The effect of an add-on treatment for sleep problems in the rehabilitation of patients with acquired brain injury and patients with chronic pain

Sleep problems are common following acquired brain injury (ABI) and are very common in patients with chronic pain. Up to date, there is limited evidence for effective treatment of sleep problems in ABI patients, although CBT interventions are most promising. In chronic pain patients CBT for sleep problems has been found effective in prior research, although this is not part of the standard care in rehabilitation centers. A problem with the standard CBT interventions for insomnia is that there is a lot of overlap with interventions within the rehabilitation setting. Furthermore, the sleep problems in these patients are not always so severe that an entire CBT protocol for insomnia is necessary. Therefore, the aim of the present study is to examine whether a short add-on treatment for sleep problems is effective within the rehabilitation of patients with ABI and chronic pain. The main hypothesis is that sleep quality will significantly improve after a short add-on treatment for sleep problems, compared to a treatment as usual (rehabilitation) control group. Patients in the control group receive the add-on treatment for sleep problems als well, but after completing the assessment at T1 and T2.
The trial comprises of two identical studies in two common rehabilitaiton population groups. We aim to include 50 patients with ABI (25 per treatment arm) and 50 patients with chronich pain (25 per treatment arm). The trial is conducted in Rehabilitation Center Klimmendaal, Arnhem, the Netherlands.

Sleep quality will significantly improve after a short add-on treatment for sleep problems, and improve more than treatment as usual (rehabilitation). Second, we expect fatigue and disfunctional beliefs about sleep to improve as well (but to lesser extent). Finally, we are interested in whether anxiety and depression symptoms and pain scores could improve following a short add-on treatment for sleep problems.

Experimental condition: T1: baseline assessment at the start of session 1, T2 post-treatment assessment at the end of session 4 (last session) and a T3 follow-up assessment 3 months after completing the treatment. Between baseline and post-treatment is a period of 6 weeks.
Control condition: T1 baseline assessment and T2 second assessment 6 weeks later (while participating in their usual rehabilitation treatment). No follow-up assessment is done, as control participants received the add-on sleep intervention as well following the second assessment. A third assessment was done post-treatment to evaluate their progression following treatment.

Short add-on treatment for sleep problems (in addition to the regular rehabilitation program). The add-on treatment for sleep problems consists of cognitive behavioural therapy for insomnia (CBT-I) elements: psychoeducation, sleep hygiene, sleep restriction and stimulus control. The intervention has a duration of 4 sessions in a 6 week period and is given individually by trained professionals.