CRITICALLY APPRAISED PAPER (CAP) Gellis, L. A., Arigo, D., & Elliott, J. C. (2013). Cognitive refocusing treatment for insomnia: A randomized controlled trial in university students. Behavior Therapy, 44(1), 100 110. https://doi.org/10.1016/j.beth.2012.07.004 CLINICAL BOTTOM LINE This study suggests that sleep hygiene education can improve sleep quality among university students, even though the effect may stay longer when the treatment is combined with cognitive refocusing treatment for insomnia (CRT-I). As listed in the Occupational Therapy Practice Framework (3rd ed.; American Occupational Therapy Association [AOTA], 2014), rest and sleep is an occupation, whereas sleep in general (including quality of sleep) is listed under client factors. Furthermore, the Framework also includes habits and routines as part of a person s performance patterns (AOTA, 2014). This study shows the importance of changing university students cognitive routines (thought processes) and habits regarding sleep preparation and hygiene to foster better quality sleep. Even though this study was limited to students who were enrolled in an introductory psychology course, findings from the study indicate that occupational therapists should emphasize good sleep hygiene practices to promote habit and routine changes when consulting individuals with sleep disturbances (AOTA, 2014). For those who have been diagnosed with insomnia, occupational therapists may want to consider to include CRT-I in the treatment plan. Occupational therapists who plan to implement CRT-I need to seek advanced training before the implementation. RESEARCH OBJECTIVE(S) To assess the efficacy of a technique specifically designed to change the style and content of presleep thoughts to reduce nighttime cognitive arousal and thereby decrease insomnia severity DESIGN TYPE AND LEVEL OF EVIDENCE Level I; randomized controlled trial, pretest posttest design PARTICIPANT SELECTION How were participants recruited and selected to participate? 1
Participants were recruited from psychology classes in a private university during two consecutive semesters. Volunteers received class credit for participating in this investigation, which might be considered biased. However, those surveyed who stated that they were participating only for class research credits were eliminated from the final analysis. Inclusion criteria: Included participants Were 18 years of age or older; Scored 8 or higher on the Insomnia Severity Index; Complained of insomnia longer than 1 month; and Identified waking up after falling asleep, difficulty falling asleep, or waking early for more than 30 minutes at least 3 nights per week for at least 1 month. Exclusion criteria: Those participating in other treatments for sleep disturbance during the study were excluded. PARTICIPANT CHARACTERISTICS N= 51 #/ % Male: 18/(35.3%) #/ % Female: 33/(64.7%) Ethnicity: White: 36 (72%) Asian: 8 (16%) Non-White Hispanic: 3 (6%) African American: 2 (4%) Not reported: 2 2
Disease/disability diagnosis: Insomnia severity: 16 (3.5) Depression severity: 10.1 (4.8) Depression severity, minus sleep item: 7.9 (4.4) Anxiety severity: 9.2 (4.7) Sleep hygiene: 44 (11.6) INTERVENTION AND CONTROL GROUPS Group 1: CRT-I group Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? CRT-I is a method designed to minimize nighttime arousal levels by manipulating the style and content of presleep cognition, thereby decreasing insomnia. CRT-I has been successfully administered to a small sample of veterans with primary insomnia, who showed significant improvement (Gellis, 2012). The participants were first given handouts, then the material was read aloud, with emphasis on the importance of changing thought content from physiologically and emotionally arousing thoughts to nonarousing thoughts to improve sleep. They were then given the opportunity to ask questions to clarify the directives. Each participant worked with the provider to identify three personally meaningful categories of thought scenarios that would capture their attention. They were then directed to focus their attention on one of those categories when trying to go to sleep or on awakening. They were also encouraged to refrain from looking at a clock or engaging in anything that would interrupt their focus on their chosen topic. Sleep hygiene education involved suggestions to alter or eliminate actions and behaviors associated with poor sleep. Participants were instructed to avoid consuming caffeine after noon; eating large meals and consuming alcohol after dinner; smoking, chewing tobacco, or exercising 2 hours before bed; and having a light on when attempting to sleep. Participants were also encouraged to use the bedroom only for sexual activity or sleep. 27 (53%) The primary intervention took place in a classroom at a university in a northeastern U.S. city. The provider was a doctoral candidate in clinical psychology. 3
How often? For how long? One individual session of CRT-I was administered. The CRT-I intervention lasted approximately 30 minutes. Group 2: Sleep hygiene group Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? The active control group participated in sleep hygiene education solely. Sleep hygiene education involved suggestions to alter or eliminate actions and behaviors associated with poor sleep. Participants were instructed to avoid consuming caffeine after noon; eating large meals and consuming alcohol after dinner; smoking, chewing tobacco, or exercising 2 hours before bed, or having a light on when attempting to sleep. Participants were also encouraged to use the bedroom only for sexual activity or sleep. 24 (47%) The primary intervention took place in a classroom at a university in a northeastern U.S. city. The same provider, a doctoral candidate in clinical psychology One individual session of sleep hygiene education was administered. The sleep hygiene intervention was approximately 15 minutes. INTERVENTION BIASES Contamination: The study did not exclude other sleep disorders that might disrupt sleep; therefore, problems such as parasomnias and circadian rhythm disorders disguised as insomnia might have hindered treatment. Class credit was given to students for participation. This could have skewed some of the self-reported results. However, 12 participants (6%) admitted they were only interested in class credits and were eliminated from the final analyses. Co-intervention: 4
