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Cost-effectiveness of transdiagnostic group cognitive behavioural therapy versus group relaxation therapy for emotional disorders in primary care (PsicAP-Costs2): Protocol for a multicentre randomised controlled trial.

ABSTRACT: Several randomised controlled trials (RCT) have demonstrated the superiority of transdiagnostic group cognitive-behavioural therapy (TD-CBT) to treatment as usual (TAU) for emotional disorders in primary care. To date, however, no RCTs have been conducted to compare TD-CBT to another active intervention in this setting. Our aim is to conduct a single-blind RCT to compare group TD-CBT plus TAU to progressive muscle relaxation (PMR) plus TAU in adults (age 18 to 65 years) with a suspected emotional disorder. We expect that TD-CBT + TAU will be more cost-effective than TAU + PMR, and that these gains will be maintained at the 12-month follow-up. Seven therapy sessions (1.5 hours each) will be offered over a 24-week period. The study will be carried out at four primary care centres in Cantabria, Spain. The study will take a societal perspective. Psychological assessments will be made at three time points: baseline, post-treatment, and at 12-months. The following variables will be evaluated: clinical symptoms (anxiety, depression, and/or somatic); functioning; quality of life (QoL); cognitive-emotional factors (rumination, worry, attentional and interpretative biases, emotion regulation and meta-cognitive beliefs); and satisfaction with treatment. Data on health service use, medications, and sick days will be obtained from electronic medical records. Primary outcome measures will include: incremental cost-effectiveness ratios (ICER) and incremental cost-utility ratios (ICURs). Secondary outcome measures will include: clinical symptoms, QoL, functioning, and treatment satisfaction. Bootstrap sampling will be used to assess uncertainty of the results. Secondary moderation and mediation analyses will be conducted. Two questionnaires will be administered at sessions 1, 4, and 7 to assess therapeutic alliance and group satisfaction. If this trial is successful, widespread application of this cost-effective treatment could greatly improve access to psychological treatment for emotional disorders in the context of increasing demand for mental healthcare in primary care. Trial registration: ClinicalTrials.gov: Cost-effectiveness of a Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care (PsicAP). NCT05314920.

SUBMITTER: Gonzalez-Blanch C

PROVIDER: S-EPMC10019745 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Cost-effectiveness of transdiagnostic group cognitive behavioural therapy versus group relaxation therapy for emotional disorders in primary care (PsicAP-Costs2): Protocol for a multicentre randomised controlled trial.

González-Blanch César C Barrio-Martínez Sara S Priede Amador A Martínez-Gómez Sandra S Pérez-García-Abad Saioa S Miras-Aguilar María M Ruiz-Gutiérrez José J Muñoz-Navarro Roger R Ruiz-Rodríguez Paloma P Medrano Leonardo A LA Prieto-Vila Maider M Carpallo-González María M Aguilera-Martín Ángel Á Gálvez-Lara Mario M Cuadrado Fátima F Moreno Eliana E García-Torres Francisco F Venceslá José F JF Corpas Jorge J Jurado-González Francisco J FJ Moriana Juan A JA Cano-Vindel Antonio A

PloS one 20230316 3

Several randomised controlled trials (RCT) have demonstrated the superiority of transdiagnostic group cognitive-behavioural therapy (TD-CBT) to treatment as usual (TAU) for emotional disorders in primary care. To date, however, no RCTs have been conducted to compare TD-CBT to another active intervention in this setting. Our aim is to conduct a single-blind RCT to compare group TD-CBT plus TAU to progressive muscle relaxation (PMR) plus TAU in adults (age 18 to 65 years) with a suspected emotiona ...[more]

PMID: 36928238

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Project description:BackgroundDemand for primary care (PC) services in Spain exceeds available resources. Part of this strong demand is due to the high prevalence of emotional disorders (EDs)-anxiety, depression, and somatic symptom disorders-and related comorbidities such as pain or chronic illnesses. EDs are often under- or misdiagnosed by general practitioners (GPs) and, consequently, treatment is frequently inadequate.ObjectiveWe aim to compare the short- and long-term effectiveness of group-delivered transdiagnostic cognitive behavioral therapy (TD-CBT) versus treatment as usual (TAU) in the treatment of EDs in the PC setting in Spain. We also aim to compare the effect of these treatments on disability, quality of life, cognitive-emotional factors, and treatment satisfaction.MethodsHere we present the study design of a two-arm, single-blind, randomized controlled trial (N=1126) to compare TAU to TD-CBT for EDs. TAU will consist primarily of pharmacological treatment and practical advice from the GP while TD-CBT will be administered in seven 90-minute group sessions held over a period ranging from 12 to 14 weeks. Psychological assessments are carried out at baseline (ie, pretreatment); posttreatment; and at 3-, 6-, and 12-month follow-up. The study is conducted in approximately 26 PC centers from the National Health System in Spain.ResultsThis study was initiated in December 2013 and will remain open to new participants until recruitment and follow-up has been completed. We expect all posttreatment evaluations to be completed by December 2017, and follow-up will end in December 2018.ConclusionsWe expect the TD-CBT group to have better results compared to TAU on all posttreatment measures and that this improvement will be maintained during follow-up. This project could serve as a model for use in other areas or services of the National Health System in Spain and even in other countries.ClinicaltrialInternational Standard Randomized Controlled Trial Number (ISRCTN): 58437086; http://www.isrctn.com/ISRCTN58437086 (Archived by WebCite at http://www.webcitation.org/6mbYjQSn3).

