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

Not Applicable

Completed

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-9-18
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br>Participants will;<br><br> 1. have a diagnosis of a schizophrenia spectrum disorder (ICD-10, F2, confirmed by<br> SCID-5)<br><br> 2. patients will be reporting distressing AH for at least six months (to be beyond the<br> startle and adjustment phase ) and score = 3 on either item 8 or item 9 of the<br> PSYRATS-AH;<br><br> 3. be = 16 years of age<br><br> 4. be judged able to understand the full implications of their decision by the<br> responsible psychiatrist or clinical psychologist.<br><br>Exclusion Criteria:<br><br>Participant must not:<br><br> 1. have AH with a clear organic cause (e.g. brain disease or injury):<br><br> 2. have exclusively hypnagogic or hypnopompic AH,<br><br> 3. have a primary diagnosis of acute substance dependence (F1x.2)<br><br> 4. have completed a course of CBT for psychotic symptoms during the past year within<br> which distressing AH have been targeted<br><br> 5. be currently participating, or be confirmed to participate in another interventional<br> study in which they are receiving an intervention which utilizes psychological<br> therapy ;<br><br> 6. be non-German speaking to the degree that the participant is unable to fully<br> understand and answer assessment questions or give informed consent;<br><br> 7. be at immediate and serious risk to self or other.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time Budget Measure;EuroQuol Quality of Life Scale (EQ-5D-5L);Columbia Suicide Severity Rating Scale (C-SSRS);Number of rehospitalizations;he Psychotic Symptom Rating Scales - PSYRATS-AH-Frequency;Patient Health Questionnaire-9 (PHQ-9)