Verbal Auditory HallucinationRELATENCT04578314
RELATE - Efficacy and Feasibility of a Cognitive Behavioural Module for Distressing Auditory Verbal Hallucinations
A study testing Relating Therapy and Treatment as usual in people with Verbal Auditory Hallucination and Psychotic Disorders, run by University of Hamburg-Eppendorf at 5 sites in Germany.
Trial summary
Auditory hallucinations (AH) are associated with distress and reduced functioning. Psychological interventions show some promising effects on psychopathology but have been less successful in reducing AH related distress, which patients report to be a priority. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Verbal Auditory Hallucination, Psychotic Disorders, Psychosis
- What is being tested?
- Relating Therapy and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 5 sitesGermany
- Study dates
- 1 Oct 2020to 29 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants will;
- have a diagnosis of a schizophrenia spectrum disorder (ICD-10, F2, confirmed by SCID-5)
- patients will be reporting distressing AH for at least six months (to be beyond the startle and adjustment phase ) and score ≥ 3 on either item 8 or item 9 of the PSYRATS-AH;
- be ≥ 16 years of age
- be judged able to understand the full implications of their decision by the responsible psychiatrist or clinical psychologist.
Who cannot join
- Participant must not:
- have AH with a clear organic cause (e.g. brain disease or injury):
- have exclusively hypnagogic or hypnopompic AH,
- have a primary diagnosis of acute substance dependence (F1x.2)
- have completed a course of CBT for psychotic symptoms during the past year within which distressing AH have been targeted
- be currently participating, or be confirmed to participate in another interventional study in which they are receiving an intervention which utilizes psychological therapy ;
- be non-German speaking to the degree that the participant is unable to fully understand and answer assessment questions or give informed consent;
- be at immediate and serious risk to self or other.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin Charité - Universitätsmedizin Berlin
Berlin, 12203
Jacobs University Bremen
Bremen, 28759
Psychotherapeutische Hoschschulambulanz Universität Hamburg
Hamburg, 20146
Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20251
Universität Leipzig
Leipzig, Saxony, 04109
About this study
Official title: RELATE - A Randomized Controlled Trial of a Cognitive Behavioural Module for Distressing Auditory Verbal Hallucinations
Auditory hallucinations (AH) are associated with distress and reduced functioning. Psychological interventions show some promising effects on psychopathology but have been less successful in reducing AH related distress, which patients report to be a priority. Research suggests that distress is associated with the hearer relating to AH in a passive and subordinate manner. A novel approach thus teaches assertive responses to AH through the use of experiential role-plays. A single centre pilot study in the United Kingdom evidenced a large effect of this approach on AH distress but independent multicentre studies are required to ascertain effectiveness across different settings. The planned feasibility trial aims to estimate the expected effect for a subsequent fully powered prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial set up to demonstrate that adding a Relating Module (RM) to Treatment as Usual (TAU) is superior to TAU alone. Feasibility questions relate to patient recruitment, therapist training and therapy monitoring in different types of psychological and psychiatric outpatient facilities.
Read the detailed description
Auditory hallucinations (AH) are associated with distress and reduced functioning. Psychological interventions show some promising effects on psychopathology but have been less successful in reducing AH related distress, which patients report to be a priority. Research suggests that distress is associated with the hearer relating to AH in a passive and subordinate manner. A novel approach thus teaches assertive responses to AH through the use of experiential role-plays. A single centre pilot study in the United Kingdom evidenced a large effect of this approach on AH distress but independent multicentre studies are required to ascertain effectiveness across different settings. The planned feasibility trial aims to estimate the expected effect for a subsequent fully powered prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial set up to demonstrate that adding a Relating Module (RM) to Treatment as Usual (TAU) is superior to TAU alone. Feasibility questions relate to patient recruitment, therapist training and therapy monitoring in different types of psychological and psychiatric outpatient facilities. A total of 75 patients diagnosed with a schizophrenia spectrum disorder (ICD-10, F2) and persistent distressing AH will be recruited across 4 sites and receive either 16 50-minute sessions of RM plus TAU or TAU alone within a 5-months period. Assessments will take place at baseline, at 5 months (post-intervention) and at 9 months (primary outcome).
