Condition category
Mental and Behavioural Disorders
Date applied
18/12/2019
Date assigned
20/03/2020
Last edited
20/03/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Hearing voices is a common symptom of psychosis and schizophrenia, but some people who do not have psychosis or schizophrenia hear voices. Current treatments attempt to reduce the voices or develop ways for people to cope with the voices. However, many people who hear voices find that medication and talking therapies do not provide much relief. Another approach is to think of the voices as part of the person and their life. The theory is that a person can develop a better relationship with the voices and accept them as part of their life. Experienced-Focused Counselling (EFC) aims to help a person to understand the connections between their individual responses to trauma and mental illness and how they experience the voices. Various different therapies can be used as part of EFC, including talking therapies, group therapy and music therapy. There has not been much research on whether EFC is effective.
The aim of this study is to investigate a larger-scale study can be conducted. It is also about getting some initial insights into the effects of EFC delivered by nurses for people hearing voices.

Who can participate?
Adults aged 18-65 years who hear voices and attend a community mental health centre in Bern (Switzerland) or Gürtersloh (Germany). They must be willing to discuss and interact with their voices.

What does the study involve?
Participants will be randomly allocated to one of two groups. One group will receive the usual counselling and treatment provided by the community mental health centre for 20 weeks. The other group will receive EFC, with 20 appointments over 20 weeks delivered by a trained nurse. The EFC programme involves a detailed interview to better understand the voices in the context of the life of the person, creating a report that describes the personal story of hearing voices from the person's perspective, an attempt to understand why the person is hearing the voices in the way they do, and development and practice of strategies enabling the person to negotiate with and take control of the voices.
During the study, all participants will fill in questionnaires at four timepoints: before the start of treatment, 10 weeks after the start of treatment, at the end of treatment (after 20 weeks) and 6 months after the end of treatment. The questionnaires will be completed with support of the study nurse. Questionnaires will measure topics like hearing voices characteristics and burden, the process of recovery, experience of psychosis, controlability of the voices and severity of symptoms related to the mental illness.

What are the possible benefits and risks of participating?
Participating in the study might have no direct benefit for study participants; however, participants in both groups might experience benefit from the treatment they receive. EFC was developed based on the experience and recommendations of people who hear voices. Experience from using EFC and from previous research suggests that few risks are expected. Especially at the beginning, a participant might experience their voices as louder or more distressing. An EFC Counsellor will support the participant in dealing with this situation.

Where is the study run from?
University Hospital for Psychiatry and Psychotherapy in Bern (Switzerland)

When is the study starting and how long is it expected to run for?
November 2019 to June 2021

Who is funding the study?
Foundation of the Bern University Services for Psychiatry (Switzerland)

Who is the main contact?
Christian Burr, christian.burr@upd.unibe.ch

Trial website

Contact information

Type

Public

Primary contact

Mr Christian Markus Burr

ORCID ID

https://orcid.org/0000-0002-1436-306X

Contact details

Bolligenstrasse 111
Bern
3000
Switzerland
+41 79 957 69 72
christian.burr@upd.unibe.ch

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2019-01093 Version 1.2 05/11/2019

Study information

Scientific title

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

Acronym

EFC-Pilotstudy

Study hypothesis

The primary goal of this pilot study, as a small version of a planned main study, is to clarify whether the most important components of the study, such as recruitment, randomization, intervention and assessments, work well together and whether they are suitable for implementation in a main study.
In order to obtain initial insights into the effectiveness of the intervention, the following hypotheses relevant to a main study are defined. The guiding principle here is to use the intervention to reduce the burden related to hearing voices and to improve the ability to control the voices.
Hypothesis: Experience-focused counselling (EFC) is better than treatment-as-usual (TAU) counselling with similar time spent on it.

Ethics approval

Approved 03/12/2019, Kantonale Ethikkommission fuer die Forschung Bern [Research Ethics Committee of the Canton of Bern] (Murtenstrasse 31, 3010 Bern, Switzerland; +41 31 633 7070; info.kek.kapa@gef.be.ch), ref: 2019-01093

Study design

Multicenter randomized controlled single-blinded interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

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

Condition

Hearing voices in the context of mental health problems

Intervention

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 randomization. This takes place after submission of the informed consent and the first assessment-interview (t0) and is carried out by an independent person non-involved otherwise in the study.
Procedure:
1. Creation of a random number list for each site according to the block length of 24 (participants) using a random generator.
2. Attribution to each block by means of a corresponding number of cards with the indication to which group (intervention or control) the participant is assigned. Each card will be sealed in opaque envelopes. When all envelopes are closed, they will be mixed and then be assigned with the numbers (1a-24a and 1b-24b) per block.
3. Upon each allocation from the study nurse of a new study participant, the independent person consults the random number list of the attributed block and takes the envelope according to random number out and sends the information to the corresponding group the participant was allocated to.

Experience-Focused Counseling (EFC) delivered by nurses:
In this arm, EFC will be given to voice hearers by qualified trained nurses. EFC consists of three major parts: the Maastricht Interview, Report and Construct, alongside the development of coping strategies. EFC is offered over 20 weeks in 20 appointments. All three parts of the intervention (Maastricht Interview, Report and Construct) should evenly take place during the course of the 20 appointments.

Treatment as Usual (TAU):
In this group, voice hearers will receive nurse-delivered unspecific counselling as usual. TAU is offered over 20 weeks without a specification regarding the number of appointments.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

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 outcome measures

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

Overall trial start date

01/11/2019

Overall trial end date

01/06/2022

Reason abandoned (if study stopped)

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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.

Recruitment start date

01/04/2020

Recruitment end date

31/12/2021

Locations

Countries of recruitment

Germany, Switzerland

Trial participating centre

University Hospital of Psychiatry and Psychotherapy
Bolligenstrasse 111
Bern 60
3000
Switzerland

Trial participating centre

LWL Hospital of Psychiatry of Gütersloh
Buxelstrasse 50
Gütersloh
33334
Germany

Sponsor information

Organisation

University Hospital for Psychiatry and Psychotherapy

Sponsor details

Bolligenstrasse 111
Bern 60
3000
Switzerland
+41 31 930 92 80
philipp.meyer@upd.ch

Sponsor type

Hospital/treatment centre

Website

https://www.upd.unibe.ch/research/university_hospitals/university_hospital_of_psychiatry_and_psychotherapy/index_eng.html

Funders

Funder type

University/education

Funder name

Foundation of the Bern University Services for Psychiatry

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

This study will be conducted in support of a doctoral thesis.
1. There is the plan to publish an article related to answering the primary research question, which whether the most important components of the study, such as recruitment, randomization, intervention and assessments are working well together and whether they are suitable for implementation in a main study.
2. A second article is planed to describe initial insights into the effectiveness of the intervention, related to reduce the burden related to hearing voices and to improve the controllability of the voices.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/06/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

29/01/2020: Trial's existence confirmed by Kantonale Ethikkommission fuer die Forschung Bern [Research Ethics Committee of the Canton of Bern].