Preventing Disordered Eating in Teenage Ballet Students: Evaluation of DancExcellent, a Combined CBT and Nutrition Education Intervention.

BACKGROUND: Disordered eating (DE) behaviors are relatively common among high-level dancers, especially in classical ballet. At the same time, interventions aimed at reducing DE behaviors in this population are scarce. METHODS: An 8-week exploratory preventive intervention for DE behaviors was carried out in a high-level ballet school for 40 teenagers aged 12-15 years (77.5% female). Both risk factors (perfectionism) and potentially protective factors (self-esteem, self-compassion) for the development of DE behaviors were considered. The intervention was created specifically for this study and consisted of five cognitive behavior therapy (CBT) workshops and four nutrition workshops. Additional components included newsletters for pupils and educational sessions and social media interactions with staff and parents. The intervention comprised two phases (control and intervention periods), with students acting as their own controls. Standardized questionnaires were completed before and after both phases. RESULTS: Questionnaire results did not indicate any changes in reported perfectionism, self-esteem, or self-compassion, nor were symptoms of DE affected during either the control or intervention periods. CONCLUSIONS: The intervention did not yield any discernible impact. However, it was affected by the onset of the COVID-19 pandemic, which limits our ability to draw conclusions about intervention effectiveness. Evaluations with pupils offer several considerations for future improvements.

Pilot of a therapist-guided digital mental health intervention (eHealth CF-CBT) for adults with cystic fibrosis.

BACKGROUND: eHealth CF-CBT is the first digital mental health intervention for depression/anxiety in adults with cystic fibrosis (awCF); an 8-session therapist-guided internet-delivered program that was developed in English and Dutch with stakeholder input and evaluation indicating high acceptability and usability. METHODS: Dutch eHealth CF-CBT was piloted in awCF with mild-moderate symptoms of depression and/or anxiety. Feasibility, usability, acceptability, and preliminary efficacy were assessed, measuring pre-post changes in depression (PHQ-9), anxiety (GAD-7), perceived stress (PSS), and health-related quality of life (CFQ-R). RESULTS: All participants (n = 10, seven female, mean age 29 [range 21-43], mean FEV1 71%pred [range 31-115]) completed all sessions. Patient-rated feasibility, usability, and acceptability of eHealth CF-CBT were positive on validated scales, as were qualitative assessments of content and format. GAD-7 improved in 90% of participants; in 50% by ≥the minimally important difference (MID) of four points. PHQ-9 improved in 90%; 40% by ≥the MID of 5. PSS improved in 80%. CFQ-R improved in the domain health perceptions (70%). CONCLUSIONS: eHealth CF-CBT demonstrated feasibility, usability, acceptability, and promising preliminary efficacy in this pilot trial with Dutch awCF with mild to moderate symptoms of depression and anxiety.

Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: study protocol for a parallel group randomized controlled trial.

BACKGROUND: Depression is a major public health concern. Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression. Traditional face-to-face CBT-I encounters many obstacles related to feasibility, accessibility, and help-seeking stigma. CBT-I delivered via smartphone application could be a potential solution. This paper reports a protocol designed to evaluate the efficacy of a self-help smartphone-based CBT-I, using a waitlist group as control, for people with major depression and insomnia. METHODS: A two-arm parallel randomized controlled trial is conducted in a target sample of 285 non-suicidal Hong Kong Chinese older than 17 years of age with major depression and insomnia. Participants complete an online rapid screening, followed by a telephone diagnostic interview. Those who meet the eligibility criteria are randomized in a ratio of 1:1 to receive either CBT-I immediately or to a waitlist control condition. The CBT-I consists of six weekly modules and is delivered through a smartphone application proACT-S. This smartphone app has been pilot tested and revamped to improve user experience. An online randomized algorithm is used to perform randomization to ensure allocation concealment. The primary outcomes are changes over the measurement points in sleep quality, insomnia severity, and depression severity. The secondary outcomes include changes over the measurement points in anxiety, subjective health, treatment expectancy, and acceptability of treatment. Assessments are administered at baseline, post-intervention, and 6-week follow-up. The recruitment is completed. Important adverse events, if any, are documented. Multilevel linear mixed model based on intention-to-treat principle will be conducted to examine the efficacy of the CBT-I intervention. DISCUSSION: It is expected that proACT-S is an efficacious brief sleep-focused self-help treatment for people with major depression and insomnia. If proven efficacious, due to its self-help nature, proACT-S may be applicable as a community-based early intervention, thereby reducing the burden of the public healthcare system in Hong Kong. TRIAL REGISTRATION: ClinicalTrials.gov NCT04228146 . Retrospectively registered on 14 January 2020.

