A blended cognitive behavioral intervention for patients with adjustment disorder with anxiety: A randomized controlled trial.
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SUBMITTER: Leterme AC
PROVIDER: S-EPMC7255181 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundSocial anxiety disorder (SAD) is one of the most prevalent psychological disorders and generally co-occurs with elevated shame levels. Previous shame-specific interventions could significantly improve outcomes in social anxiety treatments. Recent review suggests that integrating a more direct shame intervention could potentially increase the effectiveness of cognitive behavioral therapy. Web-based cognitive behavioral therapy (WCBT) has proven efficacy, sustaining benefits for 6 months to 4 years. Previous evidence indicated that shame predicted the reduction of social anxiety and mediated between engagements in exposure and changes in social anxiety during WCBT.ObjectiveThis study aimed to design a shame intervention component through a longitudinal study and conduct a randomized controlled trial to investigate the effectiveness of a shame intervention component in reducing social anxiety symptoms and shame experience in a clinical sample of people with SAD.MethodsThe development of a shame intervention component was informed by cognitive behavioral principles and insights from longitudinal data that measured the Experience of Shame Scale (ESS), the Coping Styles Questionnaire, and the Social Interaction Anxiety Scale (SIAS) in 153 participants. The psychoeducation, cognitive construct, and exposure sections were tailored to focus more on shame-related problem-solving and self-blame. A total of 1220 participants were recruited to complete questionnaires, including the ESS, the SIAS, the Social Phobia Scale (SPS), and diagnostic interviews. Following a 2-round screening process, 201 participants with SAD were randomly assigned into a shame WCBT group, a normal WCBT group, and a waiting group. After the 8-week WCBT intervention, the participants were asked to complete posttest evaluations, including the ESS, SIAS and SPS.ResultsParticipants in the shame WCBT group experienced significant reductions in shame levels after the intervention (ESS: P<.001; ηp2=0.22), and the reduction was greater in the shame intervention group compared to normal WCBT (P<.001; mean deviation -12.50). Participants in both the shame WCBT and normal WCBT groups experienced significant reductions in social anxiety symptoms (SIAS: P<.001; ηp2=0.32; SPS: P<.001; ηp2=0.19) compared to the waiting group after intervention. Furthermore, in the experience of social interaction anxiety (SIAS), the shame WCBT group showed a higher reduction compared to the normal WCBT group (P<.001; mean deviation -9.58). Problem-solving (SE 0.049, 95% CI 0.025-0.217) and self-blame (SE 0.082, 95% CI 0.024-0.339) mediated the effect between ESS and SIAS.ConclusionsThis is the first study to design and incorporate a shame intervention component in WCBT and to validate its efficacy via a randomized controlled trial. The shame WCBT group showed a significant reduction in both shame and social anxiety after treatment compared to the normal WCBT and waiting groups. Problem-solving and self-blame mediated the effect of shame on social anxiety. In conclusion, this study supports previous findings that a direct shame-specific intervention component could enhance the efficacy of WCBT.
| S-EPMC11331269 | biostudies-literature
Project description:Despite the existence of effective treatment for postpartum depression, few women seek professional help, indicating the need for a new and innovative format of treatment that can overcome help-seeking barriers. This article presents the study protocol for a blended cognitive-behavioral intervention for the treatment of postpartum depression, by integrating face-to-face sessions with a web-based program (Be a Mom) into one treatment protocol. This study will be a two-arm, noninferiority randomized controlled trial comparing blended intervention to usual treatment for postpartum depression provided in healthcare centers. Portuguese postpartum adult women diagnosed with postpartum depression (according to the DSM-5 diagnostic criteria for major depressive disorder) will be recruited during routine care appointments in local healthcare centers and will be eligible to participate. Measures will be completed at baseline, postintervention, and at three- and six-month follow-ups. The primary outcome will be depressive symptoms. Secondary outcomes will include anxiety symptoms, fatigue, quality of life, marital satisfaction, maternal self-efficacy, and mother-child bonding. Cost-effectiveness analysis and mediator and moderator analysis will be conducted. This study will provide insight into the efficacy and cost-effectiveness of a blended psychological intervention in the Portuguese context and increase the empirically validated treatment options for postpartum depression.
