OBJECTIVE: Although four meta-analytic reviews support the efficacy of pharmacotherapy and behavior therapy for the treatment of insomnia, no meta-analysis has evaluated whether these treatment modalities yield comparable outcomes during acute treatment. The authors conducted a quantitative review of the literature on the outcome of the two treatments to compare the short-term efficacy of pharmacotherapy and behavioral therapy in primary insomnia. METHOD: They identified studies from 1966 through 2000 using MEDLINE, psycINFO, and bibliographies. Investigations were limited to studies using prospective measures and within-subject designs to assess the efficacy of benzodiazepines or benzodiazepine receptor agonists or behavioral treatments for primary insomnia. Benzodiazepine receptor agonists included zolpidem, zopiclone, and zaleplon. Behavioral treatments included stimulus control and sleep restriction therapies. Twenty-one studies summarizing outcomes for 470 subjects met inclusion criteria. RESULTS: Weighted effect sizes for subjective measures of sleep latency, number of awakenings, wake time after sleep onset, total sleep time, and sleep quality before and after treatment were moderate to large. There were no differences in magnitude between pharmacological and behavioral treatments in any measures except latency to sleep onset. Behavior therapy resulted in a greater reduction in sleep latency than pharmacotherapy. CONCLUSIONS: Overall, behavior therapy and pharmacotherapy produce similar short-term treatment outcomes in primary insomnia.
OBJECTIVE: The effects of dialectical behavior therapy adapted for the treatment of binge/purge behaviors were examined. METHOD: Thirty-one women (averaging at least one binge/purge episode per week) were randomly assigned to 20 weeks of dialectical behavior therapy or 20 weeks of a waiting-list comparison condition. The manual-based dialectical behavior therapy focused on training in emotion regulation skills. RESULTS: An intent-to-treat analysis showed highly significant decreases in binge/purge behavior with dialectical behavior therapy compared to the waiting-list condition. No significant group differences were found on any of the secondary measures. CONCLUSIONS: The use of dialectical behavior therapy adapted for treatment of bulimia nervosa was associated with a promising decrease in binge/purge behaviors.
CONTEXT: Dialectical behavior therapy (DBT) is a treatment for suicidal behavior and borderline personality disorder with well-documented efficacy. OBJECTIVE: To evaluate the hypothesis that unique aspects of DBT are more efficacious compared with treatment offered by non-behavioral psychotherapy experts. DESIGN: One-year randomized controlled trial, plus 1 year of posttreatment follow-up. SETTING: University outpatient clinic and community practice. PARTICIPANTS: One hundred one clinically referred women with recent suicidal and self-injurious behaviors meeting DSM-IV criteria, matched to condition on age, suicide attempt history, negative prognostic indication, and number of lifetime intentional self-injuries and psychiatric hospitalizations. INTERVENTION: One year of DBT or 1 year of community treatment by experts (developed to maximize internal validity by controlling for therapist sex, availability, expertise, allegiance, training and experience, consultation availability, and institutional prestige). MAIN OUTCOME MEASURES: Trimester assessments of suicidal behaviors, emergency services use, and general psychological functioning. Measures were selected based on previous outcome studies of DBT. Outcome variables were evaluated by blinded assessors. RESULTS: Dialectical behavior therapy was associated with better outcomes in the intent-to-treat analysis than community treatment by experts in most target areas during the 2-year treatment and follow-up period. Subjects receiving DBT were half as likely to make a suicide attempt (hazard ratio, 2.66; P = .005), required less hospitalization for suicide ideation (F(1,92) = 7.3; P = .004), and had lower medical risk (F(1,50) = 3.2; P = .04) across all suicide attempts and self-injurious acts combined. Subjects receiving DBT were less likely to drop out of treatment (hazard ratio, 3.2; P < .001) and had fewer psychiatric hospitalizations (F(1,92) = 6.0; P = .007) and psychiatric emergency department visits (F(1,92) = 2.9; P = .04). CONCLUSIONS: Our findings replicate those of previous studies of DBT and suggest that the effectiveness of DBT cannot reasonably be attributed to general factors associated with expert psychotherapy. Dialectical behavior therapy appears to be uniquely effective in reducing suicide attempts.
CONTEXT: Tourette disorder is a chronic and typically impairing childhood-onset neurologic condition. Antipsychotic medications, the first-line treatments for moderate to severe tics, are often associated with adverse effects. Behavioral interventions, although promising, have not been evaluated in large-scale controlled trials. OBJECTIVE: To determine the efficacy of a comprehensive behavioral intervention for reducing tic severity in children and adolescents. DESIGN, SETTING, AND PARTICIPANTS: Randomized, observer-blind, controlled trial of 126 children recruited from December 2004 through May 2007 and aged 9 through 17 years, with impairing Tourette or chronic tic disorder as a primary diagnosis, randomly assigned to 8 sessions during 10 weeks of behavior therapy (n = 61) or a control treatment consisting of supportive therapy and education (n = 65). Responders received 3 monthly booster treatment sessions and were reassessed at 3 and 6 months following treatment. INTERVENTION: Comprehensive behavioral intervention. MAIN OUTCOME MEASURES: Yale Global Tic Severity Scale (range 0-50, score >15 indicating clinically significant tics) and Clinical Global Impressions-Improvement Scale (range 1 [very much improved] to 8 [very much worse]). RESULTS: Behavioral intervention led to a significantly greater decrease on the Yale Global Tic Severity Scale (24.7 [95% confidence interval {CI}, 23.1-26.3] to 17.1 [95% CI, 15.1-19.1]) from baseline to end point compared with the control treatment (24.6 [95% CI, 23.2-26.0] to 21.1 [95% CI, 19.2-23.0]) (P < .001; difference between groups, 4.1; 95% CI, 2.0-6.2) (effect size = 0.68). Significantly more children receiving behavioral intervention compared with those in the control group were rated as being very much improved or much improved on the Clinical Global Impressions-Improvement scale (52.5% vs 18.5%, respectively; P < .001; number needed to treat = 3). Attrition was low (12/126, or 9.5%); tic worsening was reported by 4% of children (5/126). Treatment gains were durable, with 87% of available responders to behavior therapy exhibiting continued benefit 6 months following treatment. CONCLUSION: A comprehensive behavioral intervention, compared with supportive therapy and education, resulted in greater improvement in symptom severity among children with Tourette and chronic tic disorder. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00218777.
BASIC CONSIDERATIONS. The Essence of Behavior Therapy. Conceptual Issues in Behavioral Assessment. Methods of Behavioral Assessment. The Therapeutic Relationship. CURRENT BEHAVIOR THERAPY TECHNIQUES. Relaxation Training. Systematic Desensitization. Behavior Rehearsal. Cognitive Relabeling. Problem Solving. Reinforcement Procedures. DECISIONS FOR CLINICAL APPLICATIONS. Selected Clinical Problems. Extended Case Illustration. The Ethics of Behavior Change. AN OVERVIEW OF CLINICAL BEHAVIOR THERAPY. Clinical Behavior Therapy: Two Decades Later. References. Indexes.
We have treated 20 autistic children with behavior therapy. At intake, most of the children were severely disturbed, having symptoms indicating an extremely poor prognosis. The children were treated in separate groups, and some were treated more than once, allowing for within- and between-subject replications of treatment effects. We have employed reliable measures of generalization across situations and behaviors as well as across time (follow-up). The findings can be summarized as follows: (1) Inappropriate behaviors (self-stimulation and echolalia) decreased during treatment, and appropriate behaviors (appropriate speech, appropriate play, and social non-verbal behaviors) increased. (2) Spontaneous social interactions and the spontaneous use of language occurred about eight months into treatment for some of the children. (3) IQs and social quotients reflected improvement during treatment. (4) There were no exceptions to the improvement, however, some of the children improved more than others. (5) Follow-up measures recorded 1 to 4 yr after treatment showed that large differences between groups of children depended upon the post-treatment environment (those groups whose parents were trained to carry out behavior therapy continued to improve, while children who were institutionalized regressed). (6) A brief reinstatement of behavior therapy could temporarily re-establish some of the original therapeutic gains made by the children who were subsequently institutionalized.
