Dose-Response Effects of Cognitive-Behavioral Insomnia Therapy: A Randomized Clinical Trial

Edinger, Jack D.; Wohlgemuth, William K.; Radtke, Rodney A.; Coffman, Cynthia J.; Carney, Colleen E.

doi:10.1093/sleep/30.2.203

Cited by 192 publications

(141 citation statements)

References 29 publications

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“…The observed rate is much higher than the average enrollment rate reported in studies of behavioral treatments for insomnia. In contrast, the enrollment rates in the PRCT are comparable to those reported in previous research (Edinger et al, 2007;Pallesen et al, 2003;Savard et al, 2005). The exact factors that could have contributed to this pattern of enrollment rates are not clear and require further investigation.…”

Section: Discussionsupporting

confidence: 75%

“…Jacobs et al (2004) reported that 27% of eligible participants declined enrollment in a RCT evaluating the effectiveness of cognitive behavior therapy and sleep medication in middle-aged adults with insomnia. In other studies aimed at determining the effects of cognitive behavior therapy only, the percentage of eligible persons who declined enrollment ranged between 26% and 45% (Edinger et al, 2007;Pallesen et al, 2003;Savard, Simrad, Ivers & Morin, 2005).…”

Section: Enrollment Pattern In Rctmentioning

confidence: 99%

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Patterns of Enrollment in Randomized and Preference Trials of Behavioral Treatments for Insomnia

Sidani

Bootzin

Moritz

et al. 2011

JMMSS

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Participants' preferences for treatment may deter enrollment in a randomized clinical trial (RCT). The Partially randomized clinical trial (PRCT) is proposed as an alternative design to increase enrollment rate and enhance representativeness of the sample. There is limited evidence supporting the advantages of the PRCT. This study aimed to examine enrollment and refusal rates, reasons for refusal, and clinical profile of persons who declined participation and those who enrolled, in the context of a RCT and a PRCT. Persons with chronic insomnia completed a questionnaire to determine if they met the eligibility criteria regarding type, frequency, and duration of insomnia. Those who declined participation indicated reasons for refusal. Enrollment rate was computed as the percentage of individuals who took part in the study out of those found eligible. Independent sample t-test was used to compare enrollees and non-enrollees on characteristics of insomnia. The results showed a higher enrollment rate in the RCT than PRCT. Reasons for refusal were similar under the RCT and PRCT. Significant differences between enrollees and non-enrollees were found on fewer characteristics in the RCT than PRCT. The results do not support the advantages of the PRCT in enhancing enrollment of participants in studies evaluating the effectiveness of behavioral treatments of chronic insomnia.

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Section: Discussionsupporting

confidence: 75%

Section: Enrollment Pattern In Rctmentioning

confidence: 99%

Patterns of Enrollment in Randomized and Preference Trials of Behavioral Treatments for Insomnia

Sidani

Bootzin

Moritz

et al. 2011

JMMSS

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“…Thus, it is unclear if the non-completers terminated because they had achieved early improvements in their sleep, if they were unsatisfied with treatment, or if they developed complications with treatment. Given recent evidence that an optimal dose of individual CBT-I is four sessions (36), it is possible that some patients who terminated after four group sessions had already received sufficient therapeutic gains from treatment. Therefore, future research should include an expanded set of variables, including patient expectations, therapeutic alliance, and pattern of medication use (e.g., dose and timing), to provide a more comprehensive evaluation of the potential risk factors for dropout.…”

Section: Discussionmentioning

confidence: 99%

Who is at risk for dropout from group cognitive-behavior therapy for insomnia?