| S-EPMC7699977 | biostudies-literature
Project description:Background and aimsInternet-based cognitive-behavioral therapy (iCBT) for social anxiety disorder has been found effective, as attested by independently conducted randomized controlled trials in four languages. The study aim is to test the efficacy of an iCBT program in a culture where it was not tested before (i.e. Romania).MethodsParticipants (n = 76) were recruited, screened and randomized to either a nine-week guided iCBT or a wait-list control group in April and May 2012. Self-report measures were collected before (April 2012) and after the intervention (July 2012), as well as six months later (January 2013). Although social anxiety was assessed with multiple measures, the Liebowitz Social Anxiety Scale - Self Report version (LSAS-SR) and Social Phobia Inventory (SPIN) were used as the primary outcome measures.ResultsA significant difference with a large between-group effect size in favor of iCBT was found (Cohen's d = 1.19 for LSAS-SR and d = 1.27 for SPIN). Recovery rates show that 36.8% (n = 14) in the treatment group score below the SPIN clinical cut-off compared to only 2.6% (n = 1) in the wait-list control group. Post-intervention clinical interviews also revealed that 34.2% (n = 13) of the treatment group was completely recovered (full remission) while additionally 36.8% (n = 14) retained some social anxiety symptoms (partial remission). However, an important study limitation is that post-intervention interviewers were not blinded to the study conditions. The program also effectively reduced depression and dysfunctional thinking (between-group Cohen's d = 0.84 for depression and d = 0.63 for dysfunctional thinking). Moreover, the iCBT intervention appears to have a long-term impact for participants' functioning, as the treatment gains were maintained six months later.ConclusionsInternet-delivered interventions display a high potential to quickly and widely disseminate effective evidence-based programs around the world. This study provides support for guided iCBT as a promising treatment approach in Romania.Trial registrationClinicalTrials.gov NCT01557894.
| S-EPMC4418823 | biostudies-literature
Project description:IntroductionAdjustment disorder (AjD) is a maladaptive response to one or more psychosocial stressors. In many cases, the symptomatology of this disorder disappears once the stressor or its consequences are no longer present. However, in some cases, if left untreated, the symptoms may worsen and develop into a more severe mental disorder. In this regard, different authors propose that a low-intensity intervention may be suitable for this disorder. Previous studies with other mental disorders and with patients with AjD found that blended interventions can be a viable and effective option. The aim of this study is to analyze the feasibility (the participants' expectations and preferences, the satisfaction and acceptance, the appropriateness of different methods of recruitment and data collection, and the reasons for dropping out) of a blended cognitive-behavioral intervention (CBT) for AjD that combines the use of a self-applied Internet-based program with videoconference sessions with a therapist. As a secondary objective, the potential efficacy of this intervention will be tested.Method and analysisA feasibility trial with a single-group and open-trial design will be conducted. A total of 41 participants will be assigned to the single treatment group. All the participants will be assessed for eligibility and respond at four measurement points: pre-treatment, post-treatment, and 3- and 12-month follow-ups. The treatment combines the use of an Internet-based intervention through a web platform with videoconference sessions with a therapist every 10-12 days. The intervention contains seven modules and is based on CBT. The main outcome measures are related to the feasibility of the intervention (adherence, treatment satisfaction and expectations, participants' opinions, preferences, therapeutic alliance, and usability). Clinical measures will also be assessed.DiscussionTo the best of our knowledge, this is the first study to test a blended intervention for AjD in the Spanish language. We expect this intervention to be feasible, and that a future Randomized Controlled Trial will be able to show its efficacy. Potential limitations include difficulties in recruiting the sample, failures in the computer systems, or a high dropout rate. Measures have been taken to try to reduce the impact of these limitations. This study received the approval of the Ethics committee of Universitat Jaume I in March 2022 (CD/42/2022).Trial registrationClinicalTrials.gov Identifier: NCT05464121. Registered 19 July 2022, https://clinicaltrials.gov/ct2/show/NCT05464121.
