Auditory HallucinationNCT05603260
Imagery Interventions for Auditory Vocal Hallucinations
A study testing Imagery intervention for voice hearing (meta-cognitive imagery rescripting), Imagery intervention for voice hearing (Imagery rescripting) and Imagery intervention for voice hearing (promoting positive imagery de novo) in people with Auditory Hallucination and Hearing Voices When No One is Talking, run by Hella Janssen at 1 site in Netherlands.
Trial summary
This study explores the feasibility, acceptability, and effectiveness of four imagery intervention techniques (metacognitive imagery intervention, imagery rescripting, promoting positive imagery and competing imagery task) for auditory vocal hallucinations using four single case series with an A-B-A within subject… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Auditory Hallucination, Hearing Voices When No One is Talking, Psychosis
- What is being tested?
- Imagery intervention for voice hearing (meta-cognitive imagery rescripting), Imagery intervention for voice hearing (Imagery rescripting) and Imagery intervention for voice hearing (promoting positive imagery de novo)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Apr 2022to 10 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 16-65
- Experiencing subclinical or clinical psychotic auditory vocal hallucinations as confirmed by a clinician and as indicated by an intensity score of 4 or more on subscale 1.3 (perceptual abnormalities) of the Comprehensive Assessment of At Risk Mental States (CAARMS) or as indicated by a score of 3 or more on item P3 (hallucinatory behavior) of the Positive and Negative Syndrome Scale (PANSS).
- A Diagnostic and Statistical Manual-5 (DSM-5; American Psychiatric Association, 2013) diagnosis in the psychosis spectrum (codes: DSM-5 codes: 297.1; 298.8; 295.40; 295.90; 295.70; 298.8; 298.9) or defined as Ultra High Risk/At Risk Mental State (ARMS or UHR) according to the CAARMS estimated by a clinician.
- Willing to complete daily monitoring throughout the duration of the study.
- Willing to be assigned to a specific imagery intervention.
- Able to attend 3 consecutive weekly session of imagery intervention and during this period 3 online check-ups.
- Able and willing to sign informed consent
Who cannot join
- Any current or previous neurological disorder or organic brain disease.
- Acute confusional state or delirium not caused by the psychotic disorder.
- Unwillingness to participate
- Intelligence quotient (IQ) < 70 estimated by clinician.
- Current severe substance or alcohol misuse impacting treatment (clinicians assessment).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Geestelijke Gezondheidszorg Eindhoven (GGzE)
Eindhoven, North Brabant, 5626 NC
About this study
Official title: An Explorative Experimental Study to Assess the Feasibility, Acceptability and Effectiveness of Imagery Intervention Techniques in the Treatment of Auditory Vocal Hallucinations
This study explores the feasibility, acceptability, and effectiveness of four imagery intervention techniques (metacognitive imagery intervention, imagery rescripting, promoting positive imagery and competing imagery task) for auditory vocal hallucinations using four single case series with an A-B-A within subject design.
Read the detailed description
Auditory vocal hallucinations (AVHs) are the most common hallucinations of psychosis and do often occur in several other mental disorders. The effects of current standard psychological therapy (cognitive behavioural therapy; CBT) for auditory vocal hallucinations are limited. Thus, there is a need to improve cognitive behavioural therapy for auditory vocal hallucinations. As for many other mental disorders specific treatments have been improved using interventions targeting mental imagery, and recent studies pointed towards an association between psychotic symptoms and mental imagery, adding imagery intervention to CBT might aid this aim.
The main objective of this study is to assess the feasibility, acceptability, and effectiveness of four imagery intervention techniques (metacognitive imagery intervention, imagery rescripting, promoting positive imagery and competing imagery task) for auditory vocal hallucinations. The investigators are primarily interested in whether these imagery intervention techniques would be associated with a decrease in auditory vocal hallucinations and imagery symptoms. Also, the investigators are interested in whether these imagery intervention techniques would be a feasible and acceptable intervention for patients with a disorder in the transdiagnostic psychosis and suffering from auditory hallucinations. Secondly, the investigators aim to assess the effects on the level of delusions, visual hallucinations and social and occupational functioning. Lastly, the investigators aim to explore the working mechanisms of imagery, affective symptomatology, and auditory vocal hallucinations by three times daily measuring these symptoms for a period of seven weeks.
