Efficacy of Cognitive Therapy for Body Dysmorphic Disorder: A Randomized Controlled Pilot Trial

Dysfunctional cognitive processes and maladaptive interpersonal patterns have been postulated to maintain body dysmorphic disorder (BDD). The present trial evaluated CT for BDD (CT-BDD), which includes modules targeting maladaptive cognitive processing in BDD, as well as elements of schema therapy related to interpersonal problems. We investigated whether (a) CT-BDD is effective, as compared with a wait-list (WL) group at Week 12; (b) outcome of CT-BDD is maintained at posttreatment and 3- and 6-months follow-up; and (c) whether changes in shame and insight mediate changes in BDD symptom severity. Forty adults with BDD were randomized to 36 weeks immediate CT-BDD (n = 21), or to 12-week WL (n = 19). At Week 12, immediate CT-BDD was significantly superior to WL in clinician-rated BDD symptom severity, insight, self-reported BDD symptoms, shame, depression, general symptomatology, and life satisfaction. Changes in outcomes were associated with moderate to large effect sizes at Week 12. Reductions in shame and increase in insight separately mediated changes in BDD symptom severity during treatment at Week 12. From baseline to posttreatment, significant improvements occurred within CT-BDD in clinician-rated symptom severity, insight, depression, global functioning, self-reported BDD symptoms, shame, depression, general symptomatology, and life satisfaction. At posttreatment, improvements were associated with large effect sizes and were maintained at 3- and 6-month follow-up. Preliminary results support the efficacy of CT-BDD. Addressing interpersonal problems in addition to cognitive dysfunctions may increase the benefit of CBT for BDD patients.     

Cognitive-Behavioral Versus Supportive Psychotherapy for Intermittent Explosive Disorder: A Randomized Controlled Trial

Few clinical trials have evaluated the efficacy of psychotherapy for Intermittent Explosive Disorder (IED). The present study tested the efficacy of a cognitive behavioral intervention (versus supportive psychotherapy) among adults with IED. In this randomized clinical trial, 44 participants with IED (22 men and 22 women) aged 20–55 years completed twelve 50-minute individual sessions of either a multi-component cognitive behavioral intervention for IED (n = 19) or a time equated supportive psychotherapy (n = 25). At baseline, posttreatment, and 3-month follow-up, all participants received the Overt Aggression Scale–Modified, which was conducted by an interviewer who was blind to the participant’s study condition. During these visits, participants also completed self-report measures of relational aggression (Self-Report of Relational Aggression and Social Behavior), anger (State-Trait Anger Expression Inventory-2), cognitive biases (e.g., Social Information Processing Questionnaire Attribution and Emotional Response Questionnaire), and associated symptoms (e.g., Beck Depression Inventory). Primary study outcomes were aggressive behavior and anger. Though participants in both treatments tended to improve over time, the cognitive behavioral intervention was superior to supportive psychotherapy in decreasing aggressive behavior and relational aggression. These findings support the efficacy of a multicomponent cognitive behavioral intervention in treating aggression in IED.     

Treating Young Adult Depression With Text-Delivered Cognitive Behavioral Therapy: A Pilot Randomized Clinical Trial

Young adults (ages 18 to 25) in the U.S. suffer from the highest rates of past-year major depressive episode and are the least likely to receive treatment compared to other age groups. As such, we examined the feasibility, acceptability, and efficacy of a text-message delivered cognitive behavioral therapy: CBT-txt with young adults. The study was a 2-month pilot RCT to test a 4-week intervention for depression that contained 197 text messages (average 12 texts every other day). The sample, recruited via Facebook and Instagram, was 102 U.S. young adults who presented with at least moderate depressive symptomatology. Assessments occurred at baseline prior to randomization and at 1 and 2 months post enrollment. The primary outcome, severity of depressive symptoms, was assessed using the Beck Depression Inventory II. Feasibility benchmarks were met and participants reported high levels of engagement with and acceptability of the intervention. Logistic regression indicated that treatment participants were three times as likely to have minimal or mild depression symptoms at 2 months compared to waitlist control participants. Latent change score modeling found that the strongest significant treatment effect appeared at the 1-month follow-up period, particularly for participants who began with severe depressive symptoms. Mediation analysis revealed significant indirect treatment effects of increases in behavioral activation on reducing depressive symptoms, suggesting a mechanism of change. Limitations were that the sample was relatively small and consisted of primarily women. These results provide initial evidence for the feasibility, acceptability, and efficacy of a text-delivered treatment for young adult depression.     

