Schizophrenia Clinical Trial
— PEPS-RCTOfficial title:
Positive Emotions Program for Schizophrenia (PEPS): A Randomized Controlled Study on Improving Pleasure and Motivation in Schizophrenia
Verified date | March 2019 |
Source | Institut et Haute Ecole de la Santé la Source |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Institut et Haute Ecole de la Santé la Source & Service de psychiatrie communautaire du Département de psychiatrie du Centre Hospitalier Universitaire Vaudois | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
Institut et Haute Ecole de la Santé la Source | University of Lausanne Hospitals |
Switzerland,
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. — View 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. — View 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 Feb — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change on the Calgary Depression Scale for Schizophrenia (CDSS) | The Calgary Depression Scale for Schizophrenia (CDSS) includes nine items: depression, hopelessness, self-depreciation, guilty ideas of reference, pathological guilt, morning depression, early wakening, suicide, and observed depression. This scale has been validated in French. | Change from Baseline CDSS score at 2 months | |
Secondary | Change on the Savoring Belief Inventory (SBI) | The Savoring Belief Inventory (SBI) is a self-reported scale for measuring beliefs about one's capacity for savoring things. The scale has twenty four items, including a positive scale (twelve items) and a negative scale (twelve items). The scale has good validity and a high test-re-test reliability. It measures a person's thinking regarding his/her capacity to savor positive experiences, in terms of past experiences, current experiences, and future anticipation. The total SBI score will be used as a secondary outcome variable. | Change from Baseline SBI total score at 2 months | |
Secondary | Change on the Temporal Experience of Pleasure Scale (TEPS) | The Temporal Experience of Pleasure Scale (TEPS) is a self-reported scale and contains eighteen items included in two sub-scales: anticipatory pleasure (ten items) and consummatory pleasure (eight items). Items targeting anticipatory pleasure reflect the pleasure felt when anticipating a positive or pleasant stimulus. Items measuring consummatory pleasure refer to the direct pleasure experienced upon exposure to a stimulus. Items can be general or specific. The response to items falls on a six-point Likert scale from 1 (very false for me) to 6 (very true for me). This scale has been validated in French. | Change from Baseline TEPS scales at 2 months | |
Secondary | Change on the Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) | The Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) is designed to assess one's ability to experience pleasure in the interpersonal domain. It is a seventeen-item self-reported measure that consists of seven anticipatory and ten consummatory items. The ACIPS is scored on a six-point Likert scale, ranging from 1 (very false for me) to 6 (very true for me). The format is therefore quite similar to that of TEPS. The difference between the two scales lies mainly in terms of the items' content. | Change from Baseline ACIPS scales at 2 months | |
Secondary | Change on the Social Functioning Scale (SFS) | The Social Functioning Scale (SFS) is constructed to assess those areas of functioning that are crucial to the community maintenance of individuals with schizophrenia. This is a reliable, valid, sensitive instrument and responsive to change. This last scale will be completed by the case-manager of the participant. | Change from Baseline SFS at 8 months | |
Secondary | Change on the Calgary Depression Scale for Schizophrenia (CDSS) | The Calgary Depression Scale for Schizophrenia (CDSS) includes nine items: depression, hopelessness, self-depreciation, guilty ideas of reference, pathological guilt, morning depression, early wakening, suicide, and observed depression. This scale has been validated in French. | Change from Baseline CDSS score at 8 months | |
Secondary | 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 variables. | Change from Baseline composite score at 8 months |
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