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

University of Hamburg-Eppendorf

Status: Completed

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

Treatments: Other: Treatment as usual; Behavioral: Relating Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04578314

419676143

Details and patient eligibility

About

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.

Full 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).

Enrollment: 85 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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85 participants in 2 patient groups

Relating module + Treatment as usual

Experimental group

Description:

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

Treatment:

Behavioral: Relating Therapy

Other: Treatment as usual

Treatment as usual

Active Comparator group

Description:

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.

Treatment:

Other: Treatment as usual