Ong

Kuo

Manber

2008

Journal of Psychosomatic Research

133

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Objective-The aim of the present study was to identify characteristics of patients who are at risk for dropout from a 7-session group cognitive-behavior therapy for insomnia (CBT-I) in a clinic setting using the receiver operating characteristics curve (ROC) approach.Methods-Two separate ROC analyses were conducted using predictor variables taken from questionnaire packets and sleep diaries collected at baseline including age, gender, Beck Depression Inventory (BDI), Morningness-Eveningness Questionnaire, Beliefs and Attitudes about Sleep, use of sleep medication, sleep onset latency (SOL), wake time after sleep onset (WASO), and total sleep time (TST).Results-The first ROC analysis was conducted on the entire sample of 528 patients with treatment completion versus dropout (non-completion) as the outcome variable. No significant predictor variables were found in this analysis. The second ROC analysis was conducted on the 211 patients who did not complete treatment with early termination (prior to fourth session) versus late termination (at or after fourth session) as the outcome variable. The results revealed that patients who reported an average baseline TST < 3.65 hours were at greatest risk for early termination. Sixty percent of patients in this group terminated early compared to 9.3% of patients with TST ≥ 3.65 hours. Among patients with TST ≥ 3.65 hours, 22% of those with BDI scores ≥ 16 were early dropouts compared to 4.3% of those who reported BDI < 16.Conclusion-These findings indicate that short sleep duration and elevated symptoms of depression at baseline are associated with increased risk of early termination from CBT-I.

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“…A biweekly four-session schedule was selected because it has been shown empirically to be the optimal dose/schedule. 61 Participants assigned to this condition also received a 10-mg daily dose of the medication, escitalopram, and they were maintained on this dose throughout the trial as there are no data supporting greater efficacy at a higher dose than 10 mg. The study physician met with each participant in this condition weekly to provide medication instructions and to assess and monitor adverse events; an MD research assistant blinded to conditions and trained in HAMD17 administration completed the HAMD17 ratings.…”

Section: Cbt-i + Admentioning

confidence: 99%

Cognitive Behavioral Insomnia Therapy for Those With Insomnia and Depression: A Randomized Controlled Clinical Trial

Carney

Edinger

Kuchibhatla

et al. 2017

Sleep

Self Cite

153

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Study Objective: To compare cognitive behavioral therapy for insomnia (CBT-I) + antidepressant medication (AD) against treatments that target solely depression or solely insomnia. Design: A blinded, randomized split-plot experimental study. Setting: Two urban academic clinical centers. Participants: 107 participants (68% female, mean age 42 ± 11) with major depressive disorder and insomnia. Interventions: Randomization was to one of three groups: antidepressant (AD; escitalopram) + CBT-I (4 sessions), CBT-I + placebo pill, or AD + 4-session sleep hygiene control (SH). Measurements and Results: Subjective sleep was assessed via 2 weeks of daily sleep diaries (use of medication was covaried in all analyses); although there were no statistically significant group differences detected, all groups improved from baseline to posttreatment on subjective sleep efficiency (SE) and total wake time (TWT) and the effect sizes were large. Objective sleep was assessed via overnight polysomnographic monitoring at baseline and posttreatment; analyses revealed both CBT groups improved on TWT (p = .03), but the AD + SH group worsened. There was no statistically significant effect for PSG SE (p = .07). There was a between groups medium effect observed for the AD + SH and CBT + placebo group differences on diary TWT and both PSG variables. All groups improved significantly from baseline to posttreatment on the Hamilton Rating Scale for Depression (HAMD-17); the groups did not differ. Conclusions: Although all groups self-reported sleeping better after treatment, only the CBT-I groups improved on objective sleep, and AD + SH's sleep worsened. This suggests that we should be treating sleep in those with depression with an effective insomnia treatment and relying on self-report obscures sleep worsening effects. All groups improved on depression, even a group with absolutely no depression-focused treatment component (CBT-I + placebo). The depression effect in CBT-I only group has been reported in other studies, suggesting that we should further investigate the antidepressant properties of CBT-I.

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Dose-Response Effects of Cognitive-Behavioral Insomnia Therapy: A Randomized Clinical Trial

Abstract: Findings suggest that 4 individual, biweekly sessions represents the optimal dosing for the CBT intervention tested. Additional dose-response studies are warranted to test CBT models that contain additional treatment components or are delivered via group therapy.

Cited by 192 publications

References 29 publications

Patterns of Enrollment in Randomized and Preference Trials of Behavioral Treatments for Insomnia

Patterns of Enrollment in Randomized and Preference Trials of Behavioral Treatments for Insomnia

Who is at risk for dropout from group cognitive-behavior therapy for insomnia?

Cognitive Behavioral Insomnia Therapy for Those With Insomnia and Depression: A Randomized Controlled Clinical Trial

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