An interventional study of Relating Therapy and Treatment as usual in Verbal Auditory Hallucination, Psychotic Disorders and Psychosis, sponsored by University of Hamburg-Eppendorf. Completed at 5 sites in Germany. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by University of Hamburg-Eppendorf · Not applicable, Interventional, and Treatment
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).
136 studies on the registry are indexed under Hallucinations; 35 are open to participants now.
This study's enrollment of 85 is above the median of 48 across 118 interventional studies indexed under Hallucinations.
Browse Hallucinations studies →University of Hamburg-Eppendorf is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants will;
Exclusion Criteria:
Participant must not:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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.
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.
Time frame: 9 months after baseline assessment
Time Budget Measure
Time that ist spent in social and vocational activities
Time frame: 5 and 9 months after baseline assessment
EuroQuol Quality of Life Scale (EQ-5D-5L)
Health-related quality of life
Time frame: 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
Time frame: 5 and 9 months after baseline assessment
Number of rehospitalizations
Number of hospitalizations after study enrollment
Time frame: 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
Time frame: 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
Time frame: 5 and 9 months after baseline assessment
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.
Time frame: 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").
Time frame: 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
Time frame: 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
Time frame: 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").
Time frame: through study completion, an average of 4 weeks after baseline assessment
Safety monitoring
Will count the number of adverse events and serious adverse events
Time frame: through study completion; 9 months after baseline assessment
Plan to share: No — only upon request
Ran from Oct 2020 to primary completion in Apr 2022, 18 months.
Of 53 non-industry interventional studies with no phase under Hallucinations, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 56. This study's 18 months is below that.
Counting every sponsor, half of 53 studies reached it within 37 months; a quarter within 20 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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University of Hamburg-Eppendorf