| S-EPMC10837064 | biostudies-literature
Project description:ObjectiveThis study aimed to investigate the cost-effectiveness of blended cognitive-behavioral therapy (CBT) compared to standard CBT for adult patients suffering from major depressive disorder (MDD).DesignA cost-utility analysis alongside the randomized controlled ENTER trial.SettingCenter for Telepsychiatry, Mental Health Services in the Region of Southern Denmark, Denmark.ParticipantsThe study included 76 patients suffering from MDD.InterventionsThe patients in the intervention group received blended CBT treatment comprising a combination of online modules and face-to-face consultations with a psychologist. The patients in the control group received standard CBT treatment, that is, solely face-to-face consultations with a psychologist. The treatment period was 12 weeks.Outcome measuresCost-effectiveness was reported as incremental cost-effectiveness ratio. A micro-costing approach was applied to evaluate the savings derived. Changes in quality-adjusted life-years (QALYs) were estimated using the EuroQol 5-Dimensions 5-Levels questionnaire at the baseline and the six-month follow-up.ResultsData for 74 patients were included in the primary analysis. The adjusted QALY difference between blended CBT and standard CBT was -0.0291 (95% CI: -0.0535 to -0.0047), and the adjusted difference in costs was -£226.32 (95% CI: -300.86 to -151.77). Blended CBT was estimated to have a 6.6% and 3.1% probability of being cost-effective based on thresholds of £20,000 and £30,000.ConclusionCompared to standard CBT, blended CBT represents a cost-saving but also a loss in QALYs for patients suffering from MDD. However, results should be carefully interpreted, given the small sample size. Future research involving larger replication studies focusing on other aspects of blended CBT with more patient involvement is advised.Trial registration numberClinicalTrial.gov: S-20150150.
| S-EPMC8886051 | biostudies-literature
Project description:BACKGROUND:Cognitive-behavioral group therapy (CBGT) is a first-line treatment for social anxiety disorder (SAD). However, since many patients remain symptomatic post-treatment, there is a need for augmenting procedures. This randomized controlled trial (RCT) examined the potential augmentation effect of attention bias modification (ABM) for CBGT. METHODS:Fifty patients with SAD from three therapy groups were randomized to receive an 18-week standard CBGT with either ABM designed to shift attention away from threat (CBGT + ABM), or a placebo protocol not designed to modify threat-related attention (CBGT + placebo). Therapy groups took place in a large mental health center. Clinician and self-report measures of social anxiety and depression were acquired pre-treatment, post-treatment, and at 3-month follow-up. Attention bias was assessed at pre- and post-treatment. RESULTS:Patients randomized to the CBGT + ABM group, relative to those randomized to the CBGT + placebo group, showed greater reductions in clinician-rated SAD symptoms post-treatment, with effects maintained at 3-month follow-up. Group differences were not evident for self-report or attention-bias measures, with similar reductions in both groups. Finally, reduction in attention bias did not mediate the association between group and reduction in Liebowitz Social Anxiety Scale Structured Interview (LSAS) scores. CONCLUSIONS:This is the first RCT to examine the possible augmenting effect of ABM added to group-based cognitive-behavioral therapy for adult SAD. Training patients' attention away from threat might augment the treatment response to standard CBGT in SAD, a possibility that could be further evaluated in large-scale RCTs.
