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Comparing group-based acceptance and commitment therapy (ACT) with enhanced usual care for adolescents with functional somatic syndromes: a study protocol for a randomised trial.

ABSTRACT: INTRODUCTION:Functional somatic syndromes (FSS) are common in adolescents, characterised by severe disability and reduced quality of life. Behavioural treatments such as acceptance and commitment therapy (ACT) has shown promising results in children and adolescents with FSS, but has focused on specific syndromes such as functional pain. The current study will compare the efficacy of group-based ACT with that of enhanced usual care (EUC) in adolescents with a range of FSS operationalised by the unifying construct of multiorgan bodily distress syndrome (BDS). METHODS AND ANALYSIS:A total of 120 adolescents aged 15-19 and diagnosed with multiorgan BDS, of at least 12?months duration, will be assessed and randomised to either: (1) EUC: a manualised consultation with a child and adolescent psychiatrist and individualised treatment plan or (2) manualised ACT-based group therapy plus EUC. The ACT programme consists of 9 modules (ie, 27?hours) and 1 follow-up meeting (3?hours). The primary outcome is physical health, assessed by an Short Form Health Survey (SF-36) aggregate score 12?months after randomisation. Secondary outcomes include self-reported symptom severity, symptom interference, depression and anxiety, illness worry, perceived stress and global improvement; as well as objective physical activity and bodily stress response measured by heart rate variability, hair cortisol and inflammatory biomarkers. Process measures are illness perception, illness-related behaviour and psychological flexibility. ETHICS AND DISSEMINATION:The study is conducted in accordance with Helsinki Declaration II. Approval has been obtained from the Science Ethics Committee of the Central Denmark Region and the Danish Data Protection. The results will be sought to be published according to the CONSORT statement in peer-reviewed journals. DISCUSSION:This is one of the first larger randomised clinical trials evaluating the effect of a group-based intervention for adolescents with a range of severe FSS. TRIAL REGISTRATION NUMBER:NCT02346071; Pre-results.

SUBMITTER: Kallesoe KH

PROVIDER: S-EPMC5030556 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Comparing group-based acceptance and commitment therapy (ACT) with enhanced usual care for adolescents with functional somatic syndromes: a study protocol for a randomised trial.

Kallesøe Karen Hansen KH Schröder Andreas A Wicksell Rikard K RK Fink Per P Ørnbøl Eva E Rask Charlotte Ulrikka CU

BMJ open 20160915 9

<h4>Introduction</h4>Functional somatic syndromes (FSS) are common in adolescents, characterised by severe disability and reduced quality of life. Behavioural treatments such as acceptance and commitment therapy (ACT) has shown promising results in children and adolescents with FSS, but has focused on specific syndromes such as functional pain. The current study will compare the efficacy of group-based ACT with that of enhanced usual care (EUC) in adolescents with a range of FSS operationalised ...[more]

PMID: 27633643

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Project description:BackgroundEvidence for treatment of adolescents with multiple functional somatic syndromes (FSS) is sparse. This study examined the efficacy of 'Acceptance and Commitment Therapy for Health in Adolescents' (AHEAD), a generic group-based treatment for adolescents with co-occurrence of multiple FSS.MethodsA randomized trial was conducted at a specialized university hospital clinic. Adolescents (15-19 years) with multiple FSS of at least 1 year's duration were randomly assigned to AHEAD or enhanced usual care (EUC). AHEAD consisted of nine modules (i.e., 27 h) and one follow-up meeting. Primary outcome was physical health (SF-36). Various secondary outcomes and treatment targets were included (e.g., symptom severity, symptom impact, and illness perception). A linear mixed-effects model was used for analysis. Trial-registration: ClinicalTrials.gov NCT02346071.ResultsNinety-one patients were included. At 12 months, no significant difference in physical health was identified between groups (mean adjusted difference 1.2 [95% CI -1.6 to 4.0], p = .404). However, different developments over time were seen with an interaction effect between intervention arm and time (χ2(5) = 14.1, p = .0148). AHEAD patients (n = 44) reported a clinically relevant improvement at end of treatment and at 8 and 12 months, while EUC patients (n = 47) displayed a clinically relevant improvement at 12 months. Furthermore, AHEAD patients showed a faster improvement on symptom severity, symptom impact and illness perception. EUC patients received more psychological treatment outside the trial (p ≤ .001) than AHEAD patients. Treatment satisfaction with AHEAD was high in contrast to EUC.ConclusionsCompared with EUC, AHEAD had no additional advantage on the improvement of physical health at the primary endpoint of 12 months. However, a faster improvement of physical health was seen in AHEAD and considerably more psychological treatment was received outside the trial in EUC with clinically meaningful improvements in both groups. The results underpin the importance of an organised and systematic treatment offer for the most severely affected youth.

