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Online cognitive-behavioural therapy for traumatically bereaved people: study protocol for a randomised waitlist-controlled trial.

ABSTRACT: INTRODUCTION:The traumatic death of a loved one, such as death due to a traffic accident, can precipitate persistent complex bereavement disorder (PCBD) and comorbid post-traumatic stress disorder (PTSD) and depression. Waitlist-controlled trials have shown that grief-specific cognitive-behavioural therapy (CBT) is an effective treatment for such mental health problems. This is the first study that will examine the effectiveness of online CBT (vs waitlist controls) in a sample exclusively comprised of people bereaved by a traumatic death. Our primary hypothesis is that people allocated to the online CBT condition will show larger reductions in PCBD, PTSD and depression symptom levels at post-treatment than people allocated to a waitlist. We further expect that reductions in symptom levels during treatment are associated with reductions of negative cognitions and avoidance behaviours and the experience of fewer accident-related stressors. Moreover, the effect of the quality of the therapeutic alliance on treatment effects and drop-out rates will be explored. METHODS AND ANALYSIS:A two-arm (online CBT vs waiting list) open-label parallel randomised controlled trial will be conducted. Participants will complete questionnaires at pretreatment and 12 and 20 weeks after study enrolment. Eligible for participation are Dutch adults who lost a loved one at least 1?year earlier due to a traffic accident and report clinically relevant levels of PCBD, PTSD and/or depression. Multilevel modelling will be used. ETHICS AND DISSEMINATION:Ethics approval has been received by the Medical Ethics Review Board of the University Medical Center Groningen (METc UMCG: M20.252121). This study will provide new insights in the effectiveness of online CBT for traumatically bereaved people. If the treatment is demonstrated to be effective, it will be made publicly accessible. Findings will be disseminated among lay people (eg, through newsletters and media performances), our collaborators (eg, through presentations at support organisations), and clinicians and researchers (eg, through conference presentations and scientific journal articles). TRIAL REGISTRATION NUMBER:NL7497.

SUBMITTER: Lenferink L

PROVIDER: S-EPMC7473627 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Online cognitive-behavioural therapy for traumatically bereaved people: study protocol for a randomised waitlist-controlled trial.

Lenferink Lonneke L de Keijser Jos J Eisma Maarten M Smid Geert G Boelen Paul P

BMJ open 20200903 9

<h4>Introduction</h4>The traumatic death of a loved one, such as death due to a traffic accident, can precipitate persistent complex bereavement disorder (PCBD) and comorbid post-traumatic stress disorder (PTSD) and depression. Waitlist-controlled trials have shown that grief-specific cognitive-behavioural therapy (CBT) is an effective treatment for such mental health problems. This is the first study that will examine the effectiveness of online CBT (vs waitlist controls) in a sample exclusivel ...[more]

PMID: 32883723

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Project description:Introduction One in six workers experience some form of mental health problems at work costing the UK economy an estimated £70 billion/year. Digital interventions provide low cost and easily scalable delivery methods to implement psychological interventions in the workplace. This trial tests the feasibility of implementing a self-guided 8-week digital cognitive behavioural therapy intervention for subthreshold to clinical depression and/or anxiety versus waitlist control (ie, life as usual) in the workplace. Methods and analysis Feasibility of implementation will be tested using a mixed-methods evaluation of the two-arm randomised waitlist-control trial. Evaluation will include examination of organisational buy-in, and the engagement of employees through the trial indicated by the completion of outcome measures. In addition, we also explore how participants use the platform, the appropriateness of the analysis both with reference to the outcome measures and linear modelling. Finally, we examine the acceptability of the intervention based on participants experiences using qualitative interviews. Assessments take place at baseline (T0), at 8 weeks post-treatment (T1), at short-term follow-up 4 weeks post-treatment (T2) and long-term follow-ups (6 and 12 months after-end of treatment). We will recruit from 1 July 2021 to 31 December 2021 for employees and self-employed workers with depression and anxiety symptoms (subclinical and clinical levels) who are not seeking or engaged in treatment at the time of the trial. Ethics and dissemination Full approval was given by the University of Warwick Biomedical and Research Ethics Committee (BSREC 45/20–21). The current protocol version is 2.8 (August 2021). Publication of results in peer-reviewed journals will inform the scientific, clinical and business communities. We will disseminate results through webinars, conferences, newsletter as well as a lay summary of results on the study website (mhpp.me). Trial registration number ISRCTN31161020.

