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Emotion-focused therapy as a transdiagnostic treatment for depression, anxiety and related disorders: Protocol for an initial feasibility randomised control trial.

ABSTRACT: Background: Depression, anxiety and related disorders, including obsessive-compulsive disorders and trauma/stressor related disorders, have high prevalence, chronic courses and cause significant impairment. These disorders are also highly co-morbid, and appear to share etiology and maintenance factors. Recent developments have seen the emergence of transdiagnostic approaches that systematically address the common/shared features of these disorders. A key advantage of transdiagnostic approaches is that they can reduce the pressure on mental health professionals to be proficient in a plethora of single-disorder focused treatments. Currently almost all transdiagnostic approaches come from cognitive-behavioural therapy (CBT). However, not all clients prefer or benefit from CBT. Emotion-focused therapy (EFT) represents an evidence-based alternative to CBT. This study aims to examine a transdiagnostic adaptation of EFT (EFT-T) as a treatment for depression, anxiety and related disorders. Method: The current study is a randomised controlled trial that aims to establish the efficacy of EFT-T vs. wait-list control in the treatment of depression, anxiety and related disorders. Up to 40 clients presenting in a psychology/counselling service will be randomly assigned to two conditions: EFT-T (n=20) and wait-list control, with delayed intervention (n=20). Primary outcome measures will be the Overall Anxiety Severity and Impairment Symptoms, the Overall Depression Severity and Impairment Symptoms, and the Clinical Outcome in Routine Evaluation - Outcome Measure. Disorder specific self-report measures will also be used to assess the main symptomatology of respective primary diagnoses. Clients will be assessed prior to therapy, at week 16, at end of therapy, and at 6 months follow-up. Discussion: This study aims to provide an initial test of EFT-T as a transdiagnostic treatment for depression, anxiety and related disorders. It will provide estimates of effects sizes that can inform power calculations for a comparative trial, comparing EFT-T to a standard transdiagnostic treatment, CBT. Registration: ISRCTN11430110; registered on 07 January 2019.

SUBMITTER: Timulak L

PROVIDER: S-EPMC7140776 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Emotion-focused therapy as a transdiagnostic treatment for depression, anxiety and related disorders: Protocol for an initial feasibility randomised control trial.

Timulak Ladislav L Keogh Daragh D McElvaney James J Schmitt Sonja S Hession Natalie N Timulakova Katarina K Jennings Ciaran C Ward Fiona F

HRB open research 20200213

<b>Background:</b> Depression, anxiety and related disorders, including obsessive-compulsive disorders and trauma/stressor related disorders, have high prevalence, chronic courses and cause significant impairment. These disorders are also highly co-morbid, and appear to share etiology and maintenance factors. Recent developments have seen the emergence of transdiagnostic approaches that systematically address the common/shared features of these disorders. A key advantage of transdiagnostic appro ...[more]

PMID: 32296754

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Project description:BackgroundThe worldwide prevalence of anxiety in older adults is estimated at between 6 and 10%. In Canada, adults 65 and older experience anxiety at a rate of 6.4%, affecting more than 300,000 people. Anxiety in older adults has been linked to difficulties retaining new information and engaging in instrumental daily activities of living. Due to COVID-19 restrictions, novel methods of delivering therapy programs remotely are needed; however, data is limited. There is some evidence that older adults prefer non-pharmacological approaches for anxiety that can be delivered in the community. Emotion-focused mindfulness therapy (EFMT) is a mindfulness-based intervention that emphasizes meditation and observing thoughts and emotions as they arise. This emphasis has been demonstrated to reduce symptoms of anxiety in general populations. This study aims to evaluate the feasibility of EFMT with older adults.MethodsThis pilot feasibility randomized controlled trial will use a wait list control trial design. Due to COVID-19 restrictions, we will use telehealth delivery via Zoom rather than in-person delivery. The first 48 people to meet the eligibility criteria will be randomly allocated to either receive EFMT immediately, or in approximately 8 weeks time from enrollment (1:1 allocation ratio). Data will be collected at baseline, 8 weeks following baseline, and 16 weeks following baseline. The primary outcomes will determine the feasibility of the intervention based on recruitment, enrolment, retention, and adherence to all components of the intervention. The secondary outcome will be changes to anxiety over time.DiscussionThe results of this trial will determine the feasibility and potential effectiveness of video-delivered EFMT for late-life anxiety compared to no treatment. If the results are promising, a larger randomized controlled trial may be conducted.Trial registrationClinicalTrials.gov, NCT04415528 . Registered on June 4, 2020 PROTOCOL VERSION: Protocol version 2, January 2, 2021.