- Being tested
- Relating Therapy, Treatment as usual
- Keywords
- Relating therapy
- Medical subject headings
- Hallucinations, Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relating TherapyBehavioural
Relating Therapy (RT) is a symptom-specific behaviourally oriented intervention that targets interpersonal relating as a key mechanism associated with auditory hallucination distress. The aim is that patients learn to relate more assertively within the difficult relationships they have with both the auditory hallucinations and other people. The RT will follow a treatment manual consisting of three phases: 1. Socialization to relating therapy and its implications; 2. Exploration of themes within the relational history of the participant and their experience of relationships with AH, and interpersonal relating within the family and social environment (identifying any prominent themes, such as abuse, disempowerment, or rivalry); 3. Exploration and development of assertive approaches to relating to AH and other people.
Treatment as usualOther
TAU will include medication management, supportive brief counselling sessions and various types of psychosocial (e.g. social work guided support, peer support) and monitoring provided by Mental Health Services, with individual and family psychological therapies offered occasionally. Individual therapies may include CBT or psychodynamic interventions. To amend for the heterogeneity of TAU across centres, the type and extent of any treatment received will be protocolled at T1 and T2.
| Study group | Role | What they receive |
|---|---|---|
| Relating module + Treatment as usual | Experimental | Participants in this arm will receive 16 weekly sessions with Relating Therapy (RT) over 5 months in addition to their treatment as usual. Receives: Behavioral: Relating Therapy; Other: Treatment as usual |
| Treatment as usual | Active comparator | Treatment as usual will include medication management, supportive brief counselling sessions and various types of psychosocial (e.g. social work guided support, peer support) and monitoring provided by Mental Health Services, with individual and family psychological therapies offered occasionally. Individual therapies may include Cognitive Behavior Therapy or psychodynamic interventions. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Psychotic Symptom Rating Scales-AH-Distress factor score (PSYRATS-AH)
Auditory hallucination associated distress. The distress factor score of the PSYRATS-AH is the primary outcome as this is what has been prioritized by patients and is relevant to functioning. Confirmatory analysis will be conducted based on the intent-to-treat population (ITT), defined on the basis of the ITT principle. The aim is to show that the intervention group is superior to the control meaning that the mean score at 9 months adjusted for the baseline value is lower in the intervention group than in the control group. Lower scores indicate less distress.
Measured: 9 months after baseline assessment
Secondary outcomes (6)
Time Budget Measure
Time that ist spent in social and vocational activities
Measured: 5 and 9 months after baseline assessment
EuroQuol Quality of Life Scale (EQ-5D-5L)
Health-related quality of life
Measured: 5 and 9 months after baseline assessment
Columbia Suicide Severity Rating Scale (C-SSRS)
Patients are interviewed about thoughts of wanting to complete suicide, active suicidal thoughts and intent to act on such thoughts (suicidal ideation, items 1-5) as well as about preparatory acts, aborted, interrupted or actual attempts (suicidal behaviour, 6-9). Completed suicide is rated on item 10. Scores on this scale range from 0 to 43 with higher scores indicating higher suicidal ideation
Measured: 5 and 9 months after baseline assessment
Number of rehospitalizations
Number of hospitalizations after study enrollment
Measured: 5 and 9 months after baseline assessment
he Psychotic Symptom Rating Scales - PSYRATS-AH-Frequency
Frequency of auditory hallucinations. Ranges from 0 to 4 with higher scores indicating higher frequency of auditory hallucinations
Measured: 5 and 9 months after baseline assessment
Patient Health Questionnaire-9 (PHQ-9)
Self-report scale measuring depressive symptoms. Total score ranges from 0 to 21with higher scores indicating more severe depressive symptoms
Measured: 5 and 9 months after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Oct 2020
- Primary completion30 Apr 2022
- Study completion29 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Verbal Auditory HallucinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leipzig, Universitätsklinikum Hamburg-Eppendorf, Jacobs University Bremen gGmbH, Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Matthias Pillny, University of Hamburg-Eppendorf
- Investigators
- Tania M Lincoln, Prof. Dr., Principal investigator, Universität Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578314
- Sponsor's protocol ID
- 419676143
- Acronym
- RELATE
- Status last verified
- Aug 2024
- First submitted
- 18 Sep 2020
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only upon request
Publications
Lincoln TM, Schlier B, Muller R, Hayward M, Fladung AK, Bergmann N, Boge K, Gallinat J, Mahlke C, Gonther U, Lang T, Exner C, Buchholz A, Stahlmann K, Zapf A, Rauch G, Pillny M. Reducing Distress from Auditory Verbal Hallucinations: A Multicenter, Parallel, Single-Blind, Randomized Controlled Feasibility Trial of Relating Therapy. Psychother Psychosom. 2024;93(5):328-339. doi: 10.1159/000539809. Epub 2024 Aug 21.
