SCIT Versus TAR for Outpatients With Schizophrenia

NCT03446703 | Completed

• 1 other identifier: SCIT-TAR2017
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Schizophrenia

Keywords

social cognition; psychotherapy; rehabilitation; theory of mind

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Theory of Mind

  24 weeks

• Attributional Style

  24 weeks

• Functioning

  24 weeks

Study Arms (2)

SCIT Social cognition interactive

EXPERIMENTAL

Psychosocial intervention based on the Spanish translation of the original SCIT (Social Cognition and Interaction Training) instruction manual (Combs \& Penn; Lahera \& Benito, in press).

Behavioral: SCIT

TAR Training in affect recognition

ACTIVE COMPARATOR

Training in Affect Recognition it is a 12-session training on facial affect recognition over a period of 6 weeks.

Behavioral: TAR

Interventions

SCIT BEHAVIORAL

SCIT is a 18 weekly sessions lasting 45-60 minutes per session. The group will include 8-12 patients, with 2 therapists. The content of the sessions is based on the Spanish translation of the original SCIT (Social Cognition and Interaction Training) instruction manual (Combs, Adams, et al., 2007); (G. Lahera et al., 2013). The manual of the program developed for the improvement of emotional perception skills, attributional style and theory of mind in people with schizophrenia.

SCIT Social cognition interactive

TAR BEHAVIORAL

TAR is a 12-session training on facial affect recognition over a period of 6 weeks. Treatment includes one therapist (psychiatrist or clinical psychologist) and 2 patients. It involves neuropsychological strategies, such as restitution and compensation, as well as principles of errorless learning, direct positive reinforcement, verbalization and self-instruction (Frommann et al., 2003; Wölwer et al., 2005).

TAR Training in affect recognition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Disorders other than schizophrenia or schizoaffective disorder, according to DSM-IV diagnosis criteria;
• Additional axis-I or axis-II diagnosis;
• Dependence to alcohol or other drugs (except nicotine);
• Serious somatic disorders or organic brain damage;
• Mental retardation or difficulty speaking or understanding the Spanish language.

Sponsors & Collaborators

• University of Alcala: lead

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Trained raters who were blind to treatment condition assessed participants on the following variables at baseline, post-treatment and 3-month follow-up
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D. Assistant Professor of Psychiatry

Model Details: A randomized three group pre-post design will be used to investigate effects of the Training of Affect Recognition (TAR), compared to the Social Cognition and Interaction Training (SCIT). Performance in social cognition measures, basic cognitive functioning symptomatology and functional capacity will be assessed before (T0), after (T1) treatment and (T2) 3 months later.

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: February 27, 2018
• Study Start: September 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: June 30, 2017
• Last Updated: February 27, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share