generalised anxiety disorder psychosis schizophrenia-spectrum disorder worrying
Conditions
Interventions
After informed consent, patients are offered fourteen weekly MCT sessions for
GAD, cf. Van der Heiden's protocol (2017). This treatment takes place alongside
the regular treatment for psychotic comp
Sponsors
Parnassia Bavo Groep (Den Haag)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18-65; 2. primary diagnosis of schizophrenia-spectrum disorder according to DSM-5 3. A score of 10 or higher on the GAD-7, a diagnostic screening list for GAD 4. A clinically significant degree of worrying, shown by a high score (* 49) on the Penn State Worry Questionnaire 5. In case of intended radical changes in the field of pharmacotherapy, patients can only enter the study if the dose is stable for at least one month.
Exclusion criteria
Exclusion criteria: Patients are excluded when: 1. they are unable or seem unable to give informed consent; 2. they don't sufficiently master the dutch language to undergo treatment without an interpreter 3. there is alcohol or drug abuse that interferes with treatment 4. they have an IQ of 70 or below 5. they have an organic disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the Penn State Worry Questionnaire (PSWQ), a reliable and valid self-report questionnaire to chart persistent, excessive and uncontrollable worry. The list consists of 16 items that are scored on a five-point Likert scale. The total score can vary from 16 to 80. This questionnaire is administered at all measuring moments. At group level, it is verified by means of paired t-tests whether worrying is stable during the baseline period (measurement 1 and measurement 3). Effects of MCT on worry, delusions and metacognitions are also examined by means of paired t-tests (measurement 3 and measurement 4). In order to check whether the effects found are maintained afterwards, paired t-tests are also performed (measurement 4 and measurement 5). The size of the effects (effect sizes) is calculated using Cohen's d (M1 - M2 / pooled SD, Cohen, 1992). All statistical analyzes will be performed using SPSS, version 23. At the individual level, two widely used methods are used in case series research, the evaluation of the graphical representation of changes in symptoms over time (Parsonson & Baer, **1992), and the more conservative method of mapping the clinical significance. for the primary outcome measure, the PSWQ, using the procedures described by Jacobson and Truax (1991). According to this method, patients are considered recovered if a) their score on a particular questionnaire after the end of the treatment falls within the normal range of scores (ie below a set cut-off point), and b) the difference between the starting and final score on that questionnaire reflects a statistically reliable improvement (ie a difference score greater than a set Reliable Change Index [RCI]). Based on the normative data of the Dutch version of the PSWQ, the RCI was set at 7 and the cut-off point at 53 (Van der Heiden et al., 2012). | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition to the primary outcome measures, the following questionnaires are taken: The PSYRATS is a semi-structured interview consisting of eleven items that measure aspects of hallucinations and six items that map characteristics of delusions. The items are scored on a 5-point Likert scale running from 0-4 and cover the past week. Items related to preoccupation, duration, conviction and disruption form the factor 'cognitive interpretation', items that deal with the frequency and intensity of experienced distress constitute the second factor, 'emotional impact'. The remission tool-PANNS is a semi-structured interview in which 7 areas, corresponding to the characteristics of the schizophrenia-spectrum disorder, are questioned. It concerns the areas Delusions and unusual thought content; Conceptual disorganization; Hallucinations; Passive / apathetic withdrawal; Lack of spontaneity; Feeling dulled; Mannerism and poses. This questionnaire is part of the standard ROM and is not an extra list. The MCQ-30 is a self-report questionnaire that maps out individual differences in positive opinions about worrying, negative views about worrying, opinions about the need to keep control over one's own thoughts, cognitive self-awareness, and cognitive self-confidence. The list consists of 30 questions scored on a 4-point Likert scale, ranging from 'disagree' (1) to 'very strongly agree' (4). For this study only the subscales positive and negative views on worrying will be used. The psychometric qualities of the MCQ-30 are good (Hermans, Crombez, Van Rijsoort & Laeremans, 2002). A final outcome measure is the already described GAD-7 (Spitzer et al., 2006), which is taken before participation (for inclusion), at the start of the treatment and then at the end of the treatment and at the follow-up measurement. | — |
Countries
Netherlands
Outcome results
None listed