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PsychosisNCT02340559

Effectiveness of Meta-Cognitive Training (EMC) in People With Psychosis of Brief Evolution.

A study testing Meta-cognitive Training and Psychoeducational group in people with Psychosis, run by Fundació Sant Joan de Déu.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the effectiveness of Meta-Cognitive Training (EMC) in people with a brief psychotic disorder, especially positive symptoms. The secondary objectives would be to assess the effect of EMC on metacognition (cognitive distortions and deficits in theory of mind), psychosocial… Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Psychosis
What is being tested?
Meta-cognitive Training and Psychoeducational group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
No sites listed yet
Study dates
Aug 2012to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Diagnosis of : schizophrenia, schizoaffective disorder, brief psychotic disorder, delusional disorder, schizophreniform disorder, psychotic disorder not otherwise specified.
  • Less than 5 years of evolution.
  • Score at or above 4 on the PANSS during the last year (delusions, grandiosity, suspiciousness).

Who cannot join

  • Neurological disorder which impairs cognition.
  • Intellectual Disability.
  • Score at or above 5 on the PANSS ( Hostility and Uncooperativeness); score at or above 6 on the PANSS (suspiciousness).

About this study

Official title: Effectiveness of Meta-Cognitive Training (EMC) on Symptmos, Metacognition, Social and Neuropsychological Functioning in People With Psychosis of Brief Evolution

The purpose of this study is to assess the effectiveness of Meta-Cognitive Training (EMC) in people with a brief psychotic disorder, especially positive symptoms.

The secondary objectives would be to assess the effect of EMC on metacognition (cognitive distortions and deficits in theory of mind), psychosocial functioning and quality of life, neuropsychological functioning and gender, as well as determine the changes produced by EMC in the insight of each session and the maintenance of the effects of EMC program at six months of treatment.

Read the detailed description

The study is a randomized clinical trial in which a group will receive the Meta-Cognitive Training (EMC) and a control group will receive a journal workshop.

The evaluator will be blind to the group that owns the patients included. The total simple will be of 122 people with a psychotic disorder, less than 5 years of evolution and a score at or above 3 on the PANSS during the last year. Patients should be attended in one of the next services: Parc Sanitari Sant Joan de Déu, Corporació Sanitària Parc Taulí, Hospital de la Santa Creu i Sant Pau, Hospital Clínic de Valencia, Centre d´Higiene Mental de les Corts, Institut d´Assitència Sanitària Girona, Servicio Andaluz de Granada, Málaga y Jaén. The assessment was performed at baseline, at the end of treatment and six month follow-up.

The assessment includes: psychopathology and insight ( PANSS, PSYRATS, PDI, GAF, BDI, BCIS, Sumd), meta-cognition (jumping to conclusions, IPSAQ, TCI), neuropsychology (WCST, TMT, CPT-II, TAVEC, WAIS) and social functioning and quality of life (EFS, DAS-SV, SLDS). The insight will be assessed at the final of each session (BCIS). The treatment and control group consist of 8 weekly sessions of 45-60 minutes with a total of 4 to 8 patients per group. The EMC group material is translated and validated in Spanish by investigators of the team.

The primary analysis variable is the difference between the scores of experimental and control group in the symptoms scales (especially positive). Secondary outcomes will change in other assessments of social functioning, metacognition (cognitive distortions and theory of mind) and neuropsychological variables. Were analyzed using regression and ANCOVA methods with SPSS 19.

Conditions
Psychosis
Being tested
Meta-cognitive Training, Psychoeducational group
Keywords
meta-cognition, positive symptoms, early phases, schizophrenia
Medical subject headings
Psychotic Disorders, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meta-cognitive TrainingBehavioural

  • Psychoeducational groupBehavioural

Study groups in NCT02340559
Study groupRoleWhat they receive
Meta-cognitive TrainingExperimentalThe metacognitive training program is comprised of eight modules targeting common cognitive errors in schizophrenia. The modules are : attributional distortions (module 1), a jumping to conclusions bias (module 2 and 7), a bias against disconfirmatory evidence (module 3), deficits in theory of mind (module 4 and 6), over-confidence in memory errors (module 5) and depressive cognitive patterns (module 8). The treatment group consist of 8 weekly sessions of 45-60 minutes with a total of 4 to 8 patients per group.
Receives: Behavioral: Psychoeducational group
Psychoeducational groupActive comparatorIn the control group the modules worked were: 1. Healthy Habits, 2. Risk Behaviors, 3. Prevention of relapse, 4 and 5.Videoforum, 6. Resources of work and development of curriculum vitae 7. Leisure activities, and 8. Resources of the community. The psychoeducational group consist of 8 weekly sessions of 45-60 minutes with a total of 4 to 8 patients per group.
Receives: Behavioral: Meta-cognitive Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PANSS. Positive and Negative Syndrome Scale