Foreword, Aaron T. Beck 1. Introduction to Cognitive Therapy 2. Overview of Treatment 3. Cognitive Conceptualization 4. The Evaluation Session 5. Structure of the First Therapy Session 6. Behavioral Activation 7. Session 2 and Beyond: Structure and Format 8. Problems with Structuring the Therapy Session 9. Identifying Automatic Thoughts 10. Identifying Emotions 11. Evaluating Automatic Thoughts 12. Responding to Automatic Thoughts 13. Identifying and Modifying Intermediate Beliefs 14. Identifying and Modifying Core Beliefs 15. Additional Cognitive and Behavioral Techniques 16. Imagery 17. Homework 18. Termination and Relapse Prevention 19. Treatment Planning 20. Problems in Therapy 21. Progressing as a Cognitive Therapist Appendices Appendix A. Cognitive Case Write-Up Appendix B. Cognitive Behavior Therapy Resources Appendix C. Cognitive Therapy Rating Scale
BACKGROUND: Chronic sleep-onset insomnia is a prevalent health complaint in adults. Although behavioral and pharmacological therapies have been shown to be effective for insomnia, no placebo-controlled trials have evaluated their separate and combined effects for sleep-onset insomnia. The objective of this study was to evaluate the clinical efficacy of behavioral and pharmacological therapy, singly and in combination, for chronic sleep-onset insomnia. METHODS: This was a randomized, placebo-controlled clinical trial that involved 63 young and middle-aged adults with chronic sleep-onset insomnia. Interventions included cognitive behavior therapy (CBT), pharmacotherapy, or combination therapy compared with placebo. The main outcome measures were sleep-onset latency as measured by sleep diaries; secondary measures included sleep diary measures of sleep efficiency and total sleep time, objective measures of sleep variables (Nightcap sleep monitor recorder), and measures of daytime functioning. RESULTS: In most measures, CBT was the most sleep effective intervention; it produced the greatest changes in sleep-onset latency and sleep efficiency, yielded the largest number of normal sleepers after treatment, and maintained therapeutic gains at long-term follow-up. The combined treatment provided no advantage over CBT alone, whereas pharmacotherapy produced only moderate improvements during drug administration and returned measures toward baseline after drug use discontinuation. CONCLUSIONS: These findings suggest that young and middle-age patients with sleep-onset insomnia can derive significantly greater benefit from CBT than pharmacotherapy and that CBT should be considered a first-line intervention for chronic insomnia. Increased recognition of the efficacy of CBT and more widespread recommendations for its use could improve the quality of life of a large numbers of patients with insomnia.
We used positron emission tomography to investigate local cerebral metabolic rates for glucose (LCMRG1c) in patients with obsessive-compulsive disorder before and after treatment with either fluoxetine hydrochloride or behavior therapy. After treatment, LCMRG1c in the head of the right caudate nucleus, divided by that in the ipsilateral hemisphere (Cd/hem), was decreased significantly compared with pretreatment values in responders to both drug and behavior therapy. These decreases in responders were also significantly greater than right Cd/hem changes in nonresponders and normal controls, in both of whom values did not change from baseline. Percentage change in obsessive-compulsive disorder symptom ratings correlated significantly with the percent of right Cd/hem change with drug therapy and there was a trend to significance for this same correlation with behavior therapy. By lumping all responders to either treatment, right orbital cortex/hem was significantly correlated with ipsilateral Cd/hem and thalamus/hem before treatment but not after, and the differences before and after treatment were significant. A similar pattern was noted in the left hemisphere. A brain circuit involving these brain regions may mediate obsessive-compulsive disorder symptoms.
We report a quasi-experimental investigation of an adaptation of Dialectical Behavior Therapy (DBT) with a group of suicidal adolescents with borderline personality features. The DBT group (n = 29) received 12 weeks of twice weekly therapy consisting of individual therapy and a multifamily skills training group. The treatment as usual (TAU) group (n = 82) received 12 weeks of twice weekly supportive-psychodynamic individual therapy plus weekly family therapy. Despite more severe pre-treatment symptomatology in the DBT group, at post-treatment this group had significantly fewer psychiatric hospitalizations during treatment, and a significantly higher rate of treatment completion than the TAU group. There were no significant differences in the number of suicide attempts made during treatment. Examining pre-post change within the DBT group, there were significant reductions in suicidal ideation, general psychiatric symptoms, and symptoms of borderline personality. DBT appears to be a promising treatment for suicidal adolescents with borderline personality characteristics.
