Clinical trial NCT02593058: Positive Emotions Program for Schizophrenia (PEPS)
Official title: Positive Emotions Program for Schizophrenia (PEPS): A Randomized Controlled Study on Improving Pleasure and Motivation in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Anhedonia
Apathy
Negative symptoms
Anticipatory pleasure
Savoring
Lead sponsor: Institut et Haute Ecole de la Santé la Source
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
First posted: 2015-10-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change on the composite score of apathy/avolition and anhedonia/asociality ot the Scale for the Assessment of Negative Symptoms (SANS).
timeFrame: Change from Baseline composite score at 2 months
Secondary outcomes:
measure: Change on the Calgary Depression Scale for Schizophrenia (CDSS)
timeFrame: Change from Baseline CDSS score at 2 months
measure: Change on the Savoring Belief Inventory (SBI)
timeFrame: Change from Baseline SBI total score at 2 months
measure: Change on the Temporal Experience of Pleasure Scale (TEPS)
timeFrame: Change from Baseline TEPS scales at 2 months
measure: Change on the Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)
timeFrame: Change from Baseline ACIPS scales at 2 months
measure: Change on the Social Functioning Scale (SFS)
timeFrame: Change from Baseline SFS at 8 months
measure: Change on the Calgary Depression Scale for Schizophrenia (CDSS)
timeFrame: Change from Baseline CDSS score at 8 months
measure: Change on the composite score of apathy/avolition and anhedonia/asociality ot the Scale for the Assessment of Negative Symptoms (SANS)
timeFrame: Change from Baseline composite score at 8 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Institut et Haute Ecole de la Santé la Source & Service de psychiatrie communautaire du Département de psychiatrie du Centre Hospitalier Universitaire Vaudois
state: Vaud
Study officials:
affiliation: Institut et Haute Ecole de la Santé la Source & Service de psychiatrie communautaire du Département de psychiatrie du Centre Hospitalier Universitaire Vaudois
name: Jérôme Favrod
role: PRINCIPAL_INVESTIGATOR
References:
citation: Favrod J, Nguyen A, Fankhauser C, Ismailaj A, Hasler JD, Ringuet A, Rexhaj S, Bonsack C. Positive Emotions Program for Schizophrenia (PEPS): a pilot intervention to reduce anhedonia and apathy. BMC Psychiatry. 2015 Sep 29;15:231. doi: 10.1186/s12888-015-0610-y.
citation: Favrod J, Giuliani F, Ernst F, Bonsack C. Anticipatory pleasure skills training: a new intervention to reduce anhedonia in schizophrenia. Perspect Psychiatr Care. 2010 Jul;46(3):171-81. doi: 10.1111/j.1744-6163.2010.00255.x.
citation: Golay P, Thonon B, Nguyen A, Fankhauser C, Favrod J. Confirmatory Factor Analysis of the French Version of the Savoring Beliefs Inventory. Front Psychol. 2018 Feb 19;9:181. doi: 10.3389/fpsyg.2018.00181. eCollection 2018.
citation: Chaix J, Golay P, Fankhauser C, Nguyen A, Gooding DC, Favrod J. Confirmatory Factor Analysis of the French Version of the Anticipatory and Consummatory Interpersonal Pleasure Scale. Front Psychol. 2017 Jul 28;8:1296. doi: 10.3389/fpsyg.2017.01296. eCollection 2017.
citation: Nguyen A, Frobert L, McCluskey I, Golay P, Bonsack C, Favrod J. Development of the Positive Emotions Program for Schizophrenia: An Intervention to Improve Pleasure and Motivation in Schizophrenia. Front Psychiatry. 2016 Feb 17;7:13. doi: 10.3389/fpsyt.2016.00013. eCollection 2016.
citation: Favrod J, Nguyen A, Chaix J, Pellet J, Frobert L, Fankhauser C, Ismailaj A, Brana A, Tamic G, Suter C, Rexhaj S, Golay P, Bonsack C. Improving Pleasure and Motivation in Schizophrenia: A Randomized Controlled Clinical Trial. Psychother Psychosom. 2019;88(2):84-95. doi: 10.1159/000496479. Epub 2019 Feb 18.