An Explorative Experimental Study to Assess the Feasibility, Acceptability and Effectiveness of Imagery Intervention Techniques in the Treatment of Auditory Vocal Hallucinations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Drop-out rate (i.e., number of participants that drop out)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Meta-cognitive imagery rescripting techniques (M-Int)
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".
干预措施: Imagery intervention for voice hearing (meta-cognitive imagery rescripting) (Behavioral)
Imagery rescripting techniques (ImRs)
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.
干预措施: Imagery intervention for voice hearing (Imagery rescripting) (Behavioral)
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.
干预措施: Imagery intervention for voice hearing (promoting positive imagery de novo) (Behavioral)
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.
干预措施: Imagery intervention for voice hearing (visuospatial working memory tasks) (Behavioral)
结局指标
主要结局
Drop-out rate (i.e., number of participants that drop out)
时间窗: Administered through study completion, an average of 7 weeks.
The investigators report drop-outs.
Treatment quality
时间窗: 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).
Number of Participants with serious adverse events
时间窗: Administered through study completion, an average of 7 weeks.
The investigators report the total number of (serious) adverse events
Treatment safety (change from baseline level of auditory verbal hallucinations to follow-up at the end of therapy).
时间窗: 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).
Change from baseline level of auditory vocal hallucinations to follow-up at two weeks after end of therapy.
时间窗: 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.
时间窗: 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)
次要结局
- 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 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)
- 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)
- 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))
研究者
Hella Janssen
coordinating investigator
Geestelijke Gezondheidszorg Eindhoven (GGzE)