Introduction. Fairburn, This Book and How to Use It. Fairburn, Eating Disorders: The Transdiagnostic View and the Cognitive Behavioral Theory. Fairburn, Cooper, Shafran, Enhanced Cognitive Behavior Therapy for Eating Disorders (CBT-E): An Overview. Fairburn, Cooper, Waller, The Patients: Their Assessment, Preparation for Treatment and Medical Management. Fairburn, Cooper, Shafran, Bohn, Hawker, Murphy, Straebler, Enhanced Cognitive Behavior Therapy for Eating Disorders: The Core Protocol. Starting Well. Achieving Early Change. Taking Stock and Designing the Rest of Treatment. Shape Concern. Shape Checking. Feeling Fat and Mindsets. Dietary Restraint, Dietary Rules and Controlling Eating. Events, Moods and Eating. Underweight and Under-eating. Ending Well. Adaptations of CBT-E. Fairburn, Cooper, Shafran, Bohn, Hawker, Clinical Perfectionism, Core Low Self-esteem and Interpersonal Problems. Cooper, Stewart, CBT-E and the Younger Patient. Grave, Bohn, Hawker, Fairburn, Inpatient, Day Patient and Two Forms of Outpatient CBT-E. Fairburn, Cooper, Waller, 'Complex Cases' and Comorbidity. Postscript. Fairburn, Looking Forward. Appendices. Fairburn, Cooper, O'Connor, Appendix A: Eating Disorder Examination (16.0D). Fairburn, Beglin, Appendix B: Eating Disorder Examination Questionnaire (EDE-Q6.0). Bohn, Fairburn, Appendix C: Clinical Impairment Assessment Questionnaire (CIA 3.0).
BACKGROUND: Anxiety disorders are common psychiatric conditions affecting children and adolescents. Although cognitive behavioral therapy and selective serotonin-reuptake inhibitors have shown efficacy in treating these disorders, little is known about their relative or combined efficacy. METHODS: In this randomized, controlled trial, we assigned 488 children between the ages of 7 and 17 years who had a primary diagnosis of separation anxiety disorder, generalized anxiety disorder, or social phobia to receive 14 sessions of cognitive behavioral therapy, sertraline (at a dose of up to 200 mg per day), a combination of sertraline and cognitive behavioral therapy, or a placebo drug for 12 weeks in a 2:2:2:1 ratio. We administered categorical and dimensional ratings of anxiety severity and impairment at baseline and at weeks 4, 8, and 12. RESULTS: The percentages of children who were rated as very much or much improved on the Clinician Global Impression-Improvement scale were 80.7% for combination therapy (P<0.001), 59.7% for cognitive behavioral therapy (P<0.001), and 54.9% for sertraline (P<0.001); all therapies were superior to placebo (23.7%). Combination therapy was superior to both monotherapies (P<0.001). Results on the Pediatric Anxiety Rating Scale documented a similar magnitude and pattern of response; combination therapy had a greater response than cognitive behavioral therapy, which was equivalent to sertraline, and all therapies were superior to placebo. Adverse events, including suicidal and homicidal ideation, were no more frequent in the sertraline group than in the placebo group. No child attempted suicide. There was less insomnia, fatigue, sedation, and restlessness associated with cognitive behavioral therapy than with sertraline. CONCLUSIONS: Both cognitive behavioral therapy and sertraline reduced the severity of anxiety in children with anxiety disorders; a combination of the two therapies had a superior response rate. (ClinicalTrials.gov number, NCT00052078.)
