Computerized Cognitive Remediation Therapy in Adolescents With a First Psychotic Episode

NCT05405946 | Unknown

• 2 other identifiers: HSJD-CCRT-2019PIC-99-19
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive deficits (CD) are considered one of the essential characteristics in psychotic disorders and occur throughout the course of the disease, being a key characteristic in the evolution of the disease and in the functionality and prognosis of patients. Intervening in the early stages of the disease and specifically in adolescence, a period of high brain plasticity can reduce disabilities in adulthood associated with early-onset psychosis. The objective of this study is to assess the efficacy of cognitive rehabilitation therapy in adolescents with a first psychotic episode, comparing two groups of these patients: a first group (CCRT) will carry out 40 sessions of a computerized cognitive remediation therapy with the usual treatment too, and a second group will perform only the usual treatment (TAU). The main hypothesis is that the CCRT group will present a significant improvement in verbal memory, visual attention, executive function, and social cognition and will present better global functioning compared to the TAU group.

Conditions

Early-onset Schizophrenia; Psychotic Disorders; Cognitive Remediation Therapy; Cognition

Keywords

Early-onset; Psychotic Disorders; Cognitive Remediation Therapy; CRT; Cognition; Functional Outcome; Adolescent

Outcome Measures

Primary Outcomes (57)

• Global Functioning

  T-score, GAF: Global Assesment Functioning-Scale (Endicott et al, 1976) Range: 0 (lowest) to 100 (highest)

  1 week

• Global Functioning

  T-score, GAF: Global Assesment Functioning-Scale (Endicott et al, 1976) Range: 0 (lowest) to 100 (highest)

  5 months

• Global Functioning

  T-score, GAF: Global Assesment Functioning-Scale (Endicott et al, 1976) Range: 0 (lowest) to 100 (highest)

  11 months

• Long term Verbal Memory

  T-score, long term, Hopkins Verbal Learning Test- Revised (HVLT-R; Brandt 1991)

  1 week

• Long term Verbal Memory

  T-score, long term, Hopkins Verbal Learning Test- Revised (HVLT-R; Brandt 1991)

  5 months

• Long term Verbal Memory

  T-score, long term, Hopkins Verbal Learning Test- Revised (HVLT-R; Brandt 1991)

  11 months

• Verbal Memory, Learning

  T-score, learning, Hopkins Verbal Learning Test- Revised (HVLT-R; Brandt 1991)

  1 week

• Verbal Memory, Learning

  T-score, learning, Hopkins Verbal Learning Test- Revised (HVLT-R; Brandt 1991)

  5 months

• Verbal Memory, Learning

  T-score, learning, Hopkins Verbal Learning Test- Revised (HVLT-R; Brandt 1991)

  11 months

• Attention

  Confidence Index, Continuous Performance Test - II (CPT-II; Rosvold, 1956)

  1 week

• Attention

  Confidence Index, Continuous Performance Test - II (CPT-II; Rosvold, 1956)

  5 months

• Attention

  Confidence Index, Continuous Performance Test - II (CPT-II; Rosvold, 1956)

  11 months

• Long Term Visual Memory

  T-score, long term, Rey-Osterrieth complex figure (HVLT-R; Brandt 1991)

  1 week

• Long term Visual Memory

  T-score, long term, Rey-Osterrieth complex figure (HVLT-R; Brandt 1991)

  5 months

• Long term Visual Memory

  T-score, long term, Rey-Osterrieth complex figure (HVLT-R; Brandt 1991)

  11 months

• Organization Visual Memory

  Percentile, organization, Rey-Osterrieth complex figure (HVLT-R; Brandt 1991)

  1 week

• Organization Visual Memory

  Percentile, organization, Rey-Osterrieth complex figure (HVLT-R; Brandt 1991)

  5 months

• Organization Visual Memory

  Percentile, organization, Rey-Osterrieth complex figure (HVLT-R; Brandt 1991)

