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Trial record 37 of 3313 for:    schizophrenia

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

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ClinicalTrials.gov Identifier: NCT02593058
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : March 25, 2019
Sponsor:
Collaborator:
University of Lausanne Hospitals
Information provided by (Responsible Party):
Jérôme Favrod, Institut et Haute Ecole de la Santé la Source

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Behavioral: Positive Emotions Program for Schizophrenia Behavioral: Treatment As Usual Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Positive Emotions Program for Schizophrenia (PEPS): A Randomized Controlled Study on Improving Pleasure and Motivation in Schizophrenia
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: PEPS+TAU
Eight one-hour weekly sessions of Positive Emotions Program for Schizophrenia (PEPS) + Treatment as Usual (TAU)
Behavioral: 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.
Other Name: PEPS

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.
Other Name: TAU

Active Comparator: Treatment As Usual (TAU)
Treatment as usual - with no attempts to standardize this treatment as TAU is tailored to the patient's specific needs
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.
Other Name: TAU




Primary Outcome Measures :
  1. Change on the composite score of apathy/avolition and anhedonia/asociality ot the Scale for the Assessment of Negative Symptoms (SANS). [ Time Frame: Change from Baseline composite score at 2 months ]
    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.


Secondary Outcome Measures :
  1. Change on the Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Change from Baseline CDSS score at 2 months ]
    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.

  2. Change on the Savoring Belief Inventory (SBI) [ Time Frame: Change from Baseline SBI total score at 2 months ]
    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.

  3. Change on the Temporal Experience of Pleasure Scale (TEPS) [ Time Frame: Change from Baseline TEPS scales at 2 months ]
    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.

  4. Change on the Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) [ Time Frame: Change from Baseline ACIPS scales at 2 months ]
    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.

  5. Change on the Social Functioning Scale (SFS) [ Time Frame: Change from Baseline SFS at 8 months ]
    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.

  6. Change on the Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Change from Baseline CDSS score at 8 months ]
    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.

  7. Change on the composite score of apathy/avolition and anhedonia/asociality ot the Scale for the Assessment of Negative Symptoms (SANS) [ Time Frame: Change from Baseline composite score at 8 months ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593058


Locations
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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, Switzerland, 1004
Sponsors and Collaborators
Institut et Haute Ecole de la Santé la Source
University of Lausanne Hospitals
Investigators
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Principal Investigator: Jérôme Favrod Institut et Haute Ecole de la Santé la Source & Service de psychiatrie communautaire du Département de psychiatrie du Centre Hospitalier Universitaire Vaudois

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Jérôme Favrod, Professor, Institut et Haute Ecole de la Santé la Source
ClinicalTrials.gov Identifier: NCT02593058     History of Changes
Other Study ID Numbers: 105319_163355 / 1
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jérôme Favrod, Institut et Haute Ecole de la Santé la Source:
Anhedonia
Apathy
Negative symptoms
Anticipatory pleasure
Savoring
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders