Cognitive Remediation Program for Family Caregivers in Schizophrenia

NCT04173598 | Unknown

• 1 other identifier: RECHMPL18_0427
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive impairments are extremely common in schizophrenia and strongly predict deficit in daily functioning, the poor managing medication and multiple hospitalizations. Cognitive remediation is recognized to have an impact on cognitive impairments by engaging preserved cognitive functions or by implementing environmental supports that sustain independent living. Pr. Velligan (University of San Antonio) developed and tested a manualized intervention, called Cognitive Adaptation Training. In this program, trained mental health specialists implement compensatory technique such as environmental supports in the individual's living environment to live more independently and achieve greater self-sufficiency. However, implementing this program needs a lot of professionals and time to maintain CAT effects. This type of intervention is not often done in community care and explains the large number of patients who are dependent on family members for daily living activities. Training family members in this form of intervention would be an appropriate way to resolve these issues. Families expressed a real interest in these types of home-support strategies that CAT offers. Recently, Pr. Kidd and Pr. Velligan developed a CAT version for families and created a manual accessible to people without any knowledge of cognitive deficit. This manual helps families to select specific cognitive-adaptative strategies with their relative to achieve targeted goals. Thism ethod has been translated in French. The aim of this study was to examine whether Web-based family Cognitive Adaptation Training can improve functioning, medication adherence and negative symptoms for individuals with schizophrenia and reduce burden for family members. A total of 60 Dyads consisting of one caregiver and one supported individual with schizophrenia will be randomized to either a Web-based family Cognitive Adaptation Training or an Internet-based control condition. Primary outcome measured will be the score on the life skills profile. Secondary outcomes will include the global score of the Zarit burden Interview, PANSS negative score, and medication adherence. This type of intervention is expected to be developed in territorial area where professionals are not trained to cognitive remediation and therefore substantially lowers the barrier to the deployment of cognitive intervention with other psychosocial interventions for individual with schizophrenia and their caregivers.

Conditions

Schizophrenia

Keywords

schizophrenia; remediation; cognitive

Outcome Measures

Primary Outcomes (3)

• Life Skills Profile Score (LSP-39)

  The "Life Scale Profile" (LSP), validated in French by Mohr et al (2004), is a scale used to assess the subject's life skills profile, particularly for patients with schizophrenia. It is a hetero-questionnaire based on the patient's functioning during the last week (excluding the acute or relapse phase). The scale is composed of 20 items picked-up in an ensemble of 39 questions. The instruction is to rate each item on a scale from 1 to 4: "always, usually, rarely and never". The lower the score, the more the patient has a deficit profile in terms of life. The maximum score is 80. The LSP scale assesses 5 subscores of life skills: sociability, self-management, treatment compliance, antisocial behaviours and strange behaviours. The total duration of the test is about 30 minutes.

  Baseline

• Life Skills Profile Score (LSP-39)

  The "Life Scale Profile" (LSP), validated in French by Mohr et al (2004), is a scale used to assess the subject's life skills profile, particularly for patients with schizophrenia. It is a hetero-questionnaire based on the patient's functioning during the last week (excluding the acute or relapse phase). The scale is composed of 20 items picked-up in an ensemble of 39 questions. The instruction is to rate each item on a scale from 1 to 4: "always, usually, rarely and never". The lower the score, the more the patient has a deficit profile in terms of life. The maximum score is 80. The LSP scale assesses 5 subscores of life skills: sociability, self-management, treatment compliance, antisocial behaviours and strange behaviours. The total duration of the test is about 30 minutes.

  16 weeks

• Life Skills Profile Score (LSP-39)

  The "Life Scale Profile" (LSP), validated in French by Mohr et al (2004), is a scale used to assess the subject's life skills profile, particularly for patients with schizophrenia. It is a hetero-questionnaire based on the patient's functioning during the last week (excluding the acute or relapse phase). The scale is composed of 20 items picked-up in an ensemble of 39 questions. The instruction is to rate each item on a scale from 1 to 4: "always, usually, rarely and never". The lower the score, the more the patient has a deficit profile in terms of life. The maximum score is 80. The LSP scale assesses 5 subscores of life skills: sociability, self-management, treatment compliance, antisocial behaviours and strange behaviours. The total duration of the test is about 30 minutes.

  6 months

Secondary Outcomes (14)

• Global score of the Zarit burden interview

  Baseline

• Global score of the Zarit burden interview

  16 weeks

• Global score of the Zarit burden interview

  6 months

• Patient quality of life: S-QoL 18

  Baseline

• Patient quality of life: S-QoL 18

  16 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

An intervention group consisting of a dyad (patient + family carer) benefiting in addition to the usual treatment from the intervention for the family carer.

Behavioral: Cognitive Adaptation Training for Caregivers (CAT Famille)

Control Group

ACTIVE COMPARATOR

A group consisting of a dyad (patient + caregiver) with usual care (control group)

Behavioral: Usual Care

Interventions

Cognitive Adaptation Training for Caregivers (CAT Famille) BEHAVIORAL

Family CAT manual, with a module each week to be read according to the patient's objectives and a 15-minute webcam feedback by the psychologist.

Intervention Group

Usual Care BEHAVIORAL

Psycho-education manual, with a weekly reading module and a 15-minute webcam feedback by the psychology student.

Control Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient group :
• Age ≥ 18 years old and \< 50 years old
• patients with a diagnosis of schizophrenia according to the criteria of DSM 5 after evaluation by the investigating psychiatrist during the preliminary medical examination
• patients who can understand, speak and read French
• Patient who has given written informed consent to participate in the study, as well as written consent from the guardian for patients under guardianship, and/or from the trusted person for patients hospitalized in Third Party Request Psychiatric Care, Psychiatric Care at the request of a state representative and in a care program. If the patient is under curatorship, the curator will be informed of the study.
• Subject's participation in the study noted in the medical file
• Obligation to be a member or beneficiary of a social security scheme
• Family caregiver group :
• The family carer is actively involved in the care of his or her relative with schizophrenia assessed by having at least one contact per week with the patient (Kidd et al., 2016).
• The carer has an internet connection with a video chat application
• Be under 75 years of age
• Understand, read and speak French
• Having signed an informed consent form

You may not qualify if:

• Patient group :
• Patients with a history of severe head injury and/or neurological pathology with cognitive impact.
• Patient who has benefited from individual or group cognitive remediation.
• Family caregiver group :
• dementia diagnosis
• a history of neurological pathology (epilepsy, multiple sclerosis, parkinson's disease, amyotrophic lateral sclerosis, Huntington's disease)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Service Universitaire de psychiatrie adulte

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Stéphane Raffard, PU

  CHU Montpellier (s-raffard@chu-montpellier.fr)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Myrtille André, MD

CONTACT

+33467339702; m-andre@chu-montpellier.fr

Delphine Capdevielle, MD/PU/PH

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparative, prospective, randomized, study including two groups of (patient / caregiver) dyads: * An intervention group consisting of a dyad (patient + family carer) benefiting in addition to the usual treatment from the intervention for the family carer. * a group consisting of a dyad (patient + caregiver) with usual care (control group).

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: November 22, 2019
• Study Start: February 6, 2020
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: April 15, 2020

Record last verified: 2020-04

Locations

FR (1)