CompletedPhase 2ACTRN12612000190808

The Impact of Social Cognition Training and Oxytocin on Social Functioning in Early Psychosis.

A Randomised Controlled Clinical Trial Investigating the Impact of Social Cognition Training and Oxytocin on Social Functioning in Early Psychosis.

Sponsor

The University of Sydney

Enrollment

50 participants

Start Date

Jan 27, 2012

Study Type

Interventional

Conditions

Early Psychosis

Summary

Evidence demonstrates that social cognition training improves social cognition and social functioning in individuals with a psychotic disorder. The aim of this study is to determine the critical cognitive and biological markers underlying the effects of social cognition training and the degree to which they predict changes in social functioning for young people with a psychotic illness. As suggested in the literature, face perception, emotion recognition, theory of mind and attribution bias are key cognitive markers of social functioning in humans. We speculate that OT may further underlie these cognitive changes via feedforward mechanisms stimulated by engaging with social cognition training. This will be investigated by examining the impact of social cognition training on plasma levels. We also directly administer OT in-order to amplify biological and cognitive markers that facilitate improvements in social-functioning. Hypotheses Following SCT treatment, individuals with early psychosis in the SCT + OT + TAU condition compared to SCT + Placebo + TAU condition will demonstrate: Outcome Hypothesis 1. Significant improvement on measures of social cognition and social function. Mechanism Hypothesis 1. OT administration will enhance social-cognitive and biological markers compared to the placebo condition. 2. OT administration will enhance social functioning outcomes following SCT training compared to the placebo group. 3. Changes in biological and social-cognitive markers in both the OT and Placebo SCT groups will predict improvements in social functioning. This association will be stronger in the OT condition given the influence of OT on critical markers will be amplified.

Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 30 Yearss

Plain Language Summary

Simplified for easier understanding

This study examines whether combining social cognition training with intranasal oxytocin can improve social functioning in young people (aged 16-30) in the early stages of schizophrenia spectrum psychosis. Participants must be within their first three years of treatment and stable on medication for at least 6 weeks. The research targets the social difficulties that are a core challenge in psychosis.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Social Cognition Training (SCT): SCT is an evidence based psychosocial intervention administered by Clinical Psychologists with expertise in social information processing deficits. Targeted treatmen

Social Cognition Training (SCT): SCT is an evidence based psychosocial intervention administered by Clinical Psychologists with expertise in social information processing deficits. Targeted treatment addresses four key areas of social cognitive impairement; emotion recognition, theory of mind, social knowledge and attribution bias. Intervention is comprised of various online training programs and group based activities. The 6 week treatment program is delivered weekly (2 x 1 hour sessions) in a small group format of 6-8 participants for a total of 12 sessions. Participants will also undergo treatment as usual (TAU), that is, continuing their standard routine clinical care (e.g., psychiatrist appointment). Oxytocin (OT) Nasal Spray: Research focused on the neurobiology of social cognition and behaviour highlights the central role of Oxytocin (OT). This neuropeptide is implicated in modulating peer recognition and social approach/avoidance in mammals. It also plays a critical role in the development of partner preference and social bonds. Approved by the Therapeutic Goods Administration (TGA), OT is supplied by a registered compounding chemist and is matched with an identical placebo containing all ingredients except the active OT. Participants are assigned one pre-packed treatment containing identical active OT or placebo nasal spray according to the randomisation schedule developed by the chemist. OT or placebo is administered twice daily for the 6 weeks of social cognition training. We use a standard adult dose of OT that has been used in previous human studies, 24 International Units (IU; 1 puff per nostril with each puff containing 12 IU) twice daily. Moreover, participants undergoing SCT will be asked to administer an additional 24 IU dose of OT (or placebo) 10 minutes prior to the commencement of group.