| S-EPMC6013362 | biostudies-literature
Project description:Cognitive behavioral group therapy (CBGT) is an effective, well-established, but not widely available treatment for social anxiety disorder (SAD). Internet-based cognitive behavior therapy (ICBT) has the potential to increase availability and facilitate dissemination of therapeutic services for SAD. However, ICBT for SAD has not been directly compared with in-person treatments such as CBGT and few studies investigating ICBT have been conducted in clinical settings. Our aim was to investigate if ICBT is at least as effective as CBGT for SAD when treatments are delivered in a psychiatric setting.We conducted a randomized controlled non-inferiority trial with allocation to ICBT (n=64) or CBGT (n=62) with blinded assessment immediately following treatment and six months post-treatment. Participants were 126 individuals with SAD who received CBGT or ICBT for a duration of 15 weeks. The Liebowitz Social Anxiety Scale (LSAS) was the main outcome measure. The following non-inferiority margin was set: following treatment, the lower bound of the 95 % confidence interval (CI) of the mean difference between groups should be less than 10 LSAS-points.Both groups made large improvements. At follow-up, 41 (64%) participants in the ICBT group were classified as responders (95% CI, 52%-76%). In the CBGT group, 28 participants (45%) responded to the treatment (95% CI, 33%-58%). At post-treatment and follow-up respectively, the 95 % CI of the LSAS mean difference was 0.68-17.66 (Cohen's d between group=0.41) and -2.51-15.69 (Cohen's d between group=0.36) favoring ICBT, which was well within the non-inferiority margin. Mixed effects models analyses showed no significant interaction effect for LSAS, indicating similar improvement across treatments (F=1.58; df=2, 219; p=.21).ICBT delivered in a psychiatric setting can be as effective as CBGT in the treatment of SAD and could be used to increase availability to CBT.ClinicalTrials.gov NCT00564967.
| S-EPMC3070741 | biostudies-literature
Project description:BackgroundWhile the efficacy of cognitive therapy (CT) has been well established for social anxiety disorder (SAD) in several randomized controlled trials, there are still large differences between trials with respect to effect sizes. The present study investigates the question of whether enhanced training and the use of behavioral experiments (BEs) increases the efficacy of traditional CT, based on verbal methods of cognitive restructuring.Methods/designA mixed within/between conditions design will be applied, with therapists and patients being randomly allocated to one of two conditions: (1) training of CT plus BEs, (2) training of CT "as usual". Sixty patients with the primary diagnosis of SAD will be recruited and treated in the outpatient clinic of the Department of Psychology, University of Frankfurt. To ensure adherence to therapist protocols, all therapists will be trained and supervised by the project coordinators. In addition, videotaped treatment sessions will be independently evaluated to guarantee both adherence to protocols and the quality of the intervention. Treatment effects will be assessed by independent SAD symptom ratings using the Liebowitz Social Anxiety Scale as the primary outcome measure and self-report measures as secondary outcome measures.DiscussionThe present cognitive behavioral therapy (CBT) trial will be the first to clarify the contribution of BEs to the efficacy of CT in a randomized controlled design. Study results are relevant to clinical training and implementation of evidence-based treatments.Trial registrationGerman Clinical Trials Register International Clinical Trials Registry Platform (ICTRP) identifier: DRKS00014349. Trial status: recruiting.