Testing an App-Assisted Treatment for Suicide Prevention in a Randomized Controlled Trial: Effects on Suicide Risk and Depression

Suicide is a global public health problem and effective psychological interventions are needed. The objective of the present study was to evaluate the effect of an app-assisted suicide prevention treatment on suicide risk and depression. One hundred twenty-nine participants were randomized to treatment as usual (TAU), consisting of psychotherapy adhering to the framework of Collaborative Assessment and Management of Suicidality (CAMS), with (TAU + APP, N = 60) or without (TAU, N = 69) access to a mobile application (i.e., LifeApp’tite). Suicide risk and symptoms of depression were assessed pre- and posttherapy, and at 4-month follow-up. The TAU + APP group showed a smaller decrease on self-reported suicide risk at the end of treatment, corresponding to a medium between-group effect size (p = .008, d = 0.46). At the 4-month follow-up this was the case only at the trend level, where the effect size was also of a smaller magnitude (p = .057, d = 0.30). No differences between the treatment groups were observed on self-reported depressive symptoms, either immediately following treatment (p = .732, d = 0.05) or at follow-up (p = .467, d = 0.11). The unexpected negative effect concerning suicide risk points to crucial consideration of issues pertaining to timing, dosing, and content when adding new technology to existing treatments both in this and other populations.     

An Internet-Based Compassion-Focused Intervention for Increased Self-Criticism: A Randomized Controlled Trial

Increased levels of self-criticism and a lack of self-compassion have been associated with the development and maintenance of a range of psychological disorders. In the current study, we tested the efficacy of an online version of a compassion-focused intervention, mindfulness-based compassionate living (MBCL), with guidance on request. A total of 122 self-referred participants with increased levels of self-criticism were randomly assigned to care as usual (CAU) or the intervention group (CAU + online intervention). Primary endpoints were self-reported depressive, anxiety and distress symptoms (DASS-21) and self-compassion (SCS) at 8 weeks. Secondary endpoints were self-criticism, mindfulness, satisfaction with life, fear of self-compassion, self-esteem, and existential shame. At posttreatment, the intervention group showed significant changes with medium to large effect sizes compared to the control group regarding primary outcomes (Cohen’s d: 0.79 [DASS] and -1.21 [SCS]) and secondary outcomes (Cohen’s ds: between 0.40 and 0.94 in favor of the intervention group). The effects in the intervention group were maintained at 6-months postrandomization. Adherence measures (number of completed modules, self-reported number of completed exercises per week) predicted postintervention scores for self-compassion but not for depressive, anxiety, and distress symptoms in the intervention group. The current study shows the efficacy of an online intervention with a transdiagnostic intervention target on a broad range of measures, including depressive and anxiety symptoms and self-compassion.     

A Randomized Community-Based Trial of Behavior Therapy vs. Usual Care for Adolescent ADHD: Secondary Outcomes and Effects on Comorbidity

Though behavior therapy (BT) for ADHD in adolescence is evidence-based, almost no work examines its implementation and effectiveness in community settings. A recent randomized community-based trial of an evidence-based BT for adolescent ADHD (Supporting Teens’ Autonomy Daily; STAND; N = 278) reported high clinician, parent, and youth acceptability but variable implementation fidelity. Primary outcome analyses suggested no significant differences between STAND and usual care (UC) unless the clinician delivering STAND was licensed. The present study reports secondary outcomes for this trial on indices of comorbidity (anxiety, depression, oppositional defiant disorder, conduct disorder) and ADHD outcomes not targeted by the active treatment (social skills, sluggish cognitive tempo). We also examine whether therapist licensure moderated treatment effects (as in primary outcome analyses). Using intent-to-treat and per protocol linear mixed models, patients randomized to STAND were compared to those randomized to UC over approximately 10 months of follow-up. Group × Time effects revealed that, overall, STAND did not outperform usual care when implemented by community clinicians. However, a Group × Time × Licensure interaction revealed a significant effect on conduct problems when STAND was delivered by licensed clinicians (d = .19–.47). When delivered in community settings, behavior therapy for adolescent ADHD can outperform UC with respect to conduct problems reduction. Community mental health clinics should consider: (1) assigning adolescent ADHD cases to licensed professionals to maximize impact and (2) choosing psychosocial approaches when ADHD presents with comorbid conduct problems. There is also a need to reduce implementation barriers for unlicensed clinicians in community settings.     

