Clinical trial NCT05603260: Imagery Interventions for Auditory Vocal Hallucinations
Official title: An Explorative Experimental Study to Assess the Feasibility, Acceptability and Effectiveness of Imagery Intervention Techniques in the Treatment of Auditory Vocal Hallucinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Auditory Hallucination
Hearing Voices When No One is Talking
Psychosis
Keywords: Mental imagery
Imagery Intervention techniques
Auditory vocal hallucinations
Hearing voices
Lead sponsor: Geestelijke Gezondheidszorg Eindhoven (GGzE)
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 32
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four single case series A-B-A within subject designs
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline level of auditory vocal hallucinations to follow-up at two weeks after end of therapy.
timeFrame: 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)
measure: 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.
timeFrame: 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)
measure: Treatment safety (change from baseline level of auditory verbal hallucinations to follow-up at the end of therapy).
timeFrame: 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
measure: Number of Participants with serious adverse events
timeFrame: Administered through study completion, an average of 7 weeks.
measure: Drop-out rate (i.e., number of participants that drop out)
timeFrame: Administered through study completion, an average of 7 weeks.
measure: Treatment quality
timeFrame: Administered immediately after the end of intervention of three weeks
Secondary outcomes:
measure: Change in level of social and occupational function from baseline to follow-up at the end of intervention.
timeFrame: Administered before baseline period of two weeks, immediately after two weeks of baseline, and immediately after the end of intervention of three weeks
measure: The change from baseline (daily) level of delusional/paranoid ideas to follow-up at two weeks after end of therapy.
timeFrame: 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)
measure: Change from baseline (daily) level of visual hallucinations to follow-up at two weeks after end of therapy.
timeFrame: 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)
measure: Change from baseline imagery characteristics to follow-up at the end of therapy.
timeFrame: 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:
measure: Mediation variable: Change from baseline level of anxiety to follow-up at two weeks after end of therapy.
timeFrame: 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)
measure: Mediation variable: Change from baseline level of depression to follow-up at two weeks after end of therapy.
timeFrame: 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)
measure: Mediation variable: Change from baseline level of anxiety to follow-up at the end of intervention.
timeFrame: Administered before baseline period of two weeks, immediately after two weeks of baseline, and immediately after the end of intervention of three weeks
measure: Mediation variable: Change from baseline level of depression to follow-up at the end of intervention.
timeFrame: Administered before baseline period of two weeks, immediately after two weeks of baseline, and immediately after the end of intervention of three weeks
Locations:
city: Eindhoven
country: Netherlands
facility: Geestelijke Gezondheidszorg Eindhoven (GGzE)
state: Noord-Brabant
Study officials:
References:
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citation: 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.