PubMed 39168112Lincoln TM, Pillny M, Schlier B, Hayward M. RELATE-a randomised controlled feasibility trial of a Relating Therapy module for distressing auditory verbal hallucinations: a study protocol. BMJ Open. 2021 Jun 2;11(6):e046390. doi: 10.1136/bmjopen-2020-046390.
PubMed 34083338
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELATE - A Randomized Controlled Trial of a Cognitive Behavioural Module for Distressing Auditory Verbal Hallucinations
- ClinicalTrials.gov ID
- NCT04578314
- Acronym / sponsor ID
- RELATE / 419676143
- Keywords
- Relating therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- University of Leipzig, Universitätsklinikum Hamburg-Eppendorf, Jacobs University Bremen gGmbH, Charite University, Berlin, Germany
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 29 Jan 2023 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Auditory hallucinations (AH) are associated with distress and reduced functioning. Psychological interventions show some promising effects on psychopathology but have been less successful in reducing AH related distress, which patients report to be a priority. Research suggests that distress is associated with the hearer relating to AH in a passive and subordinate manner. A novel approach thus teaches assertive responses to AH through the use of experiential role-plays. A single centre pilot study in the United Kingdom evidenced a large effect of this approach on AH distress but independent multicentre studies are required to ascertain effectiveness across different settings. The planned feasibility trial aims to estimate the expected effect for a subsequent fully powered prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial set up to demonstrate that adding a Relating Module (RM) to Treatment as Usual (TAU) is superior to TAU alone. Feasibility questions relate to patient recruitment, therapist training and therapy monitoring in different types of psychological and psychiatric outpatient facilities.
Detailed description
Auditory hallucinations (AH) are associated with distress and reduced functioning. Psychological interventions show some promising effects on psychopathology but have been less successful in reducing AH related distress, which patients report to be a priority. Research suggests that distress is associated with the hearer relating to AH in a passive and subordinate manner. A novel approach thus teaches assertive responses to AH through the use of experiential role-plays. A single centre pilot study in the United Kingdom evidenced a large effect of this approach on AH distress but independent multicentre studies are required to ascertain effectiveness across different settings. The planned feasibility trial aims to estimate the expected effect for a subsequent fully powered prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial set up to demonstrate that adding a Relating Module (RM) to Treatment as Usual (TAU) is superior to TAU alone. Feasibility questions relate to patient recruitment, therapist training and therapy monitoring in different types of psychological and psychiatric outpatient facilities. A total of 75 patients diagnosed with a schizophrenia spectrum disorder (ICD-10, F2) and persistent distressing AH will be recruited across 4 sites and receive either 16 50-minute sessions of RM plus TAU or TAU alone within a 5-months period. Assessments will take place at baseline, at 5 months (post-intervention) and at 9 months (primary outcome).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial
| Arm | Type | Receives |
|---|---|---|
| Relating module + Treatment as usual | Experimental | Behavioral: Relating Therapy, Other: Treatment as usualParticipants in this arm will receive 16 weekly sessions with Relating Therapy (RT) over 5 months in addition to their treatment as usual. |
| Treatment as usual | Active comparator | Other: Treatment as usualTreatment as usual will include medication management, supportive brief counselling sessions and various types of psychosocial (e.g. social work guided support, peer support) and monitoring provided by Mental Health Services, with individual and family psychological therapies offered occasionally. Individual therapies may include Cognitive Behavior Therapy or psychodynamic interventions. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Participants will;
- have a diagnosis of a schizophrenia spectrum disorder (ICD-10, F2, confirmed by SCID-5)
- patients will be reporting distressing AH for at least six months (to be beyond the startle and adjustment phase ) and score ≥ 3 on either item 8 or item 9 of the PSYRATS-AH;
- be ≥ 16 years of age
- be judged able to understand the full implications of their decision by the responsible psychiatrist or clinical psychologist.