Internet-Based Therapy for Mild to Moderate Depression in Swedish Primary Care: Short Term Results from the PRIM-NET Randomized Controlled Trial

Depression presents a serious condition for the individual and a major challenge to health care and society. Internet-based cognitive behavior therapy (ICBT) is a treatment option supported in several trials, but there is as yet a lack of effective studies of ICBT in “real world” primary care settings. We examined whether ICBT differed from treatment-as-usual (TAU) in reducing depressive symptoms after 3 months. TAU comprised of visits to general practitioner, registered nurse, antidepressant drugs, waiting list for, or psychotherapy, or combinations of these alternatives. Patients, aged ≥ 18 years, who tentatively met criteria for mild to moderate depression at 16 primary care centers in the south-western region of Sweden were recruited and then assessed in a diagnostic interview. A total of 90 patients were randomized to either TAU or ICBT. The ICBT treatment included interactive elements online, a workbook, a CD with mindfulness and acceptance exercises, and minimal therapist contact. The treatment period lasted for 12 weeks after which both groups were assessed. The main outcome measure was Beck Depression Inventory-II (BDI-II). Additional measures were Montgomery Åsberg Depression Rating Scale – self rating version (MADRS-S) and Beck Anxiety Inventory (BAI). The analyses revealed no significant difference between the two groups at post treatment, neither on BDI-II, MADRS-S, nor BAI. Twenty patients (56%) in the ICBT treatment completed all seven modules. Our findings suggest that ICBT may be successfully delivered in primary care and that the effectiveness, after 3 months, is at par with TAU.     

Shaping Medical Students' Attitudes Toward Ethically Important Aspects of Clinical Research: Results of a Randomized,Controlled Educational Intervention

The effects of research ethics training on medical students' attitudes about clinical research are examined. A preliminary randomized controlled trial evaluated 2 didactic approaches to ethics training compared to a no-intervention control. The participant-oriented intervention emphasized subjective experiences of research participants (empathy focused). The criteria-oriented intervention emphasized specific ethical criteria for analyzing protocols (analytic focused). Compared to controls, those in the participant-oriented intervention group exhibited greater attunement to research participants' attitudes related to altruism, trust, quality of relationships with researchers, desire for information, hopes about participation and possible therapeutic misconception, importance of consent forms, and deciding quickly about participation. The participant-oriented group also agreed more strongly that seriously ill people are capable of making their own research participation decisions. The criteria-oriented intervention did not affect learners' attitudes about clinical research, ethical duties of investigators, or research participants' decision making. An empathy-focused approach affected medical students' attunement to research volunteer perspectives, preferences, and attributes, but an analytically oriented approach had no influence. These findings underscore the need to further examine the differential effects of empathy-versus analytic-focused approaches to the teaching of ethics.     

Standardized Web-Based Cognitive Behavioural Therapy of Mild to Moderate Depression: A Randomized Controlled Trial with a Long-Term Follow-Up

