Randomized Controlled Trial of an Internet-Based Cognitive-Behavioral Treatment Program for Binge-Eating Disorder

Binge-eating disorder (BED) is a prevalent health condition associated with obesity. Few people with BED receive appropriate treatment. Personal barriers include shame, fear of stigma, geographic distance to mental health services, and long wait-lists. The aims of this study were to examine the efficacy of an Internet-based cognitive-behavioral intervention for adults with threshold BED (DSM-IV) and to examine the stability of treatment effects over 12 months. Participants were randomly assigned to a 16-week Internet-based cognitive-behavioral intervention (n = 69) or a wait-list condition (n = 70). Binge-eating frequency and eating disorder psychopathology were measured with the Eating Disorder Examination–Questionnaire and the Eating Disorder Examination administered over the telephone. Additionally, body weight and body mass index, depression, and anxiety were assessed before and immediately after treatment. Three-, 6-, and 12-month follow-up data were recorded in the treatment group. Immediately after the treatment the number of binge-eating episodes showed significant improvement (d = 1.02, between group) in the treatment group relative to the wait-list condition. The treatment group had also significantly reduced symptoms of all eating psychopathology outcomes relative to the wait-list condition (0.82 ≤ d ≤ 1.11). In the treatment group significant improvement was still observed for all measures 1 year after the intervention relative to pretreatment levels. The Internet-based intervention proved to be efficacious, significantly reducing the number of binge-eating episodes and eating disorder pathology long term. Low-threshold e-health interventions should be further evaluated to improve treatment access for patients suffering from BED.     

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.     

Enhancing Compassion: A Randomized Controlled Trial of a Compassion Cultivation Training Program

Psychosocial interventions often aim to alleviate negative emotional states. However, there is growing interest in cultivating positive emotional states and qualities. One particular target is compassion, but it is not yet clear whether compassion can be trained. A community sample of 100 adults were randomly assigned to a 9-week compassion cultivation training (CCT) program (n = 60) or a waitlist control condition (n = 40). Before and after this 9-week period, participants completed self-report inventories that measured compassion for others, receiving compassion from others, and self-compassion. Compared to the waitlist control condition, CCT resulted in significant improvements in all three domains of compassion—compassion for others, receiving compassion from others, and self-compassion. The amount of formal meditation practiced during CCT was associated with increased compassion for others. Specific domains of compassion can be intentionally cultivated in a training program. These findings may have important implications for mental health and well-being.     

Baby Triple P: A Randomized Controlled Trial Testing the Efficacy in First-Time Parent Couples

Journal of Child and Family Studies - In a randomized controlled trial, we tested the efficacy of Baby Triple P in a community sample of first-time parent couples. The intervention was developed to...     

Improving Women's Self‐Compassion Through an Online Program: A Randomized Controlled Trial

The benefits of self‐compassion interventions have been well documented in the counseling literature. Despite these benefits, access to such interventions remains a considerable barrier for a range of populations. We addressed the issue of limited access by using a randomized controlled trial to evaluate an online, self‐guided course on self‐compassion specifically targeted toward women. Fifty‐seven women were randomly assigned to receive immediate or delayed access to a 10‐week course designed to increase self‐compassion and reduce self‐judgment, shame, and perfectionism. Analysis of the data revealed that participants in the treatment condition experienced significant increases in self‐compassion and decreases in self‐judgment, shame, and perfectionism compared with participants in the wait‐list group. Results provide evidence that self‐compassion can be fostered in a nonclinical population of women through participation in a self‐paced online course. Related findings and potential implications, including the use of such interventions to address accessibility concerns, are discussed within the existing literature.     

Sleep-Related Safety Behaviors and Dysfunctional Beliefs Mediate the Efficacy of Online CBT for Insomnia: A Randomized Controlled Trial

Several trials have demonstrated the efficacy of online cognitive behavioral therapy (CBT) for insomnia. However, few studies have examined putative mechanisms of change based on the cognitive model of insomnia. Identification of modifiable mechanisms by which the treatment works may guide efforts to further improve the efficacy of insomnia treatment. The current study therefore has two aims: (1) to replicate the finding that online CBT is effective for insomnia and (2) to test putative mechanism of change (i.e., safety behaviors and dysfunctional beliefs). Accordingly, we conducted a randomized controlled trial in which individuals with insomnia were randomized to either online CBT for insomnia (n = 36) or a waiting-list control group (n = 27). Baseline and posttest assessments included questionnaires assessing insomnia severity, safety behaviors, dysfunctional beliefs, anxiety and depression, and a sleep diary. Three- and six-month assessments were administered to the CBT group only. Results show moderate to large statistically significant effects of the online treatment compared to the waiting list on insomnia severity, sleep measures, sleep safety behaviors, and dysfunctional beliefs. Furthermore, dysfunctional beliefs and safety behaviors mediated the effects of treatment on insomnia severity and sleep efficiency. Together, these findings corroborate the efficacy of online CBT for insomnia, and suggest that these effects were produced by changing maladaptive beliefs, as well as safety behaviors. Treatment protocols for insomnia may specifically be enhanced by more focused attention on the comprehensive fading of sleep safety behaviors, for instance through behavioral experiments.     

