Augmenting usual care SSRIs with cognitive behavioral therapy for insomnia to improve depression outcomes in youth: Design of a randomized controlled efficacy-effectiveness trial.
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ABSTRACT: Importance
Extant treatments for youth depression are only modestly effective. Alternative approaches are needed to improve health outcomes. A novel approach to improve depression outcomes is suggested by epidemiological studies finding that insomnia often predates and may contribute to depression risk. We test whether treating insomnia among youth starting a new course of SSRI antidepressants improves depression outcomes. This paper describes our study design.Design
2-arm randomized controlled efficacy-effectiveness trial.Setting
A large non-profit health maintenance organization.Participants
165 adolescents aged 12-19 with research-confirmed depression and insomnia diagnoses, starting a new episode of selective serotonin reuptake inhibitor (SSRI) antidepressant treatment prescribed by their usual care provider.Interventions
Two sleep interventions, each 6-7 sessions, both overlaying "treatment as usual" (TAU) SSRIs: a sleep hygiene (SH) attention control condition, and cognitive-behavioral therapy for insomnia (CBTI).Conclusions and relevance
If CBT-I improved sleep is shown to improve depression-related outcomes, this may provide an additional, easily tolerated intervention for an important public health target.Trial registration
clinicaltrials.gov, NCT02290496, https://clinicaltrials.gov/ct2/show/NCT02290496.
SUBMITTER: Clarke G
PROVIDER: S-EPMC7263975 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveMost tests of cognitive behavioral therapy (CBT) for youth anxiety disorders have shown beneficial effects, but these have been efficacy trials with recruited youths treated by researcher-employed therapists. One previous (nonrandomized) trial in community clinics found that CBT did not outperform usual care (UC). The present study used a more stringent effectiveness design to test CBT versus UC in youths referred to community clinics, with all treatment provided by therapists employed in the clinics.MethodA randomized controlled trial methodology was used. Therapists were randomized to training and supervision in the Coping Cat CBT program or UC. Forty-eight youths (56% girls, 8 to 15 years of age, 38% Caucasian, 33% Latino, 15% African-American) diagnosed with DSM-IV anxiety disorders were randomized to CBT or UC.ResultsAt the end of treatment more than half the youths no longer met criteria for their primary anxiety disorder, but the groups did not differ significantly on symptom (e.g., parent report, eta-square = 0.0001; child report, eta-square = 0.09; both differences favoring UC) or diagnostic (CBT, 66.7% without primary diagnosis; UC, 73.7%; odds ratio 0.71) outcomes. No differences were found with regard to outcomes of comorbid conditions, treatment duration, or costs. However, youths receiving CBT used fewer additional services than UC youths (χ(2)(1) = 8.82, p = .006).ConclusionsCBT did not produce better clinical outcomes than usual community clinic care. This initial test involved a relatively modest sample size; more research is needed to clarify whether there are conditions under which CBT can produce better clinical outcomes than usual clinical care. CLINICAL TRIAL REGISTRY INFORMATION: Community Clinic Test of Youth Anxiety and Depression Study, URL: http://clinicaltrials.gov, unique identifier: NCT01005836.
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Project description:Study objectivesThe current archival analyses examine the direct and indirect effects of cognitive behavioral therapy for insomnia (CBT-I) on depression in cancer survivors.MethodsWe report on 67 cancer survivors from a 2 × 2 randomized controlled trial of CBT-I and armodafinil for insomnia, after collapsing across the noneffective study medication conditions (armodafinil/placebo) to create CBT-I (yes/no). Depression and insomnia were assessed before, during the 7-week CBT-I intervention, at postintervention, and 3 months later by the Patient Health Questionnaire and the Insomnia Severity Index, respectively.ResultsMean depression at baseline for all participants was 6.44 (standard error = 0.41, range 0-15). Paired t tests showed that depression improved from baseline to postintervention by 48% (P < .001) in the CBT-I group versus 15% (P = .016) in the non-CBT-I group. Analysis of covariance controlling for baseline found that participants receiving CBT-I had significantly less depression at postintervention (effect size = -0.62; P = .001), compared to those who did not receive CBT-I. These benefits were maintained at the 3-month follow-up. Spearman rank correlations showed that changes in insomnia severity from baseline to postintervention were significantly correlated with concurrent changes in depression (r = .73; P < .001). Path analysis revealed that improvement in depression was mediated by improvement in insomnia severity (P < .001).ConclusionsOur findings provide preliminary support that in cancer survivors, CBT-I reduces depression via improvement in insomnia. Further, this reduction in depression remained stable 3 months after completing CBT-I. This suggests that a CBT-I intervention has a meaningful effect on depression.Clinical trial registrationRegistry: ClinicalTrials.gov; Title: Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy; Identifier: NCT01091974; URL: https://clinicaltrials.gov/ct2/show/record/NCT01091974.
