Background
Depression is the most prevalent mental health problem among people with
learning disabilities.
Objective
The trial investigated the clinical effectiveness and cost-effectiveness of
behavioural activation for depression experienced by people with mild to
moderate learning disabilities. The intervention was compared with a guided
self-help intervention.
Design
A multicentre, single-blind, randomised controlled trial, with follow-up at
4, 8 and 12 months post randomisation. There was a nested qualitative
study.
Setting
Participants were recruited from community learning disability teams and
services and from Improving Access to Psychological Therapies services in
Scotland, England and Wales.
Participants
Participants were aged ≥ 18 years, with clinically significant
depression, assessed using the Diagnostic Criteria for Psychiatric Disorders
for use with Adults with Learning Disabilities. Participants had to be able
to give informed consent and a supporter could accompany them to
therapy.
Interventions
BeatIt was a manualised behavioural activation intervention, adapted for
people with learning disabilities and depression. StepUp was an adapted
guided self-help intervention.
Main outcome measures
The primary outcome measure was the Glasgow Depression Scale for people with
a Learning Disability (GDS-LD). Secondary outcomes included carer ratings of
depressive symptoms and aggressiveness, self-reporting of anxiety symptoms,
social support, activity and adaptive behaviour, relationships, quality of
life (QoL) and life events, and resource and medication use.
Results
There were 161 participants randomised (BeatIt,
n = 84; StepUp,
n = 77). Participant retention was strong,
with 141 completing the trial. Most completed therapy (BeatIt: 86%; StepUp:
82%). At baseline, 63% of BeatIt participants and 66% of StepUp participants
were prescribed antidepressants. There was no statistically significant
difference in GDS-LD scores between the StepUp (12.94 points) and BeatIt
(11.91 points) groups at the 12-month primary outcome point. However, both
groups improved during the trial. Other psychological and QoL outcomes
followed a similar pattern. There were no treatment group differences, but
there was improvement in both groups. There was no economic evidence
suggesting that BeatIt may be more cost-effective than StepUp. However,
treatment costs for both groups were approximately only 4–6.5% of the
total support costs. Results of the qualitative research with participants,
supporters and therapists were in concert with the quantitative findings.
Both treatments were perceived as active interventions and were valued in
terms of their structure, content and perceived impact.
Limitations
A significant limitation was the absence of a treatment-as-usual (TAU)
comparison.
Conclusions
Primary and secondary outcomes, economic data and qualitative results all
clearly demonstrate that there was no evidence for BeatIt being more
effective than StepUp.
Future work
Comparisons against TAU are required to determine whether or not these
interventions had any effect.
Trial registration
Current Controlled Trials ISRCTN09753005.
Funding
This project was funded by the National Institute for Health Research Health
Technology Assessment programme and will be published in full in
Health Technology Assessment; Vol. 22, No. 53. See the
NIHR Journals Library website for further project information.