  11 months

• Working memory Spatial Span (WISC-V)

  T-score, Spatial Span Wechsler Intelligence Scale for Children-Five Edition (WISC-V) (Wechsler, 2014)

  1 week

• Working memory Spatial Span

  T-score, Spatial Span Wechsler Intelligence Scale for Adults (WAIS-IV) (Wechsler, 2012)

  1 week

• Working memory Spatial Span (WISC-V)

  T-score, Spatial Span Wechsler Intelligence Scale for Children-Five Edition (WISC-V) (Wechsler, 2014)

  5 months

• Working memory Spatial Span

  T-score, Spatial Span Wechsler Intelligence Scale for Adults (WAIS-IV) (Wechsler, 2012)

  5 months

• Working memory Spatial Span (WISC-V)

  T-score, Spatial Span Wechsler Intelligence Scale for Children-Five Edition (WISC-V) (Wechsler, 2014)

  11 months

• Working memory Spatial Span

  T-score, Spatial Span Wechsler Intelligence Scale for Adults (WAIS-IV) (Wechsler, 2012)

  11 months

• Working memory Letter-Number Span (WISC-V)

  T-score: Letter-Number Span Test, Wechsler Intelligence Scale for Children-Five Edition (WISC-V) (Wechsler, 2014)

  1 week

• Working memory Letter-Number Span

  T-score: Letter-Number Span Test, Wechsler Intelligence Scale for Adults (WAIS-IV) (Wechsler, 2012)

  1 week

• Working memory Letter-Number Span (WISC-V)

  T-score: Letter-Number Span Test, Wechsler Intelligence Scale for Children-Five Edition (WISC-V) (Wechsler, 2014)

  5 months

• Working memory Letter-Number Span

  T-score: Letter-Number Span Test, Wechsler Intelligence Scale for Adults (WAIS-IV) (Wechsler, 2012)

  5 months

• Working memory Letter-Number Span (WISC-V)

  T-score: Letter-Number Span Test, Wechsler Intelligence Scale for Children-Five Edition (WISC-V) (Wechsler, 2014)

  11 months

• Working memory Letter-Number Span

  T-score: Letter-Number Span Test, Wechsler Intelligence Scale for Adults (WAIS-IV) (Wechsler, 2012)

  11 months

• Working memory digits (WISC-V)

  T-score, Digits Test, Wechsler Intelligence Scale for Children-Five Edition (WISC-V) (Wechsler, 2014)

  1 week

• Working memory digits

  T-score, Digits Test, Wechsler Intelligence Scale for Adults (WAIS-IV) (Wechsler, 2012) Range: 0 (lowest) to 100 (highest)

  1 week

• Working memory digits (WISC-V)

  T-score, Digits Test, Wechsler Intelligence Scale for Children-Five Edition (WISC-V) (Wechsler, 2014) Range: 0 (lowest) to 100 (highest)

  5 months

• Working memory digits

  T-score, Digits Test, Wechsler Intelligence Scale for Adults (WAIS-IV) (Wechsler, 2012) Range: 0 (lowest) to 100 (highest)

  5 months

• Working memory digits (WISC-V)

  T-score, Digits Test, Wechsler Intelligence Scale for Children-Five Edition (WISC-V) (Wechsler, 2014) Range: 0 (lowest) to 100 (highest)

  11 months

• Working memory digits

  T-score, Digits Test, Wechsler Intelligence Scale for Adults (WAIS-IV) (Wechsler, 2012) Range: 0 (lowest) to 100 (highest)

  11 months

• Social Cognition

  Faces Test de Baron-Cohen (Wheelwright y Jolliffe,1997) Range: 0 (lowest) to 28 (highest)

  1 week

• Social Cognition

  Faces Test de Baron-Cohen (Wheelwright y Jolliffe,1997) Range: 0 (lowest) to 28 (highest)

  up to 5 months

• Social Cognition

  Faces Test de Baron-Cohen (Wheelwright y Jolliffe,1997) Range: 0 (lowest) to 28 (highest)

