Positive Emotions Program for Schizophrenia (PEPS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PEPS+TAU

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

Group Type EXPERIMENTAL

Positive Emotions Program for Schizophrenia

Intervention Type BEHAVIORAL

Each session of PEPS includes relaxation-meditation exercise, review of homework task given during the previous session, exercises to challenge defeatist beliefs. According to the session's theme, participants learn skills to improve their anticipation or maintenance of pleasure such as savoring a pleasant experience, expressing emotions by increasing behavioral expression, capitalizing on positive moments, and anticipating pleasant moments. A simple homework task is assigned to be done between each session. The pedagogical concept underpinning the program was built according to Kolb and Kolb's model of experiential learning. The program uses a collaborative, egalitarian approach.

Treatment As Usual

Intervention Type BEHAVIORAL

TAU consists of psychiatric management by a clinical team composed of at least one psychiatrist and a social worker and/or a psychiatric nurse with additional access to community treatment or hospital admission. Treatment involves antipsychotic medication, regular office-based or community contact with the clinical team for treatment monitoring, and socialization groups, therapy, and psychoeducational groups. No attempts have been made to standardize this treatment as TAU is tailored to the patient's specific needs.

Treatment As Usual (TAU)

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

Group Type ACTIVE_COMPARATOR

Treatment As Usual

Intervention Type BEHAVIORAL

TAU consists of psychiatric management by a clinical team composed of at least one psychiatrist and a social worker and/or a psychiatric nurse with additional access to community treatment or hospital admission. Treatment involves antipsychotic medication, regular office-based or community contact with the clinical team for treatment monitoring, and socialization groups, therapy, and psychoeducational groups. No attempts have been made to standardize this treatment as TAU is tailored to the patient's specific needs.

Interventions

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Positive Emotions Program for Schizophrenia

Each session of PEPS includes relaxation-meditation exercise, review of homework task given during the previous session, exercises to challenge defeatist beliefs. According to the session's theme, participants learn skills to improve their anticipation or maintenance of pleasure such as savoring a pleasant experience, expressing emotions by increasing behavioral expression, capitalizing on positive moments, and anticipating pleasant moments. A simple homework task is assigned to be done between each session. The pedagogical concept underpinning the program was built according to Kolb and Kolb's model of experiential learning. The program uses a collaborative, egalitarian approach.

Intervention Type BEHAVIORAL

Treatment As Usual

TAU consists of psychiatric management by a clinical team composed of at least one psychiatrist and a social worker and/or a psychiatric nurse with additional access to community treatment or hospital admission. Treatment involves antipsychotic medication, regular office-based or community contact with the clinical team for treatment monitoring, and socialization groups, therapy, and psychoeducational groups. No attempts have been made to standardize this treatment as TAU is tailored to the patient's specific needs.

Intervention Type BEHAVIORAL

Other Intervention Names

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PEPS TAU

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jérôme Favrod

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jérôme Favrod

Role: PRINCIPAL_INVESTIGATOR

Institut et Haute Ecole de la Santé la Source & Service de psychiatrie communautaire du Département de psychiatrie du Centre Hospitalier Universitaire Vaudois