UnknownNot Applicable

Benefits of Combining MCT With CR in the Recovery of Patients With Psychotic Spectrum Disorders

Spain160 participantsStarted 2022-09-01

Plain-language summary

The goal of this clinical trial is to compare the efficacy of combined REHACOP + MCT alone in persons with nonaffective psychotic disorder in terms of recovery. The main questions it aims to answer are: * Does combined REHACOP + MCT therapy increase the clinical recovery in persons with nonaffective psychotic disorder (compared to MCT alone)? * What is the impact of combined REHACOP + MCT therapy compared to MCT therapy alone on personal/psychological recovery, cognitive biases, and social cognition, taking gender differences into account? * What is the durability of the effects of combined REHACOP + MCT therapy compared to MCT therapy alone on clinical recovery, personal recovery, cognitive biases, and social cognition in the long term? Researchers will compare REHACOP+MCT therapy to MCT alone to see if there are differences in personal/psychological recovery. Participants will: * Participate in Metacognitive Training or in combined REHACOP + Metacognitive training therapy. * Do 8 weekly sessions of 45-60 minutes (MCT group). * Do 12 weekly sessions of 45-60 minutes (RECHACOP+MCT group). * Visit the clinic for checkups and tests. * Answer self-administered tests.

Who can participate

Age range

16 Years – 55 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: * Presence of one of the e following diagnostics according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5): schizophrenia, schizophreniform disorder, delusional disorder, brief psychotic disorder, schizoaffective disorder, and non specified schizophrenia spectrum disorder and other psychotic disorders. * Be in a stable clinical phase (without psychiatric hospitalization in the last 3 months). * Have good adherence to pharmacological treatment. * T-score \< 40 in any cognitive outcome measured by TAVEC, CPT-IP, TMT, Stroop, WSCT, FAS and WAIS (Vocabulary, Digit Forward, Digit Backwards and Digit Symbol Coding. * Willing to participate in the study expressed by providing signed informed consent. Exclusion Criteria: * Presence of traumatic brain lesion, dementia or intellectual discapacity (IQ \<70). * Positive and Negative Syndrome Scale (PANSS) score \>= 5 in hostility and lack of cooperation and \>= 6 in suspiciousness. * Presence of an additional diagnosis of severe disorder related to substances. * Having participated in a CR and/or MCT intervention in the year prior to incorporation into the 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

CLINICAL RECOVERY

Timeframe: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.

FUNCTIONAL RECOVERY

Timeframe: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.

Trial details

NCT IDNCT06423651

SponsorUniversitat Autonoma de Barcelona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

Contact for this trial

Ana Barajas Velez

+34935814452 ana.barajas@uab.cat

View on ClinicalTrials.gov More Schizophrenia trials

Plain-language summary

Who can participate

Age range

16 Years – 55 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

CLINICAL RECOVERY

Timeframe: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.

FUNCTIONAL RECOVERY

Timeframe: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.