The main objective of this study is to assess the feasibility, acceptability, and effectiveness of four imagery intervention techniques adapted from the protocol of Holmes (2019) for auditory vocal hallucinations. We are primarily interested in…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome variables are the level of auditory vocal hallucinations,
imagery characteristics (imagery frequency, imagery appraisals and imagery
quality) measured three times a day using a diary method, and feasibility and
acceptability measures (adverse (side) effects, drop-out rates and qualitative
review of therapy).
Secondary outcome
The secondary outcomes are the level delusions, visual hallucinations and
social and occupational functioning measured three times a day using a diary
method.
Background summary
Auditory vocal hallucinations are the most common hallucinations of psychosis
(American Psychiatric Association, 2013; Sommer et al., 2012) and do also often
occur in in patients with various other psychiatric disorders, such as
Post-Traumatic Stress Disorder (PTSD), anxiety disorders, mood disorders,
eating disorders or personality disorders (Laroi et al., 2012; van Os &
Reininghaus, 2016; Waters et al., 2018). It remains open to debate whether
theories about auditory vocal hallucinations are sufficient enough to explain
the full spectrum of psychosis, since effects of both pharmacological
(Carpenter & Davis, 2012) and psychological (Janssen et al., 2021; van der
Gaag et al., 2014; Wykes et al., 2008) therapies for auditory vocal
hallucinations are in the small to modest range. The missing link and a
potential target for treatment might be the transdiagnostic phenomenon mental
imagery, as as few studies showed that patients with psychosis experience
intrusive images associated with their psychotic symptoms (Morrison et al.,
2002; Schulze et al., 2013). In addition, psychological interventions targeting
mental imagery in several other mental disorders with overlapping features with
psychosis has yielded promising results (Ehlers et al., 2005; Hales et al.,
2018; Holmes et al., 2016; Wild & Clark, 2011). Also, few experimental
studies investigating the effects of a few imagery interventions in addition to
cognitive behavioral therapy (CBT) for patients with psychosis showed promising
results (Ison et al., 2014; Morrison, 2004; Serruya & Grant, 2009).
However, the working mechanism behind these interventions is not fully
understood. Moreover, there is no specific imagery enhanced CBT protocol for
working with auditory vocal hallucinations. Indeed, it is not known which
imagery intervention techniques are feasible for patients with hallucinations.
The aim of the current study is to assess the acceptability and feasibility of
four imagery interventions for auditory vocal hallucinations and to assess
effects of these interventions on the level of auditory vocal hallucinations
and mental imagery.
Study objective
The main objective of this study is to assess the feasibility, acceptability,
and effectiveness of four imagery intervention techniques adapted from the
protocol of Holmes (2019) for auditory vocal hallucinations. We are primarily
interested in whether these imagery intervention techniques would be associated
with a decrease in auditory vocal hallucinations and imagery symptoms. Also, we
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 vocal hallucinations.
Secondly, we aim to assess the effects on the level of delusions, visual
hallucinations and social and occupational functioning. Lastly, we 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.
Study design
The present research proposal concerns four single case series A-B-A within
subject designs. Assessments consists of clinical questionnaires and three-time
daily questions about hallucinations (both auditory and visual), delusions,
imagery and affective symptoms (anxiety and depression).
Intervention
This protocol consists of four different studies assessing four imagery
intervention techniques (metacognitive imagery intervention, imagery
rescripting, promoting positive imagery and competing imagery task).
Study burden and risks
Risks for patients participating in this study are minimal. Similar
interventions have been successfully tested in feasibility trials for patients
with psychosis suffering from delusions and auditory vocal hallucinations. The
results of these studies suggests that these interventions are well tolerated
and received by patients. All patients, during the baseline period, during the
treatment phase and during follow-up, have regular appointments with their
psychiatrists or general nurse practitioner to monitor medication use, mental
and daily functioning. Also, risks for patients with suicidal related auditory
vocal hallucinations are minimal since the urge to act on suicidal thought or
imperative auditory vocal hallucinations does not increase after talking about
these thoughts. On the contrary, it seems to have a protective effect (Dazzi et
al., 2014). This is the same for the use of imagery interventions in the
treatment of suicidal ideations (Rahnama et al., 2013). Psychological therapy
for psychosis belongs to standard care. The extra burden for participants is
the daily self-monitoring, that requires participants to complete a
questionnaire (5-10 min) at three at equidistant time points with a 4-hour
interval in between for 49 consecutive days, the first assessment in which
participants sign the informed consent and a researcher administer a clinical
interview (+/- 60 minutes) and the self-report questionnaires at T0-T1-T2
(25-35 minutes).
Dr. Poletlaan 39
Eindhoven 5626 NC
NL
Dr. Poletlaan 39
Eindhoven 5626 NC
NL
Listed location countries
Age
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; Yung et al., 2005)
or as indicated by a score of 3 or more on item P3 (hallucinatory behavior) of
the Positive and Negative Syndrome Scale (PANSS; Kay, Fiszbein, & Opler,
1987). • A DSM-5 (APA, 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.
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 • IQ < 70 estimated by clinician. • Current
severe substance or alcohol misuse impacting treatment (clinicians assessment).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
Other | ClinicalTrials.gov not finalised yet |
CCMO | NL79610.068.21 |