Effects of Neurocognitive and Social Cognitive Remediation in Patients at Ultra-High Risk of Psychosis (FOCUS)

Mental Health Services in the Capital Region, Denmark

Status: Completed

Conditions: Patients at Ultra-high Risk of Psychosis

Treatments: Behavioral: Standard treatment; Behavioral: Cognitive remediation

Study type: Interventional

Funder types: Other

Identifiers

NCT02098408

H-6-2013-015

Details and patient eligibility

About

Cognitive deficits are known to be a core feature of schizophrenia and seem to become manifest in the prodromal or Ultra-High Risk (UHR) state of psychosis. The cognitive deficits are known to pose a critical barrier to functional recovery. Hence it is of vital importance to find intervention strategies that can alleviate these cognitive deficits and consequently improve daily functioning, and quality of life, as well as the prognosis for UHR-patients. The investigators will examine whether:

• Cognitive remediation therapy will be superior to standard treatment in improving cognitive functioning in UHR- patients (null hypothesis: No difference between the two groups).
• Cognitive remediation therapy will be superior to standard treatment in improving psychosocial functioning and clinical symptoms in UHR-patients (null hypothesis: No difference between the two groups).

Enrollment: 146 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-40 yrs.

• Fulfill criteria for being at Ultra-High Risk of psychosis (defined by one or more of the following):

  • Vulnerability (Trait and State Risk Factor) Group: Individuals with a combination of a trait risk factor (schizotypal personality disorder or a family history of psychotic disorder in a first degree relative) and a significant deterioration in functioning, or sustained low functioning during the past year.
  • Attenuated Psychotic Symptoms (APS) Group: Individuals with sub-threshold (intensity or frequency) positive psychotic symptoms. The symptoms must have been present during the past year.
  • Brief Limited Intermittent Psychotic Symptoms Group (BLIPS): Individuals with a recent history of frank psychotic symptoms that resolved spontaneously (without antipsychotic medication) within one week. The symptoms must have been present during the past year.

• Provided informed consent.

Exclusion criteria

• Past history of a treated or untreated psychotic episode of one week's duration or longer
• Psychiatric symptoms that are explained by a physical illness with psychotropic effect or acute intoxication (e.g., cannabis use).
• Diagnosis of a serious developmental disorder, e.g,. Asperger's syndrome
• Currently receiving treatment with metylphenidate.
• Rejects providing informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

146 participants in 2 patient groups

Standard treatment + cognitive remediation

Experimental group

Description:

The cognitive remediation therapy targets neurocognition as well as social cognition.

Treatment:

Behavioral: Cognitive remediation

Behavioral: Standard treatment

Standard treatment

Active Comparator group

Description:

Patients allocated to the control condition are free to choose whatever standard treatment they are offered by the clinicians managing their treatment. Usually standard treatment consists of regular contact to health professionals in the in- and outpatient facilities in Copenhagen, Denmark, and encompass different kinds of supportive counselling

Treatment:

Behavioral: Standard treatment