CompletedNot Applicable

Effect of Individual Cognitive Stimulation at Home in Adults With Psychotic Disorders

Portugal38 participantsStarted 2021-03-29

Plain-language 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).

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cognitive functioning evaluated through Montreal Cognitive Assessment [MoCA]

Timeframe: baseline

Change in cognitive functioning evaluated through MoCA

Timeframe: 8 weeks after the beginning of the intervention

Change in cognitive functioning evaluated through MoCA

Timeframe: 16 weeks after the beginning of the intervention

Change in cognitive functioning evaluated through MoCA

Timeframe: 8 weeks after end of intervention

Executive functions evaluated through Frontal Assessment Battery (FAB)

Timeframe: baseline

Change in executive functions evaluated through FAB

Timeframe: 8 weeks after the beginning of the intervention

Change in executive functions evaluated through FAB

Timeframe: 16 weeks after the beginning of the intervention

Trial details

NCT IDNCT04783285

SponsorCEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-22

View on ClinicalTrials.gov More Psychotic Disorders trials

Plain-language summary

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Cognitive functioning evaluated through Montreal Cognitive Assessment [MoCA]

Timeframe: baseline

Change in cognitive functioning evaluated through MoCA

Timeframe: 8 weeks after the beginning of the intervention

Change in cognitive functioning evaluated through MoCA

Timeframe: 16 weeks after the beginning of the intervention

Change in cognitive functioning evaluated through MoCA

Timeframe: 8 weeks after end of intervention

Executive functions evaluated through Frontal Assessment Battery (FAB)

Timeframe: baseline

Change in executive functions evaluated through FAB

Timeframe: 8 weeks after the beginning of the intervention

Change in executive functions evaluated through FAB

Timeframe: 16 weeks after the beginning of the intervention