Condition category
Mental and Behavioural Disorders
Date applied
14/01/2016
Date assigned
14/01/2016
Last edited
14/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Auditory verbal hallucinations (AVH), commonly referred to as “hearing voices”, can be a distressing experience which often has a negative impact on social functioning (how a person behaves in a social setting). Until recently, they were generally associated with mental disorders such as schizophrenia (a mental illness in which a person experiences disordered beliefs and experiences) and psychosis (a serious mental illness in which thoughts and emotions are impaired, causing a person to lose touch with reality), however a recent study suggests that that it may affect around 13.2% of the general population. AVH can be very difficult to cope with, making it hard for sufferers to manage their lives. Temstem is a mobile phone application which has been developed to help users to cope better with AVH. The app uses language games which can be played at any time and do not require significant effort from the user, working on the principal that when the language centre in the brain is occupied with a task, AVH can be suppressed. Coupled with active support for the user, it is hoped that the app will help to enhance self-esteem and reduce the vividness and the emotionality of AVH. The aim of this study is to find out whether using the Temstem app can have a positive effect on users and help to suppress AVH, as well as the overall user-friendliness of the app.

Who can participate?
Adult patients of participating mental health organizations who have been hearing voices for longer than a month or on at least four days a week in at least three out of the last four weeks.

What does the study involve?
Participants are randomly allocated to one of two groups. Both groups are provided with a smartphone for 6 weeks, which can be monitored by the investigative team. Those in the first group have their AVH monitored using the PSYMATE smartphone application. This monitoring involves a 30 second assessment which is completed daily. Those in the section group also have their AVH monitored, however they also receive access to the Temstem app for 6 weeks. Participants in this group can play the language-based games in the app at any time over the 6 week study period. For both groups, six days of daily experience sampling are completed in the first and final week of the study, so participants can report on their thoughts and feelings of the study experience. At the start of the study, and then again after 1, 5, 6 and 9 weeks, all participants complete a number of questionnaires in order to assess their social functioning and levels of distress, AVH symptoms, self-esteem, and general mental wellbeing.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Nine mental health organizations in the Netherlands.

When is the study starting and how long is it expected to run for?
January 2015 to December 2017

Who is funding the study?
Innovation Fund Parnassia Group (Netherlands)

Who is the main contact?
Mr David van den Berg
d.p.g.vanden.berg@vu.nl

Trial website

Contact information

Type

Scientific

Primary contact

Mr David van den Berg

ORCID ID

http://orcid.org/0000-0002-8797-8217

Contact details

Parnassia
Zoutkeetsingel 40
The Hague
2512 HN
Netherlands
+31 88 376765
d.p.g.vanden.berg@vu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

THE TEMSTEM TRIAL: Reducing distress and dysfunction caused by auditory verbal hallucinations via a smartphone application

Acronym

TEMSTEM TRIAL

Study hypothesis

The aim of this study is to:
1. Test the effects of temstem on distress and social functioning
2. Investigate the effects of temstem on frequency and severity of AVH, control and power over AVH, the ability to cope with AVH, self-esteem, depression, quality of life, and paranoid ideations
3. Determine working mechanisms, to identify predictors and mediators of effects and to study the usability (user friendliness) of TEMSTEM

Ethics approval

Medisch ethische toetsingscommissie (medical ethics committee) VU Medical Center, 22/12/2015, ref: NL53684.029.15

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information is available in Dutch via www.temstem.nl

Condition

Auditory verbal hallucinations (AVH) in patients diagnosed with a psychotic disorder

Intervention

Participants are randomly allocated to one of two study arms.

Group 1: Participants receive AVH monitoring only. AVH monitoring means that AVH will be monitored daily in a 30 second assessment via a smartphone application, the PSYMATE (www.psymate.eu).

