NCT04418570

Brief Summary

This study aims to explore whether hormones or inflammatory markers are associated with cognitive changes following cognitive remediation therapy (CRT) in people with a recent-onset psychotic disorder. The following biomarkers for treatment response will be considered: hormones related to the hypothalamic-pituitary-adrenal (HPA) axis (plasma cortisol, cortisol awakening response, diurnal cortisol slope, salivary cortisol at assessment), free thyroxine (F-T4), prolactin, or inflammatory markers. This study was designed as a pilot clinical trial in order to know the feasibility of the intervention and to calculate the effect sizes of different hormonal and inflammatory variables on cognition. This approach would allow the design of future larger clinical trials to test specific hypotheses generated with this study.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

3.7 years

First QC Date

May 24, 2020

Last Update Submit

June 4, 2020

Conditions

Psychotic Disorders

Keywords

early psychosiscortisolinflammationthyroidprolactincognitive rehabilitationcognitive remediation

Outcome Measures

Primary Outcomes (9)

  • Plasma cortisol concentrations

    Correlation between cognitive changes, assessed with the CANTAB Cognitive battery for schizophrenia, and plasma cortisol concentrations.

    3 months

  • Cortisol awakening response

    Correlation between cognitive changes, assessed with the CANTAB Cognitive battery for schizophrenia, and the cortisol awakening response.

    3 months

  • Diurnal cortisol slope

    Correlation between cognitive changes, assessed with the CANTAB Cognitive battery for schizophrenia, and the diurnal cortisol slope (calculated as the slope between salivary cortisol between awakening and 23h).

    3 months

  • Cortisol at neuropsychological assessment

    Correlation between cognitive changes, assessed with the CANTAB Cognitive battery for schizophrenia, and salivary cortisol at neuropsychological assessment.

    3 months

  • Plasma prolactin concentrations

    Correlation between cognitive changes, assessed with the CANTAB Cognitive battery for schizophrenia, and plasma prolactin concentrations.

    3 months

  • Plasma free thyroxine (F-T4) concentrations

    Correlation between cognitive changes, assessed with the CANTAB Cognitive battery for schizophrenia, and plasma F-T4 concentrations.

    3 months

  • Neutrophil to lymphocyte ratio

    Correlation between cognitive changes, assessed with the CANTAB Cognitive battery for schizophrenia, and neutrophil to lymphocyte ratio.

    3 months

  • Plasma interleukin-6 concentrations

    Correlation between cognitive changes, assessed with the CANTAB Cognitive battery for schizophrenia, and plasma interleukin-6 concentrations.

    3 months

  • Plasma tumor necrosis factor alpha (TNF-alpha) concentrations

    Correlation between cognitive changes, assessed with the CANTAB Cognitive battery for schizophrenia, and plasma TNF-alpha concentrations.

    3 months

Secondary Outcomes (9)

  • Changes in plasma cortisol after a cognitive remediation therapy

    3 months

  • Changes in the cortisol awakening response after a cognitive remediation therapy

    3 months

  • Changes in the diurnal cortisol slope after a cognitive remediation therapy

    3 months

  • Changes in cortisol concentrations at neuropsychological assessment after a cognitive remediation therapy

    3 months

  • Changes in plasma prolactin concentrations after a cognitive remediation therapy

    3 months

  • +4 more secondary outcomes

Study Arms (2)

Cognitive remediation

EXPERIMENTAL

Computerized cognitive remediation through Neuropersonal Trainer software, 1.5 h per session twice a week for 12 weeks (36 h of total duration). Participants will also attend the Early Intervention Service for Psychosis with visits by a psychiatrist, clinical psychologist, social worker, or nurse as scheduled.

Behavioral: cognitive remediationOther: attendance to an Early Intervention Service for Psychosis

Treatment as usual

OTHER

Participants will attend the Early Intervention Service for Psychosis with visits by a psychiatrist, clinical psychologist, social worker, or nurse as scheduled.

Other: attendance to an Early Intervention Service for Psychosis

Interventions

cognitive remediationBEHAVIORAL
Cognitive remediation
attendance to an Early Intervention Service for PsychosisOTHER
Cognitive remediationTreatment as usual

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Psychotic disorder meeting Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) criteria for any of the following diagnoses: schizophrenia, schizoaffective disorder, bipolar disorder, and psychotic disorder not otherwise specified.
  • Recent-onset psychosis (\< 3 years of illness).
  • Outpatients with stable illness (\<4 points in each positive item of the Positive and Negative Syndrome Scale \[PANSS\]).
  • Being on community treatment for at least 4 weeks.

You may not qualify if:

  • Refusal to participate.
  • Severe neurological disease or intellectual disability.
  • Pregnancy.
  • Substance-induced psychosis.
  • History of severe traumatic brain injury.
  • Current treatment with glucocorticoids.
  • Visual deficits or language difficulties that could influence cognitive assessment and intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fernandez-Gonzalo S, Turon M, Jodar M, Pousa E, Hernandez Rambla C, Garcia R, Palao D. A new computerized cognitive and social cognition training specifically designed for patients with schizophrenia/schizoaffective disorder in early stages of illness: A pilot study. Psychiatry Res. 2015 Aug 30;228(3):501-9. doi: 10.1016/j.psychres.2015.06.007. Epub 2015 Jun 18.

    PMID: 26163731BACKGROUND

MeSH Terms

Conditions

Psychotic DisordersInflammationThyroid Diseases

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Javier Labad, M.D., Ph.D.

    Parc TaulĂ­ Hospital Universitari, Sabadell, Barcelona (Spain).

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 24, 2020

First Posted

June 5, 2020

Study Start

July 1, 2016

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share