Project description:ObjectiveThe aim of the Cardiovascular Health in Anxiety and Mood Problems Study (CHAMPS) is to pilot the Unified Protocol (UP) for the transdiagnostic treatment of depression and anxiety disorders in patients recently hospitalized for cardiovascular diseases (CVDs) and evaluate the feasibility.MethodsThe present study is a controlled, block randomized pragmatic pilot-feasibility trial incorporating qualitative interview data, comparing UP (n = 9) with enhanced usual care (EUC, n = 10). Eligible trial participants had a recent CVD-cause admission and were above the severity threshold for depression or anxiety denoted by Patient Health Questionnaire (PHQ-9) total scores ≥10 and/or Generalized Anxiety Disorder (GAD-7) total scores ≥7 respectively on two occasions, and met criteria for one or more depression or anxiety disorders determined by structured clinical interview. Study outcomes were analyzed as intention-to-treat using linear mixed models and qualitative interview data were analyzed with content analysis.ResultsQuantitative and qualitative measured indicated acceptability of the transdiagnostic CBT intervention for CVD patients with depression or anxiety disorders. Satisfaction with UP was comparable to antidepressant therapy and higher than general physician counseling. However, there were difficulties recruiting participants with current disorders and distress on two occasions. The UP was associated with a reduction in total number of disorders determined by blinded raters. Linear mixed models indicated that a significantly greater reduction in anxiety symptoms was evident in the UP group by comparison to the EUC group (GAD-7, p between groups = 0.011; Overall Anxiety Severity and Impairment Scale, p between groups = 0.013). Results favored the UP group by comparison to EUC for change over 6 months on measures of physical quality of life and harmful alcohol use. There was no difference between the two groups on changes in depression symptoms (PHQ-9), stress, metacognitive worry beliefs, physical activity, or adherence.DiscussionIn conclusion, this feasibility trial indicates acceptability of transdiagnostic CBT intervention for CVD patients with depression or anxiety disorders that is tempered by difficulties with recruitment. Larger trials are required to clarify the efficacy of transdiagnostic depression and anxiety disorder CBT in populations with CVDs and depressive or anxiety disorders.Clinical trial registrationhttps://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12615000555550, identifier: ACTRN12615000555550.

Project description:IntroductionEmotional disorders (anxiety and depressive disorders) are a relevant public health concern associated with high prevalence, high costs, and important disability. Therefore, research priorities include designing and testing cost-effective interventions to reach everyone in need. Internet-delivered interventions for emotional disorders are effective and can help to disseminate and implement evidence-based treatments. However, although these treatments are generally effective, not all patients benefit from this treatment format equally. Blended treatments are a new form of intervention that combines the strengths of face-to-face and Internet approaches. Nevertheless, research on blended interventions has focused primarily on individual therapy, and less attention has been paid to the potential of using this format in group psychotherapy. This study aims to analyze the feasibility of blended transdiagnostic group CBT for emotional disorders. The current article describes the study protocol for this trial.Method and analysisA one-armed pilot trial will be conducted. Participants will be 30 adults suffering from DSM-5 anxiety and/or depressive disorders. The treatment consists of a blended transdiagnostic group intervention delivered during a period of 24 weeks. Groups of 6 to 10 patients will attend a total of eight 2-hour, face-to-face sessions, alternated with the use of an online platform where they will find the contents of the treatment protocol. The intervention has four core components: present-focused awareness, cognitive flexibility, identification and modification of behavioral and cognitive patterns of emotional avoidance, and interoceptive and situational exposure. These components are delivered in 16 modules. Assessments will be performed at baseline, during the treatment, at post-treatment, and at 3-month follow-up. Clinical and treatment acceptability outcomes will be included. Quantitative and qualitative data (participants' views about blended group psychotherapy) will be analyzed.Ethics and disseminationThe trial has received ethical approval from the Ethics Committee of Universitat Jaume I (September 2019) and will be conducted in accordance with the study protocol, the Declaration of Helsinki, and good clinical practice. The results of this study will be disseminated by presentation at conferences and will be submitted for publication in a peer-reviewed journal.Trial registrationClinicalTrials.gov Identifier: NCT04008576. Registered 05 July 2019, https://clinicaltrials.gov/ct2/show/NCT04008576.