    The Positive and Negative Syndrome Scale (PANSS)(Kay et al., 1987; Peralta and Cuesta, 1994) measures 30 symptoms on a scale of 1-7, with higher scores indicating greater psychopathology. The PANSS contains three sub-scales: positive, negative and general symptoms.

    Measured: baseline, 2 months (post-treatment) and 6 months of follow-up

  2. PSYRATS. Psychotic Symptoms Rating Scale

    The PSYRATS (Haddock et al, 1999; Gonzalez et al, 2003). This scale assess delusions in 6 items.

    Measured: baseline, 2 months (post-treatment) and 6 months of follow-up

Secondary outcomes (5)

  1. Jumping to conclusions

    Three different computer tasks were used in the study. In Task 1, jars contained balls of two different colors; in one of them the proportion was 85 black versus 15 orange balls and in the other the ratio was reversed. Task 2 was the same as Task 1 but with a proportion of 60:40 in each jar. Finally, Task 3 was similar to Task 2 but instead of balls, the jars contained positive or negative comments with a proportion of 60:40. The patients had to decide which to jar belonged the extracted balls or comments. At all times the participants had information about the balls previously extracted, in order to control the effect of memory. The subjects could remove as many balls as needed to make their final decision (Garety et al., 2005). JTC was considered as taking a decision after extracting 1 or 2 balls.

    Measured: baseline, 2 months (post-treatment) and 6 months of follow-up

  2. BCIS. Beck Cognitive and Insight Scale

    The Beck Cognitive Insight Scale (BCSI; Beck et al., 2004; Gutierrez-Zotes et al., 2012) is a self-registering measure of 15 items which evaluates how the patients assess their own judgement. It has two dimensions; self-reflection (R) (9 items), and self-certainty (C) (6 items). A compound index of cognitive insight is obtained as the subtraction of self-certainty from self-reflection (R-C).

    Measured: baseline, 2 months (post-treatment) and 6 months of follow-up. Moreover in the intervention group this scale was assessed at the end of each session

  3. IPSAQ. Internal, Personal and Situational Attribution Questionnaire.

    The scale assess the attributional style in 32 situations.

    Measured: baseline, 2 months (post-treatment) and 6 months of follow-up.

  4. Hinking Task

    The Scale assess Theory of Mind. For the porpouse of the study we selected 3 different situations in each assessment

    Measured: baseline, 2 months (post-treatment) and 6 months of follow-up.

  5. TCI scale "Test de Creencias Irracionales"

    This scale assess irrational beliefs in ten subscales:Need for acceptance by others, High self-expectations, blame, Intolerance to frustration, Worry and anxiety, Emotional irresponsibility, Avoidance of problems, dependency, helplessness, perfectionism.

    Measured: baseline, 2 months (post-treatment) and 6 months of follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2015 (estimated)
  2. Study startAug 2012
  3. Primary completionSep 2013
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02340559
Sponsor's protocol ID
PI11/01347
Status last verified
Jan 2015
First submitted
13 Jan 2015
Last updated
21 Jan 2015
Results posted
No
Data monitoring committee
No

Publications

  • Salas-Sender M, Lopez-Carrilero R, Barajas A, Lorente-Rovira E, Pousa E, Barrigon ML, Grasa E, Ruiz-Delgado I, Gonzalez-Higueras F, Cid J, Aznar A, Pelaez T, Birules I, Moritz S, The Spanish Metacognition Study Group, Ochoa S. Gender differences in response to metacognitive training in people with first-episode psychosis. J Consult Clin Psychol. 2020 Jun;88(6):516-525. doi: 10.1037/ccp0000468. Epub 2019 Dec 19.

    PubMed 31855037

Questions about this trial

What is this clinical trial studying?

A study testing Meta-cognitive Training and Psychoeducational group in people with Psychosis, run by Fundació Sant Joan de Déu.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PANSS. Positive and Negative Syndrome Scale (time frame: baseline, 2 months (post-treatment) and 6 months of follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02340559, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.

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