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The BrainACT study: acceptance and commitment therapy for depressive and anxiety symptoms following acquired brain injury: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Following an acquired brain injury, individuals frequently experience anxiety and/or depressive symptoms. However, current treatments for these symptoms are not very effective. A promising treatment is acceptance and commitment therapy (ACT), which is a third-wave behavioural therapy. The primary goal of this therapy is not to reduce symptoms, but to improve psychological flexibility and general well-being, which may be accompanied by a reduction in symptom severity. The aim of this study is to investigate the effectiveness of an adapted ACT intervention (BrainACT) in people with acquired brain injury who experience anxiety and/or depressive symptoms. METHODS:The study is a multicenter, randomized, controlled, two-arm parallel trial. In total, 94 patients who survive a stroke or traumatic brain injury will be randomized into an ACT or control (i.e. psycho-education and relaxation) intervention. The primary outcome measures are the Hospital Anxiety and Depression Scale and the Depression Anxiety Stress Scale. Outcomes will be assessed by trained assessors, blinded to treatment condition, pre-treatment, during treatment, post-treatment, and at 7 and 12 months. DISCUSSION:This study will contribute to the existing knowledge on how to treat psychological distress following acquired brain injury. If effective, BrainACT could be implemented in clinical practice and potentially help a large number of patients with acquired brain injury. TRIAL REGISTRATION:Dutch Trial Register, NL691, NTR 7111. Registered on 26 March 2018. https://www.trialregister.nl/trial/6916.

SUBMITTER: Rauwenhoff J

PROVIDER: S-EPMC6935100 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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The BrainACT study: acceptance and commitment therapy for depressive and anxiety symptoms following acquired brain injury: study protocol for a randomized controlled trial.

Rauwenhoff Johanne J Peeters Frenk F Bol Yvonne Y Van Heugten Caroline C

Trials 20191227 1

<h4>Background</h4>Following an acquired brain injury, individuals frequently experience anxiety and/or depressive symptoms. However, current treatments for these symptoms are not very effective. A promising treatment is acceptance and commitment therapy (ACT), which is a third-wave behavioural therapy. The primary goal of this therapy is not to reduce symptoms, but to improve psychological flexibility and general well-being, which may be accompanied by a reduction in symptom severity. The aim o ...[more]

PMID: 31881916

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Project description:Severe health anxiety (hypochondriasis), or illness anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, is characterized by preoccupation with fear of suffering from a serious illness in spite of medical reassurance. It is a debilitating, prevalent disorder associated with increased health care utilization. Still, there is a lack of easily accessible specialized treatment for severe health anxiety.The aims of this paper were to (1) describe the development and setup of a new internet-delivered acceptance and commitment therapy (iACT) program for patients with severe health anxiety using self-referral and a video-based assessment; and (2) examine the feasibility and potential clinical efficacy of iACT for severe health anxiety.Self-referred patients (N=15) with severe health anxiety were diagnostically assessed by a video-based interview. They received 7 sessions of clinician-supported iACT comprising self-help texts, video clips, audio files, and worksheets over 12 weeks. Self-report questionnaires were obtained at baseline, post-treatment, and at 3-month follow-up. The primary outcome was Whiteley-7 Index (WI-7) measuring health anxiety severity. Depressive symptoms, health-related quality of life (HRQoL), life satisfaction, and psychological flexibility were also assessed. A within-group design was employed. Means, standard deviations, and effect sizes using the standardized response mean (SRM) were estimated. Post-treatment interviews were conducted to evaluate the patient experience of the usability and acceptability of the treatment setup and program.The self-referral and video-based assessments were well received. Most patients (12/15, 80%) completed the treatment, and only 1 (1/15, 7%) dropped out. Post-treatment (14/15, 93%) and 3-month follow-up (12/15, 80%) data were available for almost all patients. Paired t tests showed significant improvements on all outcome measures both at post-treatment and 3-month follow-up, except on one physical component subscale of HRQoL. Health anxiety symptoms decreased with 33.9 points at 3-month follow-up (95% CI 13.6-54.3, t11= 3.66, P=.004) with a large within-group effect size of 1.06 as measured by the SRM.Treatment adherence and potential efficacy suggest that iACT may be a feasible treatment for health anxiety. The uncontrolled design and small sample size of the study limited the robustness of the findings. Therefore, the findings should be replicated in a randomized controlled trial. Potentially, iACT may increase availability and accessibility of specialized treatment for health anxiety.Danish Data Protection Agency, Central Denmark Region: 1-16-02-427-14; https://www.rm.dk/sundhed/faginfo/forskning/datatilsynet/ (Archived by Webcite at http://www.webcitation.org/6yDA7WovM).

