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

  • STATUS
    Recruiting
  • End date
    Mar 23, 2023
  • participants needed
    75
  • sponsor
    University of Hamburg-Eppendorf
Updated on 23 March 2022
scid
schizophrenia
hallucinations
verbal hallucinations
auditory hallucinations

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.

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).

Details
Condition Verbal Auditory Hallucination, Psychotic Disorders, Psychosis, Schizophrenia
Treatment Treatment As Usual, Relating Therapy
Clinical Study IdentifierNCT04578314
SponsorUniversity of Hamburg-Eppendorf
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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