A multi-centre phase 3 cluster randomized controlled trial of a manualized anger management intervention for people with mild to moderate learning disabilities

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A multi-centre phase 3 cluster randomized
controlled trial of a manualized anger management
intervention for people with mild to moderate
learning disabilities
A randomized controlled trial of anger management
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Background

• We used a Cognitive Behavioural Therapy (CBT)
  approach
• CBT for anger is based on teaching clients to
• Be aware of situations that evoke anger
• Be aware of becoming angry
• Develop skills to control and manage anger
• Physiology Relaxation
• Behaviour Distraction, stop think, walk away,
  ask for help, humour
• Cognition Cognitive restructuring, problem
  solving, assertiveness
• There have been 10 small controlled trials in
  people with intellectual disabilities (treated
  vs. waiting list), all showing significant,
  sustained effects on anger
• This area of research provides the strongest
  support for use of CBT in this population
• This is the first large-scale and
  methodologically-robust trial of any
  psychological therapy for people with
  intellectual disabilities

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Limitations of earlier anger management studies

• Only two studies used randomized allocation to
  groups, and one of those was extremely small.
• In some studies the groups were not well matched.
• There was some overlap between groups or samples
  for example, in some studies, participants in the
  control group were later added to the
  intervention group.
• The relatively small size of most studies meant
  that they involved few centres and few
  therapists, and where a group format was used,
  very few groups.
• Several studies did not include a long-term
  follow-up and most of those that did only
  followed up the intervention group.
• One study only used third-party (carer) ratings
  to assess anger. All other studies included
  first-person reports from service users, but only
  three of them included both of these sources of
  information.
• Some of the interventions were manualized most
  were not.
• In those studies where the intervention was
  manualized, no assessment of fidelity to the
  manual was reported.

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The intervention

• Participants were people with mild to moderate
  intellectual disabilities who had difficulty in
  managing anger
• and were able to consent and complete the
  assessments
• The intervention was delivered to groups of
  service users
• within day services
• by day-service staff (lay therapists)
• The lay therapists received a single day of
  training
• and fortnightly supervision from a clinical
  psychologist
• They worked through a manual
• that gave detailed plans for 12 weekly sessions

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Study design
At least two staff members in each centre trained
to deliver the
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The research team

• Operations
• Wales
• Paul Willner
• CP Aimee Stimpson
• AP Christopher Woodgate
• England
• John Rose
• CP Nikki Rose
• AP Jennifer Shead
• Scotland
• Andrew Jahoda
• CP Pamela MacMahon
• AP Claire Lammie

• Support
• SE Wales Trials Unit
• Kerry Hood
• Project manager (0.5)
• Julia Townson/Jacqui Nuttall
• Statistician (0.5)
• David Gillespie
• Qualitative analysis
• Biza Stenfert Kroese
• Health economics
• David Felce
• Welsh Health Economics Support Service

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Service user demographics
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Lay therapist characteristics
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Programme

• Session 1 Introduction / getting to know you
  group rules
• Session 2 Emotions and physiological aspects of
  anger 
• Session 3 Responses to anger and counting to
  ten
• Session 4 What makes us angry What happens
  when we are angry Doing something else
  Thinking nice thoughts  
• Session 5 Practicing coping with anger Walking
  away
• Session 6 Recap on previous sessions
• Session 7 Things that make us angry, and
  asking for help are introduced, using
  role-plays
• Session 8 Role-plays practiced
• Session 9 Rethinking the situation
• Session 10 Being assertive and role-plays
• Sessions 11 -12 Recap on previous sessions

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Typical session structure

• Warm-up exercise
• Recap of previous session 
• Hassle logs (homework review)
• Role plays based on replay of real events (using
  knowledge of individual triggers and functional
  analyses from homework reports)
• Psycho-education
• Relaxation

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Examples of non-verbal materials
What is he doing? How might he feel? How do we
know? Why might he feel like this? How could he
be calmed down?
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Assessments

• Quantitative evaluation
• Anger/aggression and mental health/QoL measures
  at baseline, post-intervention and 6-month follow
  up
• Interviews for qualitative analysis
• Service users and lay therapists
  post-intervention
• Service managers at baseline and 6-month
  follow-up
• Health economic evaluation
• Costs of the intervention
• Services used by both groups in the 3-months
  preceding baseline and 6-month follow-up
  assessments
• Process evaluation
• Includes monitoring of fidelity to manual, CBT,
  group process
• Also informed by supervision notes and interview
  material