Interventions to Reduce Stress and Burnout among Teachers: A Scoping Review.

Background: Teaching is recognized as a highly challenging profession. Experience of chronic stress is a risk factor for poor mental and physical well-being, and burnout. There is limited knowledge regarding optimal interventions to address stress and burnout among teachers. Objective: To undertake a scoping review of the literature in the last five years to determine various psychological interventions to address stress and burnout among teachers. Method: The PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews was followed. Relevant search terms were used to determine different interventions adopted to reduce teachers' stress and burnout. Articles published between 2018 and 2022 were identified using five bibliographic databases. Relevant articles were extracted, reviewed, collated, and thematically analyzed, and findings s were summarized. Results: Forty studies conducted in Asia, North America, Oceania, Europe, and Africa, met the inclusion criteria. Sixteen kinds of burnout and stress-reduction interventions were identified. The most popularly studied intervention were Mindfulness-Based Interventions alone or in combination with yoga or Cognitive Behavioural Therapy (CBT), followed by Rational Emotive Behavioral Therapy (REBT). Mindfulness-Based Interventions led to decreased overall Teacher Stress Inventory (TSI) and emotional exhaustion subscale scores. REBT, primarily used with special education teachers, especially in Africa, has also shown positive results. Other interventions reporting positive outcomes include Inquiry-Based Stress Reduction (IBSR), the Stress Management and Resiliency Training Program (SMART), Cyclic Meditation, Group Sandplay, Progressive Muscle Relaxation, Autogenic Training, Sport-Based Physical Activity, Emotional Intelligence Ability Models and Christian Prayer and Prayer-Reflection. Conclusions: Stress and burnout can have a negative impact on teachers and, very often, on the students they teach. Implementing suitable school-based interventions is necessary to improve teachers' stress-coping ability, reduce the likelihood of burnout and improve general well-being. Policymakers, governments, school boards and administrators should prioritize the implementation of school-based awareness and intervention programs.

Evaluation of the effect of a midwife-led online program using cognitive behavioral therapy for pregnant women at risk for anxiety disorder in Japan: A pilot randomized controlled trial.

AIM: This study aimed to conduct a pilot randomized controlled trial (RCT) to examine the appropriateness and feasibility of a midwife-led cognitive behavioral therapy (CBT)-based, three-session program delivered remotely to pregnant women at risk for anxiety disorders. METHODS: The study design was a pilot RCT. Outcome was the difference between the two groups in the change in generalized anxiety disorder-7 (GAD-7), Kessler6 (K6) and Edinberg Postnatal Depression Scale (EPDS) etc. Recruitment was conducted from August 2020 to July 2021 in clinics and web-based survey monitors in Japan, with follow-up through November 2021. RESULTS: This program involving 63 pregnant women were administered. Although the intervention was remote, a total of three sessions was completed during pregnancy. The change in GAD-7 scores from pre- to 1 month postpartum, was mean -1.77 in the intervention group and mean -0.97 in the control group, with a p-value of .521, indicating no significant difference between the two groups, although GAD-7 scores were lower in the intervention group. The change in K6 score from pre- to 1 month postpartum, was mean -3.55 in the intervention group and mean -1.62 in the control group, with a p-value of .168, indicating no significant difference between the two groups, although the intervention group showed a greater decrease. In particular, in primiparas, the change in GAD-7 scores in the intervention group was large, and some expressed a desire for a postpartum session, suggesting that a follow-up session after delivery may be effective. In multiparas, the control group showed an increase in both GAD-7 and K6 scores from late pregnancy to 1 month postpartum, while the intervention group showed a decrease in scores. CONCLUSION: The program was implemented using CBT conducted by midwife, anxiety decreased in primiparas. In future RCTs, it was suggested that additional postpartum sessions may be effective. TRIAL REGISTRATION: UMIN Clinical trial registry ID: UMIN000040304.