  11 months

• Executive functions, categories

  T-score, Wisconsin Card Sorting Test (WCST; Heaton et al.,1981) Range: 0 (lowest) to 100 (highest)

  1 week

• Executive functions, categories

  T-score, Wisconsin Card Sorting Test (WCST; Heaton et al.,1981) Range: 0 (lowest) to 100 (highest)

  5 months

• Executive functions, categories

  T-score, Wisconsin Card Sorting Test (WCST; Heaton et al.,1981) Range: 0 (lowest) to 100 (highest)

  11 months

• Executive functions, TMT-B

  T-score, Trail Making Test: Part B (TMT; Reitan, 1971) Range: 0 (lowest) to 100 (highest)

  1 week

• Executive functions, TMT-B

  T-score, Trail Making Test: Part B (TMT; Reitan, 1971) Range: 0 (lowest) to 100 (highest)

  5 months

• Executive functions, TMT-B

  T-score, Trail Making Test: Part B (TMT; Reitan, 1971) Range: 0 (lowest) to 100 (highest)

  11 months

• Processing Speed TMT-A

  T-score, Trail Making Test: Part A (TMT; Reitan, 1971) Range: 0 (lowest) to 100 (highest)

  1 week

• Processing Speed TMT-A

  T-score, Trail Making Test: Part A (TMT; Reitan, 1971) Range: 0 (lowest) to 100 (highest)

  5 months

• Processing Speed TMT-A

  T-score, Trail Making Test: Part A (TMT; Reitan, 1971) Range: 0 (lowest) to 100 (highest)

  11 months

• Processing Speed Coding

  T-score, Symbol Coding de la Brief Assessment of Cognition in Schizophrenia (BACS)(Keefe, 2004) Range: 0 (lowest) to 100 (highest)

  1 week

• Processing Speed Coding

  T-score, Symbol Coding de la Brief Assessment of Cognition in Schizophrenia (BACS)(Keefe, 2004) Range: 0 (lowest) to 100 (highest)

  5 months

• Processing Speed Coding

  T-score, Symbol Coding de la Brief Assessment of Cognition in Schizophrenia (BACS)(Keefe, 2004) Range: 0 (lowest) to 100 (highest)

  11 months

• Processing Speed FAS Word Fluency

  T-score, FAS Word Fluency (Guilford, 1967) Range: 0 (lowest) to 100 (highest)

  1 week

• Processing Speed FAS Word Fluency

  T-score, FAS Word Fluency (Guilford, 1967) Range: 0 (lowest) to 100 (highest)

  5 months

• Processing Speed FAS Word Fluency

  T-score, FAS Word Fluency (Guilford, 1967) Range: 0 (lowest) to 100 (highest)

  11 months

• Processing Speed Semantic Word Fluency

  T-score, Semantic Word Fluency (Guilford, 1967) Range: 0 (lowest) to 100 (highest)

  1 week

• Processing Speed Semantic Word Fluency

  T-score, Semantic Word Fluency (Guilford, 1967) Range: 0 (lowest) to 100 (highest)

  5 months

• Processing Speed Semantic Word Fluency

  T-score, Semantic Word Fluency (Guilford, 1967) Range: 0 (lowest) to 100 (highest)

  11 months

Secondary Outcomes (25)

• Psychopathology

  1 week

• Positive symptoms

  1 week

• Positive symptoms

  5 months

• Positive symptoms

  11 months

• Negative symptoms

  1 week

Other Outcomes (71)

• vocabulary (WISC-V)

  1 week

• vocabulary

  1 week

• similarities (WISC-V)

  1 week

Study Arms (2)

Computerized Cognitive Remediation Intervention and Treatment as Usual (CCRT+TAU)

EXPERIMENTAL

Participants with a diagnosis of schizophrenia / schizoaffective disorder undergo Computerized CRT and the usual treatment. Three evaluations are carried out, each one divided into two sessions: an evaluation before the start of treatment, a second evaluation after finishing the Computerized CRT (after 40 sessions), and a third evaluation (follow-up) 6 months after finishing the Computerized CRT.

