NCT04783285

Brief Summary

The aim of this study is to test the effect of cognitive stimulation (CS), applied individually and at home, on the overall cognitive functioning, emotional state, functionality, and quality of life (QoL) in adults with psychotic disorders. To this end, a randomised controlled clinical trial will be conducted in which selected participants will be randomly assigned to an individual intervention group using CS or a control group. The CS program is adapted from other existing protocol, composed of 32 sessions. Each session will last 45 minutes and will be held twice weekly. There will be four evaluation points (baseline, intra-evaluation - after 8 weeks of intervention, post-evaluation - after 16 weeks of intervention, follow-up - after 8 weeks of the end of intervention).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

March 29, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 10, 2022

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

March 1, 2021

Last Update Submit

March 8, 2022

Conditions

Psychotic DisordersSchizophreniaSchizoaffective DisorderDelusional DisorderSubstance-Induced Psychotic Disorder

Keywords

cognitionmoodexecutive functionsquality of lifenon-pharmacological therapyrandomised controlled trialschizophreniapsychotic disorderscognitive stimulation

Outcome Measures

Primary Outcomes (8)

  • Cognitive functioning evaluated through Montreal Cognitive Assessment [MoCA]

    Cognitive functioning is assessed using the MoCA which is a brief cognitive screening. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.

    baseline

  • Change in cognitive functioning evaluated through MoCA

    Cognitive functioning is assessed using the MoCA which is a brief cognitive screening. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.

    8 weeks after the beginning of the intervention

  • Change in cognitive functioning evaluated through MoCA

    Cognitive functioning is assessed using the MoCA which is a brief cognitive screening. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.

    16 weeks after the beginning of the intervention

  • Change in cognitive functioning evaluated through MoCA

    Cognitive functioning is assessed using the MoCA which is a brief cognitive screening. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.

    8 weeks after end of intervention

  • Executive functions evaluated through Frontal Assessment Battery (FAB)

    The FAB is used to assess executive function in several subtests: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. Scores range from 0 to 18, with higher scores indicating better executive functioning.

    baseline

  • Change in executive functions evaluated through FAB

    The FAB is used to assess executive function in several subtests: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. Scores range from 0 to 18, with higher scores indicating better executive functioning.

    8 weeks after the beginning of the intervention

  • Change in executive functions evaluated through FAB

    The FAB is used to assess executive function in several subtests: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. Scores range from 0 to 18, with higher scores indicating better executive functioning.

    16 weeks after the beginning of the intervention

  • Change in executive functions evaluated through FAB

    The FAB is used to assess executive function in several subtests: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. Scores range from 0 to 18, with higher scores indicating better executive functioning.

    8 weeks after end of intervention

Secondary Outcomes (16)

  • Self-maintaining and instrumental activities of daily living evaluated through Lawton Instrumental Activities of Daily Living (IADL) Scale

    baseline

  • Change in self-maintaining and instrumental activities of daily living evaluated through Lawton IADL Scale

    8 weeks after the beginning of the intervention

  • Change in self-maintaining and instrumental activities of daily living evaluated through Lawton IADL Scale

    16 weeks after the beginning of the intervention

  • Change in self-maintaining and instrumental activities of daily living evaluated through Lawton IADL Scale

    8 weeks after end of intervention

  • Depressive symptomatology assessed through the Center for Epidemiologic Studies Depression Scale (CES-D)

    baseline

  • +11 more secondary outcomes

Other Outcomes (1)

  • Sociodemographic information gathered through the sociodemographic questionnaire

    baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants who meet the inclusion criteria will be randomly assigned to the intervention group receiving CS or to a control group receiving treatment as usual. Participants in the intervention group will participate in two CS sessions per week for 16 weeks besides their treatment as usual. The sessions will be based on the existing protocol.

Behavioral: Individual cognitive stimulation therapy (iCST)

Control Group

NO INTERVENTION

Participants assigned to the control group will maintain their usual treatment: social interaction activities, stimulation of personal skills, and any prescribed psychotic-specific medication.

Interventions

Individual cognitive stimulation therapy (iCST)BEHAVIORAL

The intervention group will receive 32 individual CS sessions per participant. Each session will last approximately 45 minutes and will have the following structure: session introduction (5 minutes); reality orientation (10 minutes); stimulation of cognitive domain (25 minutes); session closure (5 minutes). The sessions will be led by a previously trained therapist. The intervention program will include several activities based on the principles of CS and adjusted for participants with psychotic disorders.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Adults under 65 years.
  • Diagnosed with of schizophrenia spectrum and other psychotic disorders according to the criteria of DSM-5 (APA, 2013), determined by a professional clinician.
  • Willing to participate in all intervention and assessment sessions.
  • Provided informed consent.
  • Native speakers of Portuguese.

You may not qualify if:

  • Presentation of a condition requiring immediate intervention (e.g., suicidal thoughts).
  • Severe sensory and physical limitations that prevent participation in the sessions.
  • Severe disconnection with the environment and very limited attentional level.
  • Inability to communicate adequately.
  • Psychoactive substance use.
  • Currently participating in another study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cediara - Social Solidarity Association of Ribeira de Fráguas

Albergaria-a-Velha, Aveiro District, 3850-705, Portugal

Location

MeSH Terms

Conditions

Psychotic DisordersSchizophreniaSchizophrenia, Paranoid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Susana I Justo Henriques, Ph.D.

    Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra

    PRINCIPAL INVESTIGATOR

  • Ana E Marques Castro, M.Sc.

    Cediara - Associação de Solidariedade Social de Ribeira de Fráguas

    PRINCIPAL INVESTIGATOR

  • Enrique Pérez Sáez, Ph.D.

    National Reference Centre for Alzheimer's and Dementia Care, Imserso, Spain

    PRINCIPAL INVESTIGATOR

  • Janessa O Carvalho, Ph.D.

    Bridgewater State University, Bridgewater, USA

    PRINCIPAL INVESTIGATOR

  • Ana P Sargaço Mendes, MD

    Centro Hospitalar do Baixo Vouga, Aveiro, Portugal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 5, 2021

Study Start

March 29, 2021

Primary Completion

October 22, 2021

Study Completion

December 31, 2021

Last Updated

March 10, 2022

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)