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Is there a synergistic effect of adding social cognition remediation to cognitive remediation therapy in young people? A randomised controlled trial

Is there a synergistic effect of adding social cognition remediation to cognitive remediation therapy in young people? A randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001166268
Enrollment
10
Registered
2018-07-13
Start date
2018-07-25
Completion date
Unknown
Last updated
2018-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Cognitive Remediation Therapy (CRT) and social cognition remediation (SCRT) are treatments that have evidence for their immediate efficacy in remediating the social and neurocognitive deficits of schizophrenia and other severe mental illness. However, there is a lack of information as to whether these treatments are effective for young people, whether the combination of these two treatment approaches adds increased benefit and if so, whether the combination’s effect is lasting and contributes to improved function and outcome. We propose a randomised controlled trial to address the following aims:- 1. Does a combined program of CRT and SCRT speed reintegration into work or educational? 2. Is there an advantage to combining these treatments over and above being treated by cognitive remediation alone? 3. Is there a clinical group that is particularly advantaged by combining CRT and SCRT

Interventions

2 arms of the study. Both receive CRT. Randomised to receive either SCIT or control group. Cognitive Remediation Therapy (CRT) - designed to address cognitive deficits by utilising educational software to create a rich learning environment that is intrinsically motivating and rewarding. The treatment will be provided over 10 weeks, 2 times per week. The intervention involves game-based cognitive training with bridging provided in session by trained mental health clinicians (eg. psychologist, oc

2 arms of the study. Both receive CRT. Randomised to receive either SCIT or control group. Cognitive Remediation Therapy (CRT) - designed to address cognitive deficits by utilising educational software to create a rich learning environment that is intrinsically motivating and rewarding. The treatment will be provided over 10 weeks, 2 times per week. The intervention involves game-based cognitive training with bridging provided in session by trained mental health clinicians (eg. psychologist, occupational therapist, nurse, social worker). The game-based cognitive training is designed specifically for the study as per processes designed by Medalia, Revheim, and Herlands, 2009. The package is made up of freely available games. Attendance to the program will be monitored. Social cognition and Interaction Training (SCIT) - is a manualised treatment designed to address social cognitive deficits. It consists of 20 one-hour sessions over 10 weeks. Training is run in small groups of three to six people using a manual-driven suite of activities. The training approach of SCIT is such that participants receive repeated exposure and practice of the skills that underlie complex mental-state reasoning abilities. Activities centre on social situations with a focus on making inferences and predictions about the characters’ thoughts, feelings, and behaviours. The group is facilitated by 2 trained mental health clinicians and attendance is monitored for intervention adherence.

Sponsors

Western Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
16 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

1. A diagnosis of a severe mental illness and neurocognitive or social cognitive deficits) 2. Are aged 16 – 30 years 3. Able to provide consent (and parent/guardian if required) 4. Have reasonable English skills.

Exclusion criteria

1.Developmental delay (IQ < 75) 2.Current substance abuse or substance dependence other than caffeine or nicotine 3. History of head injury (> 10 minutes unconsciousness). 4. Electroconvulsive Therapy in last six months.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026