CONTEXT: Cognitive behavioral therapy (CBT) and hypnotic medications are efficacious for short-term treatment of insomnia, but few patients achieve complete remission with any single treatment. It is unclear whether combined or maintenance therapies would enhance outcome. OBJECTIVES: To evaluate the added value of medication over CBT alone for acute treatment of insomnia and the effects of maintenance therapies on long-term outcome. DESIGN, SETTING, AND PATIENTS: Prospective, randomized controlled trial involving 2-stage therapy for 160 adults with persistent insomnia treated at a university hospital sleep center in Canada between January 2002 and April 2005. INTERVENTIONS: Participants received CBT alone or CBT plus 10 mg/d (taken at bedtime) of zolpidem for an initial 6-week therapy, followed by extended 6-month therapy. Patients initially treated with CBT attended monthly maintenance CBT for 6 months or received no additional treatment and those initially treated with combined therapy (CBT plus 10 mg/d of zolpidem) continued with CBT plus intermittent use of zolpidem or CBT only. MAIN OUTCOME MEASURES: Sleep onset latency, time awake after sleep onset, total sleep time, and sleep efficiency derived from daily diaries (primary outcomes); treatment response and remission rates derived from the Insomnia Severity Index (secondary outcomes). RESULTS: Cognitive behavioral therapy used singly or in combination with zolpidem produced significant improvements in sleep latency, time awake after sleep onset, and sleep efficiency during initial therapy (all P<.001); a larger increase of sleep time was obtained with the combined approach (P = .04). Both CBT alone and CBT plus zolpidem produced similar rates of treatment responders (60% [45/75] vs 61% [45/74], respectively; P = .84) and treatment remissions (39% [29/75] vs 44% [33/74], respectively; P = .52) with the 6-week acute treatment, but combined therapy produced a higher remission rate compared with CBT alone during the 6-month extended therapy phase and the 6-month follow-up period (56% [43/74 and 32/59] vs 43% [34/75 and 28/68]; P = .05). The best long-term outcome was obtained with patients treated with combined therapy initially, followed by CBT alone, as evidenced by higher remission rates at the 6-month follow-up compared with patients who continued to take zolpidem during extended therapy (68% [20/30] vs 42% [12/29]; P = .04). CONCLUSION: In patients with persistent insomnia, the addition of medication to CBT produced added benefits during acute therapy, but long-term outcome was optimized when medication is discontinued during maintenance CBT. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00042146.
CONTEXT: Use of nonpharmacological behavioral therapy has been suggested for treatment of chronic primary insomnia, but well-blinded, placebo-controlled trials demonstrating effective behavioral therapy for sleep-maintenance insomnia are lacking. OBJECTIVE: To test the efficacy of a hybrid cognitive behavioral therapy (CBT) compared with both a first-generation behavioral treatment and a placebo therapy for treating primary sleep-maintenance insomnia. DESIGN AND SETTING: Randomized, double-blind, placebo-controlled clinical trial conducted at a single academic medical center, with recruitment from January 1995 to July 1997. PATIENTS: Seventy-five adults (n = 35 women; mean age, 55.3 years) with chronic primary sleep-maintenance insomnia (mean duration of symptoms, 13.6 years). INTERVENTIONS: Patients were randomly assigned to receive CBT (sleep education, stimulus control, and time-in-bed restrictions; n = 25), progressive muscle relaxation training (RT; n = 25), or a quasi-desensitization (placebo) treatment (n = 25). Outpatient treatment lasted 6 weeks, with follow-up conducted at 6 months. MAIN OUTCOME MEASURES: Objective (polysomnography) and subjective (sleep log) measures of total sleep time, middle and terminal wake time after sleep onset (WASO), and sleep efficiency; questionnaire measures of global insomnia symptoms, sleep-related self-efficacy, and mood. RESULTS: Cognitive behavioral therapy produced larger improvements across the majority of outcome measures than did RT or placebo treatment. For example, sleep logs showed that CBT-treated patients achieved an average 54% reduction in their WASO whereas RT-treated and placebo-treated patients, respectively, achieved only 16% and 12% reductions in this measure. Recipients of CBT also showed a greater normalization of sleep and subjective symptoms than did the other groups with an average sleep time of more than 6 hours, middle WASO of 26.6 minutes, and sleep efficiency of 85.1%. In contrast, RT-treated patients continued to report a middle WASO of 43.3 minutes and sleep efficiency of 78.8%. CONCLUSIONS: Our results suggest that CBT represents a viable intervention for primary sleep-maintenance insomnia. This treatment leads to clinically significant sleep improvements within 6 weeks and these improvements appear to endure through 6 months of follow-up.
