Positive Emotions Program for Schizophrenia (PEPS) (PEPS-RCT)

Institut et Haute Ecole de la Santé la Source

Status: Completed

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Behavioral: Positive Emotions Program for Schizophrenia; Behavioral: Treatment As Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT02593058

105319_163355 / 1

Details and patient eligibility

About

This study evaluates the addition of a 8 session psychological program, called Positive Emotions Program for Schizophrenia (PEPS) to improve motivation and pleasure in adults with schizophrenia. Half of the participants will receive their usual treatment and PEPS in combination, while the other half will receive usual treatment only.

Full description

Recent literature has distinguished the negative symptoms associated with a diminished capacity to experience (apathy, anhedonia) from those which are associated with a limited capacity for expression (emotional blunting, alogia). The apathy-anhedonia syndrome tends to be associated with a poorer prognosis than the symptoms related to diminished expression, suggesting that it is the more severe facet of the psychopathology. However the efficacy of drug-based treatments and psychological interventions on primary negative symptoms remains limited. There is a clear clinical need for developing treatments for negative symptoms.

The Positive Emotions Programs for Schizophrenia (PEPS) teaches skills to help overcome defeatist thinking and to increase the anticipation and maintenance of positive emotions. PEPS involves eight one-hour group sessions, administered using visual and audio materials as part of a PowerPoint presentation of slides projected onto a screen.

The goal of the study is to establish if PEPS is clinically effective by using a randomized, controlled and assessor-blind trial. A combination of PEPS plus treatment as usual will be compared to treatment as usual alone. Participants diagnosed with a schizophrenia spectrum disorder will undergo either intervention for eight weeks. Testing will evaluate individuals' current psychopathology and ability to savor pleasure and will be performed at the time of inclusion, at the end of the eight-week intervention and at six month follow-up.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• a psychotic disorder according to ICD 10 (F20 or F25), diagnoses having been established by experienced clinicians;
• presenting a score of at least 2 on the overall SANS anhedonia scale;
• French-speaking;
• Ability to consent measured with the San Diego Brief Assessment of Capacity to Consent (UBACC)-a decisional capacity instrument.

Exclusion criteria

• evidence of organic brain disease, clinically significant concurrent medical ill/ness, or learning disability;
• no understanding of the study protocol as assessed with the San Diego Brief Assessment of Capacity to Consent (UBACC)-a decisional capacity instrument

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

PEPS+TAU

Experimental group

Description:

Eight one-hour weekly sessions of Positive Emotions Program for Schizophrenia (PEPS) + Treatment as Usual (TAU)

Treatment:

Behavioral: Treatment As Usual

Behavioral: Positive Emotions Program for Schizophrenia

Treatment As Usual (TAU)

Active Comparator group

Description:

Treatment as usual - with no attempts to standardize this treatment as TAU is tailored to the patient's specific needs

Treatment:

Behavioral: Treatment As Usual