Clinical trial NCT04578314: RELATE - Efficacy and Feasibility of a Cognitive Behavioural Module for Distressing Auditory Verbal Hallucinations
Official title: RELATE - A Randomized Controlled Trial of a Cognitive Behavioural Module for Distressing Auditory Verbal Hallucinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Verbal Auditory Hallucination
Psychotic Disorders
Psychosis
Schizophrenia
Keywords: Relating therapy
Lead sponsor: University of Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: University of Leipzig
name: Universitätsklinikum Hamburg-Eppendorf
name: Jacobs University Bremen gGmbH
name: Charite University, Berlin, Germany
First posted: 2020-10-08
Enrollment: 85
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The Psychotic Symptom Rating Scales-AH-Distress factor score (PSYRATS-AH)
timeFrame: 9 months after baseline assessment
Secondary outcomes:
measure: Time Budget Measure
timeFrame: 5 and 9 months after baseline assessment
measure: EuroQuol Quality of Life Scale (EQ-5D-5L)
timeFrame: 5 and 9 months after baseline assessment
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 5 and 9 months after baseline assessment
measure: Number of rehospitalizations
timeFrame: 5 and 9 months after baseline assessment
measure: he Psychotic Symptom Rating Scales - PSYRATS-AH-Frequency
timeFrame: 5 and 9 months after baseline assessment
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 5 and 9 months after baseline assessment
Other outcomes:
measure: The Voice and You (VAY)
timeFrame: 5 and 9 months after baseline assessment
measure: Relating to Voices/Others Questionnaires (APPROVE)
timeFrame: 5 and 9 months after baseline assessment
measure: Feasibility recruitment
timeFrame: through study completion, approximately two years after recruitment commenced
measure: Feasibility completeness
timeFrame: through study completion, approximately 3 years after first participant has been randomized
measure: Therapist adherence
timeFrame: through study completion, an average of 4 weeks after baseline assessment
measure: Safety monitoring
timeFrame: through study completion; 9 months after baseline assessment
Locations:
city: Leipzig
country: Germany
facility: Universität Leipzig
state: Sachsen
city: Berlin
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin Charité - Universitätsmedizin Berlin
city: Bremen
country: Germany
facility: Jacobs University Bremen
city: Hamburg
country: Germany
facility: Psychotherapeutische Hoschschulambulanz Universität Hamburg
city: Hamburg
country: Germany
facility: Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: Universität Hamburg
name: Tania M Lincoln, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lincoln TM, Schlier B, Muller R, Hayward M, Fladung AK, Bergmann N, Boge K, Gallinat J, Mahlke C, Gonther U, Lang T, Exner C, Buchholz A, Stahlmann K, Zapf A, Rauch G, Pillny M. Reducing Distress from Auditory Verbal Hallucinations: A Multicenter, Parallel, Single-Blind, Randomized Controlled Feasibility Trial of Relating Therapy. Psychother Psychosom. 2024;93(5):328-339. doi: 10.1159/000539809. Epub 2024 Aug 21.
citation: Lincoln TM, Pillny M, Schlier B, Hayward M. RELATE-a randomised controlled feasibility trial of a Relating Therapy module for distressing auditory verbal hallucinations: a study protocol. BMJ Open. 2021 Jun 2;11(6):e046390. doi: 10.1136/bmjopen-2020-046390.