| S-EPMC6921437 | biostudies-literature
Project description:Dental anxiety affects approximately 9% of children and is associated with poor oral health, pain, and psychosocial problems. The objective of this study was to investigate the efficacy of cognitive behavioral therapy (CBT) for children with dental anxiety in specialist pediatric dentistry. The study used a parallel-group superiority randomized controlled trial design. The primary outcome measure was the behavioral avoidance test; assessors were blind to treatment allocation. Participants were 8 boys and 22 girls 7 to 18 y old (mean ± SD, 10 ± 3.1). Children fulfilling the diagnostic criteria for dental anxiety were randomized to CBT (n = 13) or treatment as usual (n = 17), such as various sedation methods. Psychologists provided 10 h of CBT based on a treatment manual. Treatments were conducted in a naturalistic real-world clinical setting. Assessments were conducted before the treatment, 3 mo after the start of treatment, and at 1-y follow-up. The analyses of the primary outcome measure by repeated-measures analysis of variance and independent t test showed that children receiving CBT made superior, statistically significant improvements at follow-up (16.8 ± 2.4) compared with treatment as usual (11.4 ± 3.1, P < 0.01). A large between-group effect size (Cohen's d = 1.9) was found. Following treatment, 73% of those in the CBT group managed all stages of the dental procedures included in the behavioral avoidance test compared with 13% in the treatment-as-usual group. Furthermore, 91% in the CBT group compared with 25% in the treatment-as-usual group no longer met the diagnostic criteria for dental anxiety at the 1-y follow-up according to the secondary outcome measure. Measures of dental anxiety and self-efficacy showed larger improvements in the CBT group compared with controls. We conclude that CBT is an efficacious treatment for children and adolescents with dental anxiety and should be made accessible in pediatric dentistry (ClinicalTrials.gov: NCT01798355). Knowledge transfer statement: The results of this study can be used by decision makers and clinicians when planning to implement evidence-based treatment in pediatric dentistry and give children and adolescents access to methods for treating dental anxiety. The results can also be used by parents of children with dental anxiety when asking dentists to cooperate with psychologists using cognitive behavioral therapy.
| S-EPMC5772454 | biostudies-literature
Project description:BackgroundAdjustment disorder with anxiety (ADWA) is a highly prevalent condition, particularly in primary care practice. There are relatively few systematic treatment trials in the area of ADWA, and there are few data on predictors of treatment response. Etifoxine is a promising agent insofar as it is not associated with dependence, but in primary care settings benzodiazepines continue to be frequently prescribed for psychiatric symptoms. A randomized controlled trial of etifoxine versus alprazolam for ADWA was undertaken, focusing on efficacy and safety measures, and including an investigation of predictors of clinical response.MethodsThis was a comparative, multicenter, double-blind, randomized trial in two parallel groups of outpatients with ADWA. One group was treated with 150 mg/day for etifoxine, and the other with 1.5 mg/day for alprazolam for 28 days. Patients were followed for 4 weeks of treatment, and for an additional week after treatment discontinuation. The primary outcome measure was the Hamilton Anxiety Rating Scale (HAM-A), while secondary outcome measures included the Sheehan Disability Scale (SDS), the Clinical Global Impressions-Change Scale (CGI-C), and the Self-Report for the Assessment of Adjustment Disorders. Non-inferiority analysis was used to assess the primary outcome measure, and a multivariate logistic regression was employed to investigate predictors of response.ResultsTwo hundred and two adult outpatients with ADWA were enrolled at 17 primary care sites. One hundred and seventy seven patients completed the study (n = 87 in the etifoxine group; n = 90 in the alprazolam group). Etifoxine and alprazolam were accompanied by decreases in the HAM-A at day 28, with a difference between treatment groups in HAM-A score of 1.78 [90% CI; 0.23, 3.33] in favor of alprazolam. However, after medication discontinuation, HAM-A scores continued to improve in the etifoxine group, but increased in the alprazolam group; the difference between groups in mean change between day 28 and day 35 was significant (p = 0.019). Secondary outcome measures showed similar results for etifoxine and alprazolam at day 35. More treatment-related adverse events were reported in patients treated with alprazolam, particularly central nervous system-related AEs, and especially after medication discontinuation. No significant predictors of treatment response were found.ConclusionThis randomized controlled trial provides support for the efficacy and safety of etifoxine in the management of adjustment disorder with anxiety, particularly when treatment discontinuation data are also assessed. Etifoxine has the important clinical advantage of having anxiolytic effects, which are not being associated with dependence. Pharmacotherapy was equally efficacious in patients with more severe anxiety symptoms at baseline. Additional work using longer-term follow-up and collecting data on cost-efficiency of management options would further advance the field of ADWA.FundingSponsorship and article processing charges for this study were provided by Biocodex, Gentilly, France.
| S-EPMC4311065 | biostudies-literature