The investigators hypothesise that 1) all four imagery interventions are associated with a significant decrease in AVHs (e.g., a decline in the level of auditory vocal hallucinations) and imagery characteristics (e.g., decline in imagery frequency, imagery appraisals and imagery quality), whereas no serious adverse side-effects would occur, drop-out rates of therapy are low and patients will give a good qualitative review of therapy. 2) Psychotic symptoms decrease and social and occupational functioning increase after treatment. 3) The severity of emotional imagery is positively associated with the severity AVHs. In addition, the investigators hypothesize that this association may be different for different imagery aspects, with stronger associations between imagery appraisals (i.e., the encapsulated beliefs, and metacognitive beliefs) and the severity of AVHs as compared to other imagery aspects (frequency and quality aspects). And 4) The associations between imagery related factors and the severity of AVHs are mediated by the level of symptoms of anxiety and depression.
The primary outcome variables, the level of auditory vocal hallucinations and imagery characteristics, are calculated using daily measurements during a two-week baseline, during the intervention and after the end of intervention at follow-up at 7 weeks. Most secondary outcome variables are assessed using self-report measures before baseline, and at pre- and post-intervention.
- Being tested
- Imagery intervention for voice hearing (meta-cognitive imagery rescripting), Imagery intervention for voice hearing (Imagery rescripting), Imagery intervention for voice hearing (promoting positive imagery de novo), Imagery intervention for voice hearing (visuospatial working memory tasks)
- Keywords
- Mental imagery, Imagery Intervention techniques, Auditory vocal hallucinations, Hearing voices
- Medical subject headings
- Hallucinations, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagery intervention for voice hearing (meta-cognitive imagery rescripting)Behavioural
The participants receive intervention for a period of 3 weeks, 6 sessions of 60 minutes.
In-depth identification of images (2 sessions): Identifying imagery which is related to the auditory vocal hallucinations, constructing a micro-formulation with the participant along the lines of regular Cognitive Behavioural Therapy. In this micro-formulation, first triggers of problematic imagery are identified, both quality and appraisals of this image are identified. Subsequent maladaptive behaviour and possible links with earlier experiences are described, as well as maintaining factors.
Imagery intervention (2 sessions): The imagery intervention consists of meta-cognitive imagery rescripting.
Consolidation (2 sessions): Relapse prevention strategies are practiced before the end of intervention.
Imagery intervention for voice hearing (Imagery rescripting)Behavioural
The participants receive intervention for a period of 3 weeks, 6 sessions of 60 minutes.
In-depth identification of images (2 sessions): Identifying imagery which is related to the auditory vocal hallucinations, constructing a micro-formulation with the participant along the lines of regular Cognitive Behavioural Therapy. In this micro-formulation, first triggers of problematic imagery are identified, both quality and appraisals of this image are identified. Subsequent maladaptive behaviour and possible links with earlier experiences are described, as well as maintaining factors.
Imagery intervention (2 sessions): The imagery intervention consists of imagery rescripting.
Consolidation (2 sessions): Relapse prevention strategies are practiced before the end of intervention.
Imagery intervention for voice hearing (promoting positive imagery de novo)Behavioural
The participants receive intervention for a period of 3 weeks, 6 sessions of 60 minutes.
In-depth identification of images (2 sessions): Identifying imagery which is related to the auditory vocal hallucinations, constructing a micro-formulation with the participant along the lines of regular Cognitive Behavioural Therapy. In this micro-formulation, first triggers of problematic imagery are identified, both quality and appraisals of this image are identified. Subsequent maladaptive behaviour and possible links with earlier experiences are described, as well as maintaining factors.
Imagery intervention (2 sessions): The imagery intervention consists of promoting positive imagery de novo.
Consolidation (2 sessions): Relapse prevention strategies are practiced before the end of intervention.
Imagery intervention for voice hearing (visuospatial working memory tasks)Behavioural
The participants receive intervention for a period of 3 weeks, 6 sessions of 60 minutes.
In-depth identification of images (2 sessions): Identifying imagery which is related to the auditory vocal hallucinations, constructing a micro-formulation with the participant along the lines of regular Cognitive Behavioural Therapy. In this micro-formulation, first triggers of problematic imagery are identified, both quality and appraisals of this image are identified. Subsequent maladaptive behaviour and possible links with earlier experiences are described, as well as maintaining factors.
Imagery intervention (2 sessions): The imagery intervention consists of visuospatial working memory tasks.
Consolidation (2 sessions): Relapse prevention strategies are practiced before the end of intervention.
| Study group | Role | What they receive |
|---|---|---|
| Meta-cognitive imagery rescripting techniques (M-Int) | Other | These techniques are developed to reduce the power of an image by changing how the client responds to an image by shifting attention away from it, or by doing something that reinforces that it is just an image and not "real". Receives: Behavioral: Imagery intervention for voice hearing (meta-cognitive imagery rescripting) |
| Imagery rescripting techniques (ImRs) | Other | These techniques are developed to update imagery appraisals, by for example adding a helpful other to the image or by imagining the scene from another perspective. Receives: Behavioral: Imagery intervention for voice hearing (Imagery rescripting) |
| Promoting positive imagery de novo | Other | These involve creating a new stand-alone positive imagery to help a client to increase his ability to self-soothe and reduce fear. Receives: Behavioral: Imagery intervention for voice hearing (promoting positive imagery de novo) |
| Visuospatial working memory tasks | Other | These tasks are also known as imagery competing tasks (such as Tetris) and are used to directly target imagery using a tax visuospatial working memory task to reduce the frequency of intrusive imagery. Receives: Behavioral: Imagery intervention for voice hearing (visuospatial working memory tasks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline level of auditory vocal hallucinations to follow-up at two weeks after end of therapy.
Participants received a text message on their mobile phone with a link to a questionnaire. Participants were asked to fill out the questionnaire immediately after the alert, or, if impossible, the same day. All questions will be preceded with the following sentence: "since the last questionnaire….". The questions about auditory vocal hallucinations are adapted from the auditory vocal hallucination rating scale (AVHRS-Q)
Measured: Measured three times a day during two weeks of baseline, three weeks of intervention and two weeks of follow-up (an average of 7 weeks)
Change from baseline level of mental imagery characteristics (frequency of imagery, quality of imagery and appraisals of imagery) to follow-up at two weeks after end of therapy.
Participants received a text message on their mobile phone with a link to a questionnaire. Participants were asked to fill out the questionnaire immediately after the alert, or, if impossible, the same day. All questions will be preceded with the following sentence: "since the last questionnaire….". The questions about mental imagery are adapted from the the Dutch Imagery Survey (DimS)
Measured: Measured three times a day during two weeks of baseline, three weeks of intervention and two weeks of follow-up (an average of 7 weeks)
Treatment safety (change from baseline level of auditory verbal hallucinations to follow-up at the end of therapy).
The investigators consider treatment to be unsafe if the severity of AVHs of more than 50% of the patients is exacerbated. This will be determined on a case-by-case basis. Worsening of the severity of auditory vocal hallucinations is determined by an increase of 25% as measured with the self-report version of the auditory vocal hallucination rating scale (AVHRS-Q).
Measured: Administered before baseline period of two weeks, immediately after two weeks of baseline, weekly during the intervention of three weeks and immediately after the end of intervention of three weeks
Number of Participants with serious adverse events
The investigators report the total number of (serious) adverse events
Measured: Administered through study completion, an average of 7 weeks.
Drop-out rate (i.e., number of participants that drop out)
The investigators report drop-outs.
Measured: Administered through study completion, an average of 7 weeks.
Treatment quality
A retrospective self-report assessment is used to evaluate treatment quality. This assessment is based on the retrospective self-report assessment used in a study of one of the co-investigators to evaluate quality of imagery cognitive therapy for bipolar disorders. This is a 32-item self-report questionnaire. Answers are rated on a 5-point Likert scale (ranging from 1 to 5, higher scores indicates a better outcome).
Measured: Administered immediately after the end of intervention of three weeks
Secondary outcomes (4)
Change in level of social and occupational function from baseline to follow-up at the end of intervention.
measured with the Social and Occupational Functioning Scale (SOFAS). The SOFAS is used to assess overall functioning in a single score. This scale ranges from 0 to 100 (higher score indicates a better outcome), is a modified version of the Global Assessment of Functioning (GAF) scale, separating the measures of social and occupations function from the measure of symptoms, and psychological functioning.
Measured: Administered before baseline period of two weeks, immediately after two weeks of baseline, and immediately after the end of intervention of three weeks
The change from baseline (daily) level of delusional/paranoid ideas to follow-up at two weeks after end of therapy.
This is measured with a visual analogue scale (ranging from 0-100, lower score indicates a better outcome) three times a day with the diary item of delusions.
Measured: Measured three times a day during two weeks of baseline, three weeks of intervention and two weeks of follow-up (an average of 7 weeks)
Change from baseline (daily) level of visual hallucinations to follow-up at two weeks after end of therapy.
This is measured with a visual analogue scale (ranging from 0-100, lower score indicates a better outcome) three times a day with the diary item of visual hallucinations.
Measured: Measured three times a day during two weeks of baseline, three weeks of intervention and two weeks of follow-up (an average of 7 weeks)
Change from baseline imagery characteristics to follow-up at the end of therapy.
Measured with the Dutch Imagery Survey (DimS). The DimS starts with an elaborate definition of imagery. Thereafter, participants are asked to recall and describe an example of an image that is typical of the imagery they have experienced over the previous two weeks. Since studies on imagery and psychoses showed that patients with psychosis experience imagery in relation to their psychotic symptoms, the investigators ask participants to recall the imagery they have experienced in conjunction to their voices in the last two weeks. Participants are instructed to recall this image and keep this image in mind while answering the subsequent questions regarding imagery. All items of the DimS are rated on a 9-point Likert scale (ranging from 1-9). The internal consistency of all subscales of the DiMS are good (Cronbachs alpha ranging from 0.71 to 0.87), consistency over time is also good.
Measured: Administered before baseline period of two weeks, immediately after two weeks of baseline, and immediately after the end of intervention of three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start7 Apr 2022
- Primary completion10 Feb 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Auditory HallucinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four single case series A-B-A within subject designs
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hella Janssen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hella Janssen, Geestelijke Gezondheidszorg Eindhoven (GGzE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603260
- Sponsor's protocol ID
- NL79610.068.21
- Status last verified
- Feb 2024
- First submitted
- 17 Oct 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The raw data is generated at the research location and is not shared with other researchers working elsewhere. After publication of the results, only data without privacy sensitive information and without study specific codes (fully anonymous), that support the findings are available from GGzE upon reasonable request (both in and outside the European Union). Before sharing this anonymous data, GGzE carefully investigates this request in consideration of the Dutch AVG and UAVG (Dutch Act on Implementation of the General Data Protection Regulation).
Publications
Hales SA, Di Simplicio M, Iyadurai L, Blackwell SE, Young K, Fairburn CG, Geddes JR, Goodwin GM, Holmes EA. Imagery-Focused Cognitive Therapy (ImCT) for Mood Instability and Anxiety in a Small Sample of Patients with Bipolar Disorder: a Pilot Clinical Audit. Behav Cogn Psychother. 2018 Nov;46(6):706-725. doi: 10.1017/S1352465818000334. Epub 2018 Jul 9.
PubMed 29983124van den Berg KC, Hendrickson AT, Hales SA, Voncken M, Keijsers GPJ. Comparing the effectiveness of imagery focussed cognitive therapy to group psychoeducation for patients with bipolar disorder: A randomised trial. J Affect Disord. 2023 Jan 1;320:691-700. doi: 10.1016/j.jad.2022.09.160. Epub 2022 Oct 5.
PubMed 36206888Taylor CDJ, Bee PE, Kelly J, Emsley R, Haddock G. iMAgery focused psychological therapy for persecutory delusions in PSychosis (iMAPS): a multiple baseline experimental case series. Behav Cogn Psychother. 2020 Sep;48(5):530-545. doi: 10.1017/S1352465820000168. Epub 2020 Apr 8.