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:Introduction: In the primary care (PC) setting in Spain, the prevalence of emotional disorders (EDs) such as anxiety, depression and somatoform disorder is high. In PC patients, these disorders are not always managed in accordance with the recommendations provided by clinical practice guidelines, resulting in major direct and indirect economic costs and suboptimal treatment outcomes. The aim is to analyze and compare the cost-effectiveness and cost-utility of group-based psychological therapy versus treatment as usual (TAU). Methods: Multicenter, randomized controlled trial involving 300 patients recruited from PC centers in Madrid, Spain, with symptoms or possible diagnosis of anxiety, mood (mild or moderate), or somatoform disorders. Patients will be randomized to one of two groups: an experimental group, which will receive group-based transdiagnostic cognitive-behavioral therapy (TD-CBT); and a control group, which will receive TAU (mainly pharmacological interventions) prescribed by their general practitioner (GP). Clinical assessment will be performed with the Patient Health Questionnaire (PHQ). Direct and indirect costs will be calculated and relevant socio-demographic variables will be registered. The Spanish version of the EuroQol 5D-5L will be administered. Patients will be assessed at baseline, immediately after treatment finalization, and at 6 and 12 months post-treatment. Discussion: To our knowledge, this is the first study to compare TD-CBT to TAU in the PC setting in Spain. This is the first comparative economic evaluation of these two treatment approaches in PC. The strength of the study is that it is a multicenter, randomized, controlled trial of psychotherapy and TAU for EDs in PC. Trial registration: Protocol code: ISCRCTN58437086; 20/05/2013. EUDRACT: 2013-001955-11. Protocol Version: 6, 11/01/2014.

Project description:BackgroundDepression is a common, debilitating, and costly disorder. Many patients request psychological therapy, but the best-evidenced therapy-cognitive behavioural therapy (CBT)-is complex and costly. A simpler therapy-behavioural activation (BA)-might be as effective and cheaper than is CBT. We aimed to establish the clinical efficacy and cost-effectiveness of BA compared with CBT for adults with depression.MethodsIn this randomised, controlled, non-inferiority trial, we recruited adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder from primary care and psychological therapy services in Devon, Durham, and Leeds (UK). We excluded people who were receiving psychological therapy, were alcohol or drug dependent, were acutely suicidal or had attempted suicide in the previous 2 months, or were cognitively impaired, or who had bipolar disorder or psychosis or psychotic symptoms. We randomly assigned participants (1:1) remotely using computer-generated allocation (minimisation used; stratified by depression severity [Patient Health Questionnaire 9 (PHQ-9) score of <19 vs ≥19], antidepressant use, and recruitment site) to BA from junior mental health workers or CBT from psychological therapists. Randomisation done at the Peninsula Clinical Trials Unit was concealed from investigators. Treatment was given open label, but outcome assessors were masked. The primary outcome was depression symptoms according to the PHQ-9 at 12 months. We analysed all those who were randomly allocated and had complete data (modified intention to treat [mITT]) and also all those who were randomly allocated, had complete data, and received at least eight treatment sessions (per protocol [PP]). We analysed safety in the mITT population. The non-inferiority margin was 1·9 PHQ-9 points. This trial is registered with the ISCRTN registry, number ISRCTN27473954.FindingsBetween Sept 26, 2012, and April 3, 2014, we randomly allocated 221 (50%) participants to BA and 219 (50%) to CBT. 175 (79%) participants were assessable for the primary outcome in the mITT population in the BA group compared with 189 (86%) in the CBT group, whereas 135 (61%) were assessable in the PP population in the BA group compared with 151 (69%) in the CBT group. BA was non-inferior to CBT (mITT: CBT 8·4 PHQ-9 points [SD 7·5], BA 8·4 PHQ-9 points [7·0], mean difference 0·1 PHQ-9 points [95% CI -1·3 to 1·5], p=0·89; PP: CBT 7·9 PHQ-9 points [7·3]; BA 7·8 [6·5], mean difference 0·0 PHQ-9 points [-1·5 to 1·6], p=0·99). Two (1%) non-trial-related deaths (one [1%] multidrug toxicity in the BA group and one [1%] cancer in the CBT group) and 15 depression-related, but not treatment-related, serious adverse events (three in the BA group and 12 in the CBT group) occurred in three [2%] participants in the BA group (two [1%] patients who overdosed and one [1%] who self-harmed) and eight (4%) participants in the CBT group (seven [4%] who overdosed and one [1%] who self-harmed).InterpretationWe found that BA, a simpler psychological treatment than CBT, can be delivered by junior mental health workers with less intensive and costly training, with no lesser effect than CBT. Effective psychological therapy for depression can be delivered without the need for costly and highly trained professionals.FundingNational Institute for Health Research.

