In psychological research, control conditions in the form of "treatment as usual" provide support for intervention efficacy, but do not allow the attribution of positive outcomes to the unique ...components of the treatment itself. Attentionally and structurally equivalent active control conditions, such as health education (HE), have been implemented in recent trials of cognitive behavioural therapy (CBT). However, descriptions and evaluations of these control conditions are limited. The aims of this paper were to (i) provide a detailed description and rationale for a novel HE active control condition and (ii) to evaluate the face validity, treatment integrity and feasibility of HE.
We developed a HE active control similar in structure and duration to a CBT intervention for reducing sleep disturbance and fatigue (CBT-SF) in a pilot randomised controlled trial (n = 51). Face validity was measured using post-treatment participant satisfaction and helpfulness ratings for fatigue and sleep symptoms, treatment fidelity was measured with integrity monitoring ratings from an independent expert and feasibility was measured with completion and attrition rates. HE and CBT-SF groups were compared using Wilcoxon rank-sum tests and chi-square tests of independence.
There were no significant differences in participant ratings of overall satisfaction between HE (n = 17) and CBT (n = 34) or in how helpful each intervention was for fatigue symptoms. Participants rated helpfulness for sleep symptoms higher in the CBT-SF group compared to HE. Integrity monitoring ratings were not significantly different for overall treatment delivery and therapist competency, but HE had greater module adherence than CBT-SF. There were no significant differences in completion or attrition rates between groups.
Our findings suggest that the HE control had adequate face validity, was delivered with fidelity and was feasible and suitable for use as a comparator for CBT-SF. In providing a real-world example of practical and theoretical issues we considered when designing this control condition, we aim to provide a framework and guidance for future investigators.
ACTRN12617000879369 (registered 15/06/2017) and ACTRN12617000878370 (registered 15/06/2017).
Sleep and physical activity are both modifiable behavioural factors that are associated with better health and are potentially related. Following traumatic brain injury, damage to the brain caused by ...an external force, sleep disturbances are common. Exploring bidirectional relationships between sleep and physical activity might provide insight into whether increasing physical activity could decrease these sleep disturbances. The current study, therefore, examined inter‐ and intra‐individual temporal associations between sleep and daytime physical activity in 64 people with traumatic brain injury reporting sleep problems or fatigue (47 males; mean age, 40 years). Sleep and physical activity were measured using actigraphy with corroborating sleep diaries over 14 consecutive days. Multilevel models were used to examine inter‐ and intra‐individual associations between physical activity and sleep. Inter‐individual variations showed that earlier bedtimes, earlier wake‐up times and lower sleep efficiency were associated with more physical activity. Intra‐individual temporal variations showed no significant association of daytime physical activity with sleep duration or continuity. However, shorter sleep time and less wake after sleep onset than usual were associated with more time spent in light‐intensity activity the next day. Therefore, sleep may have more of an influence on physical activity than physical activity has on sleep in people with traumatic brain injury. In conclusion, the results do not confirm a potential beneficial effect of physical activity on sleep but suggest that improving sleep quality might be relevant to support of a physically active lifestyle in people with traumatic brain injury. Further research is necessary to confirm these results.
To identify factors associated with treatment response to cognitive behavioral therapy for sleep disturbance and fatigue (CBT-SF) after acquired brain injury (ABI).
Community dwelling.
Thirty ...participants with a traumatic brain injury or stroke randomized to receive CBT-SF in a parent randomized controlled trial.
Participants took part in a parallel-groups, parent randomized controlled trial with blinded outcome assessment, comparing an 8-week CBT-SF program with an attentionally equivalent health education control. They were assessed at baseline, post-treatment, 2 months post-treatment, and 4 months post-treatment. The study was completed either face-to-face or via telehealth (videoconferencing). Following this trial, a secondary analysis of variables associated with treatment response to CBT-SF was conducted, including: demographic variables; injury-related variables; neuropsychological characteristics; pretreatment sleep disturbance, fatigue, depression, anxiety and pain; and mode of treatment delivery (face-to-face or telehealth).
Pittsburgh Sleep Quality Index (PSQI) and Fatigue Severity Scale (FSS).
Greater treatment response to CBT-SF at 4-month follow-up was associated with higher baseline sleep and fatigue symptoms. Reductions in fatigue on the FSS were also related to injury mechanism, where those with a traumatic brain injury had a more rapid and short-lasting improvement in fatigue, compared with those with stroke, who had a delayed but longer-term reduction in fatigue. Mode of treatment delivery did not significantly impact CBT-SF outcomes.
Our findings highlight potential differences between fatigue trajectories in traumatic brain injury and stroke, and also provide preliminary support for the equivalence of face-to-face and telehealth delivery of CBT-SF in individuals with ABI.
•Sleep disturbance and fatigue are highly prevalent after acquired brain injury.•Cognitive behavioural therapy improves sleep disturbance and fatigue after injury.•This 8-week treatment is adapted to ...support individuals with cognitive impairments.•Benefits of cognitive behavioural therapy extend over and above health education.•Additional treatment benefits include improved self-efficacy and quality of life.
Sleep disturbance and fatigue are highly prevalent after acquired brain injury (ABI) and are associated with poor functional outcomes. Cognitive behavioural therapy (CBT) is a promising treatment for sleep and fatigue problems after ABI, although comparison with an active control is needed to establish efficacy.
We compared CBT for sleep disturbance and fatigue (CBT-SF) with a health education (HE) intervention to control for non-specific therapy effects.
In a parallel-group, pilot randomised controlled trial, 51 individuals with traumatic brain injury (n = 22) and stroke (n = 29) and clinically significant sleep and/or fatigue problems were randomised 2:1 to 8 weeks of a CBT-SF (n = 34) or HE intervention (n = 17), both adapted for cognitive impairments. Participants were assessed at baseline, post-treatment, and 2 and 4 months post-treatment. The primary outcome was the Pittsburgh Sleep Quality Index; secondary outcomes included measures of fatigue, sleepiness, mood, quality of life, activity levels, self-efficacy and actigraphy sleep measures.
The CBT-SF led to significantly greater improvements in sleep quality as compared with HE, during treatment and at 2 months 95% confidence interval (CI) -24.83; -7.71, as well as significant reductions in fatigue maintained at all time points, which were not evident with HE (95% CI -1.86; 0.23). HE led to delayed improvement in sleep quality at 4 months post-treatment and in depression (95% CI -1.37; -0.09) at 2 months post-treatment. CBT-SF led to significant gains in self-efficacy (95% CI 0.15; 0.53) and mental health (95% CI 1.82; 65.06).
CBT-SF can be an effective treatment option for sleep disturbance and fatigue after ABI, over and above HE. HE may provide delayed benefit for sleep, possibly by improving mood.
Australia New Zealand Clinical Trials Registry: ACTRN12617000879369 (registered 15/06/2017) and ACTRN12617000878370 (registered 15/06/2017).
PDF
