Altru Health System, Grand Forks, ND
Dr. Feldman reports no financial relationships relevant to this field of study.
SUMMARY POINTS
- The authors randomized 3,755 university students with positive screens for insomnia to receive either online cognitive behavioral therapy (CBT) via a sleep-oriented program, aptly named Sleepio, or treatment as usual.
- The primary outcome measures were insomnia, paranoia, and hallucinations; secondary measures included depression and anxiety.
- At week 10, the group receiving digital CBT had significantly reduced insomnia compared to the usual treatment group (P < 0.0001); all other outcome measures decreased significantly.
- Statistical analysis suggests that lengthening hours of sleep mediates improvement in psychotic symptoms, depression, and anxiety.
SYNOPSIS: Authors of this large, randomized, controlled study strongly suggest that better sleep leads to improvement in several areas of mental health, and that a digital form of cognitive behavior therapy can significantly help in treatment of insomnia.
SOURCE: Freeman D, Sheaves B, Goodwin GM, et al. The effects of improving sleep on mental health (OASIS): A randomised controlled trial with mediation analysis. Lancet Psychiatry 2017;4:749-758.
Sleep is a basic need. Leaping over geographical and cultural barriers, disorders of sleep affect patients of all ages and genders worldwide.1 A common disorder of sleep, insomnia is defined broadly as difficulty initiating or staying asleep. Given that individuals’ sleep requirements vary, insomnia becomes clinically significant when a patient perceives impairment or functional interference from the sleep disturbance.2
About 10% of patients in primary care clinics have insomnia, but this commonly is overlooked as a diagnosis or factor behind other seemingly unrelated complaints. Insomnia lasting more than one month (chronic insomnia) negatively affects daytime alertness, attention, and cognitive processing. Even shorter bouts of insomnia may affect frequency of headaches, levels of energy, pain, and other medical conditions.1,2,3
Although we know many mental health diagnoses affect sleep, there is growing evidence that sleep disruption itself can lead to mood disorders and thought disorders. With an interest in better understanding the relationship between sleep and mental health, Freeman et al designed a study to investigate the effects of sleep improvement alone on psychotic symptoms (such as paranoia and hallucinations), depression, and anxiety.
The study was designed as a single-blind, randomized, controlled trial of digital cognitive behavioral therapy (CBT) vs. treatment as usual. To promote diversity, participants were recruited from 26 universities across the United Kingdom. All recruitment was via email or website advertisement. Eligibility was quite broad: Participants needed to be enrolled at the university and score 16 or lower on the sleep condition indicator (SCI), an eight-item screening tool for insomnia.4
Notably, a score of ≤ 16 on the SCI generally is accepted as a cutoff for insomnia disorder. The questions on the SCI look at several aspects of sleep, including quantity and quality of sleep, as well as effect on daytime functioning. Higher scores on the SCI (up to 32) indicate better sleep in general.4
The authors randomly assigned 3,755 participants to treatment, with 1,891 subjects in the CBT group and 1,864 in the treatment as usual group. Assessment of multiple outcomes, including insomnia (defined as difficulty initiating or staying asleep and leading to functional impairment), paranoia, hallucinations, symptoms of depression, mania, and psychological well-being, were conducted via online scales at baseline and specified intervals.
The digital form of CBT used to treat insomnia in this study is called Sleepio. This online program and app can be completed in six sessions on any browser and each session lasts about 20 minutes. An initial online assessment determines a personalized, interactive program that includes educational, behavioral, and cognitive sections. Among the techniques used are relaxation, sleep restriction (restricting sleep to certain times), imagery, and sleep hygiene. Sleep diaries play a central role in this approach and allow an animated sleep therapist to propose new sleep windows and interventions based on the sleep diary data.5
Participants were asked to complete online screens measuring the outcomes at baseline, week 3, week 10, and week 22. The week 3 measurement was inserted to help understand timing of the improvements (that is, to try to determine if sleep improved before or after changes in mental health symptoms). At each assessment, subjects were asked about any contact with mental health services, any medication changes, or any new psychological therapy.
Completion of assessments and treatment were low. In both groups, more than 50% of the participants did not complete the assessments, and only 18% of the initial 1,891 subjects in the CBT arm completed the entire six-session course of Sleepio.
However, even controlling for the dropout rate, when compared with the control group, there was significant improvement in SCI scores, indicating improvement in sleep quantity and quality, paranoia, and hallucinations at every measurement point (all P values < 0.001). Table 1 shows data for insomnia from weeks 10 and 22.
Table 1: Mean Score SCI, Weeks 10 and 22 |
||
Mean score for insomnia measured with SCI-8 on 32-point scale, week 10 |
Mean score for insomnia measured with SCI-8 on 32-point scale, week 22 |
|
|
Intervention group (digital cognitive behavioral therapy, “Sleepio”) |
18.08 (SD = 6.66) |
19.27 (SD = 7.13) |
|
Control group (treatment as usual) |
13.31 (SD = 6.45) |
14.43 (SD = 6.71) |
|
P value |
< 0.001 |
< 0.001 |
|
Sleep condition indicator (SCI) cutoff score for insomnia disorder is ≤ 16. |
||
Freeman et al sought to determine if the sleep improvement mediated the changes in paranoia and hallucinations. Mediation analysis determined that improvement in sleep by week 3 could be responsible for about half of the total reduction in psychotic experiences reported by week 22.
Scales measuring depressive symptoms, anxiety, and psychological well-being all showed sustained improvement over the course of the study. (See Tables 2-4.) Other notable findings were that the two study arms were matched evenly for contact with mental health services during the trial period. No adverse events were reported. However, the mean score on the mania scale was increased slightly in the intervention group.
Table 2: Depression Measured via Patient Health Questionnaire (PHQ-9) |
||
Control group (treatment as usual) |
Intervention group (digital CBT-Sleepio) |
|
|
Week 10 |
11.27 |
8.44 |
|
Week 22 |
10.34 |
8.00 |
|
CBT: cognitive behavioral therapy; mean values; P < 0.0001 |
||
Table 3: Anxiety Measured via Generalized Anxiety Disorder 7 (GAD-7) |
||
Control group (treatment as usual) |
Intervention group (digital CBT-Sleepio) |
|
|
Week 10 |
8.35 |
6.53 |
|
Week 22 |
7.67 |
6.14 |
|
CBT: cognitive behavioral therapy; mean values; P < 0.0001 |
||
Table 4: Psychological Well-being Measured via Warwick-Edinburgh Mental Wellbeing Scale |
||
Control group (treatment as usual) |
Intervention group (digital CBT-Sleepio) |
|
|
Week 10 |
38.73 |
40.92 |
|
Week 22 |
39.63 |
42.12 |
|
CBT: cognitive behavioral therapy; mean values; P < 0.0001 |
||
COMMENTARY
On the surface, this investigation of the relationship between sleep improvement and mental health disorders may be viewed as a study of primary interest to providers treating patients with mental health impairments. However, on second glance, the applicability of this study to a wider range of patients is clear.
The main goal of this study — determining if sleep improvement decreases mental health impairment — required first achieving significant sleep improvement. A large number of participants was needed to power the study. The 3,755 subjects were all university students with insomnia, only some of whom had mental health problems. For ease of application and accessibility to university students across the United Kingdom, digital CBT was chosen as the intervention to improve sleep. The results in sleep improvement alone are impressive and seem to have widespread relevance to this population.
Freeman et al noted that these results very well may be applicable to a larger adult population, as Sleepio was developed for adults and there was no modification in protocol for this student population. In fact, the significant improvement in sleep in this study is similar to the improvement in sleep found in previously published trials with general adult participants.
Although part of the excitement from the study results is linked to the reduction of insomnia with internet-based CBT, that was not the primary aim of this study. The primary focus was to determine if the reduction in insomnia would reduce emergence of paranoia and hallucinations. The secondary focus was determine if the intervention improved depression and anxiety symptoms while helping psychological well-being. The significant results and mediation analysis point to a direct (but not complete) link between improvement in sleep and these other outcome measures.
Some clear limitations of this study include the high dropout rate, the reliance on self-reported questionnaires, the self-selection of participants, and the lack of exclusion criteria. All of these factors may have introduced bias into the results. In particular, the high rate of noncompletion of the entire Sleepio protocol most likely skewed the results, as it is unknown why the participants stopped the treatment. The dropout rate in this study is similar to other online digital CBT trials;6 future direction in this field should include an investigation into characteristics of participants who are most likely to complete the protocol. Continuing efforts to involve broad representative populations as participants will be useful as well.
It is unclear from this study if there is a clinical significance to the slight increase in mean scores on the mania scales in the group receiving digital CBT. It may be that this group actually was reporting elevated mood and energy, but this warrants further investigation before making firm conclusions.
Overall, the study results make it clear that when university students present with insomnia, addressing the sleep problem vigorously with digital CBT may reduce the severity of mental health symptoms, such as depression, anxiety, and even paranoia. A bit less clear, but strongly suggested,
is that when university students present with mental health symptoms, addressing sleep issues vigorously may lessen the severity of these symptoms.
As this was not a head-to-head comparison of interventions to improve sleep, we have no information regarding the efficacy of digital CBT compared to pharmacotherapy or other forms of psychotherapy. Obtaining good sleep or improving insomnia by any appropriate intervention may have the same effect. However, this conclusion is premature and requires future confirmation.
A take-home message for integrative and primary care providers: Strongly consider insomnia treatment as a focus for intervention when patients present with symptoms of mental health disorders. A review of the effect of CBT and awareness of the types of digital CBT may be useful in discussions with patients. Although we cannot conclude directly from this study which patients will benefit most from digital CBT, thinking about offering this technique for intervention opens new options in creating a comprehensive, individualized treatment plan. The results of this study hold implications for future research on the pivotal role of sleep in mental health and validate the importance of addressing sleep quality and quantity in treatment of specific symptoms and disorders.
REFERENCES
- Stranges S, Tigbe W, Gomez-Olive FX, et al. Sleep problems: An emerging global epidemic? Findings from the INDEPTH WHO-SAGE study among more than 40,000 older adults from 8 countries across Africa and Asia. Sleep 2012;35;1173-1181.
- Grandner MA, Chakravorty S. Insomnia in primary care: Misreported, mishandled, and just plain missed. J Clin Sleep Med 2017;13:937-939.
- Goodie JL, Hunter CL. Practical guidance for targeting insomnia in primary care settings. Available at: https://www.sbm.org/UserFiles/file/PracticalGuidanceforTargetingInsomniainPrimaryCareSettings_GoodieHunter_2014.pdf. Accessed July 16, 2018.
- Espie CA, Kyle SD, Hames P, et al The Sleep Condition Indicator: A clinical screening tool to evaluate insomnia disorder. BMJ Open 2014;4:e004183.
- Sleepio. Available at: https://www.sleepio.com/. Accessed July 8, 2018.
- Christensen H, Batterham PJ, Gosling JA, et al. Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): A randomized controlled trial. Lancet Psychiatry 2016;3:333-341.
Authors of this large, randomized, controlled study strongly suggest that better sleep leads to improvement in several areas of mental health, and that a digital form of cognitive behavior therapy can significantly help in treatment of insomnia.
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