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Outcomes
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Anger
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Anger in personally relevant situations
Service users report less anger in relation to
strong personal triggers, but do not generalize
to hypothetical situations that perhaps they
rarely encounter
How angry would you feel if X happened (25
general scenarios)
How angry do you do feel when X happens (3
personalized scenarios)
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Anger coping
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Challenging behaviour
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Questions raised by these results 1

• Why do key-workers report larger changes in
  service-users anger than the service users
  themselves?
• Service users and carers use different
  information to rate anger
• Service users rate anger according to how they
  feel
• Carers rate anger according to what they see
• The aim was to manage anger better, not to feel
  less anger
• Emphasis on anger is OK what matters is how it
  is expressed
• Carer reports of decreased anger are linked to
  the decrease in challenging behaviour

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Questions raised by these results 2

• Why are the effects smaller than in previous
  studies?
• Variability between centres
• Control groups Intervention groups

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Questions raised by these results 3

• What do good lay therapists do well?
• Lay therapists who were rated as delivering the
  intervention well were able to create an
  environment where participants felt comfortable
  talking about their emotions

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What service users said about the group

• Most could describe the purpose of the group
• They valued the opportunity to talk about their
  problems and share experiences
• They talked about the coping strategies that they
  had learned and used successfully, particularly
  behavioural strategies such as walking away or
  asking for help
• They described improved relationships with peers
  and staff
• They expressed a sense of pride in what they had
  achieved

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What lay therapists said about the group

• They welcomed the opportunity to develop their
  professional skills
• They believed that the training, the manual and
  ongoing supervision equipped them well to run the
  groups
• They felt that they had gained had insights into
  what made the groups work
• They described some challenges
• engaging with service users differently to their
  normal role
• dealing with emotive issues or disclosures of a
  sensitive or distressing nature

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What service managers said about the group

• Before the group, managers welcomed the
  opportunity to develop their service and benefit
  from the staff training on offer
• After the group they were unanimously positive
  about hosting the intervention and its impact on
  service users and staff

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Costs and consequences

• Cost of delivering the intervention 24.68 per
  person per week
• Cost of supporting service users 22.46 less
  per person per week in the intervention group
  relative to the control group
• But the difference is not statistically
  significant so we cannot be certain that the
  intervention would recoup its costs

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Conclusions

• Both service users and key-workers reported
  decreased anger as a result of the intervention
• Service users reports of less anger were in
  relation to personally-relevant scenarios, but
  not to hypothetical situations
• Key-workers reported larger effects
• Service users and key-workers base their ratings
  on different information (feelings vs. behaviour)
• Key-workers and home carers both reported
  decreases in challenging behaviour
• Usage of anger coping skills increased as a
  result of the intervention
• Most of the effects were retained at long-term
  follow-up
• The effects observed were smaller than observed
  in previous studies where the intervention was
  delivered by psychologists
• Service users, lay therapists and service
  managers all gave very positive feedback about
  the intervention

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Overall conclusions

• The intervention was effective in increasing
  anger coping skills and has an impact on
  challenging behaviour
• Lay therapists can following a manual to deliver
  the intervention, after a brief training and with
  ongoing professional supervision
• People with mild to moderate intellectual
  disabilities are able to participate in
  interviews about their therapeutic experiences
  and also to report on their mental state through
  appropriately constructed questionnaires
• The study supports the viability of conducting
  randomized controlled trials of psychological
  interventions with people with intellectual
  disabilities

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Recommendations for services

• The lay therapist model should be used more
  widely to increase the availability of
  psychological interventions to people with
  intellectual disabilities, with support from a
  qualified clinical psychologist.
• People with intellectual disabilities referred
  for problems with anger control should be offered
  a mental health assessment, and the outcome taken
  into account in the design of the anger
  intervention.
• Manualized psychological interventions for other
  common mental health problems in people with
  intellectual disabilities should be developed and
  implemented as a matter of urgency.
• Clinical psychologists should be encouraged to
  develop consultancy models of working to support
  other staff to build psychological competency
  within organisations and to maximise the best use
  of scarce resources
• Service users should usually be seen as the
  primary source of information concerning their
  psychological difficulties, with information from
  other sources being used to support self report

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