Background: A one-to-one cognitive behavioural therapy intervention targeting worry significantly reduces both worry and persecutory delusions (Freeman et al., 2015). Aim: To adapt this intervention for group delivery and conduct a feasibility trial within routine clinical practice. Method: Thirteen participants were randomized to a weekly 8-session worry intervention group (n = 7) or wait-list control (n = 6). Results: All but one participant completed measures at all time points. Participants attended an average of six therapy sessions. Conclusions: Recruitment, retention and therapy uptake were feasible. Observed treatment effects were in the expected direction, but may be diluted compared with one-to-one interventions

Freeman, D

Grafahrend, H

Isham, SL

Mulligan, A

Nickless, A

Pleasants, S

Pugh, K

Smedley, N

Isham, S. Louise

Nickless, Alecia

Freeman, Daniel

Oxford University Research Archive

Behavioural and Cognitive Psychotherapy, 2018, 46, 619–625First published online 20 June 2018 doi:10.1017/S1352465818000383Group-Based Worry Intervention for Persecutory Delusions:an Initial Feasibility StudyLouise Isham∗Department of Psychiatry, University of Oxford, Warneford Hospital, Warneford Lane, Oxford OX3 7JXand Oxleas NHS Foundation Trust, 63 Yeoman House, Penge, London SE20 7TSHeidemarie GrafahrendOxleas NHS Foundation Trust, Bridgeways Day Hospital, Turpington Lane, Bromley BR2 8JAAlecia NicklessPrimary Care Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University ofOxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GGKatherine PughSussex Partnership NHS Foundation Trust, Research & Development Department, Sussex EducationCentre, Nevill Avenue, Hove, East Sussex BN3 7HYSteve PleasantsOxleas NHS Foundation Trust ResearchNet, 63 Croydon Road, London SE20 7TSNicola SmedleyOxleas NHS Foundation Trust, Bromley Intensive Case Management Psychosis Team East,1–6 Carlton Parade, Orpington, Kent BR6 0JBDaniel FreemanDepartment of Psychiatry, Warneford Hospital, University of Oxford, Oxford OX3 7JX∗ Correspondence to Louise Isham. E-mail: louise.isham@psych.ox.ac.uk© British Association for Behavioural and Cognitive Psychotherapies 2018620 Louise Isham et al.Alison MulliganOxleas NHS Foundation Trust, Bromley Intensive Case Management Psychosis Team West,63 Yeoman House, Penge, London SE20 7TSBackground: A one-to-one cognitive behavioural therapy intervention targeting worrysignificantly reduces both worry and persecutory delusions (Freeman et al., 2015). Aim:To adapt this intervention for group delivery and conduct a feasibility trial within routineclinical practice. Method: Thirteen participants were randomized to a weekly 8-session worryintervention group (n = 7) or wait-list control (n = 6). Results: All but one participantcompleted measures at all time points. Participants attended an average of six therapysessions. Conclusions: Recruitment, retention and therapy uptake were feasible. Observedtreatment effects were in the expected direction, but may be diluted compared with one-to-oneinterventions.Keywords: cognitive behavioural group therapy, worry intervention, persecutory delusionsIntroductionPersecutory delusions are erroneous beliefs that others intend to cause one harm. They are oneof the most common psychotic experiences and can lead to social withdrawal, exacerbation ofemotional distress, and substantially reduced quality of life (Freeman, 2016).Traditional approaches to the treatment of psychosis adopt a diagnostic approach(e.g. focusing on ‘schizophrenia’) but these yield only modest effects. Recent advancesdemonstrating the independence of different psychotic experiences have resulted in a callto develop experience-specific models and treatments to improve outcomes. Freeman’s (2016)cognitive model of persecutory delusions identifies six key evidence-based maintenancefactors. Whilst studies have shown that targeting each factor individually is beneficial, themost robust evidence to date relates to worry. A high level of worry predicts the persistenceof persecutory delusions and a large randomized control trial (RCT), the Worry InterventionTrial (WIT; Freeman et al., 2015), demonstrated that six sessions of high-intensity individualcognitive behavioural therapy (CBT) targeting worry led to significant improvements in bothworry (effect size, Cohen’s d = 0.5) and persecutory delusions (effect size, Cohen’s d = 0.5).Two-thirds of the change in delusions was accounted for by changes in worry. Worry is thereforeindicated as a contributory causal factor in