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

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

RELATE - A Randomized Controlled Trial of a Cognitive Behavioural Module for Distressing Auditory Verbal Hallucinations

University of Leipzig, Universitätsklinikum Hamburg-Eppendorf, Jacobs University Bremen gGmbH, Charite University, Berlin, Germany

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.

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).

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

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.

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.

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.

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.

Patients are interviewed about thoughts of wanting to complete suicide, active suicidal thoughts and intent to act on such thoughts (suicidal ideation, items 1-5) as well as about preparatory acts, aborted, interrupted or actual attempts (suicidal behaviour, 6-9). Completed suicide is rated on item 10. Scores on this scale range from 0 to 43 with higher scores indicating higher suicidal ideation

Frequency of auditory hallucinations. Ranges from 0 to 4 with higher scores indicating higher frequency of auditory hallucinations

Self-report scale measuring depressive symptoms. Total score ranges from 0 to 21with higher scores indicating more severe depressive symptoms

To analyse whether the putative intervention effect is explicable by the changes in the processes targeted (improved relating to AH), two self-report scales will measure relating to AH. The VAY is a 29-item measure of interrelating between the hearer and their predominant voice (see above for a description of the development of this measure). Relating is measured across four scales; two concerning the hearer's perception of the relating of the voice-voice dominance and voice intrusiveness; and two concerning the relating of the hearer-hearer distance and hearer dependence. Each item is measured on a four-point scale (0-3). Higher scores indicate more negative relating.

The APPROVE consists of two separate scales: A 46-item measure of relating to voices (Approve-Voices); and a 46-item measure of social relating (Approve-Social). The items were preceded by an introductory text inviting participants to "please select the answer that best reflects your typical response to [voices/other people] on the scale 0 (disagree completely) to 10 (agree completely). Where the item is not relevant to you then please select the not applicable (N/A) option". The following instruction - "When [voices/other people] are being difficult (e.g., treating me badly), I respond by: (...)" is presented before the list of the items (e.g., "Hearing what they are saying but also stating my own views").

Will count the number of patients referred within each site, number of self-referrals within each site, number of referred patients within each site found to be eligible, number and proportion of consenting and eligible participants who attend 5-month and 9 month assessment within each site

Will count the number and proportion of consenting participants within the RM condition who reach the point of therapy 'exposure' (attended at least 8 of 16 therapy sessions), percentage of complete of data sets

All therapy sessions will be audio-recorded. For the first participant for each therapist, one recording from the early phase of therapy (sessions 1-6) and one recording from a later phase of therapy (sessions 7-14) will be randomly selected by the trial manager. The recordings will be translated, transcribed and sent to Dr Hayward for review. Therapist adherence to the treatment protocol will be assessed by Dr. Hayward who will assess two randomly selected recordings per therapist. Adherence will be rated using an adapted version of the Cognitive Therapy Scale for Psychosis (CTS-psy). Items F, G, and H have been adapted to include relating specific items in place of cognitive therapy (e.g. "Focus on the link between cognition and affect" was replaced with "focus on the effects of the patient engaging in different patterns of relating").

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.

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

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.