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Project description:Chronic insomnia (symptoms for ≥ 6 months) is the most common sleep disorder, affecting 6% to 10% of adults in the general population, with even higher rates in patients with comorbid conditions (eg, hypertension, 44%; cardiac disease, 44.1%; breathing problems, 41.5%). Traditionally, chronic insomnia occurring with another condition has been considered secondary and rarely received direct treatment because treatment of the primary condition was expected to improve the insomnia. However, this approach often failed because chronic insomnia is maintained by behaviors, cognitions, and associations that patients adopt as they attempt to cope with poor sleep but that end up backfiring (eg, increasing caffeine, spending more time in bed, trying harder to sleep). Cognitive behavioral treatment of insomnia (CBTi) targets those behaviors, cognitions, and associations and is effective across a variety of populations, including those with medical and psychologic comorbidities. Thus, in 2005, a National Institutes of Health expert consensus panel on chronic insomnia recommended dropping the term "secondary insomnia" in favor of the term "comorbid insomnia." Because CBTi does not carry the risks associated with some sleep medications (eg, dependency, polypharmacy, cognitive and psychomotor impairment), it is an attractive option for patients with other conditions. Through the Society of Behavioral Sleep Medicine (www.behavioralsleep.org) and the American Board of Sleep Medicine (www.absm.org), it is possible to find practitioners with expertise in CBTi (as well as other aspects of behavioral sleep medicine) and other behavioral sleep resources. Given the currently limited number of trained practitioners, exploration of alternative delivery methods (eg, briefer protocols, self-help, Internet) to improve access to this highly effective treatment and expanded training in these treatments are warranted.
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Project description:BackgroundInsomnia is common in primary care, can persist after co-morbid conditions are treated, and may require long-term medication treatment. A potential alternative to medications is cognitive behavioral therapy for insomnia (CBT-I).MethodsIn accordance with PRISMA guidelines, we systematically reviewed MEDLINE, EMBASE, the Cochrane Central Register, and PsycINFO for randomized controlled trials (RCTs) comparing CBT-I to any prescription or non-prescription medication in patients with primary or comorbid insomnia. Trials had to report quantitative sleep outcomes (e.g. sleep latency) in order to be included in the analysis. Extracted results included quantitative sleep outcomes, as well as psychological outcomes and adverse effects when available. Evidence base quality was assessed using GRADE.ResultsFive studies met criteria for analysis. Low to moderate grade evidence suggests CBT-I has superior effectiveness to benzodiazepine and non-benzodiazepine drugs in the long term, while very low grade evidence suggests benzodiazepines are more effective in the short term. Very low grade evidence supports use of CBT-I to improve psychological outcomes.ConclusionsCBT-I is effective for treating insomnia when compared with medications, and its effects may be more durable than medications. Primary care providers should consider CBT-I as a first-line treatment option for insomnia.
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Project description:ImportanceBehavioral therapy and cognitive-behavioral therapy (CBT) programs targeting a single class of problems have not been widely implemented. The population of youths with common mental health problems is markedly undertreated.ObjectiveTo determine the effectiveness of a new transdiagnostic CBT program (Mind My Mind [MMM]) compared with management as usual (MAU) in youths with emotional and behavioral problems below the threshold for referral to mental health care.Design, setting, and participantsThis pragmatic, multisite, randomized clinical trial of MMM vs MAU was conducted from September 7, 2017, to August 28, 2019, including 8 weeks of postintervention follow-up, in 4 municipalities in Denmark. Consecutive help-seeking youths were randomized (1:1) to the MMM or the MAU group. Main inclusion criteria were age 6 to 16 years and anxiety, depressive symptoms, and/or behavioral disturbances as a primary problem. Data were analyzed from August 12 to October 25, 2019.InterventionsThe MMM intervention consisted of 9 to 13 weekly, individually adapted sessions of manualized CBT delivered by local psychologists. The MAU group received 2 care coordination visits to enhance usual care.Main outcomes and measuresThe primary outcome was change in mental health problems reported by parents at week 18, using the Strengths and Difficulties Questionnaire (SDQ) Impact scale (range, 0-10 points, with higher scores indicating greater severity of distress and impairment). Primary and secondary outcomes were assessed in the intention-to-treat population at week 18. Maintenance effects were assessed at week 26.ResultsA total of 396 youths (mean [SD] age, 10.3 [2.4] years; 206 [52.0%] boys) were randomized to MMM (n = 197) or MAU (n = 199), with primary outcome data available in 177 (89.8%) and 167 (83.9%), respectively, at 18 weeks. The SDQ Impact score decreased by 2.34 points with MMM and 1.23 with MAU, from initial scores of 4.12 and 4.21, respectively (between-group difference, 1.10 [95% CI, 0.75-1.45]; P < .001; Cohen d = 0.60). Number of responders (≥1-point reduction in SDQ Impact score) was greater with MMM than with MAU (144 of 197 [73.1%] vs 93 of 199 [46.7%]; number needed to treat, 4 [95% CI, 3-6]). Secondary outcomes indicated statistically significant benefits in parent-reported changes of anxiety, depressive symptoms, daily functioning, school attendance, and the principal problem. All benefits were maintained at week 26 except for school attendance.Conclusions and relevanceIn this randomized clinical trial, the scalable transdiagnostic cognitive-behavioral intervention MMM outperformed MAU in a community setting on multiple, clinically relevant domains in youth with emotional and behavioral problems.Trial registrationClinicalTrials.gov Identifier: NCT03535805.