Project description:IntroductionPersistence of attention deficit hyperactivity disorder (ADHD) into adolescence is a significant burden to patients. Clinical guidelines recommend non-pharmacological therapies, but the evidence to support this recommendation is sparse. This study aims to evaluate the effect of a 12-week group cognitive-behavioural therapy (CBT) programme for adolescents with ADHD aged 14-18 years, who still have impairing symptoms after treatment with medication. We will study the effect of the treatment on ADHD symptoms and examine moderators and mediators of the effect of the treatment on ADHD.Methods and analysisWe conduct a randomised controlled trial of CBT group therapy in adolescents with ADHD recruited from child psychiatric outpatient units in Mid-Norway. 99 adolescents who met inclusion criteria and consented to participation have been randomised to a 12-week group intervention or to a control group receiving treatment as usual. Assessments are made at admission to the clinic, preintervention, postintervention and at a 9-month follow-up, obtaining adolescent, parent and teacher reports. Clinicians blinded to group allocation rate all participants as to their functioning preintervention and at the two postintervention assessment points. The primary outcome is change in symptom scores on the ADHD Rating Scale-IV.Ethics and disseminationThe Regional Committee for Medical and Health Research Ethics in South East Norway approved the study protocol (2015/2115). We will disseminate the findings in peer-reviewed publications and conference presentations, to user organisations and at courses attended by families and professionals. Two PhD students will publish and defend dissertations relating to the study. Planned publications include primary and secondary outcomes and patient satisfaction with the treatment. Furthermore, we plan to publish a manual of CBT group therapy in adolescent ADHD to benefit treatment of patients in Norway and elsewhere.Trial registration numberNCT02937142.

Project description:BackgroundAdolescent social anxiety disorder (SAD) is common, impairing and persistent. There is a need to intervene early to avert its long-term consequences. Cognitive Therapy for SAD is the leading treatment for adults and shows promise for adolescents. However, given the scale of the problem of adolescent SAD and the limited availability of psychological therapists in child and adolescent mental health services, there is a substantial gap in service provision. Delivering therapy via the Internet may provide part of the solution to this problem. An Internet version of adult Cognitive Therapy for SAD has been developed, with outcomes similar to face-to-face therapy. We have recently adapted this treatment for use with adolescents with SAD. Here, we describe a randomised controlled trial designed to test the efficacy of Internet Cognitive Therapy for adolescent SAD compared to waitlist.Methods/designForty adolescents aged 14-18?years with a diagnosis of SAD will be recruited via schools. Participants will be randomly allocated to Internet Cognitive Therapy or to waitlist. All participants will be assessed three times during the study-at baseline (pretreatment/wait), midtreatment/wait (week 8) and posttreatment/wait (week 15). Participants in the experimental arm will also complete weekly measures as part of the online program and they will be assessed at 3 and 6?months. Postwait, participants in the waitlist arm will be offered Internet Cognitive Therapy, and weekly and posttreatment data will also be collected for them. The trial aims to test whether Internet Cognitive Therapy is superior to waitlist in reducing social anxiety symptoms and in reducing the proportion of adolescents meeting criteria for SAD. Other outcomes of interest include depression and general anxiety symptoms. Acceptability of the online treatment will also be evaluated.DiscussionThis randomised controlled trial will provide preliminary evidence on whether this intervention, requiring relatively low levels of therapist input, is safe and clinically effective. If this is shown to be the case, Internet Cognitive Therapy for adolescents has the potential to provide a service to the large population of adolescents with untreated SAD.Trial registrationISRCTN Registry, ISRCTN15079139 . Version 1 registered on 06/02/2019.

