Imagery Interventions for Auditory Vocal Hallucinations

NCT05603260 | Completed DMC

• 1 other identifier: NL79610.068.21
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 design.

Conditions

Auditory Hallucination; Hearing Voices When No One is Talking; Psychosis

Keywords

Mental imagery; Imagery Intervention techniques; Auditory vocal hallucinations; Hearing voices

Outcome Measures

Primary Outcomes (6)

• 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 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 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).

  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

  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.

  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).

  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.

  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.

  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.

  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.

  Administered before baseline period of two weeks, immediately after two weeks of baseline, and immediately after the end of intervention of three weeks

Other Outcomes (4)

• Mediation variable: Change from baseline level of anxiety to follow-up at two weeks after end of therapy.

  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)

• Mediation variable: Change from baseline level of depression to follow-up at two weeks after end of therapy.

  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)

• Mediation variable: Change from baseline level of anxiety to follow-up at the end of intervention.

  Administered before baseline period of two weeks, immediately after two weeks of baseline, and immediately after the end of intervention of three weeks

Study Arms (4)

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".

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.

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.

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.

Behavioral: Imagery intervention for voice hearing (visuospatial working memory tasks)

Interventions

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.

Meta-cognitive imagery rescripting techniques (M-Int)

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 rescripting techniques (ImRs)

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.

Promoting positive imagery de novo

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.

Visuospatial working memory tasks

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hella Janssen: lead

Study Sites (1)

Geestelijke Gezondheidszorg Eindhoven (GGzE)

Eindhoven, North Brabant, 5626 NC, Netherlands

Location

Related Publications (6)

• 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.

  PMID: 29983124 BACKGROUND

• van 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.

  PMID: 36206888 BACKGROUND

• Taylor 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.

  PMID: 32264985 BACKGROUND

• Ison 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.

  PMID: 23920004 BACKGROUND

• Paulik 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.

  PMID: 30975230 BACKGROUND

• van 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.

  PMID: 32379623 BACKGROUND

MeSH Terms

Conditions

Hallucinations; Psychotic Disorders

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: coordinating investigator

Model Details: Four single case series A-B-A within subject designs

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: November 2, 2022
• Study Start: April 7, 2022
• Primary Completion: February 10, 2024
• Study Completion: February 10, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

NL (1)