Behavioral: Computerized Cognitive Remediation Therapy; Other: Treatment as Usual

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Participants with a diagnosis of schizophrenia / schizoaffective disorder undergo the usual treatment. Two evaluations will be carried out, also divided into two sessions: a first baseline evaluation and a second evaluation 5 months later, after receiving the usual treatment. After this second evaluation, the Computerized CRT is then started to guarantee ethics in all patients. The evaluation is not carried out at 6 months since they will also have received the intervention.

Other: Treatment as Usual

Interventions

Computerized Cognitive Remediation Therapy BEHAVIORAL

Sessions of 45 minutes will be developed 2 times a week, for 4-5 months (performing a total of 40 sessions). The sessions will be led by an experienced clinician with psychotic patients, and trained for the management of CCRT. Each intervention session will be individualized according to the results of the evaluation tests and the computerized program itself will adapt the difficulty of the tasks according to the performance of each patient. The cognitive remediation NeuroPersonalTrainer platform includes two rehabilitation modules: the cognition module that includes attention, memory and executive functions with different levels of complexity and the Social Cognition module which allows working on different aspects of emotional processing, theory of mind and cognitive biases through 43 tasks based on multiple multimedia materials.

Also known as: CCRT

Computerized Cognitive Remediation Intervention and Treatment as Usual (CCRT+TAU)

Treatment as Usual OTHER

Patients receiving TAU include psychoeducation about the disorder, psychiatric visits, and follow-up and review of drug treatment. In addition, they make individual visits with psychology, nursing and / or social work. In all cases, patients are treated in outpatient clinics.

Also known as: TAU

Computerized Cognitive Remediation Intervention and Treatment as Usual (CCRT+TAU); Treatment as Usual (TAU)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \) Age between 12-18 years
• \) DSM-5 diagnostic criteria for schizophrenia or schizoaffective disorder (F20 or F25, DSM-5) beginning at age 17 or earlier;
• \) Clinically and pharmacologically stabilized;
• \) No changes in drug treatment for 6 weeks from baseline assessment;
• \) Presence of cognitive impairment according to criteria adapted in Penades et al. and following the same criteria in previous studies with similar populations. In this sense, at least one of the following criteria must be present:
• discrepant scores (a score is discrepant when the T scores are 1 DE below the patient's estimated IQ
• Either a score T below 37 in persevering Wisconsin Card Sorting Test (WCST) errors by Heaton et al. (1981).
• \) Diagnosis and diagnostic stability verified by a psychiatrist or senior psychologist or member of the research team using the DSM-5 criteria and based on clinical interviews with the patient and his family.

You may not qualify if:

• \) Intellectual disability CI estimated equivalent to or \<70);
• \) Active substance abuse;
• \) Neurological impairment;
• \) Have received electro-convulsive therapy in the 6 months prior to treatment;
• \) Do not sign informed consent.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead

Study Sites (1)

Hospital Sant Joan de Deu

Barcelona, 08950, Spain

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Ester Camprodon Rosanas, Psychology

  Hospital Sant Joan de Deu Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ester Camprodon Rosanas, Psychology

CONTACT

. +34 677056074; ester.camprodon@sjd.es

Sara Parrilla Carrasco, Psychology

CONTACT

691781294; saraparrillac@gmail.com

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: The group will be randomized as parallel groups. CCRT Group in comparison with TAU Group. Randomization will be performed using permuted blocks with a fixed size of 8 patients assigned in a relationship 4:4 according to the computerized assignment.

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: June 6, 2022
• Study Start: March 19, 2019
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)