CONTEXT: The prevalence of posttraumatic stress disorder (PTSD) is elevated among women who have served in the military, but no prior study has evaluated treatment for PTSD in this population. Prior research suggests that cognitive behavioral therapy is a particularly effective treatment for PTSD. OBJECTIVE: To compare prolonged exposure, a type of cognitive behavioral therapy, with present-centered therapy, a supportive intervention, for the treatment of PTSD. DESIGN, SETTING, AND PARTICIPANTS: A randomized controlled trial of female veterans (n=277) and active-duty personnel (n=7) with PTSD recruited from 9 VA medical centers, 2 VA readjustment counseling centers, and 1 military hospital from August 2002 through October 2005. INTERVENTION: Participants were randomly assigned to receive prolonged exposure (n = 141) or present-centered therapy (n = 143), delivered according to standard protocols in 10 weekly 90-minute sessions. MAIN OUTCOME MEASURES: Posttraumatic stress disorder symptom severity was the primary outcome. Comorbid symptoms, functioning, and quality of life were secondary outcomes. Blinded assessors collected data before and after treatment and at 3- and 6-month follow-up. RESULTS: Women who received prolonged exposure experienced greater reduction of PTSD symptoms relative to women who received present-centered therapy (effect size, 0.27; P = .03). The prolonged exposure group was more likely than the present-centered therapy group to no longer meet PTSD diagnostic criteria (41.0% vs 27.8%; odds ratio, 1.80; 95% confidence interval, 1.10-2.96; P = .01) and achieve total remission (15.2% vs 6.9%; odds ratio, 2.43; 95% confidence interval, 1.10-5.37; P = .01). Effects were consistent over time in longitudinal analyses, although in cross-sectional analyses most differences occurred immediately after treatment. CONCLUSIONS: Prolonged exposure is an effective treatment for PTSD in female veterans and active-duty military personnel. It is feasible to implement prolonged exposure across a range of clinical settings. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00032617.
BACKGROUND: Research suggests that cognitive-behavioral therapy (CBT) is the most effective psychotherapeutic treatment for bulimia nervosa. One exception was a study that suggested that interpersonal psychotherapy (IPT) might be as effective as CBT, although slower to achieve its effects. The present study is designed to repeat this important comparison. METHOD: Two hundred twenty patients meeting DSM-III-R criteria for bulimia nervosa were allocated at random to 19 sessions of either CBT or IPT conducted over a 20-week period and evaluated for 1 year after treatment in a multisite study. RESULTS: Cognitive-behavioral therapy was significantly superior to IPT at the end of treatment in the percentage of participants recovered (29% [n=32] vs 6% [n=71), the percentage remitted (48% [n=53] vs 28% [n = 31]), and the percentage meeting community norms for eating attitudes and behaviors (41% [n=45] vs 27% [n=30]). For treatment completers, the percentage recovered was 45% (n= 29) for CBT and 8% (n= 5) for IPT. However, at follow-up, there were no significant differences between the 2 treatments: 26 (40%) CBT completers had recovered at follow-up compared with 17 (27%) IPT completers. CONCLUSIONS: Cognitive-behavioral therapy was significantly more rapid in engendering improvement in patients with bulimia nervosa than IPT. This suggests that CBT should be considered the preferred psychotherapeutic treatment for bulimia nervosa.
