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

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

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.

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Schizophrenia; Psychosis; Verbal Auditory Hallucination
• Intervention / Treatment: Behavioral: Relating Therapy; Other: Treatment as usual

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).

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tania M Lincoln, Prof. Dr.; Email: tania.lincoln@uni-hamburg.de

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin Charité - Universitätsmedizin Berlin
  • Bremen, Germany, 28759
    • Jacobs University Bremen
  • Hamburg, Germany, 20146
    • Psychotherapeutische Hoschschulambulanz Universität Hamburg
  • Hamburg, Germany, 20251
    • Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum Hamburg-Eppendorf
  • Sachsen
    • Leipzig, Sachsen, Germany, 04109
      • Universität Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Relating module + Treatment as usual; 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; 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.; Other: Treatment as usual; 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.
Active Comparator: 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.	Other: Treatment as usual; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Budget Measure	Time that ist spent in social and vocational activities	5 and 9 months after baseline assessment
EuroQuol Quality of Life Scale (EQ-5D-5L)	Health-related quality of life	5 and 9 months after baseline assessment
Columbia Suicide Severity Rating Scale (C-SSRS)	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	5 and 9 months after baseline assessment
Number of rehospitalizations	Number of hospitalizations after study enrollment	5 and 9 months after baseline assessment
he Psychotic Symptom Rating Scales - PSYRATS-AH-Frequency	Frequency of auditory hallucinations. Ranges from 0 to 4 with higher scores indicating higher frequency of auditory hallucinations	5 and 9 months after baseline assessment
Patient Health Questionnaire-9 (PHQ-9)	Self-report scale measuring depressive symptoms. Total score ranges from 0 to 21with higher scores indicating more severe depressive symptoms	5 and 9 months after baseline assessment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Voice and You (VAY)	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.	5 and 9 months after baseline assessment
Relating to Voices/Others Questionnaires (APPROVE)	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").	5 and 9 months after baseline assessment
Feasibility recruitment	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	through study completion, approximately two years after recruitment commenced
Feasibility completeness	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	through study completion, approximately 3 years after first participant has been randomized
Therapist adherence	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").	through study completion, an average of 4 weeks after baseline assessment
Safety monitoring	Will count the number of adverse events and serious adverse events	through study completion; 9 months after baseline assessment

Collaborators and Investigators

• Sponsor: University of Hamburg-Eppendorf
• Collaborators: Charite University, Berlin, Germany; University of Leipzig; Universitätsklinikum Hamburg-Eppendorf; Jacobs University Bremen gGmbH
• Investigators: Principal Investigator: Tania M Lincoln, Prof. Dr., Universität Hamburg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): January 29, 2023

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Relating therapy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Perceptual Disorders; Schizophrenia; Psychotic Disorders; Hallucinations
• Other Study ID Numbers: 419676143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: only upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No