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

Schizophrenia Clinical Trial

— RELATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04578314
• Other study ID #: 419676143
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: January 29, 2023

Study information

• Verified date: May 2023
• Source: University of Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: January 29, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hallucinations
• Psychosis
• Psychotic Disorders
• Schizophrenia
• Verbal Auditory Hallucination

Intervention

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.

Locations

Country	Name	City	State
Germany	Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin Charité - Universitätsmedizin Berlin	Berlin
Germany	Jacobs University Bremen	Bremen
Germany	Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Psychotherapeutische Hoschschulambulanz Universität Hamburg	Hamburg
Germany	Universität Leipzig	Leipzig	Sachsen

Sponsors (5)

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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Safety monitoring	Will count the number of adverse events and serious adverse events	through study completion; 9 months after baseline assessment
Primary	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	Time Budget Measure	Time that ist spent in social and vocational activities	5 and 9 months after baseline assessment
Secondary	EuroQuol Quality of Life Scale (EQ-5D-5L)	Health-related quality of life	5 and 9 months after baseline assessment
Secondary	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
Secondary	Number of rehospitalizations	Number of hospitalizations after study enrollment	5 and 9 months after baseline assessment
Secondary	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
Secondary	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