Randomized trial of brief interpersonal psychotherapy and cognitive behavioral therapy for depression delivered both in-person and by telehealth.

BACKGROUND: Expert consensus guidelines recommend Cognitive Behavioral Therapy (CBT) and Interpersonal Psychotherapy (IPT), interventions that were historically delivered face-to-face, as first-line treatments for Major Depressive Disorder (MDD). Despite the ubiquity of telehealth following the COVID-19 pandemic, little is known about differential outcomes with CBT versus IPT delivered in-person (IP) or via telehealth (TH) or whether working alliance is affected. METHODS: Adults meeting DSM-5 criteria for MDD were randomly assigned to either 8 sessions of IPT or CBT (group). Mid-trial, COVID-19 forced a change of therapy delivery from IP to TH (study phase). We compared changes in Hamilton Rating Scale for Depression (HRSD-17) and Working Alliance Inventory (WAI) scores for individuals by group and phase: CBT-IP (n = 24), CBT-TH (n = 11), IPT-IP (n = 25) and IPT-TH (n = 17). RESULTS: HRSD-17 scores declined significantly from pre to post treatment (pre: M = 17.7, SD = 4.4 vs. post: M = 11.7, SD = 5.9; p < .001; d = 1.45) without significant group or phase effects. WAI scores did not differ by group or phase. Number of completed therapy sessions was greater for TH (M = 7.8, SD = 1.2) relative to IP (M = 7.2, SD = 1.6) (Mann-Whitney U = 387.50, z = -2.24, p = .025). LIMITATIONS: Participants were not randomly assigned to IP versus TH. Sample size is small. CONCLUSIONS: This study provides preliminary evidence supporting the efficacy of both brief IPT and CBT, delivered by either TH or IP, for depression. It showed that working alliance is preserved in TH, and delivery via TH may improve therapy adherence. Prospective, randomized controlled trials are needed to definitively test efficacy of brief IPT and CBT delivered via TH versus IP.

Effects of Cognitive Behavioral Therapy and Cash Transfers on Older Persons Living Alone in India : A Randomized Trial.

BACKGROUND: A growing number of older persons in developing countries live entirely alone and are physically, mentally, and financially vulnerable. OBJECTIVE: To determine whether phone-based cognitive behavioral therapy (CBT) or a cash transfer reduce functional impairment, depression, or food insecurity in this population. DESIGN: Randomized controlled trial. (ClinicalTrials.gov: NCT04225845; American Economic Association RCT Registry: AEARCTR-0007582). SETTING: Tamil Nadu, India, 2021. PARTICIPANTS: 1120 people aged 55 years and older and living alone. INTERVENTIONS: A 6-week, phone-based CBT and a 1-time cash transfer of 1000 rupees (U.S. $12 at market exchange rates) were evaluated in a factorial design. MEASUREMENTS: The World Health Organization Disability Assessment Schedule (WHODAS), the Geriatric Depression Scale, and food security, all measured 3 weeks after CBT for 977 people and 3 months after for 932. Surveyors were blind to treatment assignment. RESULTS: The WHODAS score (scale 0 to 48, greater values representing more impairment) decreased between baseline and the 3-week follow-up by 2.92 more (95% CI, -5.60 to -0.23) in the group assigned cash only than in the control group, and the depression score (ranging from 0 to 15, higher score indicating more depressive symptoms) decreased by 1.01 more (CI, -2.07 to 0.06). These effects did not persist to the 3-month follow-up, and CBT alone and the 2 together had no significant effects. There were no effects on food security. LIMITATIONS: The study cannot say whether more sustained or in-person therapy would have been effective, how results would translate outside of the COVID-19 period, or whether results in the consented sample differ from those in a larger population. Primary outcomes were self-reported. CONCLUSION: Among older people living alone, a small cash transfer was effective in alleviating short-term (3 weeks) functional impairment, produced a small but not clinically or statistically significant reduction in depression, and had no effect on food security. There were no short-term effects from CBT or the 2 interventions together. None of the interventions showed any effect at 3 months. PRIMARY FUNDING SOURCE: National Institute on Aging (NIA).

