A scientific study into the effects of Temstem, an app for voice hearers

The TEMSTEM trial: reducing distress and dysfunction caused by auditory verbal hallucinations via a smartphone application

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN75717636

Enrollment

100

Registered

2016-01-14

Start date

2016-02-01

Completion date

Unknown

Last updated

2024-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auditory verbal hallucinations (AVH) in patients diagnosed with a psychotic disorder Mental and Behavioural Disorders Auditory verbal hallucinations (AVH) in patients diagnosed with a psychotic disorder

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026