Group 2: Participants receive AVH monitoring in addition to being provided with Temstem. Temstem is a smartphone application that was developed to reduce the burden of voices and to help people with AVH to experience more control over their voices. The temstem app uses language games that can be played at any moment and require little cognitive effort. Temstem is based on three principles. First, temstem can be used as a tool to cope with AVH. By activating the language production areas in the brain while doing a motoric task, temstem aims to temporarily suppress AVH. Second, the temstem app reinforces and supports the user in such a way that it enhances self-esteem. Third, Temstem contains a potential therapeutic mechanism as playing language games while recalling an episodic memory of hearing voices may reduce the vividness and emotionality of AVH.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Levels of distress and of social functioning are measured using the Experience Sampling Method (psymate.eu) at baseline, 5 weeks (with daily monitoring for 6 days), as from baseline to six weeks as well as the with the daily monitoring function of the ESM

Secondary outcome measures

1. Frequency and severity of AVH, distress and negative influence on social functioning caused by AVH are measured using experience sampling daily from baseline to 1 week and week 5 to 6, the daily monitoring function of the ESM daily from week 1 to 6 and the Auditory Hallucinations Rating Scale (AHRS) at baseline, 1, 5, 6, and 9 weeks
2. Power and ability to cope are measured using the Beliefs about voices questionnaire revised (BAVQ-R) and ESM at baseline, 1, 5, 6, and 9 weeks
3. Power in social rank to AVH is measured using the Voice Power Differential Scale (VPDS) at baseline, 1, 5, 6, and 9 weeks
4. Social rank to AVH is measured using the Social Comparison Rating Scale To Voices (SCRS) at baseline, 1, 5, 6, and 9 weeks
5. Self-Esteem is measured using the Self-Esteem Rating Scale - Short form (SERS-F) at baseline, 1, 5, 6, and 9 weeks
6. Depression symptoms are measured using the Beck Depression Inventory second edition (BDI-II) at baseline, 1, 5, 6, and 9 weeks
7. Quality of life is measured using the Manchester short assessment of quality of life (MANSA) at baseline, 1, 5, 6, and 9 weeks
8. Quality of life, including disturbance to it by AVH is measured using the PsyQ Kwaliteit van leven (KWAL) at baseline, 1, 5, 6, and 9 weeks
9. Paranoid ideations are measured using the Paranoid thought scales (GPTS) and ESM at baseline, 1, 5, 6, and 9 weeks

Overall trial start date

01/01/2015

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 to 75 years
2. Presence of AVH (with distress) for longer than a month
3. Presence of AVH during a minimum of four days a week, in at least three of the last four weeks

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Changes in medication regiment in the last month
2. Estimated IQ under 70
3. Insufficient competence in the Dutch language
4. Previous use of temstem
5. Not willing or able to learn to use a smartphone
6. Currently undergoing cognitive behavioural therapy for AVH
7. Current involuntary admission in a closed ward

Recruitment start date

01/02/2016

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Netherlands

Trial participating centre

Parnassia
Monsterseweg 89
Den Haag
2553 RJ
Netherlands

Trial participating centre

Dijk en Duin
Duinenboschweg 124
Castricum
1901 ZZ
Netherlands

Trial participating centre

GGZ Noord-Holland Noord
Oude Hoeverweg 10
Alkmaar
1850 BA
Netherlands

Trial participating centre

UMC Groningen
UCP Noordzijde UMCG-terrein, ingang 32
Groningen
9700 RB
Netherlands

Trial participating centre

GGZ Oost Brabant
Gezondheidslaan 65
Oss
5342 JW
Netherlands

Trial participating centre

Altrecht
Lange Nieuwstraat 119
Utrecht
3512 PG
Netherlands

Trial participating centre

UMC Utrecht
Heidelberglaan 100
Utrecht
3584 CX
Netherlands

Trial participating centre

GGZ InGeest
Postbus 74077
Amsterdam
1070 BB
Netherlands

Trial participating centre

Bavo-Europoort
Prins Constantijnweg 48 - 54
Rotterdam
3014 HH
Netherlands

Sponsor information

Organisation

VU University Amsterdam , Faculty of Behavioural and Movement Sciences (Vrije Universiteit Amsterdam, Faculteit der Gedrags - en Bewegingswetenschappen)

Sponsor details

Van der Boechorstraat 1
Amsterdam
1081 BT
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Innovation Fund Parnassia Group (Innovatiefonds Parnassia Groep)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned submission to peer-reviewed journals following result analysis.

Intention to publish date

30/06/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes