RELATE - Efficacy and Feasibility of a Cognitive Behavioural Module for Distressing Auditory Verbal Hallucinations

Not Applicable

Completed

• Conditions: Psychotic Disorders; Psychosis; Schizophrenia; Verbal Auditory Hallucination

• Registration Number: NCT04578314
• Lead Sponsor: University of Hamburg-Eppendorf

Brief 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. 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 Timeline

• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-09-30
• Study Start: 2020-10-01
• Study First Posted: 2020-10-08
• Primary Completion: 2022-04-30
• Study Completion: 2023-01-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-24
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Participants will;

1. have a diagnosis of a schizophrenia spectrum disorder (ICD-10, F2, confirmed by SCID-5)
2. 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;
3. be ≥ 16 years of age
4. be judged able to understand the full implications of their decision by the responsible psychiatrist or clinical psychologist.

Exclusion Criteria

Participant must not:

1. have AH with a clear organic cause (e.g. brain disease or injury):
2. have exclusively hypnagogic or hypnopompic AH,
3. have a primary diagnosis of acute substance dependence (F1x.2)
4. have completed a course of CBT for psychotic symptoms during the past year within which distressing AH have been targeted
5. be currently participating, or be confirmed to participate in another interventional study in which they are receiving an intervention which utilizes psychological therapy ;
6. be non-German speaking to the degree that the participant is unable to fully understand and answer assessment questions or give informed consent;
7. be at immediate and serious risk to self or other.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Psychotic Symptom Rating Scales-AH-Distress factor score (PSYRATS-AH)	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.

Secondary Outcome Measures

Name	Time	Method
Time Budget Measure	5 and 9 months after baseline assessment	Time that ist spent in social and vocational activities
Columbia Suicide Severity Rating Scale (C-SSRS)	5 and 9 months after baseline assessment	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
Number of rehospitalizations	5 and 9 months after baseline assessment	Number of hospitalizations after study enrollment
EuroQuol Quality of Life Scale (EQ-5D-5L)	5 and 9 months after baseline assessment	Health-related quality of life
he Psychotic Symptom Rating Scales - PSYRATS-AH-Frequency	5 and 9 months after baseline assessment	Frequency of auditory hallucinations. Ranges from 0 to 4 with higher scores indicating higher frequency of auditory hallucinations
Patient Health Questionnaire-9 (PHQ-9)	5 and 9 months after baseline assessment	Self-report scale measuring depressive symptoms. Total score ranges from 0 to 21with higher scores indicating more severe depressive symptoms

Trial Locations

Locations (5)

Universität Leipzig; 🇩🇪 Leipzig, Sachsen, Germany

Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Jacobs University Bremen; 🇩🇪 Bremen, Germany

Psychotherapeutische Hoschschulambulanz Universität Hamburg; 🇩🇪 Hamburg, Germany

Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany