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Completed

NCT Number: NCT05603260

Imagery Interventions for 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.

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Key information

Conditions

Auditory Hallucination Hallucinations Hearing Voices When No One is Talking Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Psychosis Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geestelijke Gezondheidszorg Eindhoven (GGzE)

Eindhoven, North Brabant, 5626 NC, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

Imagery intervention for voice hearing (meta-cognitive imagery rescripting)

Behavioral

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)

Behavioral

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)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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).

  4. 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

  5. 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.

  6. 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).

Secondary outcomes

  1. 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

    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.

  2. 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)

    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.

  3. 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)

    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.

  4. 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

    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.

Other outcomes

  1. Mediation variable: Change from baseline level of anxiety 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)

    Measured daily with a visual analogue scale (ranging from 0-100, lower score indicates a better outcome) three times a day with the diary item of anxiety.

  2. Mediation variable: Change from baseline level of depression 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)

    Measured daily with a visual analogue scale (ranging from 0-100, lower score indicates a better outcome) three times a day with the diary item of depression.

  3. Mediation variable: Change from baseline level of anxiety 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

    Measured with Beck Anxiety Inventory (BAI). The BAI is a 21-item self-report questionnaire with good psychometric properties used for measuring the severity of anxiety. Answers are rated on a 4-point Likert scale.

  4. Mediation variable: Change from baseline level of depression 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

    Measured with the Beck Depression Inventory-II (BDI-II). The BDI-II is widely used self-report questionnaire to assess symptoms of depression and the level of depression. The BDI-II consists of 21 items. Good reliability and validity of the BDI-II have been supported by different studies.

Sponsors and collaborators

Lead sponsor

Hella Janssen

Other

Registry information

Official study title

An Explorative Experimental Study to Assess the Feasibility, Acceptability and Effectiveness of Imagery Intervention Techniques in the Treatment of Auditory Vocal Hallucinations

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 2, 2022
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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