Dataset Information

A comparison of emotion-focused therapy and cognitive-behavioural therapy in the treatment of generalised anxiety disorder: study protocol for a randomised controlled trial.

ABSTRACT:

Background

Generalised anxiety disorder (GAD) is a chronic and debilitating condition characterised by high co-morbidity. Alongside pharmacological treatment, cognitive behavioural therapy (CBT) is an established psychological therapy for GAD. Its effectiveness is limited, however, with only an estimated 50% of clients presenting in the non-clinical range after a course of treatment. Furthermore, not all clients prefer CBT as a psychological therapy. Recently, emotion-focused therapy (EFT) was developed for GAD and was tested in an open trial with promising results.

Methods/design

The present research project is a feasibility testing randomised controlled trial (RCT) that compares the efficacy of EFT with an established treatment for GAD, CBT. Sixty clients presenting in a primary care psychology/counselling service will be randomly assigned to one of two conditions: EFT or CBT. Outcomes will be assessed using several measures (Generalised Anxiety Disorder-7, Generalised Anxiety Disorder Severity Scale, Patient Health Questionnaire-9, and Clinical Outcome in Routine Evaluation - Outcome Measure). Clients will be assessed prior to and at the end of therapy, as well as at 6-month follow-up. On the basis of findings from the initial open EFT trial with regard to the optimal length of therapy, it is proposed that therapy last between 16 and 20 sessions.

Discussion

This study aims to test the feasibility of a full comparison RCT. It will test subject recruitment, therapist adherence to manualised treatment, and client retention rates. It will also provide estimates of comparative outcomes that can inform power calculations for a definitive trial.

Trial registration

ISRCTN Registry, ISRCTN52689081 . Registered on 24 October 2017.

SUBMITTER: Timulak L

PROVIDER: S-EPMC6146598 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Publications

A comparison of emotion-focused therapy and cognitive-behavioural therapy in the treatment of generalised anxiety disorder: study protocol for a randomised controlled trial.

Timulak Ladislav L Keogh Daragh D Chigwedere Craig C Wilson Charlotte C Ward Fiona F Hevey David D Griffin Patrick P Jacobs Louise L Irwin Brenda B

Trials 20180919 1

<h4>Background</h4>Generalised anxiety disorder (GAD) is a chronic and debilitating condition characterised by high co-morbidity. Alongside pharmacological treatment, cognitive behavioural therapy (CBT) is an established psychological therapy for GAD. Its effectiveness is limited, however, with only an estimated 50% of clients presenting in the non-clinical range after a course of treatment. Furthermore, not all clients prefer CBT as a psychological therapy. Recently, emotion-focused therapy (EF ...[more]

PMID: 30231910

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Project description:BackgroundGeneralised anxiety disorder (GAD) is a chronic and disabling condition with considerable personal and economic impact. Cognitive behavioural therapy (CBT) is a recommended psychological therapy for GAD; however, there are substantial barriers to accessing treatment. Digital CBT, in particular smartphone-delivered CBT, has the potential to improve accessibility and increase dissemination of CBT. Despite the emerging evidence of smartphone-based psychological interventions for reducing anxiety, effect size scores are typically smaller than in-person interventions, and there is a lack of research assessing the efficacy of smartphone-delivered digital interventions specifically for GAD.MethodsIn the DeLTA trial (DigitaL Therapy for Anxiety), we plan to conduct a parallel-group superiority randomised controlled trial examining the efficacy of a novel smartphone-based digital CBT intervention for GAD compared to a waitlist control. We aim to recruit 242 adults (aged 18 years or above) with moderate-to-severe symptoms of GAD. This trial will be conducted entirely online and will involve assessments at baseline (week 0; immediately preceding randomisation), mid-intervention (week 3), post-intervention (week 6; primary end point) and follow-up (week 10). The primary objective is to evaluate the efficacy of the intervention on GAD symptom severity compared to a waitlist control at post-intervention. Secondary objectives are to examine between-group effects on GAD at follow-up, and to examine the following secondary outcomes at both post-intervention and follow-up: 1) worry; 2) depressive symptoms; 3) wellbeing; 4) quality of life; and 5) sleep difficulty.DiscussionThis trial will report findings on the initial efficacy of a novel digital CBT intervention for GAD. Results have the potential to contribute towards the evidence base for digital CBT for GAD and increase the dissemination of CBT.Trial registrationISRCTN, ISRCTN12765810. Registered on 11 January 2019.