Project description:BackgroundRecurrent and impairing functional somatic syndromes (FSS) are common in adolescents. Despite a high need for care, empirically supported treatments are lacking for youth. The aim of this uncontrolled pilot study was to assess feasibility and treatment potential of a new intervention with group-based Acceptance and Commitment Therapy (ACT) in a generic treatment approach for adolescents with multiple FSS.MethodsTwenty-one patients received 'ACT for Health in Adolescents' (AHEAD) (30 h), specifically developed for adolescents (aged 15-19 years) with moderate to severe FSS. Close relatives attended an information meeting to facilitate support of the patients throughout treatment. Treatment satisfaction was evaluated by means of self-report and relatives' impressions. Self-reported physical health at 3 months follow-up (FU) after end of treatment was the primary outcome whereas secondary outcomes included symptom burden, limitation due to symptoms, illness worry, emotional distress and physical and emotional symptoms. Treatment targets were assessed by measures on illness behaviour, illness perception and psychological inflexibility.ResultsNineteen patients (90.5%) completed the treatment with a high overall attendance rate of 93%. All would recommend the treatment to a friend with similar problems. Close relatives rated it valuable to participate in an information meeting. Patients' physical health improved significantly from assessment to FU with a clinically relevant mean change of 8.9 points (95% CI [5.4; 12.4]; SRM 0.91 [0.26;1.57]). Improvement was also seen on all secondary outcome measures, from assessment to FU. Maladaptive illness behaviours and perceptions as well as psychological inflexibility showed a significant decline from assessment to FU.ConclusionAHEAD was feasible and potentially efficacious and warrants testing in a larger clinical trial.Trial registrationClinical Trials gov NCT04464447 , registration date July 9th, 2020. Retrospectively registered.

Project description:IntroductionIntegrating diabetes self-management into daily life involves a range of complex challenges for affected individuals. Environmental, social, behavioural and emotional psychological factors influence the lives of those with diabetes. The aim of this study is to evaluate the impact of a stress management group intervention based on acceptance and commitment therapy (ACT) among adults living with poorly controlled type 1 diabetes.Methods and analysisThis study will use a randomised controlled trial design evaluating treatment as usual (TAU) and ACT versus TAU. The stress management group intervention will be based on ACT and comprises a programme divided into seven 2-hour sessions conducted over 14 weeks. A total of 70 patients who meet inclusion criteria will be recruited over a 2-year period with follow-up after 1, 2 and 5 years.The primary outcome measure will be HbA1c. The secondary outcome measures will be the Depression Anxiety Stress Scales, the Swedish version of the Hypoglycemia Fear Survey, the Swedish version of the Problem Areas in Diabetes Scale, The Summary of Self-Care Activities, Acceptance Action Diabetes Questionnaire, Swedish Acceptance and Action Questionnaire and the Manchester Short Assessment of Quality of Life. The questionnaires will be administered via the internet at baseline, after sessions 4 (study week 7) and 7 (study week 14), and 6, 12 and 24 months later, then finally after 5 years. HbA1c will be measured at the same time points.Assessment of intervention effect will be performed through the analysis of covariance. An intention-to-treat approach will be used. Mixed-model repeated measures will be applied to explore effect of intervention across all time points.Ethics and disseminationThe study has received ethical approval (Dnr: 2016/14-31/1). The study findings will be disseminated through peer-reviewed publications, conferences and reports to key stakeholders.Trial registration numberNCT02914496; Pre-results.