Group trauma focused cognitive behavior therapy for parents of premature infants compared to individual therapy intervention.

BACKGROUND: The current study compares results of a group-based intervention developed to reduce symptoms of posttraumatic stress, depression, and anxiety in parents of premature infants with a prior study using an individual version of the treatment manual. METHODS: 26 mothers of preterm infants (25-34 weeks' gestational age; >600 g) received 6 sessions of trauma-focused cognitive behavior therapy (CBT). Outcomes were compared with those of a previously published RCT, which tested an individual therapy based on the same model in a group of 62 mothers. Results were also compared across in-person and telehealth treatment. RESULTS: From baseline to follow up, the individual intervention showed greater improvement in trauma symptoms assessed with the Davidson Trauma Scale (d = 0.48, p = 0.016), although both conditions showed clinically significant improvement. Similar patterns were found for maternal depression and anxiety. In-person treatment was found to be superior to telehealth treatment administered during the COVID-19 pandemic, although the difference was not significant. CONCLUSIONS: Group-based trauma focused CBT is an effective treatment modality for parents of premature infants with symptoms of psychological distress but not as effective as individual therapy using the same treatment model.

Digital Addiction Intervention for Children and Adolescents: A Scoping Review.

Digital devices play a significant role in the learning and living of children and adolescents, whose overuse or addiction has become a global concern. This scoping review seeks to synthesize existing studies to investigate relevant interventions and their effects on digital addiction in children (ages 0-18). To understand the latest advances, we have identified 17 studies published in international peer-reviewed journals between 2018-2022. The findings revealed that, first, most interventions for digital addiction in children and adolescents were cognitive-behavioral therapies (CBT) or CBT-based interventions, which could improve anxiety, depression, and related symptoms of digital addiction. Second, rather than directly targeting addictive behaviors, some family-based interventions aim to strengthen family functions and relationships. Finally, digital-based interventions, such as website-based, application-based, and virtual reality interventions, are promising in adolescent digital addiction interventions. However, these studies shared the same limitations: small sample sizes, short intervention durations, no control group, and nonrandomized assignments. The small sample size problem is difficult to solve by offline intervention. Meanwhile, online digital-based intervention is still in its infancy, resulting in limited generalizability of the findings and the inability to popularize digital intervention. Accordingly, future intervention studies should integrate various assessments and interventions to form an integrated platform to provide interventions for addicted children and adolescents worldwide.

Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: a parallel-group randomized controlled trial.

BACKGROUND: Despite its efficacy in treating comorbid insomnia and depression, cognitive behavioral therapy for insomnia (CBT-I) is limited in its accessibility and, in many countries, cultural compatibility. Smartphone-based treatment is a low-cost, convenient alternative modality. This study evaluated a self-help smartphone-based CBT-I in alleviating major depression and insomnia. METHODS: A parallel-group randomized, waitlist-controlled trial was conducted with 320 adults with major depression and insomnia. Participants were randomized to receive either a 6-week CBT-I via a smartphone application, proACT-S, or waitlist condition. The primary outcomes included depression severity, insomnia severity, and sleep quality. The secondary outcomes included anxiety severity, subjective health, and acceptability of treatment. Assessments were administered at baseline, post-intervention (week 6) follow-up, and week 12 follow-up. The waitlist group received treatment after the week 6 follow-up. RESULTS: Intention to treat analysis was conducted with multilevel modeling. In all but one model, the interaction between treatment condition and time at week 6 follow-up was significant. Compared with the waitlist group, the treatment group had lower levels of depression [Center for Epidemiologic Studies Depression Scale (CES-D): Cohen's d = 0.86, 95% CI (-10.11 to -5.37)], insomnia [Insomnia Severity Index (ISI): Cohen's d = 1.00, 95% CI (-5.93 to -3.53)], and anxiety [Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A): Cohen's d = 0.83, 95% CI (-3.75 to -1.96)]. They also had better sleep quality [Pittsburgh Sleep Quality Index (PSQI): Cohen's d = 0.91, 95% CI (-3.34 to -1.83)]. No differences across any measures were found at week 12, after the waitlist control group received the treatment. CONCLUSION: proACT-S is an efficacious sleep-focused self-help treatment for major depression and insomnia. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04228146. Retrospectively registered on 14 January 2020. http://www.w3.org/1999/xlink">https://clinicaltrials.gov/ct2/show/NCT04228146.

