Positive Emotions Program for Schizophrenia (PEPS)

NCT02593058 | Completed DMC

• 1 other identifier: 105319_163355 / 1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Anhedonia; Apathy; Negative symptoms; Anticipatory pleasure; Savoring

Outcome Measures

Primary Outcomes (1)

• Change on the composite score of apathy/avolition and anhedonia/asociality ot the Scale for the Assessment of Negative Symptoms (SANS).

  The Scale for the Assessment of Negative Symptoms (SANS) measures schizophrenia's deficit symptoms within the framework of schizophrenic disorders. It comprises 25 items, scored from 0 to 5. A definition of each item, including examples, facilitates a better understanding of the scale's content. The rating system is ordinal, from 0 (absent) to 5 (severe). The twenty-five items are grouped into five components: 1) withdrawal or emotional poverty; 2) alogia (lack of speech); 3) avolition and apathy (lack of energy, lack of initiative); 4) anhedonia and social withdrawal (loss of interests); 5) attention. The scale was translated into French with acceptable validity. The composite score for the avolition-apathy and anhedonia-social withdrawal scale will be used as the main outcome variable.

  Change from Baseline composite score at 2 months

Secondary Outcomes (7)

• Change on the Calgary Depression Scale for Schizophrenia (CDSS)

  Change from Baseline CDSS score at 2 months

• Change on the Savoring Belief Inventory (SBI)

  Change from Baseline SBI total score at 2 months

• Change on the Temporal Experience of Pleasure Scale (TEPS)

  Change from Baseline TEPS scales at 2 months

• Change on the Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)

  Change from Baseline ACIPS scales at 2 months

• Change on the Social Functioning Scale (SFS)

  Change from Baseline SFS at 8 months

Study Arms (2)

PEPS+TAU

EXPERIMENTAL

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

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

Treatment As Usual (TAU)

ACTIVE COMPARATOR

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

Behavioral: Treatment As Usual

Interventions

Positive Emotions Program for Schizophrenia 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.

Also known as: PEPS

PEPS+TAU

Treatment As Usual 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.

Also known as: TAU

PEPS+TAU; Treatment As Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut et Haute Ecole de la Santé la Source: lead
• University of Lausanne Hospitals: collaborator

Study Sites (1)

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

Lausanne, Canton of Vaud, 1004, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 26419356 BACKGROUND

• 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.

  PMID: 20591125 BACKGROUND

• 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.

  PMID: 29515496 BACKGROUND

• 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.

  PMID: 28804473 BACKGROUND

• 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.

  PMID: 26924992 BACKGROUND

• 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.

  PMID: 30783071 RESULT

Related Links

• Intervention description and materials

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Anhedonia; Lethargy

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jérôme Favrod

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: October 30, 2015
• Study Start: February 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)