Project description:With a prevalence of 3 to 8% among women of reproductive age, severe premenstrual symptoms are very common. Symptoms range from emotional and cognitive to physical changes. Severe symptoms (that is, premenstrual syndrome) can have a strong impact on everyday functioning and quality of life. Impairment can be as serious as that of dysthymic disorders. Many affected women receive either no treatment at all or are unsatisfied with their treatment. Although there is some evidence for the reduction of distress through cognitive behavioural therapy, there are only a small number of randomised controlled trials carefully investigating the efficacy of this psychotherapeutic approach. Thus, this study aims to evaluate the efficacy of a cognitive behavioural self-help treatment for women suffering from premenstrual syndrome.The study is conducted as a randomised controlled trial. The complex diagnostic assessment includes the completion of a symptom diary over two consecutive cycles and a telephone interview. Eligible women are randomly assigned to either a treatment or a wait-list control group. The intervention is based on cognitive behavioural therapy principles and is provided via the internet. It consists of 14 different modules on which participants work over 8 consecutive weeks. In addition to written information, participants receive email feedback from a clinical psychologist on a weekly basis. Participants assigned to the wait-list receive the treatment after the end of the waiting period (8 weeks). The primary outcome measure is the Premenstrual Syndrome Impairment Measure. Secondary outcomes include the Premenstrual Syndrome Coping Measure, the Short-Form Social Support Questionnaire, the Questionnaire for the Assessment of Relationship Quality, and the Perceived Stress Scale. Data is collected during the premenstrual (luteal) phase at pre-treatment, post-treatment, and 6-month follow-up.So far, there is no study investigating internet-based cognitive behavioural therapy for premenstrual syndrome. The programme approaches the problem of high prevalence in combination with severe impairment and insufficient treatment options.ClinicalTrials.gov: NCT01961479, 9 October 2013.

Project description:Around 40 % of individuals with eating disorders of recurrent binge eating, namely bulimia nervosa and binge eating disorder, are obese. In contrast to binge eating disorder, currently there is no evidence base for weight management or weight loss psychological therapies in the treatment of bulimia nervosa despite their efficacy in binge eating disorder. Thus, a manualised therapy called HAPIFED (Healthy APproach to weIght management and Food in Eating Disorders) has been developed. HAPIFED integrates the leading evidence-based psychological therapies, cognitive behavioural therapy-enhanced (CBT-E) and behavioural weight loss treatment (BWLT) for binge eating disorder and obesity respectively. The aim of the present study is to detail the protocol for a randomised controlled trial (RCT) of HAPIFED versus CBT-E for people with bulimia nervosa and binge eating disorder who are overweight/obese.A single-blind superiority RCT is proposed. One hundred Brazilian participants aged???18 years, with a diagnosis of bulimia nervosa or binge eating disorder, BMI?>?27 to?<?40 kg/m(2), will be recruited from both community and clinics and individually randomised to a therapy arm. Five groups of ten participants will receive the experimental intervention (HAPIFED) and the other five groups of ten the control intervention (CBT-E). Both therapies are manualised, and in this RCT will comprise 1 individual session and 29 office-based group sessions over 6 months. Assessment points will be at baseline, end of therapy, and 6 and 12 months after end of therapy. The primary outcome of this intervention will be reduced weight. Secondary outcomes will be improved metabolic indicators of weight management, reduction in eating disorder symptoms including improved control over eating, improved adaptive function, physical and mental health-related quality of life, and reduced levels of depression and anxiety.This study will be the first to investigate a psychological therapy that aims to assist weight management in people with co-morbid overweight or obesity bulimia nervosa as well as with binge eating disorder. It will have the potential to improve health outcomes for the rapidly increasing number of adults with co-morbid obesity and binge eating disorder or bulimia nervosa.US National Institutes of Health clinical trial registration number NCT02464345 , date of registration 1 June 2015.

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Online cognitive-behavioural therapy for traumatically bereaved people: study protocol for a randomised waitlist-controlled trial.

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Online cognitive-behavioural therapy for traumatically bereaved people: study protocol for a randomised waitlist-controlled trial.

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