Effects of a online brief modified mindfulness-based stress reduction therapy for anxiety among Chinese adults: A randomized clinical trial.

The COVID-19 pandemic has exacerbated anxiety and related symptoms among the general population. In order to cope with the mental health burden, we developed an online brief modified mindfulness-based stress reduction (mMBSR) therapy. We performed a parallel-group randomized controlled trial to evaluate the efficacy of the mMBSR for adult anxiety with cognitive-behavioral therapy (CBT) as an active control. Participants were randomized to mMBSR, CBT or waitlist group. Those in the intervention arms performed each therapy for 6 sections in 3 weeks. Measurements were conducted at baseline, post-treatment and 6 months post-treatment by Generalized Anxiety Disorder-7, Patient Health Questionnaire-9, Patient Health Questionnaire-15, reverse scored Cohen Perceived Stress scale, Insomnia Severity Index, and Snaith-Hamilton Pleasure Scale. 150 participants with anxiety symptoms were randomized to mMBSR, CBT or waitlist group. Post intervention assessments showed that mMBSR improved the scores of all the six mental problem dimensions (anxiety, depression, somatization, stress, insomnia, and the experience of pleasure) significantly compared to the waitlist group. During 6-month post treatment assessment, the scores of all six mental problem dimensions in the mMBSR group still showed improvement compared to baseline and showed no significant difference with the CBT group. Our results provide positive evidence for the efficacy and feasibility of an online brief modified MBSR program to alleviate anxiety and related symptoms of individuals from the general population, and the therapeutic benefits of mMBSR persisted for up to six months. This low resource-consuming intervention could facilitate the challenges of supplying psychological health therapy to large scale of population.

CBT treatment delivery formats for panic disorder: a systematic review and network meta-analysis of randomised controlled trials.

Several in-person and remote delivery formats of cognitive-behavioural therapy (CBT) for panic disorder are available, but up-to-date and comprehensive evidence on their comparative efficacy and acceptability is lacking. Our aim was to evaluate the comparative efficacy and acceptability of all CBT delivery formats to treat panic disorder. To answer our question we performed a systematic review and network meta-analysis of randomised controlled trials. We searched MEDLINE, Embase, PsycINFO, and CENTRAL, from inception to 1st January 2022. Pairwise and network meta-analyses were conducted using a random-effects model. Confidence in the evidence was assessed using Confidence in Network Meta-Analysis (CINeMA). The protocol was published in a peer-reviewed journal and in PROSPERO. We found a total of 74 trials with 6699 participants. Evidence suggests that face-to-face group [standardised mean differences (s.m.d.) -0.47, 95% confidence interval (CI) -0.87 to -0.07; CINeMA = moderate], face-to-face individual (s.m.d. -0.43, 95% CI -0.70 to -0.15; CINeMA = Moderate), and guided self-help (SMD -0.42, 95% CI -0.77 to -0.07; CINeMA = low), are superior to treatment as usual in terms of efficacy, whilst unguided self-help is not (SMD -0.21, 95% CI -0.58 to -0.16; CINeMA = low). In terms of acceptability (i.e. all-cause discontinuation from the trial) CBT delivery formats did not differ significantly from each other. Our findings are clear in that there are no efficacy differences between CBT delivered as guided self-help, or in the face-to-face individual or group format in the treatment of panic disorder. No CBT delivery format provided high confidence in the evidence at the CINeMA evaluation.