persecutory delusions that is amenable to change.Recent interest in group-based therapies for psychosis reflects the view that groups may offerparticular benefits (e.g. learning from others in a normalizing environment; Newton et al., 2007)and that they could be a cost-effective alternative to individual therapy. Some evidence suggeststhey may be less clinically effective, however (Barrowclough et al., 2006). The current studywas a small feasibility RCT conducted within routine clinical practice. The WIT interventionhas not previously been delivered in a group format and our aim was to adapt the originalmanual for this purpose and test it to inform the potential next stages of trial development.Primary outcomes were recruitment rates, retention and therapy uptake. A secondary aim wasto preliminarily inspect possible treatment effects, expecting that the worry intervention groupwould show evidence of a greater reduction in worry and persecutory delusions than the controlgroup.Group CBT: worry and persecutory delusions 621MethodDetailed information about the trial can be found in the full version of this paper online.Study design and participantsThis wait-list controlled non-blind feasibility RCT tested an 8-week worry interventiongroup plus standard care versus standard care alone. Participants were adults recruited fromcommunity mental health teams in Oxleas NHS Foundation Trust. Inclusion criteria were: aged18–65 years, current persecutory delusion (persisting >6 months), schizophrenia-spectrumdiagnosis, and clinically significant worry (>45 on the Penn State Worry Questionnaire(Behar et al., 2003)). Exclusion criteria included: primary diagnosis of alcohol/substancedependency, organic syndrome or learning disability, and acute symptomatic distress requiringhospital admission. Standardized measures of worry, paranoia and persecutory delusions wereadministered at baseline and at 8 and 12 weeks. Recruitment and assessments were conductedby trial therapists, L.I. and A.M. (clinical psychologists within the teams).RandomizationParticipants were randomized to the worry group (WG) or wait-list control (CG).ProcedureThe worry group had eight weekly 1.5-hour sessions. ‘Worry periods’ and strategies forpostponing worry were the main interventions. A key adaptation from the WIT trial was anincreased number of sessions (eight versus six) to allow additional space for group discussionand processes (e.g. setting ground rules). Aspects of the original one-to-one interventiondeemed unsuitable for group delivery were excluded. As in WIT, group facilitators offeredbetween-session contact (e.g. telephone calls, texts and/or postcards) to provide support. Afterstudy completion, participants were invited to give feedback via focus groups led by a service-user researcher (S.P.).Outcomes measures and statistical analysisPrimary outcomes were recruitment rate, participant retention and therapy uptake. Thresholdsfor feasibility were: recruitment rates exceeding 30% of those referred and 50% of thosescreened for eligibility, retention rates greater than 80% for each assessment time point, andtherapy uptake of at least three-quarters of WG participants attending four or more therapysessions. Secondary outcome measures of persecutory delusions, paranoia and worry wereutilized and adjusted treatment difference and confidence intervals were estimated using alinear mixed-effects model. As this was a feasibility study, p-values are not reported.ResultsRecruitment and retentionOver an 18-week period, 41 individuals were referred, 25 (61%) of whom proceeded to ascreening assessment. Thirteen participants (32% of those referred and 52% of those assessed622 Louise Isham et al.for eligibility) were recruited and randomized to WG (n = 7) or CG (n = 6). Of those assessedfor eligibility but not recruited, the majority did not meet the central inclusion criterion of havinga persecutory delusion. The recruitment rate was considered good given the staff resourceavailable for recruitment (the equivalent of one clinician, 0.5 days per week, across threeteams). All but one participant completed assessments at all time points.Baseline and clinical characteristicsThe demographic details of the participants were similar across groups. The average age was48 years, and most participants were single and living alone. All were unemployed. Mosthad a diagnosis of schizophrenia and were open to Recovery Services, but one participant ineach pathway was recruited from the Assertive Outreach and Rehabilitation Team. Baselineassessments showed that