کارآزمایی تصادفی کنترل شده از مداخله نگرانی برای افراد با هذیان آزار و شکنجه مداوم

Recent research has shown that worry is associated with distressing paranoia. Therefore, the aim was to target worry in a therapeutic intervention for individuals with delusions. It was predicted that a worry intervention would reduce levels of worry and paranoia distress. Twenty-four individuals with persistent persecutory delusions and high levels of worry were randomly assigned to receive a four session cognitive-behavioural worry intervention (W-CBT) or treatment as usual (TAU). The worry intervention was specifically designed not to target the content of delusions. In this open-label evaluation, assessments of worry and paranoia were conducted at baseline, at one month (end of treatment) and at two months. The worry intervention achieved a statistically significant reduction in worry which was maintained at two month follow up. A significant reduction in delusional distress was also reported. There was an indication that the worry intervention may also reduce the frequency of paranoid thoughts but this was not statistically significant. In the first trial specifically for persecutory delusions, a brief worry intervention was shown to have benefits. The results support a causal role for worry in paranoid experience.

Developments in the understanding of persecutory delusions have the potential to lead to improvements in treatments. Worry, defined as ‘a chain of thoughts and images, negatively affect-laden and relatively uncontrollable’ (Borkovec, Wilkinson, Folensbee, & Lerman, 1983), is a factor that has recently been implicated in paranoid experience. Clinical levels of worry are present in almost two-thirds of individuals with persecutory delusions and the presence of worry is associated with more distressing delusional experience (Bassett et al., 2009, Freeman and Garety, 1999, Morrison and Wells, 2007 and Startup et al., 2007). A catastrophising worry style predicts the occurrence of non-clinical paranoia and the persistence of persecutory delusions (Freeman et al., 2008 and Startup et al., 2007). Emphasis is placed on the importance of worry in a cognitive model of persecutory delusions (Freeman, 2007 and Freeman and Freeman, 2008). The intriguing implication is that treatment of worry in individuals with persecutory delusions will also lessen paranoia. Worry has been successfully targeted in people with generalised anxiety disorder using cognitive-behavioural interventions (see review by Covin, Ouimet, Seeds, & Dozois, 2008). We aimed to examine in a small pilot study whether a brief cognitive-behavioural worry intervention has the potential to be effective at reducing levels of worry and delusional distress in individuals with persecutory delusions and clinically significant levels of worry. The main prediction was that the worry intervention would reduce both worry and paranoia distress compared with treatment as usual. A secondary hypothesis was that the worry intervention would reduce the overall occurrence of delusional thoughts. Strengthening the support for the causal role of worry, it was also predicted that changes in worry would be associated with changes in paranoia.