PubMed 32264985Ison R, Medoro L, Keen N, Kuipers E. The use of rescripting imagery for people with psychosis who hear voices. Behav Cogn Psychother. 2014 Mar;42(2):129-42. doi: 10.1017/S135246581300057X. Epub 2013 Aug 7.
PubMed 23920004Paulik G, Steel C, Arntz A. Imagery rescripting for the treatment of trauma in voice hearers: a case series. Behav Cogn Psychother. 2019 Nov;47(6):709-725. doi: 10.1017/S1352465819000237. Epub 2019 Apr 12.
PubMed 30975230van den Berg KC, Voncken M, Hendrickson AT, Houterman S, Keijsers GPJ. Image qualities and mood variability: Evaluating the utility of an imagery survey for bipolar disorder. J Affect Disord. 2020 Jul 1;272:77-83. doi: 10.1016/j.jad.2020.03.098. Epub 2020 Apr 29.
PubMed 32379623
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative Experimental Study to Assess the Feasibility, Acceptability and Effectiveness of Imagery Intervention Techniques in the Treatment of Auditory Vocal Hallucinations
- ClinicalTrials.gov ID
- NCT05603260
- Acronym / sponsor ID
- NL79610.068.21
- Keywords
- Mental imagery, Imagery Intervention techniques, Auditory vocal hallucinations, Hearing voices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hella JanssenUniversity, hospital or other
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores the feasibility, acceptability, and effectiveness of four imagery intervention techniques (metacognitive imagery intervention, imagery rescripting, promoting positive imagery and competing imagery task) for auditory vocal hallucinations using four single case series with an A-B-A within subject design.
Detailed description
Auditory vocal hallucinations (AVHs) are the most common hallucinations of psychosis and do often occur in several other mental disorders. The effects of current standard psychological therapy (cognitive behavioural therapy; CBT) for auditory vocal hallucinations are limited. Thus, there is a need to improve cognitive behavioural therapy for auditory vocal hallucinations. As for many other mental disorders specific treatments have been improved using interventions targeting mental imagery, and recent studies pointed towards an association between psychotic symptoms and mental imagery, adding imagery intervention to CBT might aid this aim.
The main objective of this study is to assess the feasibility, acceptability, and effectiveness of four imagery intervention techniques (metacognitive imagery intervention, imagery rescripting, promoting positive imagery and competing imagery task) for auditory vocal hallucinations. The investigators are primarily interested in whether these imagery intervention techniques would be associated with a decrease in auditory vocal hallucinations and imagery symptoms. Also, the investigators are interested in whether these imagery intervention techniques would be a feasible and acceptable intervention for patients with a disorder in the transdiagnostic psychosis and suffering from auditory hallucinations. Secondly, the investigators aim to assess the effects on the level of delusions, visual hallucinations and social and occupational functioning. Lastly, the investigators aim to explore the working mechanisms of imagery, affective symptomatology, and auditory vocal hallucinations by three times daily measuring these symptoms for a period of seven weeks.
The investigators hypothesise that 1) all four imagery interventions are associated with a significant decrease in AVHs (e.g., a decline in the level of auditory vocal hallucinations) and imagery characteristics (e.g., decline in imagery frequency, imagery appraisals and imagery quality), whereas no serious adverse side-effects would occur, drop-out rates of therapy are low and patients will give a good qualitative review of therapy. 2) Psychotic symptoms decrease and social and occupational functioning increase after treatment. 3) The severity of emotional imagery is positively associated with the severity AVHs. In addition, the investigators hypothesize that this association may be different for different imagery aspects, with stronger associations between imagery appraisals (i.e., the encapsulated beliefs, and metacognitive beliefs) and the severity of AVHs as compared to other imagery aspects (frequency and quality aspects). And 4) The associations between imagery related factors and the severity of AVHs are mediated by the level of symptoms of anxiety and depression.