participants had high levels of worry and persecutory ideation, anddelusions that were distressing and preoccupying.Therapy uptakeThe mean number of therapy sessions attended was 5.7 (SD 1.3). All participants attendedat least four sessions, with one attending all eight sessions, three attending six sessions, twoattending five sessions, and one attending four sessions. Across the WG condition, 40 of 56possible sessions were attended (71%).Efficacy outcomeCompared with CG, the treatment effect of CBT on worry was in the medium effect sizerange at 8 and 12 weeks (Table 1). The treatment effect on delusions was in the small effectsize range at 8 weeks and no longer apparent at 12 weeks. The effect size found on generalparanoia was 0. However, in all outcomes wide confidence intervals spanning zero meant thatthe true direction of effect cannot be determined.Adverse eventsNo adverse events were reported during the main trial period.DiscussionIt was feasible to recruit and retain participants. Commensurate with similar studies, one-third of those referred, and half of those assessed for eligibility, entered the trial. Initially therecruitment target was 20 participants but unforeseen job changes for the researchers limitedavailable recruitment time. Over 4 months, 13 participants were recruited with a resourceequivalent to one clinician for 0.5 days per week. The decision to proceed with this sample sizewas made due to concerns that participants may withdraw if there were longer delays betweenrecruitment and intervention commencing. A larger study would benefit from external fundingto increase resources and thus expedite the recruitment process.Retention rates were high; all but one participant completed all assessments. Therapy uptakewas also feasible. No WG participants dropped out and all completed at least four sessionsGroup CBT: worry and persecutory delusions 623Table 1. Scores for efficacy outcome measuresOutcome Worry group Wait-list control Adjusted mean Standardizedmeasures (n = 7) (n = 6) difference (95% CI) effect size (d)Worry (PSWQ)Week 0 61.0 (5.7) 62.5 (12.90)Week 8 58.9 (10.8) 66.0 (12.73) –6.0 (–15.4, 3.4) –0.5Week 12 58.4 (9.3) 67.1 (8.26) –7.6 (–15.7, 0.6) –0.6PSYRATS-delusionsWeek 0 18.4 (3.4) 16.0 (5.1)Week 8 12.3(5.5) 12.8 (6.7) –2.2 (–9.4, 5.1) –0.4Week12 15.7 (4.6) 14.7 (4.4) –0.6 (–5.1, 4.0) –0.1Paranoia (GPTS-B)Week 0 57.5 (10.7) 55.3 (12.7)Week 8 52.5 (9.7) 51.2 (20.9) –0.2 (–17.6, 17.3) –0.0Week 12 56.6 (8.3) 56.2 (15.3) –0.8 (–13.4, 11.7) –0.1Data are means (SD). PSWQ, Penn State Worry Questionnaire; PSYRATS-delusions, PsychoticSymptoms Rating Scale_delusions; GPTS-B, Green Paranoid Thoughts Scale, Part B. Standardizedeffect sizes were calculated conservatively using pooled standard deviations from week 8 and week 12,respectively.(average attendance was six of eight sessions). As three (of seven) participants (43%) missedat least three sessions, however, some significant content was missed.Focus group interviews with four participants revealed that the group was, overall, highlyvalued. There was a sense of the group targeting an important issue and being beneficial, withcoping strategies developing, and self-esteem and activity levels improving. The importance ofthe group context was noted not only in terms of normalizing participants’ experiences but alsoproviding a supportive environment. Participants were unanimous that the number of groupsessions felt too few, however.Observed effect sizes were in the expected direction such that WG may have had a beneficialimpact on worry at 8 and 12 weeks and on delusions at 8 weeks, but not 12 weeks. Confidenceintervals were wide and spanned 0; a fully powered RCT would be required to adequatelyestimate the true size and direction of effect. The observed effect on worry may be partiallylinked to worry increasing in CG participants, a pattern not observed in the WIT trial. Thiscould be due to environmental factors affecting this sample or simply chance given the smallsample size. Overall, effect sizes were diluted from the individual delivery method, and changesin delusions did not translate into changes in general levels of paranoia. In the test of one-to-one therapy in WIT (an assessor-blind trial), all primary and secondary outcome measuresimproved with the CBT intervention.Participants and therapists agreed that future groups should be longer, and therapistsfelt that in-session time pressure had impacted on efficacy. They found it difficult to tailortechniques individually to each client, and balance the ‘didactic’ components (communicatingkey techniques) and the less structured supportive group discussions within the time. Increasingthe intervention length (e.g. twelve 2-hour sessions) would help to address this, although gettingthe detailed individualized plans possible in individual therapy could still be difficult. Pacingsessions was also challenging, and so as to include everyone, the pace was slower than idealfor some participants.624 Louise Isham et al.Future trials could consider incorporating a one-to-one therapy arm (rather than CG) andan economic evaluation. A full RCT of this design would allow comparative effectiveness andcost-effectiveness of group versus individual treatment to be established. This would be crucialbefore recommendations to adopt a group version of this intervention could be incorporatedinto clinical guidelines (especially given the gold-standard evidence that exists demonstratingthe effectiveness of the individual approach; Freeman et al., 2015)We suspect that, whilst at first glance groups seem like a less costly option, the need for agreater number of sessions, as well as the presence of two staff members may mean this is notthe case. We felt the group format also decreases therapist flexibility in terms of schedulingsessions and hence may inadvertently increase the number of missed sessions.Study limitations included a small sample size and the lack of an active control. Furthermore,the feasibility of recruiting to multiple groups in each arm was not established (which would berequired in a larger trial) and the in-service nature of the study meant the therapists conductedthe assessments and were unblind to treatment allocation. Feasibility to retain participantsover a 1-month follow-up was established, but not whether retention could extend for a longerperiod (e.g. 6 months), which would be required in a full RCT.This study provides an early indication that it may be feasible to run a larger trial to test theeffectiveness of a group-based worry intervention for persecutory delusions. However, a largerscale pilot would need to test feasibility more extensively before a full RCT could be justified.AcknowledgementsThe authors would like to thank the participants and the clinical teams within Oxleas NHSFoundation Trust for their support of this study.Ethical statement: The authors assert that all procedures contributing to this work complywith ethical standards of the relevant national and institutional committees on humanexperimentation and with the Helsinki Declaration of 1965, and its most recent revision.Conflicts of interest: The authors have no conflicts of interest with respect to this publication.Financial support: This work was supported by Oxleas NHS Foundation Trust.Supplementary materialTo view supplementary material for this article, please visit https://doi.org/10.1017/S1352465818000383ReferencesBarrowclough, C., Haddock, G., Lobban, F., Jones, S., Siddle, R. O. N., Roberts, C. and Gregg, L.(2006). Group cognitive-behavioural therapy for schizophrenia. British Journal of Psychiatry, 189,527–532.Behar, E., Alcaine, O., Zuellig, A. R. and Borkovec, T. D. (2003). Screening for generalized anxietydisorder using the Penn State Worry Questionnaire: a receiver operating characteristic analysis.Journal of Behavior Therapy and Experimental Psychiatry, 34, 25–43. https://doi.org/10.1016/S0005-7916(03)00004-1Group CBT: worry and persecutory delusions 625Freeman, D. (2016). Persecutory delusions: a cognitive perspective on understanding and treatment. TheLancet Psychiatry, 3, 685–692. https://doi.org/10.1016/S2215-0366(16)00066-3Freeman, D., Dunn, G., Startup, H., Pugh, K., Cordwell, J., Mander, H. et al. (2015). Effects ofcognitive behaviour therapy for worry on persecutory delusions in patients with psychosis (WIT): aparallel, single-blind, randomised controlled trial with a mediation analysis. The Lancet Psychiatry,2, 305–313. https://doi.org/10.1016/S2215-0366(15)00039-5Newton, E., Larkin, M., Melhuish, R. and Wykes, T. (2007). More than just a place to talk:young people’s experiences of group psychological therapy as an early intervention for auditoryhallucinations. Psychology and Psychotherapy: Theory, Research and Practice, 80, 127–149. https://doi.org/10.1348/147608306X110148

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Group-based worry intervention for persecutory delusions: an initial feasibility study

Group-based worry intervention for persecutory delusions: an initial feasibility study

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