Project description:IntroductionA number of studies have established that children, adolescents and adults with Asperger syndrome (AS) and high functioning autism (HFA) have significant problems with anxiety. Cognitive behavioural therapy (CBT) is an effective treatment for anxiety in a variety of clinical populations. There is a growing interest in exploring the effectiveness of CBT for people with AS who have mental health problems, but currently there are no known clinical trials involving adults with AS or HFA. Studies with children who have AS have reported some success. The current study aims to examine whether modified group CBT for clinically significant anxiety in an AS population is likely to be efficacious.Methods and analysisThis study is a randomised, single-blind crossover trial. At least 36 individuals will be recruited and randomised into a treatment arm or a waiting-list control arm. During treatment, individuals will receive 3 sessions of individual CBT, followed by 21 sessions of group CBT. Primary outcome measures focus on anxiety. Secondary outcome measures focus on everyday social and psychiatric functioning, additional measures of anxiety and fear, depression, health-related quality of life and treatment cost. Assessments will be administered at pregroup and postgroup and at follow-up by researchers who are blinded to group allocation. The trial aims to find out whether or not psychological treatments for anxiety can be adapted and used to successfully treat the anxiety experienced by people with AS. Furthermore, we aim to determine whether this intervention represents good value for money.Ethics and disseminationThe trial received a favourable ethical opinion from a National Health Service (NHS) Research Ethics Committee. All participants provided written informed consent. Findings will be shared with all trial participants, and the general public, as well as the scientific community.Trial registrationISRCTN 30265294 (DOI: 10.1186/ISRCTN30265294), UKCRN 8370.

Project description:IntroductionPersistence of attention deficit hyperactivity disorder (ADHD) into adolescence is a significant burden to patients. Clinical guidelines recommend non-pharmacological therapies, but the evidence to support this recommendation is sparse. This study aims to evaluate the effect of a 12-week group cognitive-behavioural therapy (CBT) programme for adolescents with ADHD aged 14-18 years, who still have impairing symptoms after treatment with medication. We will study the effect of the treatment on ADHD symptoms and examine moderators and mediators of the effect of the treatment on ADHD.Methods and analysisWe conduct a randomised controlled trial of CBT group therapy in adolescents with ADHD recruited from child psychiatric outpatient units in Mid-Norway. 99 adolescents who met inclusion criteria and consented to participation have been randomised to a 12-week group intervention or to a control group receiving treatment as usual. Assessments are made at admission to the clinic, preintervention, postintervention and at a 9-month follow-up, obtaining adolescent, parent and teacher reports. Clinicians blinded to group allocation rate all participants as to their functioning preintervention and at the two postintervention assessment points. The primary outcome is change in symptom scores on the ADHD Rating Scale-IV.Ethics and disseminationThe Regional Committee for Medical and Health Research Ethics in South East Norway approved the study protocol (2015/2115). We will disseminate the findings in peer-reviewed publications and conference presentations, to user organisations and at courses attended by families and professionals. Two PhD students will publish and defend dissertations relating to the study. Planned publications include primary and secondary outcomes and patient satisfaction with the treatment. Furthermore, we plan to publish a manual of CBT group therapy in adolescent ADHD to benefit treatment of patients in Norway and elsewhere.Trial registration numberNCT02937142.

Dataset Information

Cost-effectiveness of transdiagnostic group cognitive behavioural therapy versus group relaxation therapy for emotional disorders in primary care (PsicAP-Costs2): Protocol for a multicentre randomised controlled trial.

Publications

Cost-effectiveness of transdiagnostic group cognitive behavioural therapy versus group relaxation therapy for emotional disorders in primary care (PsicAP-Costs2): Protocol for a multicentre randomised controlled trial.

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