Improving Personal Happiness Through Couple Intervention: A Randomized Controlled Trial of a Self-directed Couple Enhancement Program

Although personal happiness is highly associated with social relationships, basic questions remain regarding the causal effect of improved social relationships on happiness. The main aim of this study was to test whether emotional and cognitive dimensions of personal happiness can be increased by means of a self-directed relationship enhancement program, which aims to increase relationship-relevant skills such as dyadic coping, communication, and conflict resolution. N = 220 couples were randomly assigned either to an intervention or to a waiting list control group (survey: pre-, post-, 3- and 6-month follow-ups). Multi-group latent change score models reveal that (1) personal happiness can be increased through a couple intervention; (2) change in personal happiness was predicted by an increase in skills and relationship satisfaction through the intervention; (3) the least happy participants benefited most from the intervention. Improving spousal interactions may help people become and stay happier. Participants in this study did not relapse to their set point of personal happiness as could be expected by adaptation theory. Thus, not treating individuals directly, but rather the dynamic system of spousal interactions as a whole, offers a potentially very powerful area for happiness research.     

A Randomized Controlled Trial of the Say Yes to Life (SYTL) Positive Psychology Group Psychotherapy Program for Depression: An Interim Report

An RCT was conducted to evaluate the effectiveness of the Say Yes to Life (SYTL) positive psychology group psychotherapy program compared with treatment as usual (TAU). The current interim report is based on data from the first 82 cases recruited into the trial. There were 57 trial completers at post-treatment. At pretreatment on demographic and clinical variables, there were no significant differences between trial completers and dropouts in SYTL and TAU groups. There were two main significant (p < .01) findings. Compared with TAU treatment-completers, more than twice as many SYTL treatment-completers (28 vs. 72 %) were recovered 3 months after therapy using stringent recovery criteria (no longer meeting DSM-5 diagnostic criteria for major depressive disorder and scoring below clinical cut-off scores on the Beck Depression Inventory II, the Hamilton Rating Scale for Depression, and the Montgomery–Asberg Depression Rating Scale and showing reliable change on these three measures of depressive symptom severity). Second, the overall average service use cost per case in the SYTL group was significantly lower than that of the TAU group (€726 vs.€1187). This was largely due to the lower cost of the SYTL group therapy program compared with TAU which involved individual therapy. The pattern of results in an intention-to-treat analysis was similar to that in the completer analysis, though group difference did not reach significance due to inadequate statistical power and conservative missing data imputation procedures. It is planned to collect data on 100 trial completers, based on a power analysis.     

Brief Interventions to Reduce Ecstasy Use: A Multi-Site Randomized Controlled Trial

Studies examining the ability of motivational enhancement therapy (MET) to augment education provision among ecstasy users have produced mixed results and none have examined whether treatment fidelity was related to ecstasy use outcomes. The primary objectives of this multi-site, parallel, two-group randomized controlled trial were to determine if a single-session of MET could instill greater commitment to change and reduce ecstasy use and related problems more so than an education-only intervention and whether MET sessions delivered with higher treatment fidelity are associated with better outcomes. The secondary objective was to assess participants’ satisfaction with their assigned interventions. Participants (N = 174; M_age = 23.62) at two Australian universities were allocated randomly to receive a 15-minute educational session on ecstasy use (n = 85) or a 50-minute session of MET that included an educational component (n = 89). Primary outcomes were assessed at baseline, and then at 4-, 16-, and 24-weeks postbaseline, while the secondary outcome measure was assessed 4-weeks postbaseline by researchers blind to treatment allocation. Overall, the treatment fidelity was acceptable to good in the MET condition. There were no statistical differences at follow-up between the groups on the primary outcomes of ecstasy use, ecstasy-related problems, and commitment to change. Both intervention groups reported a 50% reduction in their ecstasy use and a 20% reduction in the severity of their ecstasy-related problems at the 24-week follow up. Commitment to change slightly improved for both groups (9%–17%). Despite the lack of between-group statistical differences on primary outcomes, participants who received a single session of MET were slightly more satisfied with their intervention than those who received education only. MI fidelity was not associated with ecstasy use outcomes. Given these findings, future research should focus on examining mechanisms of change. Such work may suggest new methods for enhancing outcomes.Australia and New Zealand Clinical Trial Registry: ACTRN12611000136909     