Depression is common but undertreated. Web-based self-help provides a widely accessible treatment alternative for mild to moderate depression. However, the lack of therapist guidance may limit its efficacy. The authors assess the efficacy of therapist-guided web-based cognitive behavioural treatment (web-CBT) of mild to moderate depression. Fifty-four individuals with chronic, moderate depression participated in a randomized wait-list controlled trial, with an 18-month follow-up (immediate treatment: n = 36, wait-list control: n = 18). Primary outcome measures were the Beck Depression Inventory (BDI-IA) and the Depression scale of the Symptom Checklist-90-Revised (SCL-90-R. DEP). Secondary outcome measures were the Depression Anxiety Stress Scales and the Well-Being Questionnaire. Five participants (9%) dropped out. Intention-to-treat analyses of covariance revealed that participants in the treatment condition improved significantly more than those in the wait-list control condition (.011 < p < .015). With regard to the primary measures, between-group effects (d) were 0.7 for the BDI-IA and 1.1 for the SCL-90-R DEP. Posttest SCL-90- R DEP scores indicated recovery of 49% of the participants in the treatment group compared with 6% in the control group (odds ratio = 14.5; p < .004). On average, the effects were stable up to 18 months (n = 39), although medication was a strong predictor of relapse. The results demonstrate the efficacy of web-CBT for mild to moderate depression and the importance of therapist guidance in psychological interventions.     

Analysis of Recruitment Strategies: Enrolling Veterans With PTSD Into a Clinical Trial

This analysis evaluated the efficacy of a variety of recruitment methods employed in a medication trial in a veteran population. Recruitment and demographic data were collected over the course of a randomized controlled trial (RCT) assessing the efficacy of an experimental medication for posttraumatic stress disorder (PTSD). Multivariate logistic regression was used to identify demographic and recruitment variables predictive of consenting to participation in the trial. Data were collected for 1,050 potential study participants. As compared with individuals contacted by mail based on chart review, potential participants who were referred by a clinician were 3 times more likely to consent to participate, and individuals who responded to an advertisement were 5 times more likely to consent to participate. Females were more likely to respond to advertisements, whereas males were more likely to be referred. Those who were referred were significantly older than potential participants identified via the directed mailing. Clinician referral was the method most likely to lead to identifying an eligible and willing participant. When designing a recruitment plan for a clinical trial, factors such as the target sample and available staff should be carefully considered.     

Process Analyses of Impulsive Behavior in Binge-Eating Disorder During the Randomized Controlled IMPULS Trial

Impulsivity represents a risk factor for patients with binge-eating disorder, and we therefore investigated the treatment process of impulsive behaviors including binge-eating episodes in the randomized controlled IMPULS trial. Using 8 weekly online questionnaires throughout the assessment period, we compared 41 patients participating in the IMPULS program, which emphasized impulsive eating behavior (IG), with 39 control patients who received no intervention (CG). We assessed the frequency of binge eating, other impulsive behaviors, situations in which such behaviors could be inhibited, and the execution of alternative behaviors. Results indicate a stronger binge-eating reduction in the IG compared to the CG at the fifth, seventh, and eighth treatment weeks. Overall, both groups reduced other impulsive behaviors. They did not differ in the amount of inhibited impulsive behaviors and showed similar alternative behaviors, “distraction” most frequently used. IG patients evaluated the IMPULS program as very helpful. The stronger reduction of binge eating in the IG and positive evaluation of the treatment indicate a specific treatment effect regarding impulsive eating behavior. The reduction of other impulsive behaviors across both groups, and the initial reduction of binge eating within the CG, could be explained by an increased degree of self-observation.     

Relationship Education for Military Couples: A Pilot Randomized Controlled Trial of the Effects of Couple CARE in Uniform

Military life can place excess strain on couple relationships. The Couple CARE relationship education program was tailored to address the challenges of military couples. Thirty-two Australian military couples participated in a pilot feasibility study assessing the Couple CARE in Uniform adaptation against an active control. Relationship satisfaction and communication improved in both conditions, with no significant difference between the conditions. Couples' high relationship satisfaction on presentation, paired with modest statistical power, might have contributed to the null results. However, Couple CARE in Uniform had significantly higher consumer satisfaction than the comparison condition, suggesting it is a program worthy of further evaluation.     