Project description:BackgroundBipolar disorder is a chronic and disabling psychiatric condition, characterised by recurrent episodes of mania, hypomania and depression. It places a heavy burden on sufferers and families, with high societal and healthcare costs. Many service users with a diagnosis of bipolar disorder also experience prominent psychotic symptoms, with differential diagnoses of schizoaffective disorder, and relapses characterised by repeated manic psychotic episodes and grandiosity. Such presentations require specific adaptations to standard bipolar disorder interventions in order to address their psychosis, alongside mood regulation, with a particular emphasis on impulsivity, irritability, disinhibition and elation. The Balancing ACT study aims to evaluate an innovative group intervention combining Acceptance and Commitment Therapy and psychoeducation approaches (ACT/PE) with individuals experiencing bipolar disorder and/or symptoms within community psychosis services.MethodsThe Balancing ACT study is a randomised controlled trial comparing Balancing ACT groups (ACT/PE) plus routine care to routine care alone. Balancing ACT (ACT/PE) comprises ten group sessions, each lasting 2 hours, delivered weekly. The primary outcome is psychological wellbeing; secondary outcomes are mental health relapses (measured by service use averages for the 12 months pre baseline and 3 months post baseline). We will also measure mood, distress, recovery and psychological change processes. Participants will be randomised in a 1:1 ratio, after baseline assessment. Outcomes will be assessed by trained assessors blind to treatment condition at 0, 10 and 14 weeks. Recruitment began in April 2017 and is on-going until the end of October 2017.DiscussionThe Balancing ACT study will contribute to the currently limited evidence base for psychological interventions for people experiencing bipolar disorder and/or symptoms in the context of community psychosis services.Trial registrationISRCTN73327972 . Registered on 27 March 2017. Balancing ACT: evaluating the effectiveness of psychoeducation and Acceptance and Commitment Therapy (ACT) groups for people with bipolar disorder.

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:BackgroundMotor neuron disease (MND) is a rapidly progressive, fatal neurodegenerative disease that predominantly affects motor neurons from the motor cortex to the spinal cord and causes progressive wasting and weakening of bulbar, limb, abdominal and thoracic muscles. Prognosis is poor and median survival is 2-3 years following symptom onset. Psychological distress is relatively common in people living with MND. However, formal psychotherapy is not routinely part of standard care within MND Care Centres/clinics in the UK, and clear evidence-based guidance on improving the psychological health of people living with MND is lacking. Previous research suggests that Acceptance and Commitment Therapy (ACT) may be particularly suitable for people living with MND and may help improve their psychological health.AimsTo assess the clinical and cost-effectiveness of ACT modified for MND plus usual multidisciplinary care (UC) in comparison to UC alone for improving psychological health in people living with MND.MethodsThe COMMEND trial is a multi-centre, assessor-blind, parallel, two-arm RCT with a 10-month internal pilot phase. 188 individuals aged ≥ 18 years with a diagnosis of definite, laboratory-supported probable, clinically probable, or possible familial or sporadic amyotrophic lateral sclerosis, and additionally the progressive muscular atrophy and primary lateral sclerosis variants, will be recruited from approximately 14 UK-based MND Care Centres/clinics and via self-referral. Participants will be randomly allocated to receive up to eight 1:1 sessions of ACT plus UC or UC alone by an online randomisation system. Participants will complete outcome measures at baseline and at 6- and 9-months post-randomisation. The primary outcome will be quality of life at six months. Secondary outcomes will include depression, anxiety, psychological flexibility, health-related quality of life, adverse events, ALS functioning, survival at nine months, satisfaction with therapy, resource use and quality-adjusted life years. Primary analyses will be by intention to treat and data will be analysed using multi-level modelling.DiscussionThis trial will provide definitive evidence on the clinical and cost-effectiveness of ACT plus UC in comparison to UC alone for improving psychological health in people living with MND.Trial registrationISRCTN Registry, ISRCTN12655391. Registered 17 July 2017, https://www.isrctn.com/ISRCTN12655391 .Protocol version3.1 (10/06/2020).

