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Is it feasible to conduct a study to compare effectiveness of experience-focused counselling (EFC) and usual counselling for people hearing voices?

Pilot study of a randomized, controlled, single-blinded interventional study on the effectiveness of experience-focused counselling (EFC) for people hearing voices

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17990518
Enrollment
40
Registered
2020-03-20
Start date
2020-09-15
Completion date
Unknown
Last updated
2024-01-15

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

Conditions

Hearing voices in the context of mental health problems Mental and Behavioural Disorders

Interventions

Randomisation: In order to have a similar distribution of the study participants on both study-sides, randomization is carried out separately for both study sides as block randomizatio

Sponsors

University Hospital for Psychiatry and Psychotherapy
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 Aged over 18 and under 65 years. This data is gathered from the patient record. 2. Presence of hearing voices or acoustic hallucination as a perception without external stimulus source. This criterion will be collected from the patient record and will be validated at the first contact before informed consent. 3. Experiencing distress from the voices. This will be validated with the Psychotic Symptom Rating Scales (PSYRATS) with at least one non-zero score on questions 8, 9, or 10. 4. Willingness to participate regularly in conversations about voice hearing: This will be validated at the first contact before informed consent.

Exclusion criteria

Exclusion criteria: 1. Inability to consent: This is regularly noted in the patient record by the doctor in charge. The nurses at the community mental health centers will be asked this question. 2. Not able to speak and understand (Swiss) German: This will be assessed by the study nurse based on the conversation at first contact. 3. Acuity: If the person is in an acute crisis situation and is unable to follow 15 minutes long conversation. This information can be obtained from the responsible nurse or doctor on the unit or can be assessed by the study nurse based on the first contact conversation.

Design outcomes

Primary

MeasureTime frame
Characteristics of the voices and related burden assessed using the Psychotic Symptom Rating Scales (PSYRATS) at baseline (upon inclusion but before being assigned to the group; T0), after 10 appointments (T1), upon completion of the intervention (T2) and 6 months after completion of the intervention (follow-up; T3)

Secondary

MeasureTime frame
1. Locus of control assessed using the Multidimensional Health Locus of Control Scale (MHLC, Form-C) at baseline (upon inclusion but before being assigned to the group; T0), after 10 appointments (T1), upon completion of the intervention (T2) and 6 months after completion of the intervention (follow-up; T3) 2. Personal Recovery assessed using the Questionnaire about the Process of Recovery (QPR) at baseline, T2 and T3 3. Subjective experience and meaning of psychosis or hearing voices assessed using the Subjective Sense in Psychosis Questionnaire (SUSE) at baseline, T2 and T3 4. Use of antipsychotic medication assessed using the patient's medical records, with the medication used converted into chlorpromazine equivalents, at baseline, T2 and T3 5. Psychopathology severity assessed using the Brief Psychiatric Rating Scale Expanded (BPRS-E) at baseline, T2 and T3 6. Qualitative assessment of the participant's views on the study burden and feasibility of a larger study assessed by interview at T2 7. Sociodemographic and health-related data assessed using an investigator-designed questionnaire at baseline, T1, T2 and T3

Countries

Germany, Switzerland

Contacts

Public ContactChristian Markus Burr
christian.burr@upd.unibe.ch+41 79 957 69 72

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026