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Completed

NCT Number: NCT04429412

Effectiveness of the Individualized Metacognitive Training (EMC+) in People With Psychosis of Brief Evolution

The main aim of the study is to evaluate the effectiveness of Individualized Meta-Cognitive Training (EMC +), in people with psychosis of brief evolution on symptoms, especially on positive symptoms. Secondary aims would be to assess the effect of EMC+ in metacognition, psychosocial and neuropsychological functioning, and to assess the maintenance of program effects on 6 months.

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Key information

Conditions

Brief Psychotic Disorder Mental Disorders Psychosis; Episode Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This is a randomized clinical trial in which some patients receive the EMC+ and others treatment as usual.The evaluator will be blind to the group to which the patients belong. The sample for the overall project will be a total of 70 people with a diagnosis of psychotic spectrum, less than 5 years of experience and with a score => 3 positive PANSS (last month) and treated in one of the participating institutions. The evaluation was performed at baseline, at post-treatment and at 6 months follow up. Symptoms, metacognition, psychosocial and neuropsychological functioning were assessed.

The EMC consists of 10 therapeutic units with weekly sessions of 45-60 minutes. The material available for the Individualized Metacognitive Training (EMC) program is made up of power-point presentations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Traumatic brain injury, dementia, or intellectual disability (premorbid IQ ≤70).
  • Substance dependence.
  • Score at or above 5 on the PANSS ( Hostility and Uncooperativeness); score at or above 6 on the PANSS (suspiciousness).

Treatment and study plan

MCT+

Behavioral

Metacognitive training

Primary outcomes

  1. PANSS. Positive and Negative Syndrome Scale. (Kay et al., 1987; Peralta and Cuesta, 1994)

    Time frame: baseline.

    The Positive and Negative Syndrome Scale (PANSS). This scale 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. Range: 7-112. Higher values represent a worse outcome.

  2. PANSS. Positive and Negative Syndrome Scale. (Kay et al., 1987; Peralta and Cuesta, 1994)

    Time frame: immediately after the intervention

    The Positive and Negative Syndrome Scale (PANSS). This scale 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.Range: 7-112. Higher values represent a worse outcome.

  3. PANSS. Positive and Negative Syndrome Scale. (Kay et al., 1987; Peralta and Cuesta, 1994)

    Time frame: 6 months follow-up

    The Positive and Negative Syndrome Scale (PANSS). This scale 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.Range: 7-112. Higher values represent a worse outcome.

Secondary outcomes

  1. Jumping to conclusions. (Brett-Jones et al. 1987).

    Time frame: baseline

    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.Dichotomous: yes/no. A "yes" represents a worse outcome

  2. Jumping to conclusions. (Brett-Jones et al. 1987).

    Time frame: immediately after the intervention

    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.Dichotomous: yes/no. A "yes" represents a worse outcome

  3. Jumping to conclusions. (Brett-Jones et al. 1987).

    Time frame: 6 months follow-up

    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.Dichotomous: yes/no. A "yes" represents a worse outcome

  4. BCIS. Beck Cognitive and Insight Scale. (Beck et al., 2004; Gutierrez-Zotes et al., 2012)

    Time frame: baseline

    The Beck Cognitive Insight Scale. this scale 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).Range: 0-45. Higher values represent a better outcome

  5. BCIS. Beck Cognitive and Insight Scale. (Beck et al., 2004; Gutierrez-Zotes et al., 2012)

    Time frame: immediately after the intervention

    The Beck Cognitive Insight Scale. this scale 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).Range: 0-45. Higher values represent a better outcome

  6. BCIS. Beck Cognitive and Insight Scale. (Beck et al., 2004; Gutierrez-Zotes et al., 2012)

    Time frame: 6 months follow-up

    The Beck Cognitive Insight Scale. this scale 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).Range: 0-45. Higher values represent a better outcome

  7. IPSAQ. Internal, Personal and Situational Attribution Questionnaire. (Kinderman & Bentall, 1996)

    Time frame: baseline

    The scale assess the attributional style in 32 situations. Personalizing Bias (PB) indicates the proportion of external attributions for negative events which are personal as opposed to situational. A PB score of greater than 0.5 therefore represents a greater tendency to use personal rather than situational external attributions for negative events.

  8. IPSAQ. Internal, Personal and Situational Attribution Questionnaire. (Kinderman & Bentall, 1996)

    Time frame: immediately after the intervention

    The scale assess the attributional style in 32 situations. Personalizing Bias (PB) indicates the proportion of external attributions for negative events which are personal as opposed to situational. A PB score of greater than 0.5 therefore represents a greater tendency to use personal rather than situational external attributions for negative events.

  9. IPSAQ. Internal, Personal and Situational Attribution Questionnaire. (Kinderman & Bentall, 1996)

    Time frame: 6 months follow-up

    The scale assess the attributional style in 32 situations. Personalizing Bias (PB) indicates the proportion of external attributions for negative events which are personal as opposed to situational. A PB score of greater than 0.5 therefore represents a greater tendency to use personal rather than situational external attributions for negative events.