Lessons Learned From a Randomized Controlled Pilot Trial Testing an Inhibitory Learning Approach to Exposure in Anxious Youth

Accumulating evidence from basic and translational research indicates that fear extinction may be best explained by principles of “inhibitory learning,” by which prefrontal cortical structures inhibit activity in the amygdala. New guidelines for the clinical practice of exposure therapy have arisen from research on inhibitory learning, but these guidelines have received little empirical testing in clinical samples of youth receiving treatment for anxiety disorders. We investigated the acceptability, feasibility, and initial efficacy of conducting exposure therapy for anxiety disorders in youth according to clinical guidelines developed from basic research on inhibitory learning principles, using a pilot randomized controlled trial design. Thirteen youths (ages 7 to 16) were recruited from a university hospital-based pediatric outpatient clinic to participate in a 9-week treatment study and were randomized to either an inhibitory learning-based exposure condition or a standard exposure condition. Results supported the feasibility and acceptability of an inhibitory learning-based approach to exposure therapy in youth and, despite the small sample size, effect sizes were in favor of the inhibitory learning approach on several measures. Differences between the standard exposure and inhibitory learning conditions are discussed using two case examples. Discussion of results and lessons learned may contribute to changes in clinical guidelines for optimally effective practice of exposure.     

Testing a Low-Intensity Single-Session Self-Compassion Intervention for State Body Shame in Adult Women: A Dismantling Randomized Controlled Trial

State body shame is a risk factor for eating disorders, and self-compassion is emerging as a potentially effective treatment option in such cases. This study tested the efficacy of a brief (15-minute) self-compassion intervention in reducing state body shame. Using dismantling trial methodology, participants were randomly allocated to an active compassion condition (n = 23), an inactive control compassion condition (n = 23), or an educational control condition (n = 23). Measures of state body image and state shame were collected pre-intervention, immediately after the intervention, and a day after the intervention. Subjective units of state body shame (SUBS) were intensively measured during each invention. Self-compassion interventions were equally efficacious at protecting against deterioration of state body shame and were effective at reducing state shame compared to the educational control condition, with medium effect sizes (respectively – n_p² = .07 and n_p² = .08). Reductions in state shame were retained at follow-up. None of the interventions had an effect on body image (n_p² = .04). Findings demonstrate the clinical promise of brief self-compassion interventions, particularly as evidenced-based “homework” exercises.     

The Efficacy of Systemic Therapy for Internalizing and Other Disorders of Childhood and Adolescence: A Systematic Review of 38 Randomized Trials

Systemic therapy (ST) is one of the most widely applied psychotherapeutic approaches in the treatment of children and adolescents, yet few systematic reviews exist on the efficacy of ST with this age group. Parallel to a similar study on adults, a systematic review was performed to analyze the efficacy of ST in the treatment of children and adolescents. All randomized or matched controlled trials (RCT) evaluating ST in any setting with child and adolescent index patients were identified by database searches and cross‐references, as well as in existing meta‐analyses and reviews. Inclusion criteria were: index patient diagnosed with a DSM‐IV or ICD‐10 listed psychological disorder, or suffering from other clinically relevant conditions, and trial published by December 2011. Studies were analyzed according to their sample, research methodology, interventions applied, and results at end‐of‐treatment and at follow‐up. This article presents findings for internalizing and mixed disorders. Thirty‐eight trials were identified, with 33 showing ST to be efficacious for the treatment of internalizing disorders (including mood disorders, eating disorders, and psychological factors in somatic illness). There is some evidence for ST being also efficacious in mixed disorders, anxiety disorders, Asperger disorder, and in cases of child neglect. Results were stable across follow‐up periods of up to 5 years. Trials on the efficacy of ST for externalizing disorders are presented in a second article. There is a sound evidence base for the efficacy of ST as a treatment for internalizing disorders of child and adolescent patients.     

