A feasibility study piloting a randomised controlled trial of computerised Cognitive Behavioural Therapy to treat emotional distress after stroke

Background: Depression and anxiety are common complications following stroke. Symptoms may be treatable with psychological therapy but there is little research on its efficacy. Objectives: To investigate: i) the acceptability and feasibility of computerised Cognitive Behavioural Therapy (cCBT) to treat symptoms of depression and anxiety; and ii) a trial design for comparing the efficacy of cCBT compared to an active comparator. Methods: Of 134 people screened for symptoms of depression and anxiety following stroke, 28 were cluster randomised in blocks with an allocation ratio 2:1 to cCBT (n=19) or an active comparator of computerised Cognitive Remediation Therapy (cCRT; n=9). Qualitative and quantitative feedback was sought on the acceptability and feasibility of both interventions, alongside measuring levels of depression, anxiety and activities of daily living (ADLs) before, immediately after and three-months post treatment. Results: Both cCBT and cCRT group were rated as near equally useful (mean = 6.4 vs. 6.5, d = 0.05), while cCBT was somewhat less relevant (mean = 5.5 vs. 6.5, d = 0.45) but somewhat easier to use (mean = 7.0 vs. 6.3, d = 0.31). Participants tolerated randomisation and drop-out rates were comparable to similar trials, with only three participants discontinuing due to potential adverse effects; however, drop-out was higher from the cCBT arm (7/19, 37% vs 1/9, 11% for cCRT). The trial design required some small alterations and highlighted that future related studies may need to control for participants receiving antidepressant medication, which significantly differed between groups (p = .05). Descriptive statistics of the proposed outcome measures and qualitative feedback about the cCBT intervention are reported. Conclusions: A pragmatic approach is required to deliver computerised interventions to accommodate individual needs. We report a preliminary investigation to inform the development of a full RCT for testing the efficacy of computerised interventions for people with long-term neurological conditions such as stroke and conclude that this is a potentially promising way of improving accessibility of psychological support