The primary objective is to test the effects of temstem on distress, disturbance to life and social functioning. Second, we aim to investigate the effect of temstem on frequency and severity of AVH, to determine working mechanisms, to identify…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes are changes in distress, disturbance to life and social
dysfunction caused by AVHs.
Secondary outcome
Changes in frequency and severity of AVHs; control and power over AVHs; ability
to cope with AVHs; self-esteem; depression; quality of life; paranoid
ideations.
Background summary
Temstem is a smartphone application which was designed to help people that
suffer from auditory verbal hallucinations (AVHs) to cope better with these
experiences, which may reduce distress and improve social functioning.
Study objective
The primary objective is to test the effects of temstem on distress,
disturbance to life and social functioning. Second, we aim to investigate the
effect of temstem on frequency and severity of AVH, to determine working
mechanisms, to identify predictors and mediators of effects and to study the
usability (user friendliness) of temstem, to improve customer satisfaction in
the future. Third, we want to determine the psychometric properties of two new
questionnaires that which may be useful in the clinical usage of temstem, the
Trauma and Life Event Checklist (TALE) and the Trauma Voice Associations
questionnaire (TVAq).
Study design
A multicentre single blind randomized clinical trial with two arms and a 3-week
follow-up using experience sampling method.
Intervention
*Temstem + AVHs monitoring* will be compared with *AVH monitoring only*. In the
AVH monitoring only condition participants will daily monitor their AVHs in a
30 second assessment. In the temstem + AVHs monitoring condition participants
will daily monitor AVHs and will be provided with the temstem app, a smartphone
application that was developed to assist the user in coping better with AVHs
via language games, enhance self-esteem, and possibly reduce vividness and
emotionality of AVHs.
Study burden and risks
All participants will be assessed with a number of clinical scales/interviews.
There are no risks for individuals to participate in this study.
V.d.Boechorststraat 1-3
Amsterdam 1081 BT
NL
V.d.Boechorststraat 1-3
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
* Presence of AVHs (with distress) for longer than a month
* Presence of AVHs during a minimum of four days a week, in at least three of the last four weeks
Exclusion criteria
* Changes in medication regiment in the last month
* Estimated IQ under 70; the researchers will examine the schoolcareer of the patient. If problems during the primaryschool period are found, the short version of the WAIS-IV will be conducted to determine intelligence.
* Insufficient competence in the Dutch language
* Previous use of temstem
* Not willing or able to learn to use a smartphone
* Currently undergoing cognitive behavioural therapy for AVHs
* Current involuntary admission in a closed ward
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53684.029.15 |