Project description:BackgroundAnxiety is among the most prevalent and disabling mental health problems in older adults. Few older adults with mild to moderately severe anxiety symptoms receive adequate interventions, putting them at risk for developing anxiety disorders, depression, and various somatic problems. Effective, low-threshold interventions should be developed. Blended care, in which a web-based intervention is combined with a limited amount of face-to-face contacts with a mental healthcare counselor at the general practice, is a promising option. The online self-help intervention "Living to the Full"-an Acceptance and Commitment Therapy (ACT) intervention-has been proven to reduce depression and anxiety in several patient groups, but has not yet been investigated in older adults. The aim of this study is to evaluate the (cost-)effectiveness of a blended form of "Living to the Full" in reducing anxiety symptoms in adults aged 55 to 75 years. Furthermore, moderators and mediators of the treatment effect are investigated.Methods/designThe (cost-)effectiveness of the ACT intervention will be investigated in a cluster single-blind randomized controlled trial (RCT). The blended intervention will be compared to treatment-as-usual. Thirty-six mental health counselors working at general practices in the Netherlands will be randomized to deliver blended care or treatment as usual. A total of 240 participants (aged 55-75 years) with mild to moderately severe anxiety complaints (defined as a total score of 5-15 on the GAD-7) will be recruited. There are four measurements consisting of online questionnaires (primary outcome: GAD-7) and a telephone interview: before the start of the intervention; directly following the intervention (14 weeks after baseline); and six and twelve months after baseline. Possible mediator variables will be assessed multiple times basis during the intervention.DiscussionThis RCT will evaluate the effectiveness of a blended ACT intervention for older adults with anxiety symptoms. If the intervention is shown to be effective, it will be implemented, thereby improving the accessibility and quality of preventive interventions for older adults with anxiety problems.Trial registrationNetherlands Trial Register, NTR6270 . Registered on 21 March 2017.

Project description:BACKGROUND:Anxiety conditions are debilitating and prevalent throughout the world. Acceptance and Commitment Therapy (ACT) is an effective, acceptance-based behavioral therapy for anxiety. However, there are treatment barriers (eg, financial, geographical, and attitudinal), which prevent people from accessing it. To overcome these barriers, internet-delivered ACT (iACT) interventions have been developed in recent years. These interventions use websites to deliver ACT information and skill training exercises on the Web, either as pure self-help or with therapist guidance. OBJECTIVE:This systematic review aimed to examine the therapeutic impact of iACT on all anxiety conditions. METHODS:The EMBASE, MEDLINE, ProQuest Central, PsycINFO, Scopus, and Web of Science databases were searched up to September 2018. The titles and abstracts of remaining records after deduplication were screened by 2 authors with a total of 36 full-text articles being retained for closer inspection next to eligibility criteria. Empirical studies of all designs, population types, and comparator groups were included if they appraised the impact of iACT treatment on any standardized measure of anxiety. Included studies were appraised on methodological quality and had their data extracted into a standardized coding sheet. Findings were then tabulated, and a narrative synthesis was performed because of the heterogeneity found between studies. RESULTS:A total of 20 studies met inclusion criteria. There were 11 randomized controlled trials (RCTs) and 9 uncontrolled pilot studies. Participants across all studies were adults. The anxiety conditions treated were as follows: generalized anxiety disorder (GAD), social anxiety disorder (SAD), illness anxiety disorder (IAD), and general anxiety symptoms, with or without comorbid physical and mental health problems. A total of 18 studies reported significant anxiety reduction after iACT treatment. This was observed in studies that delivered iACT with (n=13) or without (n=5) therapist guidance. The average attrition rate across all included studies during the active iACT treatment phase was 19.19%. In the 13 studies that assessed treatment satisfaction, participants on average rated their iACT experience with above average to high treatment satisfaction. CONCLUSIONS:These findings indicate that iACT can be an efficacious and acceptable treatment for adults with GAD and general anxiety symptoms. More RCT studies are needed to corroborate these early iACT findings using empirical treatments in active control groups (eg, internet-delivered cognitive behavioral therapy). This would potentially validate the promising results found for SAD and IAD as well as address the full spectrum of anxiety disorders.

