SchizophreniaNCT03446703
SCIT Versus TAR for Outpatients With Schizophrenia
A study testing SCIT and TAR in people with Schizophrenia, run by University of Alcala.
Trial 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'… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- SCIT and TAR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2013to 30 Jun 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Comparative Effectiveness of Social Cognition and Interaction Training Program (SCIT) Versus Training of Affect Recognition Program (TAR) for Outpatients With Schizophrenia.
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).
Read the detailed description
In recent years, there has been an interest in the development of intervention programs focused on the social cognition for people with schizophrenia (Andres et al., 2001; P Penn et al. 2005). At least, five reviews and one meta-analysis have been conducted to date, which demonstrate promising results of the effectiveness of such interventions on social cognitive deficits and functional outcomes (Tan et al; 2016; Choi et al., 2009; Horan et al., 2008; Kurtz and Richardson, 2012; Statucka and Walder, 2013; Wolwer et al., 2010). Some approaches are focused on one specific domain of social cognition ("targeted" interventions, such as the Training in Affect Recognition (TAR, Wolwer et al., 2005), and others incorporate multiple domains to create more complex, eclectic programs ("broad-based" interventions, such as the Social Cognition and Interaction Training (SCIT; Penn et al. 2007; Kurtz \& Richardson, 2012).
TAR (Frommann et al., 2003) is one of the social cognition interventions with greater empirical support (Statucka \& Walder, 2016) and has been shown to effectively attenuate facial affect recognition deficits in patients with schizophrenia (Wölwer et al. 2005; Wölwer and Frommann 2011; Sachs et al. 2012; Luckhaus et al. 2013). TAR teaches compensation strategies using errorless learning principles, positive reinforcement, feature abstraction, self-instruction and, most importantly, verbalization of characteristic features of facial affect. In a randomized controlled trial, the TAR group achieved significant improvements in facial affect recognition -in particular in recognizing sad faces- and in the quality of life domain social relationship. Furthermore, the TAR training contributed to enhancing some aspects of cognitive functioning and negative symptoms (Sachs et al, 2012). In the other hand, SCIT is a 24-session manual-based group treatment, including elements of cognitive behavioral therapy and social skills training. It is designed for those with schizophrenia spectrum disorders to improve social functioning by enhancing social cognition. Across different studies and research groups, SCIT has been also shown to improve in emotion perception, theory of mind (ToM), and social functioning (Bartholomeusz et al., 2013; Combs et al., 2007; Hasson-Ohayon, 2014; Parker et al. 2013; Penn et al., 2007; Roberts \& Penn, 2009; Roberts et al. 2010; Roberts et al., 2014, 2016; Wang et al., 2013).
The efficacy of both interventions has been demonstrated in randomized controlled trials compared to "treatment as usual", occupational therapy or cognitive remediation (Kurtz et al. 2016) but to date no study has compared the efficacy of two different social cognitive interventions (a direct comparison design). A more precise knowledge about the effect of each intervention on the 4 main domains of social cognition (affect recognition, theory of mind, attributional style and social perception) is needed, and this would enable to identify potential candidates for each program.
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).
- Methods
2.1. Participants Outpatients who met DSM-IV criteria for schizophrenia and schizoaffective disorder (SCID-P; First et al. 1994) with stable symptoms in the range from 18 to 65 years were included into the study. Patients were recruited from 4 Mental Healt Centers in Madrid, Barcelona, Zaragoza and Teruel (Spain). All were clinically stable, 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. Exclusion criteria were: 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.
The study was approved by the loval ethics committee and all participants gave their informed consent. Overall 100 participants were randomized either to TAR group (n = 49) or to the SCIT group (n = 51) (Consort diagram, Graphic 1).
2.1.1. Treatment
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). The program is divided into three blocks, whereas each block consists of 4 sessions: during the first block patients learn to identify and discriminate the prototypical facial signs of the six basic emotions (happiness, sadness, fear, disgust, anger and surprise). The next block aims at a more holistic processing mode with fast decisions, relying on first impression, nonverbal processing and recognition of facial expressions with small intensities. The third block deals with the role of facial emotions in social, behavioral and situational context. Baseline assessments (T0=pre-treatment) were performed after enrolment to the study and post treatment assessments (T1=post-treatment) after the end of the training period (Sachs et al. 2012).
SCIT is a manual-based group intervention that is delivered in 20-24weekly, hour-long sessions. Groups include two clinicians and six to ten patients. SCIT uses a combination of psychoeducation, drill-and-repeat skill practice, strategy games, heuristic rehearsal, and homework assignments to remediate deficits and decrease biases in social cognition. Each SCIT group participant was encouraged to identify a 'practice partner', a family member or acquaintance who was willing to practice SCIT skills with the participant weekly in lieu of, or in addition to, traditional homework. SCIT clinicians attempted to reach practice partners by phone each week to check -in and provide guidance in their efforts to support SCIT participants' learning (Roberts et al. 2014).
- Conditions
- Schizophrenia
- Being tested
- SCIT, TAR
- Keywords
- social cognition, psychotherapy, rehabilitation, theory of mind
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCITBehavioural
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.
TARBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: TAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 weeks
Secondary outcomes (3)
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.
Measured: 24 weeks
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.
Measured: 24 weeks
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).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Sep 2013
- Primary completion1 Oct 2016
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Lahera, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446703
- Sponsor's protocol ID
- SCIT-TAR2017
- Status last verified
- Feb 2018
- First submitted
- 20 Oct 2017
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Social Cognition and Interaction Training Program (SCIT) Versus Training of Affect Recognition Program (TAR) for Outpatients With Schizophrenia.
