Schizophrenia Clinical Trial
Official title:
Comparative Effectiveness of Social Cognition and Interaction Training Program (SCIT) Versus Training of Affect Recognition Program (TAR) for Outpatients With Schizophrenia.
Verified date | February 2018 |
Source | University of Alcala |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The present work consists of a randomized clinical trial comparing the effectiveness of two interventions based on social cognition training in outpatients with schizophrenia. The investigators sought to compare the effect of a "targeted" (TAR) and a "broad-based" (SCIT) intervention on schizophrenia patients' performance in facial affect recognition, theory of mind and attributional style. Secondarily, the investigators compare the effect on symptomatology, general cognition and functioning. The main hypothesis was that the patient group receiving TAR would exhibit a greater improvement in emotion recognition performance at the post-intervention assessment in comparison to patients receiving the SCIT, and, conversely, patients receiving SCIT would show more effect in ToM and attributional style. To assess the durability of these effects, performance in measures of social cognition, basic cognitive functioning, symptomatology and functional capacity were assessed before (T0), after treatment (T1) and 3 months later (T2).
Status | Completed |
Enrollment | 100 |
Est. completion date | June 30, 2017 |
Est. primary completion date | October 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Outpatients who met DSM-IV criteria for schizophrenia and schizoaffective disorder (SCID-P; First et al. 1994) - Clinical stability: without any psychiatric hospitalizations in the last 3 months, with the same antipsychotic medication during the previous 6 weeks, and no planned change in the drug regime for the next 3 months. - Age in the range from 18 to 65 years Exclusion Criteria: 1. Disorders other than schizophrenia or schizoaffective disorder, according to DSM-IV diagnosis criteria; 2. Additional axis-I or axis-II diagnosis; 3. Dependence to alcohol or other drugs (except nicotine); 4. Serious somatic disorders or organic brain damage; 5. Mental retardation or difficulty speaking or understanding the Spanish language. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Alcala |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Face emotion recognition | Emotion recognition was measured with the Penn Emotion Recognition-40 (ER40) task, in which participants are asked to judge, one at a time, which emotion is shown on a series of 40 faces (Kohler et al, 2003). | 24 weeks | |
Secondary | Theory of Mind | Theory of Mind was assessed with the Spanish version of the Hinting Task (Corcoran et al., 1995; Gil et al., 2012), consisting of 10 brief vignettes containing social hints that the respondent must interpret. Trials are scored from 0 to 2, with higher scores indicating better performance. | 24 weeks | |
Secondary | Attributional Style | Attributional Style was assessed using the Ambiguous Intentions Hostility Questionnaire (AIHQ, Combs et al., 2007). Scored vignettes consist of situations in which the intentions of the vignette characters are ambiguous. Participants are asked to rate on a Likert scale why they think the protagonist acts this way (AIHQHB subscale, Hostility Bias), whether the other person performed the action on purpose (AIHQIS sub- scale, Intentionality score) and how much they would blame him/her (AIHQBS subscale, Blame score). Likewise, they rate how angry the situation would make them feel (AIHQAS, Anger score) and how they would respond to this situation (AIHQAB, Aggressivity Bias). Higher scores reflect more hostile, negative, personal, and aggressive attributions. | 24 weeks | |
Secondary | Functioning | Global functioning was meausured by the Personal and Social Performance scale (PSP) PSP (Morosini et al, 2000; Spanish validation García-Portilla et al, 2012): it is a brief. Clinician-rated, reliable, valid and sensitive instrument for measuring functioning in outpatients with schizophrenia. After a structured interview, clinicians score 4 domains following the stablished criteria using a Likert scale from 1 (absence of functional impairment) to 6 (severe). | 24 weeks |
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