Therapist Voices on a Youth Mental Health Pilot: Responsiveness to Diversity and Therapy Modality.

This article explores therapists' views on a large youth mental health pilot project (for 18-25-year-olds), which included an individual cognitive behavior therapy (CBT)-informed individual therapy component. Therapists' views on cultural responsiveness, therapy (delivery, modality and duration) and working with LGBTQIA+ youth were explored using two surveys, individual interviews and focus groups at various stages of the life of the pilot. Some therapists saw the CBT approach as imposed on them, preferring familiar therapy modalities. Many therapists were positive toward CBT for its client-centered approach and reported using CBT-informed approaches with many of their clients to good effect. Some therapists felt pressured by their workplace to see clients for fewer sessions than they needed. Therapists wanted to see a more culturally diverse workforce, to increase their cultural competence through training and to have more easily available cultural supervision. There was some acknowledgement of the importance of training therapists to work competently with LGBTQIA+ young people. Involving therapists in co-design of services from the outset will likely benefit future service development.

A COVID-19-járvány miatt kialakult betegségszorongás és depresszió kezelése kognitív viselkedésterápiával egy emlorákos no esete kapcsán.

Cancer and the various medical treatments and tests are a major physical and psychological challenge for patients, their relatives and for the medical staff as well. Adherence and compliance become critical factors during prolonged oncological therapies. The mental health of people with malignant cancer, untreated psychological symptoms can affect survival by increasing distress and suffering, weakening quality of life and reducing adherence. Furthermore, they have a particularly high comorbidity with psychiatric disorders. The aim of this study is to introduce the tools of cognitive behavioural therapy and the therapeutic indications in the context of mental disorders associated with chronic somatic illness. Our study presents the case of a 66-year-old woman with breast cancer. She was diagnosed with mild depressive episodes and hypochondriasis based on psychodiagnostic assessment. Instead of interpreting the patient's symptoms as a serious organic illness, the goal of psychotherapy is to develop new, more adaptive attitudes and more comforting perspective of the symptoms, and to reduce secondary depression. The elements of the 16-session cognitive behavioural therapy included behavioural activation, analysis of symptomatic behaviour, diary management, development of new alternatives and behavioural experiments, conceptualisation, and summarising learned techniques and future planning. Orv Hetil. 2022; 163(23): 895-901.

Interventions for generalized anxiety disorder.

PURPOSE OF REVIEW: To provide an overview of recently published work on anxiety, focusing on generalized anxiety disorder (GAD) and its treatment. RECENT FINDINGS: Self-reported anxiety symptoms were highly prevalent during the COVID-19 global pandemic in both the general population and in selected groups. There remains divided opinion about whether internet-based cognitive behavioural therapy (CBT) is noninferior to face-to-face CBT for GAD. A systematic review of drug treatment for GAD showed efficacy for selective serotonin reuptake inhibitors (SNRIs), agomelatine, and quetiapine. There may be a place for repetitive transcranial magnetic stimulation in the treatment of GAD. There was some evidence of efficacy for complementary therapies, including physical exercise, yoga, acupuncture, and Withania somnifera (ashwagandha). However, a systematic review of cannabidiol and tetrahydrocannabinol found insufficient evidence of efficacy in anxiety disorders. SUMMARY: Antidepressants and quetiapine show efficacy in the treatment of GAD. Internet-based psychological interventions have a place in the treatment of GAD when face-to-face treatment is inaccessible. There is increasing evidence for the use of physical exercise in the management of GAD. Some other complementary therapies, including cannabinoids, require further, methodologically sound, research.

Multisite randomised controlled trial of trauma-focused cognitive behaviour therapy for psychosis to reduce post-traumatic stress symptoms in people with co-morbid post-traumatic stress disorder and psychosis, compared to treatment as usual: study protocol for the STAR (Study of Trauma And Recovery) trial.