A moderate decrease of cognitive arousal occurred in the sleep hygiene only group, presumably because of the sleep hygiene educational component. Cognitive arousal decreased significantly in the CRT-I group, but somatic arousal over time was limited. The decrease in cognitive arousal over both groups could have occurred because of sleep improvement. Timing of intervention: The intervention took place over two consecutive semesters. The authors did not state at what point in the semester the intervention took place. Different times in the semester, such as test times or seasonal affective disorder, could have had an impact on perceived insomnia and depression severity. Site of intervention: The participants completed baseline questionnaires online in the presence of the therapist at the site just before the intervention. Posttreatment measures, however, were completed online at the discretion of the participants. Given the absence of accountability, there was no verification of the identity of actual respondents. Did not use different therapists to provide intervention: The therapist providing the intervention was employed to provide the intervention for both treatment groups. Because of this, it is possible that therapist bias or treatment elements other than the assigned interventions were incorporated into the sessions as a result of the provider s bias when implementing intervention to both groups. Baseline equality: Although group assignment was randomized, baseline equivalence on relevant mental health variables was not achieved. Independent-sample t tests showed higher baseline depression severity, t(35) = 2.3, p =.028; nonsleep depression severity, t(32) = 2.5, p =.017; and anxiety severity, t(49) = 2.1, p =.038, in the sleep hygiene group, as compared with the CRT-I group. MEASURES AND OUTCOMES (Only on measures relevant to occupational therapy practice) Measure 1: Insomnia Severity Index Name/type of measure used: What outcome is measured? Insomnia Severity Index Severity of insomnia 5
Is the measure reliable (as reported in the article)? Is the measure valid (as reported in the article)? When is the measure used? Not Reported Not Reported Pretreatment and posttreatment Measure 2: Pre-Sleep Arousal Scale Name/type of measure used: What outcome is measured? Is the measure reliable as reported in the article? Is the measure valid as reported in the article? When is the measure used? Pre-Sleep Arousal Scale Nighttime hyperarousal: cognitive and somatic components of arousal at bedtime Not Reported Not Reported Pretreatment and posttreatment Measure 3: Treatment Evaluation Questionnaire Name/type of measure used: What outcome is measured? Is the measure reliable as reported in the article? Is the measure valid as reported in the article? When is the measure used? Two items from the Treatment Evaluation Questionnaire Credibility of treatment YES Not Reported YES Not Reported Posttreatment only 6
Measure 4: Patient Health Questionnaire Name/type of measure used: What outcome is measured? Is the measure reliable as reported in the article? Is the measure valid as reported in the article? When is the measure used? Patient Health Questionnaire Severity of depression Not Reported Not Reported Pretreatment and posttreatment Measure 5: Generalized Anxiety Disorder Seven-Item Scale Name/type of measure used: What outcome is measured? Is the measure reliable as reported in the article? Is the measure valid as reported in the article? When is the measure used? Generalized Anxiety Disorder Seven-Item Scale General anxiety over the previous 2 weeks Not Reported Not Reported Pretreatment and posttreatment MEASUREMENT BIASES Were the evaluators blind to treatment status? YES NO The evaluators in this study were aware of which students received which type of cognitive retraining treatments. Therefore, the evaluators might have influenced the results by giving some students, such as those who received the CRT-I intervention, a more favorable evaluation. 7
Was there recall or memory bias? Most of the measurement tools used to gather information for this study relied heavily on self-report documents that ask the participants to recall past experiences compared with their new experiences after receiving the intervention. People typically remember positive memories more than negative ones, which could have led to bias for the participants who were questioned about insomnia and their new experiences with CRT-I. Other measurement biases: There was the possibility of population bias. Readers should use caution in considering the generalizability of these findings to the general population with insomnia, because the sample consisted of college students. Also, this population might be susceptible to other lifestyle circumstances presenting issues related to sleep hygiene behaviors. Simply altering previous habits might have also improved participants sleep while they were receiving the CRT-I intervention. RESULTS In general, participants from both groups agreed that the treatment they received was a reasonable and logical treatment for insomnia. The authors found no significance when examining group differences in regard to adherence to sleep hygiene behaviors. It is worth noting that the randomization did not achieve complete baseline