Importance: Weight loss improves cardiometabolic risk factors in people with overweight or obesity. Intensive lifestyle intervention and pharmacotherapy are the most effective noninvasive weight loss approaches. Objective: To compare the effects of once-weekly subcutaneous semaglutide, 2.4 mg vs placebo for weight management as an adjunct to intensive behavioral therapy with initial low-calorie diet in adults with overweight or obesity. Design, Setting, and Participants: Randomized, double-blind, parallel-group, 68-week, phase 3a study (STEP 3) conducted at 41 sites in the US from August 2018 to April 2020 in adults without diabetes (N = 611) and with either overweight (body mass index ≥27) plus at least 1 comorbidity or obesity (body mass index ≥30). Interventions: Participants were randomized (2:1) to semaglutide, 2.4 mg (n = 407) or placebo (n = 204), both combined with a low-calorie diet for the first 8 weeks and intensive behavioral therapy (ie, 30 counseling visits) during 68 weeks. Main Outcomes and Measures: The co-primary end points were percentage change in body weight and the loss of 5% or more of baseline weight by week 68. Confirmatory secondary end points included losses of at least 10% or 15% of baseline weight. Results: Of 611 randomized participants (495 women [81.0%], mean age 46 years [SD, 13], body weight 105.8 kg [SD, 22.9], and body mass index 38.0 [SD, 6.7]), 567 (92.8%) completed the trial, and 505 (82.7%) were receiving treatment at trial end. At week 68, the estimated mean body weight change from baseline was -16.0% for semaglutide vs -5.7% for placebo (difference, -10.3 percentage points [95% CI, -12.0 to -8.6]; P < .001). More participants treated with semaglutide vs placebo lost at least 5% of baseline body weight (86.6% vs 47.6%, respectively; P < .001). A higher proportion of participants in the semaglutide vs placebo group achieved weight losses of at least 10% or 15% (75.3% vs 27.0% and 55.8% vs 13.2%, respectively; P < .001). Gastrointestinal adverse events were more frequent with semaglutide (82.8%) vs placebo (63.2%). Treatment was discontinued owing to these events in 3.4% of semaglutide participants vs 0% of placebo participants. Conclusions and Relevance: Among adults with overweight or obesity, once-weekly subcutaneous semaglutide compared with placebo, used as an adjunct to intensive behavioral therapy and initial low-calorie diet, resulted in significantly greater weight loss during 68 weeks. Further research is needed to assess the durability of these findings. Trial Registration: ClinicalTrials.gov Identifier: NCT03611582.
CONTEXT: Panic disorder (PD) may be treated with drugs, psychosocial intervention, or both, but the relative and combined efficacies have not been evaluated in an unbiased fashion. OBJECTIVE: To evaluate whether drug and psychosocial therapies for PD are each more effective than placebo, whether one treatment is more effective than the other, and whether combined therapy is more effective than either therapy alone. DESIGN AND SETTING: Randomized, double-blind, placebo-controlled clinical trial conducted in 4 anxiety research clinics from May 1991 to April 1998. PATIENTS: A total of 312 patients with PD were included in the analysis. INTERVENTIONS: Patients were randomly assigned to receive imipramine, up to 300 mg/d, only (n=83); cognitive-behavioral therapy (CBT) only (n=77); placebo only (n=24); CBT plus imipramine (n=65); or CBT plus placebo (n=63). Patients were treated weekly for 3 months (acute phase); responders were then seen monthly for 6 months (maintenance phase) and then followed up for 6 months after treatment discontinuation. MAIN OUTCOME MEASURES: Treatment response based on the Panic Disorder Severity Scale (PDSS) and the Clinical Global Impression Scale (CGI) by treatment group. RESULTS: Both imipramine and CBT were significantly superior to placebo for the acute treatment phase as assessed by the PDSS (response rates for the intent-to-treat [ITT] analysis, 45.8%, 48.7%, and 21.7%; P=.05 and P=.03, respectively), but were not significantly different for the CGI (48. 2%, 53.9%, and 37.5%, respectively). After 6 months of maintenance, imipramine and CBT were significantly more effective than placebo for both the PDSS (response rates, 37.8%, 39.5%, and 13.0%, respectively; P=.02 for both) and the CGI (37.8%, 42.1%, and 13.0%, respectively). Among responders, imipramine produced a response of higher quality. The acute response rate for the combined treatment was 60.3% for the PDSS and 64.1% for the CGI; neither was significantly different from the other groups. The 6-month maintenance response rate for combined therapy was 57.1% for the PDSS (P=.04 vs CBT alone and P=.03 vs imipramine alone) and 56.3% for the CGI (P=.03 vs imipramine alone), but not significantly better than CBT plus placebo in either analysis. Six months after treatment discontinuation, in the ITT analysis CGI response rates were 41.0% for CBT plus placebo, 31.9% for CBT alone, 19.7% for imipramine alone, 13% for placebo, and 26.3% for CBT combined with imipramine. CONCLUSIONS: Combining imipramine and CBT appeared to confer limited advantage acutely but more substantial advantage by the end of maintenance. Each treatment worked well immediately following treatment and during maintenance; CBT appeared durable in follow-up. JAMA. 2000;283:2529-2536
