Condition category
Mental and Behavioural Disorders
Date applied
12/05/2015
Date assigned
18/05/2015
Last edited
01/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jérôme Favrod

ORCID ID

http://orcid.org/0000-0002-1132-9472

Contact details

Avenue Vinet 30
Lausanne
1004
Switzerland
+41794473157
j.favrod@ecolelasource.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Positive Emotions Program for Schizophrenia (PEPS): a pilot intervention to reduce anhedonia and apathy

Acronym

PEPS pilot

Study hypothesis

Eight sessions of PEPS will reduce anhedonia and apathy, as measured using the Scale for the Assessment of Negative Symptoms (SANS).

Ethics approval

Vaud Cantonal Ethics Commission on Human Research, 06/05/2014, ref: 127/14.

Study design

Open pre-/post-comparison within subject design

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

13/05/2014

Overall trial end date

03/02/2015

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

Failure to demonstrate capacity for consent according to the San Diego Brief Assessment of Capacity to Consent.

Recruitment start date

20/05/2014

Recruitment end date

30/11/2014

Locations

Countries of recruitment

Switzerland

Trial participating centre

Organisation de Soins à Domicile (OSAD) SISP SA
Avenue des Oiseaux 13
Lausanne
1018
Switzerland

Trial participating centre

Fondation HorizonSud
Route de la Rotonde 25 case postale 41
Marsens
1633
Switzerland

Trial participating centre

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

Sponsor information

Organisation

La Source School of Nursing Sciences (HEdS La Source)

Sponsor details

Avenue Vinet 30
Lausanne
1004
Switzerland
+41 21 641 38 06
n.vienspython@ecolelasource.ch

Sponsor type

University/education

Website

http://www.ecolelasource.ch/

Funders

Funder type

Other

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26419356

Publication citations

Additional files

Editorial Notes