Jaime Delgadillo, PhD Leeds Community Healthcare NHS Trust and University of York Feasibility RCT of brief interventions for depression and co-occurring substance use disorders

Co-morbidity: Prevalence and impact Depression commonly co-exists with substance use disorders (Kessler et al, 1997; Merikangas et al, 1998; Farrell et al, 2001; Schifano et al, 2002) Point prevalence of MDD = 2.6%, MDD+MDA = 11.4% in the UK (National Institute of Health and Clinical Excellence, 2010) Point prevalence of depression in UK substance misuse services is around 50% (Strathdee et al, 2002; Weaver et al, 2003) Pharmacological treatments for depression in alcohol and drug users have mixed evidence, with some reviews that indicate a modest beneficial effect (Iovieno et al., 2011; Nunes & Levin, 2004) and other reviews that question its efficacy (Lingford-Hughes, Welch & Nutt, 2012; Pedrelli et al., 2011; Torrens et al., 2005). In view of such evidence, exploring the potential of psychological treatments may be a fruitful avenue for research and practice.

Methods Design Feasibility RCT comparing: (A) 12-session behavioural activation delivered by IAPT therapist vs. (B) 1 session CBT Guided Self-Help delivered by drugs worker Eligibility criteria Include: patients accessing community OST, screen positive for Major Depression Exclude: primary anxiety disorder is presenting problem, psychotic or bipolar disorder, severe dependency (SDS>10) Measures Primary outcome: PHQ-9 (Kroenke et al, 2001) Secondary: Percentage of days abstinent derived from TOP (Marsden et al, 2008) Follow-up was at end, 6, 12 and 24 weeks follow-up Randomisation Individual randomisation to BA or GSH BA condition was delivered in parallel and co-located modalities

Step-wise screening and recruitment strategy BA in primary care Usual drugs treatment + guided self-help Random allocation Suitability screening interview & informed consent If: PHQ-9 >= 12 Routine case-finding If: TOP <= 12 Then: PHQ-9 + GAD-7 References: (Delgadillo et al, 2011, 2012)

Results: feasibility Screening and randomization  Approached 207 potential participants; of whom 186 (90%) were screened  Screened was refused or inappropriate in about 10% of cases  Consented and randomized 50 participants who met criteria  Ratio of screened and recruited patients was 4 : 1 Engagement in brief interventions  Only 42% actually attended at least 1 therapy appointment (engaged)  Engagement was not associated with demographics, abstinence, or baseline severity of depression  Non-engagement was associated with poly-substance use  Patients offered therapy appointments co-located in addiction clinics (vs. general primary care clinics) were more likely to engage with treatment (Odds ratio = 7.14, p =.04).

Results: predicting engagement

Results: preliminary treatment effects Within-group effect sizes were: d =.49 for BA d =.63 for GSH Overall NNT for all participants = 5.83

Concluding summary It was feasible to apply a high volume, step-wise screening method in routine addiction treatment Patients offered therapy appointments co-located in addiction clinics (vs. general primary care clinics) were more likely to engage with treatment Poly-substance users were less likely to engage with treatment No significant differences were found between brief behavioral activation and CBT workbook based guided self-help in terms of depression symptom reductions or percent days abstinence Participants in both groups appeared to generally improve over time; the within-group effect sizes were moderate These findings could inform the development of a fully-powered efficacy trial, ideally only applying co-located care, delivered by non-specialists, combining brief CBT plus contingency management

Acknowledgements RESEARCH TEAM Chief investigator: Jaime Delgadillo 1 Study Co-ordinator: Stuart Gore 2 Academic collaborators: Liz Hughes 3, Dean McMillan 3, Shehzad Ali 3, Simon Gilbody 3, Dave Ekers 4, Gail Gilchrist 5 Randomisation facilitator: Rebecca Forster 1 CLINICAL TEAMS BA therapists: Geraldine Greenwood 1, Omar Moreea 1, Helen Stocks 1, Susan Watson 1, Jodi Clark 1 GSH therapists: Julio Mendoza 2, Iain Cullum 6, Jo Craven 7, Tony Hargreaves 8, Zoe Patterson 9, Melanie Senior 9 ORGANISATIONS INVOLVED 1. Leeds Community Healthcare NHS 6. BARCA Leeds 2. St. Anne’s Community Services7. DISC 3. University of York8. ADS 4. Durham University9. Multiple Choice 5. Institute of Psychiatry, KCL