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Efficacy of a Smartphone-Based Digital Therapeutic (Anzeilax) in Generalized Anxiety Disorder: Randomized Controlled Trial
Individuals with generalized anxiety disorder (GAD) often face challenges with self-regulation and limited access to traditional therapy. Although acceptance and commitment therapy (ACT) has demonstrated both efficacy and effectiveness in promoting psychological flexibility, scalable solutions are necessary to address these barriers. This study introduces Anzeilax, an ACT-based digital therapeutic (DTx) that incorporates self-talk as a novel mechanism of action (MoA) to enhance psychological flexibility in the treatment of GAD.
This study aimed to evaluate the efficacy of Anzeilax in reducing anxiety symptoms in individuals with GAD.
A 10-week, parallel-group, superiority randomized controlled trial (RCT) was conducted with 96 participants diagnosed with GAD (Generalized Anxiety Disorder 7-item scale [GAD-7] scores≥10, age≥19 years). The participants were randomly assigned (1:1) to receive either Anzeilax alongside treatment as usual (TAU, treatment group; n=48, 50%) or TAU alone (control group; n=48). Only the outcome evaluators were blinded to the group assignment. The primary outcome was the change in the GAD-7 score from baseline to week 10. The secondary outcomes included the Beck Anxiety Inventory (BAI) for anxiety symptoms, the Penn State Worry Questionnaire (PSWQ) for pathological worry, and the Hospital Anxiety and Depression Scale (HADS) for anxiety (HADS-A) and depression (HADS-D) symptoms. All self-report outcomes were assessed at baseline and at weeks 5 (midintervention), 10 (postintervention), and 15 (follow-up).
During the trial, 34 (71%) and 31 (65%) participants in the treatment group maintained at least 80% of the prescribed usage frequency at weeks 5 and 10, respectively. Based on the full analysis set (FAS), participants using Anzeilax demonstrated significant improvement in anxiety symptoms compared to the control group. Analysis of the primary outcome at 10 weeks postintervention compared to baseline exhibited a significant reduction in GAD-7 scores (adjusted mean difference -2.26, 95% CI -3.78 to -0.74, P=.002). Secondary outcomes at the same time point indicated consistent improvements, with significant group-by-time interactions observed in the GAD-7 (Cohen d=0.60, P=.008), BAI (Cohen d=0.50, P=.008), PSWQ (Cohen d=0.62, P=.002), and HADS-A (Cohen d=0.50, P=.01) scores. These improvements were sustained at the follow-up assessment (week 15). Although the differences in depressive symptoms between the two groups did not present statistical significance, notable improvements were observed in the treatment group.
Anzeilax demonstrated clinically meaningful efficacy in reducing anxiety symptoms when combined with TAU. The results showed consistent improvements across multiple anxiety measures, with effects sustained through follow-up. The incorporation of context-sensitive self-talk within an ACT-based DTx framework offers a promising and accessible solution for treating individuals with GAD.
ClinicalTrials.gov NCT06010654; https://clinicaltrials.gov/study/NCT06010654.
Journal Article
Cognitive behavior therapy
Learn and apply the 14 core principles of cognitive behavior therapy
In this invaluable guide, clinicians will find—identified and summarized by leading researchers and clinicians—fourteen core principles that subsume the more than 400 cognitive behavioral therapy (CBT) treatment protocols currently in use, so they may apply them to their everyday practice. This unique contribution to the field provides practitioners with a balance of history, theory, and evidence-based applications.
Edited by renowned experts in the field, Cognitive Behavior Therapy explores the core principles behind all CBT protocols including:
* Clinical functional analysis
* Skills training
* Exposure
* Relaxation
* Cognitive restructuring
* Problem solving
* Self-regulation
A straightforward introduction to CBT principles with guidance for all mental health professionals seeking to improve the lives of clients spanning a range of psychological problems, Cognitive Behavior Therapy is designed for both new and experienced clinicians alike who want to deepen and broaden their understanding of CBT principles.
eBook
Effectiveness of an intervention led by lay health counsellors for depressive and anxiety disorders in primary care in Goa, India (MANAS): a cluster randomised controlled trial
Depression and anxiety disorders are common mental disorders worldwide. The MANAS trial aimed to test the effectiveness of an intervention led by lay health counsellors in primary care settings to improve outcomes of people with these disorders.
In this cluster randomised trial, primary care facilities in Goa, India, were assigned (1:1) by computer-generated randomised sequence to intervention or control (enhanced usual care) groups. All adults who screened positive for common mental disorders were eligible. The collaborative stepped-care intervention offered case management and psychosocial interventions, provided by a trained lay health counsellor, supplemented by antidepressant drugs by the primary care physician and supervision by a mental health specialist. The research assessor was masked. The primary outcome was recovery from common mental disorders as defined by the International Statistical Classification of Diseases and Related Health Problems—10th revision (ICD-10) at 6 months. This study is registered with
ClinicalTrials.gov, number
NCT00446407.
24 study clusters, with an equal proportion of public and private facilities, were randomised equally between groups. 1160 of 1360 (85%) patients in the intervention group and 1269 of 1436 (88%) in the control group completed the outcome assessment. Patients with ICD-10-confirmed common mental disorders in the intervention group were more likely to have recovered at 6 months than were those in the control group (n=620 [65·0%] vs 553 [52·9%]; risk ratio 1·22, 95% CI 1·00–1·47; risk difference=12·1%, 95% CI 1·6%–22·5%). The intervention had strong evidence of an effect in public facility attenders (369 [65·9%] vs 267 [42·5%], risk ratio 1·55, 95% CI 1·02–2·35) but no evidence for an effect in private facility attenders (251 [64·1%] vs 286 [65·9%], risk ratio 0·95, 0·74–1·22). There were three deaths and four suicide attempts in the collaborative stepped-care group and six deaths and six suicide attempts in the enhanced usual care group. None of the deaths were from suicide.