  10. The Hinting Task. (Corcoran et al. 1995; Gil et al. 2012)

    Time frame: baseline

    The Scale assess Theory of Mind.Possible range: 0-12. Higher values represent a better outcome

  11. The Hinting Task. (Corcoran et al. 1995; Gil et al. 2012)

    Time frame: immediately after the intervention

    The Scale assess Theory of Mind. Possible range: 0-12. Higher values represent a better outcome

  12. The Hinting Task. (Corcoran et al. 1995; Gil et al. 2012)

    Time frame: 6 months follow-up

    The Scale assess Theory of Mind. Possible range: 0-12. Higher values represent a better outcome

  13. Emotional Recognition Test Faces. (Baron-Cohen et al. 1997)

    Time frame: baseline

    20 photographs that express ten basic and ten complex emotions.Possible range: 0-20. Higher values represent a better outcome

  14. Emotional Recognition Test Faces. (Baron-Cohen et al. 1997)

    Time frame: immediately after the intervention

    20 photographs that express ten basic and ten complex emotions. Possible range: 0-20. Higher values represent a better outcome

  15. Emotional Recognition Test Faces. (Baron-Cohen et al. 1997)

    Time frame: 6 months follow-up

    20 photographs that express ten basic and ten complex emotions.Possible range: 0-20. Higher values represent a better outcome

  16. MASC. (Lahera et al.2014).

    Time frame: immediately after the intervention

    A Movie for the Assessment of Social Cognition. Spanish Validation. 46 multiple-choice questions about the emotions, thoughts or intentions of the protagonists.

    Only one answer out of four is correct. The four choices of each answer include, (1) correct attribution of ToM to the characters of the film, (2) excessive ToM errors (a mental state that is attributed when there is no reason to), (3) reduced ToM errors (a present mental state that is not attributed) and (4) total absence of mental inference (a physical causality attribution instead of a mental state). These errors could be classified as overmentalization, undermentalization and absence of mentalization.

Other outcomes

  1. SFS. Social Functioning Scale.(Birchwood et al, 1990; Torres y Olivares, 2000).

    Time frame: baseline

    This scale assess social functioning in people with psychotic disorders. Range: 45-195

  2. SFS. Social Functioning Scale.(Birchwood et al, 1990; Torres y Olivares, 2000).

    Time frame: immediately after the intervention

    This scale assess social functioning in people with psychotic disorders.Range: 45-195

  3. SFS. Social Functioning Scale.(Birchwood et al, 1990; Torres y Olivares, 2000).

    Time frame: 6 months follow-up

    This scale assess social functioning in people with psychotic disorders.Range: 45-195

  4. WCST(Wisconsin Card Sorting Test, Bergs et al, 1948)

    Time frame: baseline

    measure of executive function. Categories completed and perseverative errors. Higher values represent a better outcome.

  5. WCST(Wisconsin Card Sorting Test, Bergs et al, 1948)

    Time frame: immediately after the intervention

    measure of executive function. Categories completed and perseverative errors. Higher values represent a better outcome.

  6. WCST(Wisconsin Card Sorting Test, Bergs et al, 1948)

    Time frame: 6 months follow-up

    measure of executive function. Categories completed and perseverative errors. Higher values represent a better outcome.

  7. Test Stroop (Stroop, 1935)

    Time frame: baseline

    flexibility and inhibition of automatic responses.Higher values represent a better outcome.

  8. Test Stroop (Stroop, 1935)

    Time frame: immediately after the intervention

    flexibility and inhibition of automatic responses.Higher values represent a better outcome.

  9. Test Stroop (Stroop, 1935)

    Time frame: 6 months follow-up

    flexibility and inhibition of automatic responses.Higher values represent a better outcome.

  10. TMT A B (Trail Making Test, Reitan, 1993)

    Time frame: baseline

    visual attention and task switching. Higher values represent a worse outcome.

  11. TMT A B (Trail Making Test, Reitan, 1993)

    Time frame: immediately after the intervention

    visual attention and task switching. Higher values represent a worse outcome.

  12. TMT A B (Trail Making Test, Reitan, 1993)

    Time frame: 6 months follow-up

    visual attention and task switching. Higher values represent a worse outcome.

  13. CPT-IP (Continous Performance Test, Matrics)

    Time frame: baseline

    measure of attention. Higher values represent a better outcome.

  14. CPT-IP (Continous Performance Test, Matrics)

    Time frame: 6 months follow-up

    measure of attention.Higher values represent a better outcome.

  15. TAVEC (Verbal Learning Test), Benedet and Aleixandre 1998)

    Time frame: baseline

    measure of verbal memory.Higher values represent a better outcome.

  16. TAVEC (Verbal Learning Test), Benedet and Aleixandre 1998)

    Time frame: 6 months follow-up

    measure of verbal memory. Higher values represent a better outcome.

  17. WAIS-III (Weschler Adults Intelligence Scale, Wechsler 1955)

    Time frame: baseline

    vocabulary subscale. Higher values represent a better outcome.

  18. WAIS-III (Weschler Adults Intelligence Scale, Wechsler 1955)

    Time frame: baseline

    digits subscale. Higher values represent a better outcome.

  19. WAIS-III (Weschler Adults Intelligence Scale, Wechsler 1955)

    Time frame: immediately after the intervention

    digits subscale. Higher values represent a better outcome.

  20. WAIS-III (Weschler Adults Intelligence Scale, Wechsler 1955)

    Time frame: 6 months follow-up

    digits subscale. Higher values represent a better outcome.

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Collaborators

  • Centre d'Higiene Mental Les Corts
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • Hospital Clínico Universitario de Valencia
  • Institut Assistència Sanitària Girona
  • Institut Pere Mata
  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
  • Parc Sanitari Sant Joan de Déu
  • Parc de Salut Mar
  • Servicio Andaluz Jaén y Málaga

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Jun 12, 2020
Registry last updated
Jun 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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