Project description:IntroductionAnxiety disorders have a high lifetime prevalence, early-onset and long duration or chronicity. Exposure therapy is considered one of the most effective elements in cognitive behavioural therapy (CBT) for anxiety, but in vivo exposure can be challenging to access and control, and is sometimes rejected by patients because they consider it too aversive. Virtual reality allows flexible and controlled exposure to challenging situations in an immersive and protected environment.AimThe SoREAL-trial aims to investigate the effect of group cognitive behavioural therapy (CBT-in vivo) versus group CBT with virtual reality exposure (CBT-in virtuo) for patients diagnosed with social anxiety disorder and/or agoraphobia, in mixed groups.Methods and analysisThe design is an investigator-initiated randomised, assessor-blinded, parallel-group and superiority-designed clinical trial. Three hundred two patients diagnosed with social anxiety disorder and/or agoraphobia will be included from the regional mental health centres of Copenhagen and North Sealand and the Northern Region of Denmark. All patients will be offered a manual-based 14-week cognitive behavioural group treatment programme, including eight sessions with exposure therapy. Therapy groups will be centrally randomised with concealed allocation sequence to either CBT-in virtuo or CBT-in vivo. Patients will be assessed at baseline, post-treatment and 1-year follow-up by treatment blinded researchers and research assistants. The primary outcome will be diagnosis-specific symptoms measured with the Liebowitz Social Anxiety Scale for patients with social anxiety disorder and the Mobility Inventory for Agoraphobia for patients with agoraphobia. Secondary outcome measures will include depression symptoms, social functioning and patient satisfaction. Exploratory outcomes will be substance and alcohol use, working alliance and quality of life.Ethics and disseminationThe trial has been approved by the research ethics committee in the Capital Region of Denmark. All results, positive, negative as well as inconclusive, will be published as quickly as possible and still in concordance with Danish law on the protection of confidentially and personal information. Results will be presented at national and international scientific conferences. The trial has obtained approval by the Regional Ethics Committee of Zealand (H-6-2013-015) and the Danish Data Protection Agency (RHP-2014-009-02670). The trial is registered at ClinicalTrial.gov as NCT03845101. The patients will receive information on the trial both verbally and in written form. Written informed consent will be obtained from each patient before inclusion in the trial. The consent form will be scanned and stored in the database system and the physical copy will be destroyed. It is emphasised that participation in the trial is voluntary and that the patient can withdraw his or her consent at any time without consequences for further and continued treatment.Trial registration numberNCT03845101.

Project description:BACKGROUND:Half of all lifetime anxiety disorders emerge before age 12 years; however, access to evidence-based psychological therapies for affected children is poor. We aimed to compare the clinical outcomes and cost-effectiveness of two brief psychological treatments for children with anxiety referred to routine child mental health settings. We hypothesised that brief guided parent-delivered cognitive behavioural therapy (CBT) would be associated with better clinical outcomes than solution-focused brief therapy and would be cost-effective. METHODS:We did this randomised controlled trial at four National Health Service primary child and mental health services in Oxfordshire, UK. Children aged 5-12 years referred for anxiety difficulties were randomly allocated (1:1), via a secure online minimisation tool, to receive brief guided parent-delivered CBT or solution-focused brief therapy, with minimisation for age, sex, anxiety severity, and level of parental anxiety. The allocation sequence was not accessible to the researcher enrolling participants or to study assessors. Research staff who obtained outcome measurements were masked to group allocation and clinical staff who delivered the intervention did not measure outcomes. The primary outcome was recovery, on the basis of Clinical Global Impressions of Improvement (CGI-I). Parents recorded patient-level resource use. Quality-adjusted life-years (QALYs) for use in cost-utility analysis were derived from the Child Health Utility 9D. Assessments were done at baseline (before randomisation), after treatment (primary endpoint), and 6 months after treatment completion. We did analysis by intention to treat. This trial is registered with the ISCRTN registry, number ISRCTN07627865. FINDINGS:Between March 23, 2012, and March 31, 2014, we randomly assigned 136 patients to receive brief guided parent-delivered CBT (n=68) or solution-focused brief therapy (n=68). At the primary endpoint assessment (June, 2012, to September, 2014), 40 (59%) children in the brief guided parent-delivered CBT group versus 47 (69%) children in the solution-focused brief therapy group had an improvement of much or very much in CGI-I score, with no significant differences between groups in either clinical (CGI-I: relative risk 1·01, 95% CI 0·86-1·19; p=0·95) or economic (QALY: mean difference 0·006, -0·009 to 0·02; p=0·42) outcome measures. However, brief guided parent-delivered CBT was associated with lower costs (mean difference -£448; 95% CI -934 to 37; p=0·070) and, taking into account sampling uncertainty, was likely to represent a cost-effective use of resources compared with solution-focused brief therapy. No treatment-related or trial-related adverse events were reported in either group. INTERPRETATION:Our findings show no evidence of clinical superiority of brief guided parent-delivered CBT. However, guided parent-delivered CBT is likely to be a cost-effective alternative to solution-focused brief therapy and might be considered as a first-line treatment for children with anxiety problems. FUNDING:National Institute for Health Research.