The flow of participants through the trial is shown in Fig. 1. Full-size image (76 K) Fig. 1. CONSORT flow diagram. Figure options 3.1. Demographic and clinical characteristics of the participants Demographic details are presented in Table 1. The participants were very similar to those in other studies of persistent psychosis; the mean age was approximately forty years old, most were single, and there were high rates of unemployment. The main diagnosis was schizophrenia (n = 21, 88%) and the majority of participants were outpatients (n = 22, 92%). Table 1. The demographic characteristics of the participants. W-CBT (n = 12) TAU (n = 12) Age Mean age in years 40.0 39.1 Standard deviation 10.0 9.2 Sex (n) Male 7 (58%) 7 (58%) Female 5 (42%) 5 (42%) Ethnicity (n) White British 4 (33%) 4 (33%) White other 2 (17%) 0 (0%) Black British 2 (17%) 5 (42%) Black African 1 (8%) 3 (25%) Asian 2 (17%) 0 (0%) South American 1 (8%) 0 (0%) Employment (n) Employed 1 (8%) 1 (8%) Employed p/t 0 (0%) 1 (8%) Voluntary employment 1 (8%) 0 (0%) Unemployed 8 (67%) 9 (75%) Student 2 (17%) 1 (8%) Marital status (n) Single 10 (83%) 11 (92%) Married 0 (0%) 1 (8%) Divorced/separated 1 (8%) 0 (0%) Cohabiting 1 (8%) 0 (0%) IQ Mean 98.4 94.2 Standard deviation 8.5 13.6 Table options 3.2. Intervention effects: worry The assessment scores at each time point are displayed in Table 2. Table 2. Summary statistics for the assessment measures. Measure Time point W-CBT TAU N Mean SD N Mean SD PSWQ Baseline 12 67.3 9.9 12 62.9 9.1 1 month 9 56.3 13.3 11 62.6 8.7 2 months 10 53.0 14.1 10 62.5 11.3 PSYRATS Total Baseline 12 17.6 2.0 12 17.8 2.3 1 month 9 14.6 4.2 11 17.8 2.6 2 months 10 14.4 3.8 10 17.3 3.4 Factor 1 (frequency/duration) Baseline 12 11.1 1.7 12 11.8 1.8 1 month 9 9.3 2.7 11 11.4 1.9 2 months 10 9.5 2.7 10 11.1 2.4 Factor 2 (distress) Baseline 12 6.5 1.1 12 5.9 1.2 1 month 9 5.2 1.8 11 6.4 1.4 2 months 10 4.9 1.6 10 6.2 1.5 GPTS Total Baseline 12 112.9 23.0 12 100.6 32.7 1 month 9 86.8 41.4 10 89.7 26.1 2 months 10 80.0 40.9 10 100.9 31.7 Part A (social reference) Baseline 12 50.4 15.5 12 47.9 17.1 1 month 9 40.9 22.3 10 41.0 9.3 2 months 10 36.0 21.3 10 48.0 13.5 Part B (persecution) Baseline 12 62.1 12.8 12 52.7 18.2 1 month 9 45.9 21.4 11 49.3 18.1 2 months 10 44.0 21.8 10 52.9 20.3 Distress Baseline 12 28.4 7.8 12 26.9 8.2 1 month 9 21.7 10.4 10 24.1 8.2 2 months 10 20.6 11.0 10 26.3 8.9 Table options Within the W-CBT arm of the trial, mean scores on the Penn State Worry Questionnaire reduced by 11.0 points at one month and 14.3 points at two months compared to baseline scores. Within TAU, mean worry score on the PSWQ reduced by 0.3 points at the one month assessment and 0.4 points at the two month assessment. This is illustrated in Fig. 2. The outcome of the PSWQ at one month and two months post-randomisation was modelled by a random intercept multilevel model with patients included as a random effect (see Table 3). The results indicate that W-CBT reduced worry by 10.0 points (95% CI: −18.8, −1.2, p = 0.025, SE = 4.48) in comparison to TAU adjusting for baseline differences. The results failed to show a significant change in PSWQ by time and by a treatment time interaction, indicated by non-significant p-values. This indicates that W-CBT reduced worry by ten points in comparison to TAU post-treatment and this difference was maintained at two month follow up when accounting for baseline scores. Full-size image (85 K) Fig. 2. Bar charts showing mean scores (95% CI error bars) for the outcome measures (a) PSWQ scores; (b) PSYRATS: delusions total score; (c) PSYRATS Factor 2 (distress) scores; (d) GPTS Part B Total Score; (e) GPTS distress score. Figure options Table 3. Results of the random intercept multilevel models. Coefficient SE p-value 95% CI Worry (PSWQ) PSWQ baseline 0.79 0.22 <0.001 (0.35, 1.23) CBT worry intervention −10.00 4.48 0.025 (−18.77, −1.23) Time 0.79 2.46 0.746 (−4.02, 5.60) Time by CBT worry intervention −5.03 3.57 0.159 (−12.03, 1.97) Constant 14.12 13.99 0.313 (−13.29, 41.53) Between patient SD 7.90 – – – Within