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Metacognitive therapy versus cognitive-behavioural therapy in adults with generalised anxiety disorder.

ABSTRACT: Background:Cognitive-behavioural therapy (CBT) is the treatment of choice for generalised anxiety disorder (GAD), yielding significant improvements in approximately 50% of patients. There is significant room for improvement in the outcomes of treatment, especially in recovery. Aims:We aimed to compare metacognitive therapy (MCT) with the gold standard treatment, CBT, in patients with GAD (clinicaltrials.gov identifier: NCT00426426). Method:A total of 246 patients with long-term GAD were assessed and 81 were randomised into three conditions: CBT (n = 28), MCT (n = 32) and a wait-list control (n = 21). Assessments were made at pre-treatment, post-treatment and at 2 year follow-up. Results:Both CBT and MCT were effective treatments, but MCT was more effective (mean difference 9.762, 95% CI 2.679-16.845, P = 0.004) and led to significantly higher recovery rates (65% v. 38%). These differences were maintained at 2 year follow-up. Conclusions:MCT seems to produce recovery rates that exceed those of CBT. These results demonstrate that the effects of treatment cannot be attributed to non-specific therapy factors. Declaration of interest:A.W. wrote the treatment protocol in MCT and several books on CBT and MCT, and receives royalties from these. T.D.B. wrote the protocol in CBT and has published several articles and chapters on CBT and receives royalties from these. All other authors declare no competing interests.

SUBMITTER: Nordahl HM

PROVIDER: S-EPMC6171331 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Metacognitive therapy versus cognitive-behavioural therapy in adults with generalised anxiety disorder.

Nordahl Hans M HM Borkovec Thomas D TD Hagen Roger R Kennair Leif E O LEO Hjemdal Odin O Solem Stian S Hansen Bjarne B Haseth Svein S Wells Adrian A

BJPsych open 20180911 5

<h4>Background</h4>Cognitive-behavioural therapy (CBT) is the treatment of choice for generalised anxiety disorder (GAD), yielding significant improvements in approximately 50% of patients. There is significant room for improvement in the outcomes of treatment, especially in recovery.<h4>Aims</h4>We aimed to compare metacognitive therapy (MCT) with the gold standard treatment, CBT, in patients with GAD (clinicaltrials.gov identifier: NCT00426426).<h4>Method</h4>A total of 246 patients with long- ...[more]

PMID: 30294448

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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:BackgroundGeneralised anxiety disorder (GAD) is a frequent and severe anxiety disorder among older adults. GAD increases the risk of developing other disorders such as depression and coronary heart disease. Older adults with GAD exhibit a poorer response to cognitive behaviour therapy (CBT) compared to younger patients with GAD. The normal age-related cognitive decline can be a contributor to reduced treatment efficacy. One strategy for improving treatment efficacy is to combine CBT with adjunctive interventions targeted at improving cognitive functions. Physical exercise is a viable intervention in this regard. Increased levels of brain-derived neurotrophic factor may mediate improvement in cognitive function. The present study aims to investigate the proposed effects and mechanisms related to concomitant physical exercise.MethodsThe sample comprises 70 participants aged 60-75 years, who have GAD. Exclusion criteria comprise substance abuse and unstable medication; inability to participate in physical exercise; and conditions which precludes GAD as primary diagnosis. The interventions are individual treatment in the outpatient clinic at the local psychiatric hospital, with two experimental arms: (1) CBT + physical exercise and (2) CBT + telephone calls. The primary outcome measure is symptom reduction on the Penn State Worry Questionnaire. Other measures include questionnaires, clinical interviews, physiological, biological and neuropsychological tests. A subset of 40 participants will undergo magnetic resonance imaging (MRI). After inclusion, participants undergo baseline testing, and are subsequently randomized to a treatment condition. Participants attend five sessions of the add-on treatment in the pre-treatment phase, and move on to interim testing. After interim testing, participants attend 10 sessions of CBT in parallel with continued add-on treatment. Participants are tested post-intervention within 2 weeks of completing treatment, with follow-up testing 6 and 12 months later.DiscussionThis study aims to develop better treatment for GAD in older adults. Enhancing treatment response will be valuable from both individual and societal perspectives, especially taking the aging of the general population into account.Trial registrationClinicalTrials.gov, NCT02690441 . Registered on 24 February 2016.

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:In the last forty years therapy outcomes for depression have remained the same with approximately 50% of patients responding to treatments. Advances are urgently required. We hypothesised that a recent treatment, metacognitive therapy (MCT), might be more effective, by targeting mental control processes that directly contribute to depression. We assessed the clinical efficacy of MCT compared to current best psychotherapy practice, CBT, in adults with major depressive disorder. A parallel randomized single-blind trial was conducted in a primary care outpatient setting. This trial is registered with the ISCRTN registry, number ISRCTN82799488. In total 174 adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder were eligible and consented to take part. 85 were randomly allocated to MCT and 89 to CBT. Randomisation was performed independently following pre-treatment assessment and was stratified for severity of depression (low?<?20 vs high?>?=20) on the Hamilton Depression Rating Scale (HDRS) and on sex (male/female). Assessors and trial statisticians were blind to treatment allocation. Each treatment arm consisted of up to 24 sessions of up to 60?minutes each, delivered by trained clinical psychologists. The co-primary outcome measures were assessor rated symptom severity on the HDRS and self-reported symptom severity on the Beck Depression Inventory II (BDI-II) at post treatment. Secondary outcomes were scores six months post treatment on these measures and a range of symptom and mechanism variables. A key trial design feature was that each treatment was implemented to maximize individual patient benefit; hence time under therapy and number of sessions delivered could vary. Treated groups in the trial were very similar on most baseline characteristics. Data were analyzed on the basis of intention to treat (ITT). No differences were found on the HDRS at post treatment or follow-up (-0.95 [-2.88 to 0.98], p?=?0.336; and -1.61 [-3.65 to 0.43], p?=?0.122), but floor effects on this outcome were high. However, a significant difference favouring MCT was found on the BDI-II at post treatment (-5.49 [95% CI -8.90 to -2.08], p?=?0.002), which was maintained at six-month follow-up (-4.64 [-8.21 to -1.06], p?=?0.011). Following MCT 74% of patients compared with 52% in CBT met formal criteria for recovery on the BDI-II at post treatment (odds-ratio=2.42 [1.20 to 4.92], p?=?0.014). At follow-up the proportions were 74% compared to 56% recovery (odds-ratio=2.19 [1.05 to 4.54], p?=?0.036). Significant differences favouring MCT, also maintained over time, were observed for most secondary outcomes. The results were robust against controlling for time under therapy and when outcomes were assessed at a common 90 day mid-term time-point. Limitations of the study include the use of only two therapists where one treated 69% of patients, possible allegiance effects as the study was conducted in an established CBT clinic and the chief investigator is the originator of MCT and group differences in time under therapy. Never the less evidence from this study suggests that MCT had considerable beneficial effects in treating depression that may exceed CBT.

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Metacognitive therapy versus cognitive-behavioural therapy in adults with generalised anxiety disorder.

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Metacognitive therapy versus cognitive-behavioural therapy in adults with generalised anxiety disorder.

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