Effects of cognitive behavioral therapy for insomnia and armodafinil on quality of life in cancer survivors: a randomized placebo-controlled trial

Abstract • Background: Attention Deficit Hyperactivity Disorder (ADHD) is frequently associated with emotional dysregulation (ED). ED is characterized by excessive and inappropriate emotional reactions compared to social norms, uncontrolled and rapid shifts in emotion, and attention focused on emotional stimuli. Few studies have evaluated non-pharmacological interventions to improve ED in children with ADHD. The current randomized controlled trial assesses the efficacy of a Cognitive-Behavioral Therapy (CBT) intervention compared with a theater-based intervention (TBI) in children with ADHD and ED. • Methods: Sixty-eight 7 to 13-year-old children with ADHD and ED will be recruited and randomly assigned to the CBT or TBI group. CBT aims to reduce ED by teaching anger management strategies. TBI seeks to reduce ED by improving emotion understanding and expression through mimics and movement. In both groups, children participate in 15 one-hour sessions, and parents participate in 8 sessions of a parent management program. The primary outcome measure is the change in the “Aggression” sub-score of the Child Behavior Checklist (CBCL). Secondary outcome measures include overall impairment (Children’s Global Assessment Scale, Strengths and Difficulties Questionnaire), personality profile (Hierarchical Personality Inventory for Children), executive function (Behavioral Rating Inventory of Executive Function), quality of life (Kidscreen-27), parental stress (Parenting Stress Index, 4th edition), parental depression (Beck Depression Inventory-II), and impact of child disorders on the quality of the family life (Parental Quality of Life and Developmental Disorder). • Discussion: Children with ADHD and ED are at risk of functional impairment and poor outcomes, and have specific therapeutic needs. This randomized controlled trial wants to assess non-pharmacological treatment options for this population. • Trial registration:Clinicaltrials.gov. Number: NCT03176108. Registered on June 5, 2017

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Acupuncture Versus Cognitive Behavioral Therapy for Insomnia in Cancer Survivors: A Randomized Clinical Trial

JNCI Journal of the National Cancer Institute ◽

10.1093/jnci/djz050 ◽

2019 ◽

Vol 111 (12) ◽

pp. 1323-1331 ◽

Cited By ~ 14

Author(s):

Sheila N Garland ◽

Sharon X Xie ◽

Kate DuHamel ◽

Ting Bao ◽

Qing Li ◽

...

Keyword(s):

Quality Of Life ◽

Confidence Interval ◽

Cognitive Behavioral Therapy ◽

Cancer Survivors ◽

Comparative Effectiveness ◽

Behavioral Therapy ◽

Cognitive Behavioral ◽

Hypnotic Medication ◽

Insomnia Severity

AbstractBackgroundInsomnia is a common and debilitating disorder experienced by cancer survivors. Although cancer survivors express a preference for using nonpharmacological treatment to manage insomnia, the comparative effectiveness between acupuncture and Cognitive Behavioral Therapy for Insomnia (CBT-I) for this disorder is unknown.MethodsThis randomized trial compared 8 weeks of acupuncture (n = 80) and CBT-I (n = 80) in cancer survivors. Acupuncture involved stimulating specific points on the body with needles. CBT-I included sleep restriction, stimulus control, cognitive restructuring, relaxation training, and education. We measured insomnia severity (primary outcome), pain, fatigue, mood, and quality of life posttreatment (8 weeks) with follow-up until 20 weeks. We used linear mixed-effects models for analyses. All statistical tests were two-sided.ResultsThe mean age was 61.5 years and 56.9% were women. CBT-I was more effective than acupuncture posttreatment (P < .001); however, both acupuncture and CBT-I produced clinically meaningful reductions in insomnia severity (acupuncture: −8.31 points, 95% confidence interval = −9.36 to −7.26; CBT-I: −10.91 points, 95% confidence interval = −11.97 to −9.85) and maintained improvements up to 20 weeks. Acupuncture was more effective for pain at the end of treatment; both groups had similar improvements in fatigue, mood, and quality of life and reduced prescription hypnotic medication use. CBT-I was more effective for those who were male (P < .001), white (P = .003), highly educated (P < .001), and had no pain at baseline (P < .001).ConclusionsAlthough both treatments produced meaningful and durable improvements, CBT-I was more effective and should be the first line of therapy. The relative differences in the comparative effectiveness between the two interventions for specific groups should be confirmed in future adequately powered trials to guide more tailored interventions for insomnia.

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