The primary outcome variables, the level of auditory vocal hallucinations and imagery characteristics, are calculated using daily measurements during a two-week baseline, during the intervention and after the end of intervention at follow-up at 7 weeks. Most secondary outcome variables are assessed using self-report measures before baseline, and at pre- and post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Four single case series A-B-A within subject designs
| Arm | Type | Receives |
|---|---|---|
| Meta-cognitive imagery rescripting techniques (M-Int) | Other | Behavioral: Imagery intervention for voice hearing (meta-cognitive imagery rescripting)These techniques are developed to reduce the power of an image by changing how the client responds to an image by shifting attention away from it, or by doing something that reinforces that it is just an image and not "real". |
| Imagery rescripting techniques (ImRs) | Other | Behavioral: Imagery intervention for voice hearing (Imagery rescripting)These techniques are developed to update imagery appraisals, by for example adding a helpful other to the image or by imagining the scene from another perspective. |
| Promoting positive imagery de novo | Other | Behavioral: Imagery intervention for voice hearing (promoting positive imagery de novo)These involve creating a new stand-alone positive imagery to help a client to increase his ability to self-soothe and reduce fear. |
| Visuospatial working memory tasks | Other | Behavioral: Imagery intervention for voice hearing (visuospatial working memory tasks)These tasks are also known as imagery competing tasks (such as Tetris) and are used to directly target imagery using a tax visuospatial working memory task to reduce the frequency of intrusive imagery. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age 16-65
- Experiencing subclinical or clinical psychotic auditory vocal hallucinations as confirmed by a clinician and as indicated by an intensity score of 4 or more on subscale 1.3 (perceptual abnormalities) of the Comprehensive Assessment of At Risk Mental States (CAARMS) or as indicated by a score of 3 or more on item P3 (hallucinatory behavior) of the Positive and Negative Syndrome Scale (PANSS).
- A Diagnostic and Statistical Manual-5 (DSM-5; American Psychiatric Association, 2013) diagnosis in the psychosis spectrum (codes: DSM-5 codes: 297.1; 298.8; 295.40; 295.90; 295.70; 298.8; 298.9) or defined as Ultra High Risk/At Risk Mental State (ARMS or UHR) according to the CAARMS estimated by a clinician.
- Willing to complete daily monitoring throughout the duration of the study.
- Willing to be assigned to a specific imagery intervention.
Key exclusion criteria (5 listed)
- Any current or previous neurological disorder or organic brain disease.
- Acute confusional state or delirium not caused by the psychotic disorder.
- Unwillingness to participate
- Intelligence quotient (IQ) < 70 estimated by clinician.
- Current severe substance or alcohol misuse impacting treatment (clinicians assessment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imagery intervention for voice hearing (meta-cognitive imagery rescripting)The participants receive intervention for a period of 3 weeks, 6 sessions of 60 minutes. In-depth identification of images (2 sessions): Identifying imagery which is related to the auditory vocal hallucinations, constructing a micro-formulation with the participant along the lines of regular Cognitive Behavioural Therapy. In this micro-formulation, first triggers of problematic imagery are identified, both quality and appraisals of this image are identified. Subsequent maladaptive behaviour and possible links with earlier experiences are described, as well as maintaining factors. Imagery intervention (2 sessions): The imagery intervention consists of meta-cognitive imagery rescripting. Consolidation (2 sessions): Relapse prevention strategies are practiced before the end of intervention. | Behavioural | Meta-cognitive imagery rescripting techniques (M-Int) |
| Imagery intervention for voice hearing (Imagery rescripting)The participants receive intervention for a period of 3 weeks, 6 sessions of 60 minutes. In-depth identification of images (2 sessions): Identifying imagery which is related to the auditory vocal hallucinations, constructing a micro-formulation with the participant along the lines of regular Cognitive Behavioural Therapy. In this micro-formulation, first triggers of problematic imagery are identified, both quality and appraisals of this image are identified. Subsequent maladaptive behaviour and possible links with earlier experiences are described, as well as maintaining factors. Imagery intervention (2 sessions): The imagery intervention consists of imagery rescripting. Consolidation (2 sessions): Relapse prevention strategies are practiced before the end of intervention. | Behavioural | Imagery rescripting techniques (ImRs) |
