The Protocol and Design of a Randomized Controlled Study on Attention Training in First Year After Acquired Brain Injury

STUDY METHODS The primary objectives of the study were: 1. In the acute stage, to evaluate the effectiveness of APT measured by the changes in performance in the attention measure, Paced Auditory Serial Addition Test, (PASAT) evaluated by Statistical Process Control 2. In the postacute stage, to evaluate and compare effects of Attention process training (APT) vs. standard rehabilitation on daily activities and return to work three months and one year after participating in a rehabilitation programme with regard to resource utilisation and health economics.

STUDY DESIGN AND SETTING The study was conducted in a specialised rehabilitation clinic. Several in- and outpatient units on two sites were involved. It was a randomised, controlled (www.consort-statement.org/?o=1011) study with an open extension and a follow up at three and six months and one year. Due to the nature of the rehabilitation procedures, neither patients nor rehabilitation professionals were blinded as to the nature of the intervention, but different professionals conducted assessments and training. The study was designed to reflect normal clinical practice while allowing comparison between two rehabilitation approaches. Patients in the acute phase (< 4 months) were recruited from both in- and outpatient units. For those, ready to be discharged from inpatient wards, the training was continued in the outpatient setting. Subacute patients (4-12 months) participated in the study as part of their outpatient rehabilitation. The study was approved by the regional ethics committee, Karolinska Institutet, Stockholm, Sweden.

The participants comprised a consecutive series of patients with mild to moderate stroke or traumatic brain injury. Inclusion criteria were deficits in attention defined by the APT test, scores on the lower average and above for reasoning skills and abstract thinking, age range; 18-60 years and a good understanding of the Swedish language. Exclusion criteria were moderate to severe aphasia, ongoing psychiatric illness, a history of severe somatic disorder causing anoxic periods, ongoing substance abuse and severe pain. Patients with Hospital Anxiety and Depression Scale scores =>10 were offered antidepressant treatment and were included in the study three weeks after pharmacological treatment had been initiated. Further, exclusion was also based on severe memory disorders, neglect, visual field defects and motor disability interfering with participation.

All patients participated in a comprehensive interdisciplinary brain injury rehabilitation programme. After baseline assessment, the participants received 20 hours of attention training, at least three days a week, for a period of 5-6 weeks. They were randomly assigned to one of the two intervention programmes: intensive area-specific cognitive training with the APT or activity-based attention training provided by the occupational therapist. Evaluation of treatment effects was monitored by pre and post assessment and by repeated assessment by the primary outcome measure at baseline, after every third hour of intervention and post intervention for patients in the acute stage. Subacute patients were assessed by pre and post measurements. The open-label extension of the study comprised of client-centred standard interdisciplinary rehabilitation. Discharge was based on clinical decisions and the participants returned to the clinic for follow-up assessments.

The APT programme provides a theoretically based, individualised, highly structured intervention of organised assignments at four attention levels: sustained, selective, divided and alternating attention. Progress is based on the intensity of training, on continuous feedback promoting motivation and on metacognitive training. The APT also includes education in acquired attention deficits and training for generalisation, enabling the transfer of treatment tasks and techniques to self-selected cognitive problems in everyday situations. Each session took 45-90 minutes to perform, working with material from APTs I and II.