Key exclusion criteria (8 listed)
- have AH with a clear organic cause (e.g. brain disease or injury):
- have exclusively hypnagogic or hypnopompic AH,
- have a primary diagnosis of acute substance dependence (F1x.2)
- have completed a course of CBT for psychotic symptoms during the past year within which distressing AH have been targeted
- be currently participating, or be confirmed to participate in another interventional study in which they are receiving an intervention which utilizes psychological therapy ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relating TherapyRelating Therapy (RT) is a symptom-specific behaviourally oriented intervention that targets interpersonal relating as a key mechanism associated with auditory hallucination distress. The aim is that patients learn to relate more assertively within the difficult relationships they have with both the auditory hallucinations and other people. The RT will follow a treatment manual consisting of three phases: 1. Socialization to relating therapy and its implications; 2. Exploration of themes within the relational history of the participant and their experience of relationships with AH, and interpersonal relating within the family and social environment (identifying any prominent themes, such as abuse, disempowerment, or rivalry); 3. Exploration and development of assertive approaches to relating to AH and other people. | Behavioural | Relating module + Treatment as usual |
| Treatment as usualTAU will include medication management, supportive brief counselling sessions and various types of psychosocial (e.g. social work guided support, peer support) and monitoring provided by Mental Health Services, with individual and family psychological therapies offered occasionally. Individual therapies may include CBT or psychodynamic interventions. To amend for the heterogeneity of TAU across centres, the type and extent of any treatment received will be protocolled at T1 and T2. | Other | Relating module + Treatment as usual, Treatment as usual |
Primary outcome
The Psychotic Symptom Rating Scales-AH-Distress factor score (PSYRATS-AH)
Time frame: 9 months after baseline assessment
Auditory hallucination associated distress. The distress factor score of the PSYRATS-AH is the primary outcome as this is what has been prioritized by patients and is relevant to functioning. Confirmatory analysis will be conducted based on the intent-to-treat population (ITT), defined on the basis of the ITT principle. The aim is to show that the intervention group is superior to the control meaning that the mean score at 9 months adjusted for the baseline value is lower in the intervention group than in the control group. Lower scores indicate less distress.
6 secondary outcomes
Time Budget Measure
Time frame: 5 and 9 months after baseline assessment
EuroQuol Quality of Life Scale (EQ-5D-5L)
Time frame: 5 and 9 months after baseline assessment
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 5 and 9 months after baseline assessment
Number of rehospitalizations
Time frame: 5 and 9 months after baseline assessment
he Psychotic Symptom Rating Scales - PSYRATS-AH-Frequency
Time frame: 5 and 9 months after baseline assessment
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 5 and 9 months after baseline assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Results publication: PubMed 39168112Lincoln TM, Schlier B, Muller R, Hayward M, Fladung AK, Bergmann N, Boge K, Gallinat J, Mahlke C, Gonther U, Lang T, Exner C, Buchholz A, Stahlmann K, Zapf A, Rauch G, Pillny M. Reducing Distress from Auditory Verbal Hallucinations: A Multicenter, Parallel, Single-Blind, Randomized Controlled Feasibility Trial of Relating Therapy. Psychother Psychosom. 2024;93(5):328-339. doi: 10.1159/000539809. Epub 2024 Aug 21.
- Derived from this study: PubMed 34083338Lincoln TM, Pillny M, Schlier B, Hayward M. RELATE-a randomised controlled feasibility trial of a Relating Therapy module for distressing auditory verbal hallucinations: a study protocol. BMJ Open. 2021 Jun 2;11(6):e046390. doi: 10.1136/bmjopen-2020-046390.
- Individual participant dataSharing planned: No. only upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tania M Lincoln, Prof. Dr. principal investigator
Universität Hamburg
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relating Therapy and Treatment as usual in people with Verbal Auditory Hallucination and Psychotic Disorders, run by University of Hamburg-Eppendorf at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Psychotic Symptom Rating Scales-AH-Distress factor score (PSYRATS-AH) (time frame: 9 months after baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04578314, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.