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Project description:We tested whether augmenting conventional depression treatment in youth by treating sleep issues with cognitive behavioral therapy for insomnia (CBT-I) improved depression outcomes. We randomized youth 12-20 years of age to 10 weekly sessions of a sleep hygiene control condition (SH) combined with CBT for depression (CBT-D) (n = 20), or an experimental condition consisting of CBT-I combined with CBT-D (n = 21). We assessed outcomes through 26 weeks of follow-up and found medium-large effects favoring the experimental CBT-I arm on some sleep outcomes (actigraphy total sleep time and Insomnia Severity Index "caseness") and depression outcomes (higher percentage recovered, faster time to recovery), but little effect on other measures. Total sleep time improved by 99 min from baseline to week 12 in the CBT-I arm, but not in the SH arm. In addition, our pilot yielded important products to facilitate future studies: the youth-adapted CBT-I program; the study protocol; estimates of recruitment, retention, and attrition; and performance and parameters of candidate outcome measures. ClinicalTrials.gov Identifier NCT00949689.
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Project description:Insomnia is a common precursor to depression; yet, the potential for insomnia treatment to prevent depression has not been demonstrated. Cognitive behavioral therapy for insomnia (CBT-I) effectively reduces concurrent symptoms of insomnia and depression and can be delivered digitally (dCBT-I); however, it remains unclear whether treating insomnia leads to sustained reduction and prevention of depression. This randomized controlled trial examined the efficacy of dCBT-I in reducing and preventing depression over a 1-year follow-up period. Patients with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) insomnia disorder were randomly assigned to receive dCBT-I or an attentional control. The follow-up sample included 358 patients in the dCBT-I condition and 300 patients in the online sleep education condition. The primary outcome measure was relative rate ratios for depression at 1-year follow-up. Insomnia responses to treatment were also tested as predictors of incident depression at the 1-year follow-up. At 1-year follow-up, depression severity continued to be significantly lower in the dCBT-I condition relative to control. In addition, the number of individuals who reported no depression at 1-year follow-up was 51% higher in the dCBT-I condition relative to control. In those with minimal to no depression at baseline, the incident rate of moderate-to-severe depression at 1-year follow-up was reduced by half in the dCBT-I condition relative to the control condition. dCBT-I showed robust effects as an intervention that prevents depression. Future research should examine dose-response requirements and further characterize mechanisms of action of dCBT-I for depression prevention. Sleep to Prevent Evolving Affective Disorders; NCT02988375.
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Project description:ObjectiveThe current investigation examined the effectiveness of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) in treating child traumatic stress when implemented in community settings on a state-wide level.MethodSeventy-two youths (ages 7-16 years) with a history of documented trauma (sexual or physical abuse, traumatic loss, domestic or community violence) and symptoms of Posttraumatic Stress Disorder (PTSD) received an average of 10 sessions delivered in a state-contracted mental health agency. PTSD symptoms and internalizing and externalizing behavior problems were assessed at pre-treatment and then at 3-, 6-, 9-, and 12-months after intake.ResultsPiecewise hierarchical linear modeling revealed that symptoms of PTSD, as well as internalizing and externalizing problems, decreased significantly over the six months after intake (pretreatment, 3-month, 6-month assessments), and these gains were maintained over the next 6 months (6, 9, and 12 month assessments). Symptoms of externalizing symptoms increased somewhat during the follow-up period, but this change was not statistically significant.ConclusionsThese findings suggest that TF-CBT can be implemented effectively in community settings. Treatment outcomes were similar to those reported in efficacy trials of TF-CBT delivered in specialty clinic settings. Improvements in PTSD symptoms and internalizing and externalizing problems were maintained up to one year after treatment began, although the changes in externalizing symptoms were the least stable.
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