence, Aura, France, 26000
E.P.S.M. Ariane Not yet recruiting
Caen, Normandie, France, 14012
Contact: Elodie ED DECERLE, MD         
Principal Investigator: ELodie ED DECERLE, MD         
Hopital La Colombière, University Hospital Montpellier Not yet recruiting
Montpellier, Occitanie, France, 34000
Contact: Nicolas Rainteau, MD         
Principal Investigator: Nicolas Rainteau, MD         
Hospital Center SAINTE MARIE Not yet recruiting
Nice, Paca, France, 06009
Contact: Jean-Yves JG GIORDANA, MD         
Principal Investigator: Jean-Yves JG GIORDANA, MD         
Switzerland
Service des Specialités psychiatriques Not yet recruiting
Geneva, Switzerland, 1201
Contact: Hélène HR RICHARD LEPOURRIEL, MD         
Principal Investigator: Hélèné HR RICHARD LEPOURRIEL, MD         
Sponsors and Collaborators
Hospital Center Alpes-Isère
Hôpital le Vinatier
University Hospital, Grenoble
Clinique du Dauphiné
Centre Hospitalier Annecy Genevois
University Hospital, Clermont-Ferrand
Centre Hospitalier Esquirol
Centre Hospitalier Universitaire de Nice
CHS LE VALMONT
University Hospital, Caen
University Hospital, Geneva
University Hospital, Montpellier
Investigators
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Principal Investigator: Julien JD DUBREUCQ, MD Hospital Center Alpes-Isère

Publications of Results:
Other Publications:

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Responsible Party: Dr Julien Dubreucq, Medical doctor, Hospital Center Alpes-Isère
ClinicalTrials.gov Identifier: NCT03972735     History of Changes
Other Study ID Numbers: 2018-A03237-48
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Schizophrenia
Bipolar Disorder
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders