RELATE - Efficacy and Feasibility of a Cognitive Behavioural Module for Distressing Auditory Verb… (NCT04578314) | Clinical Trial Compass
CompletedNot Applicable
RELATE - Efficacy and Feasibility of a Cognitive Behavioural Module for Distressing Auditory Verbal Hallucinations
Germany85 participantsStarted 2020-10-01
Plain-language 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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. have AH with a clear organic cause (e.g. brain disease or injury):
. have exclusively hypnagogic or hypnopompic AH,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Psychotic Symptom Rating Scales-AH-Distress factor score (PSYRATS-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.