Positive Emotions Program for Schizophrenia (PEPS)

ISRCTN	ISRCTN74048461
DOI	https://doi.org/10.1186/ISRCTN74048461
Secondary identifying numbers	N/A

Submission date: 12/05/2015
Registration date: 18/05/2015
Last edited: 01/10/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Schizophrenia is a serious, long term mental health condition that causes a wide range of psychological symptoms broadly categorised as positive and negative. The positive symptoms of schizophrenia include hallucinations (hearing or seeing things that are not real), delusions (believing things that cannot be true), and disorganised thinking and behaviour. Negative symptoms include apathy (general lack of interest) and anhedonia (inability to feel pleasure) which describe an individual’s limited ability to experience life events. Other significant negative symptoms are associated with people’s inability to express themselves, namely emotional blunting (inability to express feelings) and alogia (inability to verbally express oneself). People with schizophrenia who show mainly negative symptoms often have a poorer prognosis compared to patients who show mainly positive symptoms, and people who express symptoms of apathy-anhedonia fare even worse than those expressing emotional blunting and alogia. This is because there are very few effective drug-based and psychological treatments for negative symptoms in schizophrenia, particularly ones targeting apathy-anhedonia. The Positive Emotions Program for Schizophrenia (PEPS) is a new psychological treatment that has been developed to tackle the symptoms of apathy and anhedonia in people with schizophrenia. PEPS aims to teach participants various skills to help them overcome feelings of hopelessness, and to increase the anticipation and maintenance of positive emotions. The aim of this study is to see how well PEPS works to reduce the symptoms of anhedonia and apathy in patients diagnosed with schizophrenia or schizoaffective disorders.

Who can participate?
French-speaking adults diagnosed with schizophrenia or a schizoaffective disorder.

What does the study involve?
All participants attend eight weekly 1-hour PEPS sessions which involve a presentation and group discussion. Participants are asked to fill in questionnaires before the start of the study, then again 1 week after the PEPS sessions have been completed.

What are the possible benefits and risks of participating?
This study has no specific physical or psychological risks. Some people may not appreciate the intervention, feel uncomfortable or tired. In this case, there is no obligation to speak to the group, or even to continue following the sessions. In case of discomfort, participants are free to stop their participation in the study at any time.

Where is the study run from?
1. Organisation de Soins à Domicile (OSAD) SISP SA (Switzerland)
2. Fondation HorizonSud (Switzerland)
3. Fondation Pro-Home (Switzerland)

When is the study starting and how long is it expected to run for?
May 2014 to February 2015

Who is funding the study?
This study is supported by a donation from Dr Alexander Engelhorn (Switzerland)

Who is the main contact?
Prof J Favrod
j.favrod@ecolelasource.ch

Contact information

Prof Jérôme Favrod
Scientific

Avenue Vinet 30
Lausanne
1004
Switzerland

ORCID ID	0000-0002-1132-9472
Phone	+41794473157
Email	j.favrod@ecolelasource.ch

Study information

Study design	Open pre-/post-comparison within subject design
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Community
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	Positive Emotions Program for Schizophrenia (PEPS): a pilot intervention to reduce anhedonia and apathy
Study acronym	PEPS pilot
Study objectives	Eight sessions of PEPS will reduce anhedonia and apathy, as measured using the Scale for the Assessment of Negative Symptoms (SANS).
Ethics approval(s)	Vaud Cantonal Ethics Commission on Human Research, 06/05/2014, ref: 127/14.
Health condition(s) or problem(s) studied	Anhedonia and apathy in schizophrenia
Intervention	Eight 1-hour group PEPS sessions, administered using visual and audio materials and presented as a PowerPoint presentation. PEPS is an intervention intended to reduce anhedonia and apathy in patients with schizophrenia. The program teaches skills to help overcome defeatist thinking and to increase the anticipation and maintenance of positive emotions.
Intervention type	Behavioural
Primary outcome measure	Scale for the Assessment of Negative Symptoms (SANS) at pre and post-test. Baseline assessment is done the week before participation in PEPS, and one week following the end of PEPS intervention. Duration of PEPS is 8 weeks overall.
Secondary outcome measures	Calgary Depression Scale for Schizophrenia (CDSS) at pre and post-test.
Overall study start date	13/05/2014
Completion date	03/02/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	20
Key inclusion criteria	1. ICD-10 criteria for a diagnosis of schizophrenia or a schizoaffective disorder 2. Presenting a score of at least 2 on the overall SANS anhedonia scale 3. Aged 18-65 4. Read and understand French 5. Capacity for consent according to the San Diego Brief Assessment of Capacity to Consent. This tool measures a patient's understanding of an information sheet. If the potential participant is unable to respond correctly to the questions asked after reading the sheet, the patient is excluded. The procedure can be conducted a maximum of twice.
Key exclusion criteria	Failure to demonstrate capacity for consent according to the San Diego Brief Assessment of Capacity to Consent.
Date of first enrolment	20/05/2014
Date of final enrolment	30/11/2014

Locations

Countries of recruitment

Switzerland

Study participating centres

Organisation de Soins à Domicile (OSAD) SISP SA

Avenue des Oiseaux 13
Lausanne
1018
Switzerland

Fondation HorizonSud

Route de la Rotonde 25
case postale 41
Marsens
1633
Switzerland

Fondation Pro-Home

Appartements FOND-VERT
Chemin de l’Eglise 8
Gilly
1182
Switzerland

Sponsor information

La Source School of Nursing Sciences (HEdS La Source)
University/education

Avenue Vinet 30
Lausanne
1004
Switzerland

Phone	+41 21 641 38 06
Email	n.vienspython@ecolelasource.ch
Website	http://www.ecolelasource.ch/

Funders

Funder type

Other

This study is supported by a donation from Dr Alexander Engelhorn (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Results of this pilot study will be submitted to a peer review journal. The results of this study will be used to calculate the power of the intervention to apply for a grant for a randomised study. The grant has been submitted to the Swiss National Scientific Fundation request number 320030_163355.
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/09/2015		Yes	No