- ClinicalTrials.gov ID
- NCT03446703
- Acronym / sponsor ID
- SCIT-TAR2017
- Conditions
- Schizophrenia
- Keywords
- social cognition, psychotherapy, rehabilitation, theory of mind
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
In recent years, there has been an interest in the development of intervention programs focused on the social cognition for people with schizophrenia (Andres et al., 2001; P Penn et al. 2005). At least, five reviews and one meta-analysis have been conducted to date, which demonstrate promising results of the effectiveness of such interventions on social cognitive deficits and functional outcomes (Tan et al; 2016; Choi et al., 2009; Horan et al., 2008; Kurtz and Richardson, 2012; Statucka and Walder, 2013; Wolwer et al., 2010). Some approaches are focused on one specific domain of social cognition ("targeted" interventions, such as the Training in Affect Recognition (TAR, Wolwer et al., 2005), and others incorporate multiple domains to create more complex, eclectic programs ("broad-based" interventions, such as the Social Cognition and Interaction Training (SCIT; Penn et al. 2007; Kurtz \& Richardson, 2012).
TAR (Frommann et al., 2003) is one of the social cognition interventions with greater empirical support (Statucka \& Walder, 2016) and has been shown to effectively attenuate facial affect recognition deficits in patients with schizophrenia (Wölwer et al. 2005; Wölwer and Frommann 2011; Sachs et al. 2012; Luckhaus et al. 2013). TAR teaches compensation strategies using errorless learning principles, positive reinforcement, feature abstraction, self-instruction and, most importantly, verbalization of characteristic features of facial affect. In a randomized controlled trial, the TAR group achieved significant improvements in facial affect recognition -in particular in recognizing sad faces- and in the quality of life domain social relationship. Furthermore, the TAR training contributed to enhancing some aspects of cognitive functioning and negative symptoms (Sachs et al, 2012). In the other hand, SCIT is a 24-session manual-based group treatment, including elements of cognitive behavioral therapy and social skills training. It is designed for those with schizophrenia spectrum disorders to improve social functioning by enhancing social cognition. Across different studies and research groups, SCIT has been also shown to improve in emotion perception, theory of mind (ToM), and social functioning (Bartholomeusz et al., 2013; Combs et al., 2007; Hasson-Ohayon, 2014; Parker et al. 2013; Penn et al., 2007; Roberts \& Penn, 2009; Roberts et al. 2010; Roberts et al., 2014, 2016; Wang et al., 2013).
The efficacy of both interventions has been demonstrated in randomized controlled trials compared to "treatment as usual", occupational therapy or cognitive remediation (Kurtz et al. 2016) but to date no study has compared the efficacy of two different social cognitive interventions (a direct comparison design). A more precise knowledge about the effect of each intervention on the 4 main domains of social cognition (affect recognition, theory of mind, attributional style and social perception) is needed, and this would enable to identify potential candidates for each program.
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).
- Methods
2.1. Participants Outpatients who met DSM-IV criteria for schizophrenia and schizoaffective disorder (SCID-P; First et al. 1994) with stable symptoms in the range from 18 to 65 years were included into the study. Patients were recruited from 4 Mental Healt Centers in Madrid, Barcelona, Zaragoza and Teruel (Spain). All were clinically stable, 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. Exclusion criteria were: 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.
The study was approved by the loval ethics committee and all participants gave their informed consent. Overall 100 participants were randomized either to TAR group (n = 49) or to the SCIT group (n = 51) (Consort diagram, Graphic 1).
2.1.1. Treatment
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). The program is divided into three blocks, whereas each block consists of 4 sessions: during the first block patients learn to identify and discriminate the prototypical facial signs of the six basic emotions (happiness, sadness, fear, disgust, anger and surprise). The next block aims at a more holistic processing mode with fast decisions, relying on first impression, nonverbal processing and recognition of facial expressions with small intensities. The third block deals with the role of facial emotions in social, behavioral and situational context. Baseline assessments (T0=pre-treatment) were performed after enrolment to the study and post treatment assessments (T1=post-treatment) after the end of the training period (Sachs et al. 2012).
SCIT is a manual-based group intervention that is delivered in 20-24weekly, hour-long sessions. Groups include two clinicians and six to ten patients. SCIT uses a combination of psychoeducation, drill-and-repeat skill practice, strategy games, heuristic rehearsal, and homework assignments to remediate deficits and decrease biases in social cognition. Each SCIT group participant was encouraged to identify a 'practice partner', a family member or acquaintance who was willing to practice SCIT skills with the participant weekly in lieu of, or in addition to, traditional homework. SCIT clinicians attempted to reach practice partners by phone each week to check -in and provide guidance in their efforts to support SCIT participants' learning (Roberts et al. 2014).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SCIT Social cognition interactive | Experimental | Behavioral: SCITPsychosocial intervention based on the Spanish translation of the original SCIT (Social Cognition and Interaction Training) instruction manual (Combs \& Penn; Lahera \& Benito, in press). |
| TAR Training in affect recognition | Active comparator | Behavioral: TARTraining in Affect Recognition it is a 12-session training on facial affect recognition over a period of 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCITSCIT 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. | Behavioural | SCIT Social cognition interactive |
| TARTAR 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). | Behavioural | TAR Training in affect recognition |
Primary outcome
Face emotion recognition
Time frame: 24 weeks
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).
3 secondary outcomes
Theory of Mind
Time frame: 24 weeks
Attributional Style
Time frame: 24 weeks
Functioning
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 2
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Schizophrenia
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
Recruiting
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
Schizophrenia Spectrum Disorders (SSD)
RecruitingObservational study
Sensory Profile and Early Clinical Signs of Calm Room Users
Psychotic Disorders, Personality Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SCIT and TAR in people with Schizophrenia, run by University of Alcala.
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 5 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 27 Feb 2018. 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?
Face emotion recognition (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2018.