equivalence on mental health related variables. Results showed that compared with the CRT-I, the control group (sleep hygiene only) had significantly higher baseline depression severity, t(35) = 2.3, p =.028; nonsleep depression severity, t(32) = 2.5, p =.017; and anxiety severity, t(49) = 2.1, p =.038. Additionally, both groups showed improvements measured by the Insomnia Severity Index. However, after the authors controlled for baseline anxiety and nonsleep depression, the results showed that participants in the CRT-I group significantly improved sleep over time in comparison with those in the control group, F(1, 46) = 5.1, p =.03. Moreover, after controlling for baseline insomnia severity, the authors found that participants in the CRT-I group were significantly more likely to have a clinically meaningful response (p =.04, odds ratio = 4.8, confidence interval: 1.1, 22.0). Was this study adequately powered (large enough to show a difference)? 8
YES NO The significance values spanned from.479 to.210 in independent-sample t tests, which demonstrates that there was no statistical difference between the CRT-I group and the sleep hygiene group. The authors also used independent-samples t tests in comparing the two groups concerning their consistency of sleep hygiene actions. The significance values ranged from.148 to.977, showing no statistical differences between the groups. If the sample sizes had been larger, the significance values might have been smaller, yielding a statistically significant difference between the CRT-I and sleep hygiene groups and between the two group and their sleep hygiene. Were the analysis methods appropriate? The researchers used a multilevel modeling approach, which takes into account the dependency of repeated measurements that are present for each participant and also takes into consideration missing data rather than omitting those participants who did not have follow-up data. The authors conducted this type of analysis for each of the groups (CRT-I and sleep hygiene) for all three of the outcome variables. This type of analysis technique is appropriate for this type of randomized controlled trial. Were statistics appropriately reported (in written or table format)? The study included a large, concise flow chart regarding the cognitive refocusing method used. It also included a clear table that depicted the final baseline sample characteristics (Table 1) and a table that showed the adjusted means, standard errors, and effect sizes regarding insomnia severity and nighttime arousal at both baseline and follow-up periods (Table 2). Was participant dropout less than 20% in total sample and balanced between groups? YES NO Seven participants disengaged after finishing the baseline measures and acquiring the intervention; however, none of the 7 completed the posttreatment evaluation. The dropout rate was less than 20% (7 of 58 = 12%) and therefore was insignificant. What are the overall study limitations? 9
The study used a sample composed of college students; it is not clear whether these results would apply to a more general clinical sample. Subjective insomnia and treatment consistency were measured retrospectively, which might not have been as valid as continuous measurements taken daily throughout the length of the study. Participants who began an intervention (e.g., antidepressants or sleep aids) before the study were not eliminated. It is possible that therapist bias or treatment elements other than the assigned interventions were incorporated into the sessions. CONCLUSION The study was designed to help individuals retrain their mind to change their thoughts from arousing and sleep disturbing to alternative and more adaptive thought content, resulting in decreased cognitive arousal. This study emphasized that consistency of thought category aids in developing learned associations among the thought categories, which squelches negative, arousing thoughts. After 1 month posttreatment, CRT-I added a statistically significant and moderate clinical effect after the authors accounted for the sleep hygiene control group. However, it is not evident whether these findings can be generalized to the general population with insomnia because the sample consisted of only college students. The results are consistent with conclusive findings from Gellis (2012) that support the theory that because of decreased cognitive arousal, CRT-I can purportedly improve sleep for those who have insomnia, even after only one treatment. Using the CBT-I intervention may help change presleep thoughts and thereby aid in sleep initiation. These findings, along with previous research, suggest that further studies are needed to test this intervention. Future research testing this type of sleep intervention would benefit most by using a community-based sample diagnosed with chronic insomnia so the results can be applied to the general population. References American Occupational Therapy Association. (2014). Occupational therapy practice framework: Domain & process (3rd ed.). American Journal of Occupational Therapy, 68(Suppl. 1), S1 S48. https://doi.org/10.5014/ajot.2014.682006 Gellis, L. A. (2012). An investigation of a cognitive refocusing technique to improve sleep. Psychotherapy, 49, 251 257. https://doi.org/10.1037/a0025746 This work is based on the evidence-based literature review completed by Sarah Kwee, Jen Shaul, Tim Stanbach, Julie Stringari, Tamara Turner, and Faculty Advisor Megan Chang, Ph.D., OTR/L. CAP Worksheet adapted from Critical Review Form Quantitative Studies. Copyright 1998 by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, and M. Westmorland, McMaster University. Used with permission. For personal or educational use only. All other uses require permission from AOTA. Contact: www.copyright.com 10
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