The Effects of Modafinil on Convergent and Divergent Thinking of Creativity: A Randomized Controlled Trial

Modafinil is a drug licensed for the treatment of narcolepsy and sleep apnea. Recently, modafinil has been reported to be used as a pharmacological cognitive enhancer by healthy individuals with no psychiatric disorders. This paper reports on a study that investigated the effects of modafinil on divergent and convergent thinking tasks of creativity. Sixty‐four healthy male (n = 31) and female (n = 33) volunteers participated in a randomized double‐blind placebo‐controlled parallel group design study. For the convergent thinking tasks, modafinil had no significant main effect on the Group Embedded Figures Task and the Remote Associates Task (RAT). However, a median split analysis showed that modafinil participants low in creativity personality trait had significantly higher RAT scores (Mean [M] = 6.85, SD = 3.39; 95% confidence interval [95% CI]: 5.53–8.2) than those high in creativity personality trait (M = 4.27, SD = 3.0; 95% CI: 2.4–6.0). For the divergent thinking tasks, relative to placebo (M = 1.195, SD = 0.28; 95% CI: 1.0–1.3), modafinil (M = 0.77, SD = 0.37; 95% CI: 0.63–0.92) significantly reduced the performance of flexibility scores and marginally reduced the elaboration scores as measured by the Abbreviated Torrance Test for Adults (ATTA). Overall, participants on modafinil (M = 6.3, SD = 2.6; 95% CI: 5.3–7.4) had significantly lower ATTA scores relative to participants on placebo (M = 9.5, SD = 2.3; 95% CI: 8.6–10.4). These results indicate that modafinil might reduce divergent thinking of creativity in healthy individuals. They suggest that, rather than being a more general cognitive enhancer, modafinil might have negative and subtle effects on creativity. However, the results are from a small‐scale trial, which tested a small number of participants. Therefore, the results need to be interpreted with caution. A replication with a large sample of participants is recommended.     

Modular Cognitive-Behavioral Therapy for Body Dysmorphic Disorder: A Randomized Controlled Trial

There are few effective treatments for body dysmorphic disorder (BDD) and a pressing need to develop such treatments. We examined the feasibility, acceptability, and efficacy of a manualized modular cognitive-behavioral therapy for BDD (CBT-BDD). CBT-BDD utilizes core elements relevant to all BDD patients (e.g., exposure, response prevention, perceptual retraining) and optional modules to address specific symptoms (e.g., surgery seeking).     

针灸治疗周围性面瘫随机对照研究的文献分析

遵循循证医学评价文献的原则,在中国生物医学文献数据库、CNKI等数据库全面检索2002—2006年间的相关文献并进行计量学评价分析。共检索出文献1284篇,其中RCT文献共有169篇,按照循证医学评价文献的原则及方法,从研究对象、随机分配方法、对照措施、盲法采用情况等多个方面进行分析评价。2002—2006五年间报道的RCT数量比从建国到2000年报道的RCT数量多,但仍需进一步改善文献质量。     

Comprehensive Behavioral (ComB) Treatment of Trichotillomania: A Randomized Clinical Trial

ObjectiveThis study is the first controlled trial of comprehensive behavioral (ComB) treatment of trichotillomania (TTM). ComB provides individualized treatment based on factors triggering and maintaining hair pulling. Method: Participants (N = 36) were adults (M = 34.08 years old, SD = 12.26) meeting DSM5 criteria for TTM. A majority were female (80%) and Caucasian (75%), whereas 17% were African American and 19% Hispanic/Latinx. In a parallel-group design, participants were randomly assigned to (a) Immediate ComB (12 sessions) or (b) Minimal Attention Control (MAC), followed by delayed ComB after week 12. Follow-up continued through week 38. Primary outcomes were self-report (Massachusetts General Hospital Hair pulling Scale; MGH-HPS) and interviewer-rated (NIMH-Trichotillomania Impact Scale and Trichotillomania Severity Scale; TIS/TSS) TTM symptom severity, as well as diagnosis (Trichotillomania Diagnostic Interview).ResultsImmediate efficacy of ComB (vs. MAC) was statistically significant (p = .03) for self-reported symptoms, with an effect size d = −.78, but not significant for interviewer-rated symptoms or diagnostic status. Immediate ComB was significantly more likely than MAC (27% vs. 0%) to lead to complete abstinence from hair pulling at week 12. Follow-ups showed good maintenance of effects.ConclusionsEfficacy of ComB was established for self-reported symptoms. Future research is needed to establish whether the lack of more widespread effects stems from limitations of the model or to a need for more extensive therapist training, as secondary analyses suggested stronger results among therapists with more TTM experience.