| Imagery intervention for voice hearing (promoting positive imagery de novo)The participants receive intervention for a period of 3 weeks, 6 sessions of 60 minutes. In-depth identification of images (2 sessions): Identifying imagery which is related to the auditory vocal hallucinations, constructing a micro-formulation with the participant along the lines of regular Cognitive Behavioural Therapy. In this micro-formulation, first triggers of problematic imagery are identified, both quality and appraisals of this image are identified. Subsequent maladaptive behaviour and possible links with earlier experiences are described, as well as maintaining factors. Imagery intervention (2 sessions): The imagery intervention consists of promoting positive imagery de novo. Consolidation (2 sessions): Relapse prevention strategies are practiced before the end of intervention. | Behavioural | Promoting positive imagery de novo |
| Imagery intervention for voice hearing (visuospatial working memory tasks)The participants receive intervention for a period of 3 weeks, 6 sessions of 60 minutes. In-depth identification of images (2 sessions): Identifying imagery which is related to the auditory vocal hallucinations, constructing a micro-formulation with the participant along the lines of regular Cognitive Behavioural Therapy. In this micro-formulation, first triggers of problematic imagery are identified, both quality and appraisals of this image are identified. Subsequent maladaptive behaviour and possible links with earlier experiences are described, as well as maintaining factors. Imagery intervention (2 sessions): The imagery intervention consists of visuospatial working memory tasks. Consolidation (2 sessions): Relapse prevention strategies are practiced before the end of intervention. | Behavioural | Visuospatial working memory tasks |
Primary outcome
Change from baseline level of auditory vocal hallucinations to follow-up at two weeks after end of therapy.
Time frame: Measured three times a day during two weeks of baseline, three weeks of intervention and two weeks of follow-up (an average of 7 weeks)
Participants received a text message on their mobile phone with a link to a questionnaire. Participants were asked to fill out the questionnaire immediately after the alert, or, if impossible, the same day. All questions will be preceded with the following sentence: "since the last questionnaire….". The questions about auditory vocal hallucinations are adapted from the auditory vocal hallucination rating scale (AVHRS-Q)
Change from baseline level of mental imagery characteristics (frequency of imagery, quality of imagery and appraisals of imagery) to follow-up at two weeks after end of therapy.
Time frame: Measured three times a day during two weeks of baseline, three weeks of intervention and two weeks of follow-up (an average of 7 weeks)
Participants received a text message on their mobile phone with a link to a questionnaire. Participants were asked to fill out the questionnaire immediately after the alert, or, if impossible, the same day. All questions will be preceded with the following sentence: "since the last questionnaire….". The questions about mental imagery are adapted from the the Dutch Imagery Survey (DimS)
Treatment safety (change from baseline level of auditory verbal hallucinations to follow-up at the end of therapy).
Time frame: Administered before baseline period of two weeks, immediately after two weeks of baseline, weekly during the intervention of three weeks and immediately after the end of intervention of three weeks
The investigators consider treatment to be unsafe if the severity of AVHs of more than 50% of the patients is exacerbated. This will be determined on a case-by-case basis. Worsening of the severity of auditory vocal hallucinations is determined by an increase of 25% as measured with the self-report version of the auditory vocal hallucination rating scale (AVHRS-Q).
Number of Participants with serious adverse events
Time frame: Administered through study completion, an average of 7 weeks.
The investigators report the total number of (serious) adverse events
Drop-out rate (i.e., number of participants that drop out)
Time frame: Administered through study completion, an average of 7 weeks.
The investigators report drop-outs.
Treatment quality
Time frame: Administered immediately after the end of intervention of three weeks
A retrospective self-report assessment is used to evaluate treatment quality. This assessment is based on the retrospective self-report assessment used in a study of one of the co-investigators to evaluate quality of imagery cognitive therapy for bipolar disorders. This is a 32-item self-report questionnaire. Answers are rated on a 5-point Likert scale (ranging from 1 to 5, higher scores indicates a better outcome).
4 secondary outcomes
Change in level of social and occupational function from baseline to follow-up at the end of intervention.
Time frame: Administered before baseline period of two weeks, immediately after two weeks of baseline, and immediately after the end of intervention of three weeks
The change from baseline (daily) level of delusional/paranoid ideas to follow-up at two weeks after end of therapy.