Reproductive Health CHOICES for Young Adults with Sickle Cell Disease or Trait: Randomized Controlled Trial Outcomes over Two Years

Interventions to assist reproductive health decision-making in populations affected by sickle cell disease (SCD) or trait (SCT) lack proven efficacy over time. Our aim was to compare effects of CHOICES, a Web-based multimedia education program on implementing informed reproductive plans, and usual care education (e-Book) on reproductive knowledge, intention, and behavior over 24 months. We randomized 234 participants with SCD (n?=?138) or SCT (n?=?96) (age 18–35 years, 35 % male, 94 % African American) to CHOICES and e-Book groups. Participants completed a sickle cell-specific reproductive measure before and four times after the intervention (6, 12, 18 and 24 months). Compared to the e-Book group the CHOICES group had significantly more improvement in knowledge over time (p?=?.004) but not intention (p?=?.18) or behavior (p?=?.69). At baseline, 114 (48.7 %) participants reported having partners who would not put the couple at risk for their children inheriting SCD. Of the 116 (49.6 %) at-risk participants, a higher poroportion of those who were in the CHOICES group chose partners that reduced their risk by the last visit than the e-Book group (p?=?.04). Study findings provide important insights for designing a national trial of the CHOICES intervention focusing on subjects whose partner status puts them at risk for having a child with SCD.     

Treatment Fidelity of a Randomized Controlled Trial for Suicidal Risk

Treatment fidelity is a crucial consideration within randomized controlled trials (RCTs). The present study relies on data from a feasibility RCT conducted with 62 treatment-seeking suicidal college students. Issues of experimental fidelity were germane in this investigation because the same clinicians provided both the experimental (the Collaborative Assessment and Management of Suicidality—CAMS) and the control (treatment as usual—TAU) care. The first aim of the current study was to determine adherence to the CAMS model within the experimental (CAMS) and control (TAU) treatment conditions. A second exploratory aim was included to examine how treatment fidelity impacted treatment outcomes (i.e., depression, suicidal ideation, hopelessness, and potential treatment moderators). The CAMS Rating Scale (CRS.3-R) was used to determine treatment adherence to the CAMS model and to ensure between-group fidelity within the trial. The CRS.3-R was completed throughout the course of care based on reviews of a selected number of video recordings of both CAMS and TAU sessions to measure treatment fidelity. Mean CRS.3-R scores revealed differences across treatment conditions such that clinicians were successfully able to provide each treatment separately without contamination. Further, higher CRS.3-R scores in CAMS sessions resulted in decreased hopelessness over the treatment period. Higher CRS.3-R scores in TAU sessions resulted in an increased likelihood of suicidal ideation and less reduction in hopelessness over the treatment period. Overall, clinicians can serve as their own controls in a RCT and levels of adherence to the CAMS model have different effects on suicidal ideation and hopelessness.

     

Instruction Modes for Motor Control Skills Acquisition: A Randomized Controlled Trial

Abstract

The objective was to compare two different instruction modes used to teach patients with nonspecific chronic low back pain (CLBP) to perform a lumbar motor control task. The three intervention instruction modes used were: common verbal explanation of a motor task based on a motor control therapeutic exercise (MCTE-control group), MTCE instructed using motor imagery (MI) and MCTE instructed using tactile feedback (TF). The main outcome measure was lumbar motor control of the neutral position test. Forty-eight patients with CLBP were randomly allocated into three groups of 16 patients per group. The MI strategy was the most effective mode for developing the motor control task in an accurate and controlled manner, obtaining better outcomes than TF or verbal instruction.     

Internet-Based Cognitive Behavior Therapy for Loneliness: A Pilot Randomized Controlled Trial

Loneliness has been described as a common source of discomfort based on a subjective discrepancy between the actual and desired social situation. For some people this feeling may become a sustained state that is associated with a wide range of psychiatric and psychosocial problems. While there are few existing treatment protocols, interventions based on cognitive behavioral therapy (CBT) have shown positive effects. The current study investigated the efficacy of an 8-week internet-based treatment containing CBT components aimed at reducing feelings of loneliness. Seventy-three participants were recruited from the general public and randomly allocated to treatment or a wait-list control condition. Participants were assessed with standardized self-report measures of loneliness, depression, social anxiety, worry, and quality of life at pretreatment and posttreatment. Robust linear regression analysis of all randomized participants showed significant treatment effects on the primary outcome measure of loneliness (between group Cohen’s d = 0.77), and on secondary outcomes measuring quality of life and social anxiety relative to control at postassessment. The results suggest the potential utility of internet-based CBT in alleviating loneliness but more research on the long-term effects and the mechanisms underlying the effects is needed.     