Project description:BackgroundThe prevalence of major depressive disorder (MDD) is on the rise globally, and the use of antidepressant medications for its treatment does not usually result in full remission. However, the combination of physical exercise and psychotherapy for the treatment of MDD increase the rate of full remission among patients. This three-armed, parallel-group, double-blinded randomised controlled trial (RCT) aims to assess and compare the effects between the combination of exergame and acceptance and commitment therapy (e-ACT) programme, ACT only and treatment-as-usual (TAU) control groups on the severity of depression and anxiety symptoms, the degree of experiential avoidance and quality of life (QoL) and the serum levels of depression biomarkers (such as brain-derived neurotrophic factor, C-reactive protein and vascular endothelial growth factor) among patients with MDD across three time points.Methods and analysisThis RCT will recruit 126 patients with MDD who will be randomised using stratified permuted block randomisation into three groups, which are the combined e-ACT programme, ACT-only and TAU control groups in a 1:1:1 allocation ratio. The participants in the e-ACT and ACT-only intervention groups will undergo once a week intervention sessions for 8 weeks. Assessments will be carried out through three time points, such as the pre-intervention assessment (t0), assessment immediately after completion of the intervention at 8 weeks (t1) and assessment at 24 weeks after completion of the intervention (t2). During each assessment, the primary outcome to be assessed includes the severity of depression symptoms, while the secondary outcomes to be assessed are the severity of anxiety symptoms, experiential avoidance, QoL and depression biomarkers.Ethics and disseminationApproval of this study was obtained from the Human Research Ethics Committee of Universiti Sains Malaysia (USM/JEPeM/PP/23050420). The findings of the study will be published in academic peer-reviewed journals.Trial registration numberNCT05812001 (ClinicalTrials.gov). Registered on 12 April 2023.

Project description:Background>Patients with functional gastrointestinal disorders have a high psychiatric co-morbidity. This study aimed to investigate and characterise gastrointestinal symptoms in relation to depressive symptoms and trait anxiety in a well-defined population of young adult psychiatric outpatients and healthy controls.MethodsGastrointestinal symptoms were assessed with the Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS). Depressive symptoms were assessed with the Montgomery-Åsberg Depression Rating Scale- Self assessment (MADRS-S). Trait anxiety was estimated with three of the Swedish universities of Personality (SSP) scales: Somatic trait anxiety, Psychic trait anxiety and Stress susceptibility. Self-ratings were collected from 491 young adult psychiatric outpatients and 85 healthy controls. Gastrointestinal symptom severity was compared between patients with and without current psychotropic medication and controls. Associations between gastrointestinal symptoms, depressive symptoms and trait anxiety were assessed using Spearman's coefficients and generalized linear models adjusting for possible confounders (sex, body mass index, bulimia nervosa).ResultsPatients, with and without current psychotropic medication, reported significantly more gastrointestinal symptoms than controls. In the generalized linear models, total MADRS-S score (p < 0.001), Somatic trait anxiety (p < 0.001), Psychic trait anxiety (p = 0.002) and Stress susceptibility (p = 0.002) were independent predictors of the total GSRS-IBS score. Further exploratory analysis using unsupervised learning revealed a diverse spectrum of symptoms that clustered into six groups.ConclusionGastrointestinal symptoms are both highly prevalent and diverse in young adult psychiatric outpatients, regardless of current psychotropic medication. Depressive symptom severity and degree of trait anxiety are independently related to the total gastrointestinal symptom burden.

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The BrainACT study: acceptance and commitment therapy for depressive and anxiety symptoms following acquired brain injury: study protocol for a randomized controlled trial.

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The BrainACT study: acceptance and commitment therapy for depressive and anxiety symptoms following acquired brain injury: study protocol for a randomized controlled trial.

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