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SchizophreniaNCT03446703

SCIT Versus TAR for Outpatients With Schizophrenia

A study testing SCIT and TAR in people with Schizophrenia, run by University of Alcala.

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 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
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).

  1. 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 groups in NCT03446703
Study groupRoleWhat they receive
SCIT Social cognition interactiveExperimentalPsychosocial 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 recognitionActive comparatorTraining 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.

  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).

    Measured: 24 weeks

Secondary outcomes (3)
  1. 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

  2. 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

  3. 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.

  1. First posted27 Feb 2018
  2. Study start1 Sep 2013
  3. Primary completion1 Oct 2016
  4. Study completion30 Jun 2017

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
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)
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

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.

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SCIT Versus TAR for Outpatients With Schizophrenia | AzTrials