STUDY OBJECTIVE: Insomnia impacts the course of major depressive disorder (MDD), hinders response to treatment, and increases risk for depressive relapse. This study is an initial evaluation of adding cognitive behavioral therapy for insomnia (CBTI) to the antidepressant medication escitalopram (EsCIT) in individuals with both disorders. DESIGN AND SETTING: A randomized, controlled, pilot study in a single academic medical center. PARTICIPANTS: 30 individuals (61% female, mean age 35 +/- 18) with MDD and insomnia. INTERVENTIONS: EsCIT and 7 individual therapy sessions of CBTI or CTRL (quasi-desensitization). MEASUREMENTS AND RESULTS: Depression was assessed with the HRSD17 and the depression portion of the SCID, administered by raters masked to treatment assignment, at baseline and after 2, 4, 6, 8, and 12 weeks of treatment. The primary outcome was remission of MDD at study exit, which required both an HRSD17 score < or =7 and absence of the 2 core symptoms of MDD. Sleep was assessed with the insomnia severity index (ISI), daily sleep diaries, and actigraphy. EsCIT + CBTI resulted in a higher rate of remission of depression (61.5%) than EsCIT + CTRL (33.3%). EsCIT + CBTI was also associated with a greater remission from insomnia (50.0%) than EsCIT + CTRL (7.7%) and larger improvement in all diary and actigraphy measures of sleep, except for total sleep time. CONCLUSIONS: This pilot study provides evidence that augmenting an antidepressant medication with a brief, symptom focused, cognitive-behavioral therapy for insomnia is promising for individuals with MDD and comorbid insomnia in terms of alleviating both depression and insomnia.
OBJECTIVE: Cognitive-behavioral therapy (CBT) is frequently used for various adult anxiety disorders, but there has been no systematic review of the efficacy of CBT in randomized placebo-controlled trials. The present study meta-analytically reviewed the efficacy of CBT versus placebo for adult anxiety disorders. DATA SOURCES: We conducted a computerized search for treatment outcome studies of anxiety disorders from the first available date to March 1, 2007. We searched MEDLINE, PsycINFO, PubMed, Scopus, the Institute of Scientific Information, and Dissertation Abstracts International for the following terms: random*, cognitive behavior*therap*, cognitive therap*, behavior*therap*, GAD, generalized anxiety disorder, OCD, obsessive compulsive disorder, social phobia, social anxiety disorder, specific phobia, simple phobia, PTSD, post-traumatic stress disorder, and acute stress disorder. Furthermore, we examined reference lists from identified articles and asked international experts to identify eligible studies. STUDY SELECTION: We included studies that randomly assigned adult patients between ages 18 and 65 years meeting DSM-III-R or DSM-IV criteria for an anxiety disorder to either CBT or placebo. Of 1165 studies that were initially identified, 27 met all inclusion criteria. DATA EXTRACTION: The 2 authors independently identified the eligible studies and selected for each study the continuous measures of anxiety severity. Dichotomous measures reflecting treatment response and continuous measures of depression severity were also collected. Data were extracted separately for completer (25 studies for continuous measures and 21 studies for response rates) and intent-to-treat (ITT) analyses (6 studies for continuous measures and 8 studies for response rates). DATA SYNTHESIS: There were no significant differences in attrition rates between CBT and placebo. Random-effects models of completer samples yielded a pooled effect size (Hedges' g) of 0.73 (95% CI = 0.88 to 1.65) for continuous anxiety severity measures and 0.45 (95% CI = 0.25 to 0.65) for depressive symptom severity measures. The pooled odds ratio for completer treatment response rates was 4.06 (95% CI = 2.78 to 5.92). The strongest effect sizes were observed in obsessive-compulsive disorder and acute stress disorder, and the weakest effect size was found in panic disorder. The advantage of CBT over placebo did not depend on placebo modality, number of sessions, or study year. CONCLUSIONS: Our review of randomized placebo-controlled trials indicates that CBT is efficacious for adult anxiety disorders. There is, however, considerable room for improvement. Also, more studies need to include ITT analyses in the future.