BACKGROUND: People with psychosis have high rates of trauma, with a post-traumatic stress disorder (PTSD) prevalence rate of approximately 15%, which exacerbates psychotic symptoms such as delusions and hallucinations. Pilot studies have shown that trauma-focused (TF) psychological therapies can be safe and effective in such individuals. This trial, the largest to date, will evaluate the clinical effectiveness of a TF therapy integrated with cognitive behaviour therapy for psychosis (TF-CBTp) on post-traumatic stress symptoms in people with psychosis. The secondary aims are to compare groups on cost-effectiveness; ascertain whether TF-CBTp impacts on a range of other meaningful outcomes; determine whether therapy effects endure; and determine acceptability of the therapy in participants and therapists. METHODS: Rater-blind, parallel arm, pragmatic randomised controlled trial comparing TF-CBTp + treatment as usual (TAU) to TAU only. Adults (N = 300) with distressing post-traumatic stress and psychosis symptoms from five mental health Trusts (60 per site) will be randomised to the two groups. Therapy will be manualised, lasting 9 months (m) with trained therapists. We will assess PTSD symptom severity (primary outcome); percentage who show loss of PTSD diagnosis and clinically significant change; psychosis symptoms; emotional well-being; substance use; suicidal ideation; psychological recovery; social functioning; health-related quality of life; service use, a total of four times: before randomisation; 4 m (mid-therapy); 9 m (end of therapy; primary end point); 24 m (15 m after end of therapy) post-randomisation. Four 3-monthly phone calls will be made between 9 m and 24 m assessment points, to collect service use over the previous 3 months. Therapy acceptability will be assessed through qualitative interviews with participants (N = 35) and therapists (N = 5-10). An internal pilot will ensure integrity of trial recruitment and outcome data, as well as therapy protocol safety and adherence. Data will be analysed following intention-to-treat principles using generalised linear mixed models and reported according to Consolidated Standards of Reporting Trials-Social and Psychological Interventions Statement. DISCUSSION: The proposed intervention has the potential to provide significant patient benefit in terms of reductions in distressing symptoms of post-traumatic stress, psychosis, and emotional problems; enable clinicians to implement trauma-focused therapy confidently in this population; and be cost-effective compared to TAU through reduced service use. TRIAL REGISTRATION: ISRCTN93382525 (03/08/20).

INTERNET-DELIVERED LOW-INTENSITY CBT FOR PEOPLE WITH SOCIAL ANXIETY DISORDER IN A PERIOD OF COVID-19: RESULTS OF PILOT RESEARCH.

OBJECTIVE: The aim: The study aims to provide evidence of the effectiveness of online low-intensity CBT-based psychological interventions on the psychological well-being of people with social anxiety disorders and related impairments in the COVID-19 pandemic. PATIENTS AND METHODS: Materials and methods: 222 volunteers aged 18-35 years included in study: low-intensity CBT group (n=106) and control group (n=116). To assess the mental health prob¬lems were used International Neuropsychiatric Interview (MINI) and a set of IAPT scales. Analyses considered levels of pre-post intervention effect sizes and clinically significant improvement of symptoms of social anxiety disorder, generalized anxiety disorder, depression, and distress in maintaining general and work activity scores. RESULTS: Results: Comparisons between the low-intensity interventions group and control (self-help guide psychological care as usual) indicated more reduction in the severity of symp¬toms of social anxiety disorder and comorbid impairments associated with depression or generalized anxiety disorder. Changes for social phobia and other outcomes indicate that the odds of relapse or exacerbation of symptoms in the control group are more significant than those after a CBT-based low-intensity psychosocial care program. Analysis showed a significant interaction between outcomes scores and the number of sessions: more than five online sessions and homework with a self-help guide improved outcome. CONCLUSION: Conclusions: This pilot trial provides initial evidence that low-intensity online interventions based on CBT result in reductions in psychological problems for persons with a social anxiety disorder during the COVID-19 pandemic.