RELATE - A Randomized Controlled Trial of a Cognitive Behavioural Module for Distressing Auditory Verbal Hallucinations
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Verbal Auditory Hallucination
- Sponsor
- University of Hamburg-Eppendorf
- Enrollment
- 85
- Locations
- 5
- Primary Endpoint
- The Psychotic Symptom Rating Scales-AH-Distress factor score (PSYRATS-AH)
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
Matthias Pillny
Trial Manager
University of Hamburg-Eppendorf
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Time Budget Measure(5 and 9 months after baseline assessment)
- Columbia Suicide Severity Rating Scale (C-SSRS)(5 and 9 months after baseline assessment)
- Number of rehospitalizations(5 and 9 months after baseline assessment)
- EuroQuol Quality of Life Scale (EQ-5D-5L)(5 and 9 months after baseline assessment)
- he Psychotic Symptom Rating Scales - PSYRATS-AH-Frequency(5 and 9 months after baseline assessment)
- Patient Health Questionnaire-9 (PHQ-9)(5 and 9 months after baseline assessment)