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).     

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.     

Exposing Clinicians to Exposure: A Randomized Controlled Dissemination Trial of Exposure Therapy for Anxiety Disorders

ObjectiveThe present study evaluated three technology-based methods of training mental health providers in exposure therapy (ET) for anxiety disorders. Training methods were designed to address common barriers to the dissemination of ET, including limited access to training, negative clinician attitudes toward ET, and lack of support during and following training.MethodClinicians naïve to ET (N = 181, M_age = 37.4, 71.3% female, 72.1% Caucasian) were randomly assigned to (a) an interactive, multimedia online training (OLT), (b) OLT plus a brief, computerized motivational enhancement intervention (OLT + ME), or (c) OLT + ME plus a Web-based learning community (OLT + ME + LC). Assessments were completed at baseline, posttraining, and 6 and 12 weeks following training. Outcomes include satisfaction, knowledge, self-efficacy, attitudes, self-reported clinical use, and observer-rated clinical proficiency.ResultsAll three training methods led to large and comparable improvements in self-efficacy and clinical use of ET, indicating that OLT alone was sufficient for improving these outcomes. The addition of the ME intervention did not significantly improve outcomes in comparison to OLT alone. Supplementing the OLT with both the ME intervention and the LC significantly improved attitudes and clinical proficiency in comparison to OLT alone. The OLT + ME + LC condition was superior to both other conditions in increasing knowledge of ET.ConclusionsMulticomponent trainings that address multiple potential barriers to dissemination appear to be most effective in improving clinician outcomes. Technology-based training methods offer a satisfactory, effective, and scalable way to train mental health providers in evidence-based treatments such as ET.     

Critical Time Intervention for Homeless People Making the Transition to Community Living: A Randomized Controlled Trial

To help create an evidence base in Europe for effective interventions that improve the well‐being of homeless people, we tested whether critical time intervention (CTI), a time‐limited intervention developed to support vulnerable people during times of transition, is effective outside the United States. For this multicenter, parallel‐group randomized controlled trial, 183 adults who were moving from shelters in the Netherlands to supported or independent housing were allocated to CTI or care‐as‐usual. The primary outcome was number of days rehoused, which was assessed by interviewing participants four times during a 9‐month follow‐up. Outcomes were analyzed with three‐level mixed‐effects models. The primary outcome did not differ between groups. CTI had a significant effect on family support and, for people experiencing less social support, psychological distress. Groups did not differ significantly on social support, fulfillment of care needs, quality of life, self‐esteem, excessive alcohol use, or cannabis use. Because few participants were homeless at 9 months, more research is needed to establish whether CTI can prevent long‐term recurrent homelessness. Given recent emphasis on informal support in public services and positive effects of CTI on family support and psychological distress, CTI is a fitting intervention for Dutch shelter services.     

Compassion-Focused Therapy to Reduce Body Weight Shame for Individuals With Obesity: A Randomized Controlled Trial

Adults living in larger bodies (Body Mass Index > 30) often experience body weight shame, are highly self-critical, and are at increased risk for anxiety and depression. To date, there have been no RCTs examining the efficacy of Compassion-Focused Therapy (CFT) to help those experiencing body weight shame. The aim of the current study was to investigate the efficacy of CFT as a 12-session group intervention to reduce body weight shame for individuals living in larger bodies. The study used an RCT design with participants randomized to the CFT (n = 28) or waitlist control (n = 27) condition. Participants in both groups were assessed at pre- and postintervention, with the CFT group alone assessed at 3- and 6-month follow-up intervention. Both self-report and a physiological measure of parasympathetic nervous system activity were used (i.e., heart rate variability). Results indicated that CFT had a significant positive impact at postintervention compared to the control group for body weight shame (internal and external), increasing self-compassion, reducing fears of compassion (self, other, and receiving), reducing self-criticism, and reducing external shame. Although there were no significant group effects at postintervention on depression and anxiety, 66% of participants had clinical improvement on depression in the CFT group compared to 8% in the control group at postintervention. CFT did not shift baseline heart rate variability at postintervention. The evidence from this RCT supports CFT as an efficacious intervention to reduce body weight shame for individuals with obesity.