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

NCT04578314 | Completed DMC

• 1 other identifier: 419676143
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 5

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.

Conditions

Verbal Auditory Hallucination; Psychotic Disorders; Psychosis; Schizophrenia

Keywords

Relating therapy

Outcome Measures

Primary Outcomes (1)

• The Psychotic Symptom Rating Scales-AH-Distress factor score (PSYRATS-AH)

  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.

  9 months after baseline assessment

Secondary Outcomes (6)

• Time Budget Measure

  5 and 9 months after baseline assessment

• EuroQuol Quality of Life Scale (EQ-5D-5L)

  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

• he Psychotic Symptom Rating Scales - PSYRATS-AH-Frequency

  5 and 9 months after baseline assessment

Other Outcomes (6)

• The Voice and You (VAY)

  5 and 9 months after baseline assessment

• Relating to Voices/Others Questionnaires (APPROVE)

  5 and 9 months after baseline assessment

• Feasibility recruitment

  through study completion, approximately two years after recruitment commenced

Study Arms (2)

Relating module + Treatment as usual

EXPERIMENTAL

Participants in this arm will receive 16 weekly sessions with Relating Therapy (RT) over 5 months in addition to their treatment as usual.

Behavioral: Relating Therapy; Other: Treatment as usual

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual will include medication management, supportive brief counselling sessions and various types of psychosocial (e.g. social work guided support, peer support) and monitoring provided by Mental Health Services, with individual and family psychological therapies offered occasionally. Individual therapies may include Cognitive Behavior Therapy or psychodynamic interventions.

Other: Treatment as usual

Interventions

Relating Therapy BEHAVIORAL

Relating Therapy (RT) is a symptom-specific behaviourally oriented intervention that targets interpersonal relating as a key mechanism associated with auditory hallucination distress. The aim is that patients learn to relate more assertively within the difficult relationships they have with both the auditory hallucinations and other people. The RT will follow a treatment manual consisting of three phases: 1. Socialization to relating therapy and its implications; 2. Exploration of themes within the relational history of the participant and their experience of relationships with AH, and interpersonal relating within the family and social environment (identifying any prominent themes, such as abuse, disempowerment, or rivalry); 3. Exploration and development of assertive approaches to relating to AH and other people.

Relating module + Treatment as usual

Treatment as usual OTHER

TAU will include medication management, supportive brief counselling sessions and various types of psychosocial (e.g. social work guided support, peer support) and monitoring provided by Mental Health Services, with individual and family psychological therapies offered occasionally. Individual therapies may include CBT or psychodynamic interventions. To amend for the heterogeneity of TAU across centres, the type and extent of any treatment received will be protocolled at T1 and T2.

Relating module + Treatment as usual; Treatment as usual

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Hamburg-Eppendorf: lead
• University of Leipzig: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Jacobs University Bremen gGmbH: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (5)

Universität Leipzig

Leipzig, Saxony, 04109, Germany

Location

Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

Jacobs University Bremen

Bremen, 28759, Germany

Location

Psychotherapeutische Hoschschulambulanz Universität Hamburg

Hamburg, 20146, Germany

Location

Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20251, Germany

Location

Related Publications (2)

• 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.

  PMID: 39168112 RESULT

• 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.

  PMID: 34083338 DERIVED

MeSH Terms

Conditions

Hallucinations; Psychotic Disorders; Schizophrenia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Tania M Lincoln, Prof. Dr.

  Universität Hamburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trial Manager

Model Details: prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: October 8, 2020
• Study Start: October 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: January 29, 2023
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)