patient SD 5.54 – – – Intraclass correlation 0.67 – – – Delusion (PSYRATS) PSYRATS total score baseline 1.02 0.24 <0.001 (0.55, 1.50) CBT worry intervention −2.91 1.20 0.015 (−5.27, −0.56) Time −0.31 0.86 0.722 (−2.00, 1.38) Time by CBT worry intervention 0.32 1.26 0.802 (−2.14, 2.78) Constant −0.61 4.42 0.891 (−9.27, 8.06) Between patient SD 1.84 – – – Within patient SD 1.96 – – – Intraclass correlation 0.47 – – – Delusion (PSYRATS – Distress) PSYRATS Factor 2 baseline −0.81 0.20 <0.001 (0.42, 1.20) CBT worry intervention −1.66 0.57 0.003 (−2.77, −0.56) Time −0.09 0.41 0.826 (−0.90, 0.72) Time by CBT worry intervention −0.11 0.60 0.851 (−1.28, 1.06) Constant 1.53 1.25 0.224 (−0.93, 3.98) Between patient SD 0.81 – – – Within patient SD 0.93 – – – Intraclass correlation 0.43 – – – Paranoia (GPTS – distress) Green Paranoid Thoughts Scale distress score baseline 0.40 0.25 0.107 (−0.09, 0.90) CBT worry intervention −4.58 4.28 0.285 (−12.97. 3.82) Time 2.20 1.76 0.212 (−1.26, 5.66) Time by CBT worry intervention −2.01 2.56 0.432 (−7.03, 3.00) Constant 13.3 7.31 0.068 (−0.99, 27.67) Between patient SD 8.53 – – – Within patient SD 3.94 – – – Intraclass correlation 0.82 – – – Paranoia (GPTS – Part B) Green Paranoid Thoughts Scale Part B baseline 0.39 0.27 0.145 (0.13, 0.91) CBT worry intervention −10.50 9.23 0.255 (−28.59, 7.60) Time 4.12 3.08 0.181 (−1.91, 10.14) Time by CBT worry intervention −3.27 4.47 0.465 (−12.02, 5.49) Constant 29.08 15.10 0.054 (−0.52, 58.67) Between patient SD 18.61 – – – Within patient SD 6.90 – – – Intraclass correlation 0.87 – – – Table options 3.3. Intervention effects: paranoia Within the W-CBT arm of the trial, mean total scores on the PSYRATS reduced by 3.0 points at one month assessment and 3.2 points at two month assessment as compared to baseline scores. Within TAU, there was no change in mean total PSYRATS scores at one month assessment and there was a reduction of 0.5 points at two month assessment compared to baseline scores, as illustrated in Fig. 2. Fitting a random intercept model indicated that W-CBT reduced the PSYRATS total score by 2.9 points (95% CI: −5.3, −0.6, p = 0.015, SE = 1.20) points in comparison to TAU when adjusting for baseline differences (see Table 3). The results failed to show a significant change in PSYRATS total score by time and by a treatment time interaction indicated by non-significant p-values. Therefore, W-CBT reduced PSYRATS total score by 2.9 points in comparison to TAU post-treatment and this difference was maintained at two month follow up. Factor 2 (emotional distress) of the PSYRATS offers a summary score of two distress related items; intensity of distress and amount of distress. Within the W-CBT arm of the trial, mean distress scores on the PSYRATS reduced by 1.3 points at one month assessment and 1.6 points at two month assessment compared to baseline scores. Within TAU, there was an increase in mean distress PSYRATS scores by 0.5 points at one month assessment and 0.3 points at two month assessment as compared to baseline scores, as illustrated in Fig. 2. Fitting a random intercept model showed that W-CBT reduced PSYRATS Factor 2 by 1.7 points (95% CI: −2.8, −0.6, p-value = 0.003, SE = 0.57) in comparison to treatment as usual when adjusting for baseline differences (see Table 3). The results failed to show a significant change in PSYRATS Factor 2 by time and by a treatment time interaction indicated by non-significant p-values. Therefore, W-CBT reduced Factor 2 scores by 1.7 points in comparison to TAU post-treatment and this difference was maintained at two months follow up when accounting for baseline differences.