Project description:Social anxiety is among the most prevalent and debilitating affective disturbances manifest in people with psychosis. It is usually accompanied by high levels of depression and leads to significant social disability, lower quality of life and poorer prognosis as it raises the possibility of an early relapse. Despite its elevated prevalence and severity in psychosis, social anxiety remains under-recognized and under-treated. Cognitive-behavioural therapy is recommended for the treatment of people with psychosis. However, its focus and evaluation has primarily revolved around the reduction of psychotic symptoms, and not for co-morbid affective disturbances such as social anxiety. There is lack of evidence on the clinical effectiveness and cost-effectiveness of cognitive-behavioural interventions for the treatment of social anxiety disorder in psychosis.Electronic databases will be systematically searched for randomised controlled trials and quasi-experimental studies investigating the effectiveness and cost-effectiveness of cognitive-behavioural interventions for the treatment of social anxiety disorder in people with psychosis. Grey literature will also be searched by screening trial registers. Only studies published in English will be included in the review. Date restrictions will not be applied. Eligible studies will have as the primary outcome social anxiety (continuous data) measured using any psychometrically validated scale both self-reported and clinician administered. Secondary outcomes will include general anxiety symptoms, distress, depression, positive and negative symptoms of schizophrenia, and quality of life measured using any psychometrically validated scale, both self-reported and clinician administered, and the cost of cognitive-behaviour therapy (CBT) intervention (with another treatment or treatment-as-usual).This review will provide an evidence synthesis of the effectiveness and cost-effectiveness of cognitive-behavioural interventions for the treatment of social anxiety disorder in people with psychosis. The review will identify the specific intervention components associated with effectiveness which will facilitate the translation of the existing evidence to the development of new, targeted interventions optimising these components. In doing so, this review will provide recommendations for the treatment of social anxiety and associated distress in psychosis and will further inform the development of future interventions in this area.PROSPERO registration numberCRD42014009052.

Project description:BackgroundInsomnia is a prevalent sleep disorder associated with significant economic and personal burdens. Cognitive behavioural therapy for insomnia (CBTI) is considered the gold standard intervention for insomnia and its efficacy has been well demonstrated. However, the core treatment strategies of CBTI require significant behavioural change, which many individuals find challenging. As a result, although CBTI is efficacious, its effectiveness is reduced by modest levels of adherence in typical clinical settings. This is problematic as adherence is essential to attain desired treatment outcomes. Sleep is often a dyadic process, with approximately 60% of Australian adults sharing a bed. Hence, the present study aims to determine whether incorporating bed partners into treatment for insomnia increases treatment adherence and completion. The impact of adherence on symptoms of insomnia will also be examined.MethodsThis study is a mixed-effects randomised effectiveness trial of partner-assisted CBTI (PA-CBTI). It is an "effectiveness" (as opposed to "efficacy") trial, due to the focus on "real world" clinic-based clients and adherence/attrition as outcomes. Participants will include 120 clients with insomnia who are randomly assigned, in equal numbers, to PA-CBTI, traditional individual CBTI (i-CBTI), or partner-assisted sleep management therapy (PA-SMT; which serves as the control group). All interventions consist of seven weekly 1-h sessions. Treatment outcome is evaluated using clinician-rated treatment adherence, and diary-based adherence to stimulus control and sleep restriction. Clients and partners complete major assessments at pre- and post-treatment, and at 6-month follow-up. Secondary outcome variables include actigraphy, self-report measures related to sleep, comorbid psychopathology, and relationship functioning.DiscussionThis is the first randomised clinical trial to examine the impact of incorporating the bed partner in the treatment of insomnia. Results will provide new information about the role partners play in clients' insomnia presentation and treatment response, and better define the role of adherence in CBTI. This trial has the potential to optimise treatment outcomes for insomnia by improving adherence and reducing attrition. Results could have far-reaching impacts. Improvements in insomnia have been linked to improvements in mental and physical health and, given the high financial costs of insomnia, this study could have a positive economic impact.Trial registrationACTRN, ACTRN12616000586415 . Registered on 5 May 2016.

Dataset Information

A comparison of emotion-focused therapy and cognitive-behavioural therapy in the treatment of generalised anxiety disorder: study protocol for a randomised controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

A comparison of emotion-focused therapy and cognitive-behavioural therapy in the treatment of generalised anxiety disorder: study protocol for a randomised controlled trial.

Similar Datasets

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