Project description:IntroductionMost people suffering from depression and anxiety disorders are entirely treated in primary care. Due to growing challenges in ageing societies, for example, patients' immobility and multimorbidity, the transition to specialised care becomes increasingly difficult. Although the co-location of general practitioners and mental health specialists improves the access to psychosocial care, integrated in-person approaches are not practical for rural and single-doctor practices with limited personnel and financial resources. Treating primary care patients via internet-based video consultations by remotely located mental health specialists bears the potential to overcome structural barriers and provide low-threshold care. The aim of this randomised controlled feasibility trial is to investigate the feasibility of implementing of mental health specialist video consultations in primary care practices.Methods and analysisFifty primary care patients with significant depression and/or anxiety symptomatology will be randomised in two groups receiving either the treatment as usual as provided by their general practitioner or up to five video consultations conducted by a mental health specialist. The video consultations focus on (1) systematic diagnosis plus proactive monitoring using validated clinical rating scales, (2) the establishment of an effective working alliance and (3) a stepped-care algorithm within integrated care adjusting treatments based on clinical outcomes. We will investigate the following outcomes: effectiveness of the recruitment strategies, patient acceptance of randomisation, practicability of the technical and logistical processes related to implementing video consultations in the practices' workflows, feasibility of the data collection and clinical parameters.Ethics and disseminationThis trial has undergone ethical scrutiny and has been approved by the Medical Faculty of the University of Heidelberg Ethics Committee (S-634/2018). The findings will be disseminated to the research community through presentations at conferences and publications in scientific journals. This feasibility trial will prepare the ground for a large-scale, fully powered randomised controlled trial.Trial registration numberDRKS00015812.

Project description:INTRODUCTION:Anxiety, mood and trauma-related disorders are common, affecting up to 20% of adults. Many of these individuals will experience symptoms of more than one disorder as diagnostically defined. However, most psychological treatments focus on individual disorders and are less effective for those who experience comorbid disorders. The Healthy and Resilient Mind Programme: Building Blocks for Mental Wellbeing (HARMONIC) trial introduces a novel transdiagnostic intervention (Shaping Healthy Minds (SHM)), which synthesises several evidence-based treatment techniques to address the gap in effective interventions for people with complex and comorbid difficulties. This early phase trial aims to estimate the efficacy and feasibility of the transdiagnostic intervention in preparation for a later-phase randomised controlled trial, and to explore mechanisms of change. METHODS/ANALYSIS:We outline a patient-level two-arm randomised controlled trial (HARMONIC) that compares SHM to treatment-as-usual for individuals aged >18 years (n=50) with comorbid mood, anxiety, obsessive-compulsive or trauma/stressor disorders diagnoses, recruited from outpatient psychological services within the UK National Health Service (NHS). The co-primary outcomes will be 3-month follow-up scores on self-report measures of depressive symptoms, anxiety symptoms, and disability and functional impairment. Secondary outcomes include changes in symptoms linked to individual disorders. We will assess the feasibility and acceptability of SHM, the utility of proposed outcome measures, and refine the treatment manuals in preparation for a later-phase trial. ETHICS AND DISSEMINATION:This trial protocol has been approved by the Health Research Authority of the NHS of the UK (East of England, Reference: 16/EE/0095). We anticipate that trial findings will inform future revisions of clinical guidelines for numerous forms of mood, anxiety and stressor-related disorders. Findings will be disseminated broadly via peer-reviewed empirical journal articles, conference presentations, clinical workshops and a trial website. TRIAL REGISTRATION:NCT03143634; Pre-results.

Dataset Information

Emotion-focused therapy as a transdiagnostic treatment for depression, anxiety and related disorders: Protocol for an initial feasibility randomised control trial.

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Emotion-focused therapy as a transdiagnostic treatment for depression, anxiety and related disorders: Protocol for an initial feasibility randomised control trial.

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