A trained lay counsellor-led collaborative care intervention can lead to an improvement in recovery from CMD among patients attending public primary care facilities.
The Wellcome Trust.
Journal Article
Play-based interventions for childhood anxieties, fears, and phobias
\"Description Illustrating the power of play for helping children overcome a wide variety of worries, fears, and phobias, this book provides a toolkit of play therapy approaches and techniques. Coverage encompasses everyday fears and worries in 3- to 12-year-olds as well as anxiety disorders and posttraumatic problems. Leading practitioners describe their approaches step by step and share vivid illustrative case material. Each chapter also summarizes the research base for the interventions discussed. Key topics include adapting therapy to each child's developmental level, engaging reluctant or less communicative clients, and involving parents in treatment. Keywords children, childhood anxieties, anxiety disorders, play therapy, psychotherapy, therapeutic play, interventions, techniques, worries, fears, phobias, schools, posttraumatic stress disorder, PTSD, treatments, approaches, Theraplay, nightmares, nighttime fears, afraid of the dark, selective mutism, obsessive-compulsive disorder, OCD, separation anxiety, social anxiety disorder, generalized anxiety disorder, disasters, child sexual abuse, play-based treatments, play activities, counseling children, counselors, psychotherapists, parents, parenting strategies, school-age children, preschoolers, anxious children, fearful children, traumatized children, worrying, car accidents, stressful life events, books on play therapy, books on childhood anxiety\"-- Provided by publisher.
Book
The Impact of Treatment Expectations on Exposure Process and Treatment Outcome in Childhood Anxiety Disorders
This study examined the relationship between caregivers’ and youths’ treatment expectations and characteristics of exposure tasks (quantity, mastery, compliance) in cognitive-behavioral therapy (CBT) for childhood anxiety. Additionally, compliance with exposure tasks was tested as a mediator of the relationship between treatment expectations and symptom improvement. Data were from youth (N = 279; 7–17 years old) enrolled in the Child/Adolescent Anxiety Multimodal Study (CAMS) and randomized to cognitive-behavioral therapy (CBT) or the combination of CBT and sertraline for the treatment of separation anxiety disorder, generalized anxiety disorder, and social phobia. Caregivers and youth independently reported treatment expectations prior to randomization, anxiety was assessed pre- and post-treatment by independent evaluators blind to treatment condition, and exposure characteristics were recorded by the cognitive-behavioral therapists following each session. For both caregivers and youths, more positive expectations that anxiety would improve with treatment were associated with greater compliance with exposure tasks, and compliance mediated the relationship between treatment expectations and change in anxiety symptoms following treatment. Additionally, more positive parent treatment expectations were related to a greater number and percentage of sessions with exposure. More positive youth treatment expectations were associated with greater mastery during sessions focused on exposure. Findings underscore the importance of addressing parents’ and youths’ treatment expectations at the outset of therapy to facilitate engagement in exposure and maximize therapeutic gains.
Journal Article
Treatment plans and interventions for depression and anxiety disorders
\"_This widely used book is packed with indispensable tools for treating the most common clinical problems encountered in outpatient mental health practice. Chapters provide basic information on depression and the six major anxiety disorders; step-by-step instructions for evidence-based assessment and intervention; illustrative case examples; and practical guidance for writing reports and dealing with third-party payers. In a convenient large-size format, the book features 125 reproducible client handouts, homework sheets, and therapist forms for assessment and record keeping. The included CD-ROM enables clinicians to rapidly generate individualized treatment plans, print extra copies of the forms, and find information on frequently prescribed medications._New to This Edition*The latest research on each disorder and its treatment.*Innovative techniques that draw on cognitive, behavioral, mindfulness, and acceptance-based approaches.*Two chapters offering expanded descriptions of basic behavioral and cognitive techniques.*47 of the 125 reproducibles are entirely new. __\"--Provided by publisher.
Book
Enduring effects of psychological treatments for anxiety disorders: meta-analysis of follow-up studies
It is a widespread opinion that after treatment with psychotherapy, patients with anxiety disorders maintain their gains beyond the active treatment period, whereas patients treated with medication soon experience a relapse after treatment termination.AimsWe aimed to provide evidence on whether enduring effects of psychotherapy differ from control groups.
We searched 93 randomised controlled studies with 152 study arms of psychological treatment (cognitive-behavioural therapy or other psychotherapies) for panic disorder, generalised anxiety disorder and social anxiety disorder that included follow-up assessments. In a meta-analysis, pre-post effect sizes for end-point and all follow-up periods were calculated and compared with control groups (medication: n = 16 study arms; pill and psychological placebo groups: n = 17 study arms).
Gains with psychotherapy were maintained for up to 24 months. For cognitive-behavioural therapy, we observed a significant improvement over time. However, patients in the medication group remained stable during the treatment-free period, with no significant difference when compared with psychotherapy. Patients in the placebo group did not deteriorate during follow-up, but showed significantly worse outcomes than patients in cognitive-behavioural therapy.
Not only psychotherapy, but also medications and, to a lesser extent, placebo conditions have enduring effects. Long-lasting treatment effects observed in the follow-up period may be superimposed by effects of spontaneous remission or regression to the mean.Declaration of interestIn the past 12 months and in the near future, Dr Bandelow has been/will be on the speakers/advisory board for Hexal, Mundipharma, Lilly, Lundbeck, Pfizer and Servier. Dr Wedekind was on the speakers' board of AstraZeneca, Essex Pharma, Lundbeck and Servier. All other authors have nothing to declare.
Journal Article