In the last ten years there has been a lot of research to understand persecutory delusions, but these findings had not yet been translated into treatment until Freeman and colleagues (2011). They targeted worry, but showed that rumination has to be…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary measurements will be the scales taken from the Green Paranoid Thought
Scale (GPTS) that assesses delusion, and the Psychotic Symptoms Rating Scale -
Delusions (PSYRATS-DRS), rumination, assessed with the Ruminative Response
Scale (RRS) and worry, assessed with the Penn State Worry Questionnaire (PSWQ).
Secondary outcome
Secondary measurements will be anxiety, assessed with the Beck Anxiety
Inventory (BAI) and depression, assessed with the Beck Inventory of Depression
- II (BDI2). In addition feasibility will be evaluated by interviewing patients
on their opinion about the treatment and its effects. Also the participating
therapists will be interviewed on their opinion about the feasibility and
effectiveness of the treatment and on their collaboration. If a patient drops
out of treatment, the reason for drop-out will be assessed by contacting the
patient and the therapist.
Background summary
Previous research found that worry is a factor that plays an important role in
generating persecutory delusions. The tendency to worry is found to be a
predictor of the prevelance of paranoid thinking, the severity of worry
predicts persistence of persecutory delusions and worry makes delusional ideas
more distressing. Foster and colleagues (2010) randomly assigned patients with
persecutory delusions to a four session worry reduction intervention or
treatment as usual. They found that reducing levels of worry leads to the
decrease of persecutory delusions. This research also suggests that rumination
may be a significant feature of the cognitive style of patients with paranoia.
One research that explored the association between paranoia and rumination is a
study done by Martinelli, Cavanagh and Dudley in 2013. They found that
rumination was associated with maintained levels of paranoia and suggested that
rumination could be considered as a potential pathway to the persistence of
delusional distress and paranoid beliefs. Based on these findings and the
notion that little research had explored the role of rumination in paranoid
beliefs, we intend to study the effect of a new treatment which targets both
worry and rumination, the competitive memory training for worry and rumination
or COMET-wr
Study objective
In the last ten years there has been a lot of research to understand
persecutory delusions, but these findings had not yet been translated into
treatment until Freeman and colleagues (2011). They targeted worry, but showed
that rumination has to be targeted too. It had been proposed that patients with
paranoia ruminate on their negative interpersonal experiences. This leads to
increased feelings of vulnerability. Because of this, patients will develop a
certain attention bias toward negative experiences, which leads to greater
awareness of negative information. This enhances the sense of being victimized
and increases feelings of anxiety. These increased feelings of anxiety leads in
turn to reinforced paranoid beliefs. This vicious cycle can be disengaged by
using adaptive coping strategies and that is what the COMET-wr targets.
COMET-wr was originally developed by Ekkers, Korrelboom & van der Gaag to
reduce rumination in depressed patients. The aim of this study is to examine in
a small pilot study whether the COMET-wr intervention has potential to be
effective at reducing levels of worry and rumination and therefore reducing
delusional distress in patients with paranoid delusions.
Study design
This research is a pilot study with an ABA-design as used in Hepworth et al.
(2011). Patients will be assessed three times during the research: before the
intervention, after the intervention and after one month follow-up. The
COMET-wr will be an add-on, patients receive their treatment as usual and an
extra intervention. There will be no control group and thus no randomnisation.
Intervention
COMET is a cognitive treatment for rumination in depressed patients, developed
by Ekkers and collegues (2011). The COMET protocol encompasses six steps or
stages: (1) Motivation enhancing, (2) treatment rationale, (3) awereness of
their paranoia, (4) indentify ealier successes in letting go, (5) strengthening
successes by imagining and (6) apply in real life. The ability to let go,
during step two, can be done following two strategies: a) acceptence or b)
being indifferent. One or both strategies can be learned and will be practiced.
A COMET session takes 7 sessions of 45 minutes, homework assignments not
included.
Study burden and risks
This study does not acknowledge any risks.
The burden for each patiënt is estimated to be 550 minutes. This includes the
weekly sessions and three assessments but it does not include the homework
assignments. We expect patients will be engaged with these homework assignments
for approximately 15 minutes a day.
Leggelostraat 85
Den Haag 2541 HR
NL
Leggelostraat 85
Den Haag 2541 HR
NL
Listed location countries
Age
Inclusion criteria
Age above 18, primary diagnosis of schizophrenia, schizoaffective disorder, or delusional disorder, all with current experience of persecutory delusions or paranoid thinking based on the criteria from the Diagnostic and Statistical Manual of Mental Disorders IV. Text Revision (DSM-IV-TR) and verified with the Mini International Neuropsychiatric Interview Plus (MINI-plus), a score above 50 on the persecutory item from the Green Paranoid Thought Scales (GPTS) and one question from the Positive and Negative Syndrome Scale (PANSS) regarding delusion which has to have a score between four and eight.
Exclusion criteria
Insufficient knowledge of the Dutch language, cognitive impairment with a cut-off score of < 24 on the Mini Mental State Examination (MMSE) (only assessed in patients 55 years and older), acute suicidal behavior, current involvement in any other cognitive behavior therapy and comorbid diagnosis of severe drug or alcohol dependence that requires primary treatment.
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 |
---|---|
CCMO | NL49626.058.14 |