Lessons Learnt in Trial Development and Implementation

Steven Jones

Individual Interventions

CBT for Anxiety Recovery CBT for early BD

Recovery CBT for established BD

MI-CBT for alcohol in BD

Group Interventions

Family intervention

REACT trial

CA REACTPsycho-education vs peer support

Online Interventions

Triple P pilot

IBPI study ERP

Living with BD

• In a recent survey of 9000 people with a bipolar diagnosis.

• 92% has at least one other comorbid diagnosis

• Main ones highlighted

• Anxiety

• Alcohol/substance use

• Impulse control disorders (attention, behaviour or anger problems)

• Merikangas et al., 2007

• 93% of people with a bipolar diagnosis have lifetime experience of anxiety.

• 32% of people have current anxiety difficulties

• Co-morbid anxiety and bipolar are associated with– poor treatment response – increased suicidality– earlier age of onset – greater risk of relapse

• Effective interventions exist for anxiety and bipolar separately.

• No definitive research into psychological treatment of bipolar and anxiety together.

McIntyre, et al., 2006 Otto et al., 2006

Feske, et al., 2000Frank, et al., 2002Henry, et al., 2003Ouimet et al, 2009

The following slides present independent research commissioned by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RP-PG-0407-10389). Further support was received from primary care trusts, mental health trusts, the Mental Health Research Network and Comprehensive Local Research Networks in North West England.

The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

• Most therapy approaches split anxiety and BD.

• Common therapist question – which do we treat first?

• People’s lived experience however integrates both.

• “I think the thing to do would be to find out why I become so anxious, unreasonably so over little things and why I would get so anxious that ...I would do something as dramatic as abandon my son, jump in my car and drive away. Why would that be a good idea? but that is driven seriously by anxiety”

• Informed by evidence-based CBT for anxiety & bipolar

• 10 therapy sessions over 4 months

• Delivered by BABCP accredited therapists

• Therapy individualised and formulation driven

• Recruitment = 72 participants (37 intervention/35 control).

• Bipolar disorder & anxiety (HADS 8+)

• 18+

• English speaking

• No episode in the past 4 weeks

• No current suicidal intent

• Not taking part in any other intervention study

• Better able to control BD

• Change views of BD – averting relapse

• Anxiety improved – better coping skills

• Reduced medication

• Changes to lifestyle and behaviour

• Feel like a better person!

• Integrating service user views into development of therapy led to more individualised therapy

• Consequence – good recruitment and retention

• General positive experiences of therapy process and structure -– NB not everyone some felt a bit rushed

• Next step definitive trial – hopefully

• Contact Steve Jones – s.jones7@lancaster.ac.uk

Clinical Outcomes

• Primary clinical outcomes• Anxiety symptoms - HAM-AD and STAI • Time to relapses of mood episodes as

measured by SCID-LIFE• Mood symptoms - HAM-AD and MAS

• Analysis to take place in next few weeks!