Project description:Acceptance and commitment therapy (ACT) is considered by the American Psychological Association as an evidence-based treatment for a variety of disorders, including chronic pain. The main objective of the present systematic review was to determine the effectiveness of ACT in patients with central pain sensitization syndromes (CPSS). This systematic review was conducted according to the guidelines of the Cochrane Collaboration and PRISMA statements. The protocol was registered in advance in the Prospective Register of Systematic Reviews (PROSPERO) international database. The selected articles were evaluated using the Cochrane risk of bias (ROB) assessment tool. The PubMed, Scopus, and Web of Science databases were searched. The literature search identified 21 studies (including investigations of fibromyalgia syndrome, irritable bowel syndrome, and migraine) eligible for the systematic review. There were no studies regarding the effectiveness of ACT for chronic tension-type headache (CTTH), interstitial cystitis (IC), or temporomandibular disorder (TMD). The evaluation of ROB showed that 12 of the selected studies were of low quality, 5 were of moderate quality, and 4 were high quality. ACT reduces some clinical symptoms, such as anxiety, depression, and pain. This positive effect of ACT might be mediated by pain acceptance, psychological flexibility, optimism, self-efficacy, or adherence to values. ACT showed better results in comparison to non-intervention (e.g., "waiting list") conditions, as well as pharmacological and psychoeducational interventions. It is not entirely clear whether extended ACT treatments are more advantageous than briefer interventions. There are few studies about the effectiveness of ACT on CPSS. However, ACT seems to reduce subjective CPSS symptoms and improve the health-related quality of life of these patients. The absence of studies on the effectiveness of ACT in CTTH, IC, and TMD, indicate the pressing need for further ACT studies in these CPSS.

Project description:BackgroundPsychological interventions, along with antipsychotic medications, are recommended for adults diagnosed with a psychotic disorder. While initially designed to mitigate positive symptoms, psychological interventions targeting personal recovery were developed and aligned with the recovery framework that many mental health services have adopted. Acceptance and Commitment Therapy (ACT) for psychosis is one such intervention that shows promise when delivered in an individual format. There is preliminary evidence that ACT for psychosis in a group format improves recovery.ObjectiveThis trial aims to evaluate the effectiveness of the "Recovery ACT" group program on personal recovery among adults living with a psychotic disorder.MethodsOur unfunded study is a multiagency, prospective, nonrandomized, waitlist control, single-group trial of the Recovery ACT group program. The program involves 7 weekly group sessions of 90 minutes duration and a 90-minute booster session held 1 month later. We intend to recruit 160 adults living with a psychotic disorder who enroll in a group that is offered as a routine clinical service at participating public mental health services in Melbourne, Victoria, Australia. The 4 assessment time points are 4-6 weeks before the start of the group program, at the start of the group program, at the end of the group program, and at the booster session. There is an optional midgroup assessment and follow-up study. The primary outcome is personal recovery. Secondary outcomes include participants' well-being and psychological flexibility processes. Qualitative data are also collected from participants and facilitators.ResultsRecruitment began in September 2019 and is ongoing until 2024, subsequent to a 24-month disruption due to the COVID-19 pandemic. As of the submission of this paper, 93 participants consented to the evaluation, 65 completed T1 measures, and 40 had a complete data set for the proposed analyses.ConclusionsThis is the first trial evaluating the effectiveness of the Recovery ACT group program on personal recovery for adults living with a psychotic disorder. Findings will contribute to knowledge about psychosocial interventions for adults living with psychosis. This trial may also serve as an example of a partnership between clinicians and academics that can facilitate the translation of research into practice.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12620000223932; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000223932.International registered report identifier (irrid)DERR1-10.2196/49849.

Dataset Information

Comparing group-based acceptance and commitment therapy (ACT) with enhanced usual care for adolescents with functional somatic syndromes: a study protocol for a randomised trial.

Publications

Comparing group-based acceptance and commitment therapy (ACT) with enhanced usual care for adolescents with functional somatic syndromes: a study protocol for a randomised trial.

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