Time frame: Measured three times a day during two weeks of baseline, three weeks of intervention and two weeks of follow-up (an average of 7 weeks)
Change from baseline (daily) level of visual hallucinations to follow-up at two weeks after end of therapy.
Time frame: Measured three times a day during two weeks of baseline, three weeks of intervention and two weeks of follow-up (an average of 7 weeks)
Change from baseline imagery characteristics to follow-up at the end of therapy.
Time frame: Administered before baseline period of two weeks, immediately after two weeks of baseline, and immediately after the end of intervention of three weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 29983124Hales SA, Di Simplicio M, Iyadurai L, Blackwell SE, Young K, Fairburn CG, Geddes JR, Goodwin GM, Holmes EA. Imagery-Focused Cognitive Therapy (ImCT) for Mood Instability and Anxiety in a Small Sample of Patients with Bipolar Disorder: a Pilot Clinical Audit. Behav Cogn Psychother. 2018 Nov;46(6):706-725. doi: 10.1017/S1352465818000334. Epub 2018 Jul 9.
- Background: PubMed 36206888van den Berg KC, Hendrickson AT, Hales SA, Voncken M, Keijsers GPJ. Comparing the effectiveness of imagery focussed cognitive therapy to group psychoeducation for patients with bipolar disorder: A randomised trial. J Affect Disord. 2023 Jan 1;320:691-700. doi: 10.1016/j.jad.2022.09.160. Epub 2022 Oct 5.
- Background: PubMed 32264985Taylor CDJ, Bee PE, Kelly J, Emsley R, Haddock G. iMAgery focused psychological therapy for persecutory delusions in PSychosis (iMAPS): a multiple baseline experimental case series. Behav Cogn Psychother. 2020 Sep;48(5):530-545. doi: 10.1017/S1352465820000168. Epub 2020 Apr 8.
- Background: PubMed 23920004Ison R, Medoro L, Keen N, Kuipers E. The use of rescripting imagery for people with psychosis who hear voices. Behav Cogn Psychother. 2014 Mar;42(2):129-42. doi: 10.1017/S135246581300057X. Epub 2013 Aug 7.
- Background: PubMed 30975230Paulik G, Steel C, Arntz A. Imagery rescripting for the treatment of trauma in voice hearers: a case series. Behav Cogn Psychother. 2019 Nov;47(6):709-725. doi: 10.1017/S1352465819000237. Epub 2019 Apr 12.
- Background: PubMed 32379623van den Berg KC, Voncken M, Hendrickson AT, Houterman S, Keijsers GPJ. Image qualities and mood variability: Evaluating the utility of an imagery survey for bipolar disorder. J Affect Disord. 2020 Jul 1;272:77-83. doi: 10.1016/j.jad.2020.03.098. Epub 2020 Apr 29.
- Individual participant dataSharing planned: Undecided. The raw data is generated at the research location and is not shared with other researchers working elsewhere. After publication of the results, only data without privacy sensitive information and without study specific codes (fully anonymous), that support the findings are available from GGzE upon reasonable request (both in and outside the European Union). Before sharing this anonymous data, GGzE carefully investigates this request in consideration of the Dutch AVG and UAVG (Dutch Act on Implementation of the General Data Protection Regulation).
Related trials for Auditory Hallucination
Recruiting
Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations
Auditory Verbal Hallucinations, Schizophrenia
Not yet recruiting
DecNef for Auditory Verbal Hallucinations (AVH) in Schizophrenia
Schizophrenia Disorder, Schizoaffecitve Disorder
Recruiting
Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations
Schizophrenia, Auditory Verbal Hallucinations
Recruiting
fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations
Schizophrenia, Hallucinations, Auditory
Recruiting
Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation
Treatment Resistant Schizophrenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imagery intervention for voice hearing (meta-cognitive imagery rescripting), Imagery intervention for voice hearing (Imagery rescripting) and Imagery intervention for voice hearing (promoting positive imagery de novo) in people with Auditory Hallucination and Hearing Voices When No One is Talking, run by Hella Janssen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline level of auditory vocal hallucinations to follow-up at two weeks after end of therapy. (time frame: Measured three times a day during two weeks of baseline, three weeks of intervention and two weeks of follow-up (an average of 7 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05603260, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.