Unguided low intensity cognitive behaviour therapy for anxiety and depression during the COVID-19 pandemic: A randomised trial.
Ontology highlight
ABSTRACT:
SUBMITTER: Egan SJ
PROVIDER: S-EPMC8197681 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BackgroundCognitive behavioural therapy is an effective treatment for depression. However, one third of the patients do not respond satisfactorily, and relapse rates of around 30 % within the first post-treatment year were reported in a recent meta-analysis. In total, 30-50 % of remitted patients present with residual symptoms by the end of treatment. A common residual symptom is rumination, a process of recurrent negative thinking and dwelling on negative affect. Rumination has been demonstrated as a major factor in vulnerability to depression, predicting the onset, severity, and duration of future depression. Rumination-focused cognitive behavioural therapy is a psychotherapeutic treatment targeting rumination. Because rumination plays a major role in the initiation and maintenance of depression, targeting rumination with rumination-focused cognitive behavioural therapy may be more effective in treating depression and reducing relapse than standard cognitive behavioural therapy.Method/designThis study is a two-arm pragmatic randomised controlled superiority trial comparing the effectiveness of group-based rumination-focused cognitive behaviour therapy with the effectiveness of group-based cognitive behavioural therapy for treatment of depression. One hundred twenty-eight patients with depression will be recruited from and given treatment in an outpatient service at a psychiatric hospital in Denmark. Our primary outcome will be severity of depressive symptoms (Hamilton Rating Scale for Depression) at completion of treatment. Secondary outcomes will be level of rumination, worry, anxiety, quality of life, behavioural activation, experimental measures of cognitive flexibility, and emotional attentional bias. A 6-month follow-up is planned and will include the primary outcome measure and assessment of relapse.DiscussionThe clinical outcome of this trial may guide clinicians to decide on the merits of including rumination-focused cognitive behavioural therapy in the treatment of depression in outpatient services.Trial registrationClinicalTrials.gov Identifier: NCT02278224 , registered 28 Oct. 2014.
| S-EPMC4532251 | biostudies-literature
Project description:BackgroundIn 2006, the British government launched 'Improving Access to Psychological Therapies' (IAPT), a low intensity cognitive behaviour therapy intervention (LiCBT) designed to manage people with symptoms of anxiety and depression in the community. The evidence of the effectiveness of IAPT has been demonstrated in multiple studies from the UK, USA, Australia and other countries. MindStep™ is the first adaptation of IAPT in Australia, delivered completely by telephone, targeting people with a recent history of a hospital admission for mental illnesses within the private health system. This paper reports on the outcome of the first 17 months of MindStep™ implemented across Australia from March 2016.MethodsThis prospective observational study investigated the MindStep™ program in a cohort of clients with a recent hospitalisation for mental illnesses. The study used quantitative methods to compare pre-post treatment clinical measures (N = 680) using Patient Health Questionnaire (PHQ-9) and the Generalised Anxiety Disorder (GAD-7). This study also included in-depth interviews with participants (N = 14) and coaches (N = 4) to determine the feasibility and acceptability of the program.ResultsOf the 867 clients referred to MindStep™, 757 had initial assessments by phone making an enrolment rate of 87.3%. Following assessment, 680 commenced treatment and of them, 427 (62.7%) completed treatment. According to 'per-protocol' analysis (N = 427), there was a large effect size for post-treatment PHQ-9 (d = 1.03) and GAD-7 (d = 0.99) scores; reliable recovery rate was 62% (95% CI: 57-68%). For intent-to-treat analysis using multiple imputation (N = 680), effect sizes were also large for pre-post treatment change: PHQ-9 (d = 0.78) and GAD-7 (d = 0.76). The reliable recovery rate was 49% (95% CI: 45-54%). Qualitative findings supported these claims where participants were positive about MindStep™ and found the telephone delivery and use of mental health coaches highly acceptable.ConclusionsMindStep™ has demonstrated encouraging outcomes that suggest LiCBT can be successfully delivered to people with a history of hospital admissions for anxiety and depressive disorders and achieve target recovery rates of > 50%. Other promising evaluation findings indicate the MindStep™ option is acceptable, feasible and safe within the stepped models of mental health care delivery in Australia.
| S-EPMC6319009 | biostudies-literature
Project description:BackgroundObsessive-compulsive disorder (OCD) is prevalent and without adequate treatment usually follows a chronic course. "High-intensity" cognitive-behaviour therapy (CBT) from a specialist therapist is current "best practice." However, access is difficult because of limited numbers of therapists and because of the disabling effects of OCD symptoms. There is a potential role for "low-intensity" interventions as part of a stepped care model. Low-intensity interventions (written or web-based materials with limited therapist support) can be provided remotely, which has the potential to increase access. However, current evidence concerning low-intensity interventions is insufficient. We aimed to determine the clinical effectiveness of 2 forms of low-intensity CBT prior to high-intensity CBT, in adults meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for OCD.Methods and findingsThis study was approved by the National Research Ethics Service Committee North West-Lancaster (reference number 11/NW/0276). All participants provided informed consent to take part in the trial. We conducted a 3-arm, multicentre randomised controlled trial in primary- and secondary-care United Kingdom mental health services. All patients were on a waiting list for therapist-led CBT (treatment as usual). Four hundred and seventy-three eligible patients were recruited and randomised. Patients had a median age of 33 years, and 60% were female. The majority were experiencing severe OCD. Patients received 1 of 2 low-intensity interventions: computerised CBT (cCBT; web-based CBT materials and limited telephone support) through "OCFighter" or guided self-help (written CBT materials with limited telephone or face-to-face support). Primary comparisons concerned OCD symptoms, measured using the Yale-Brown Obsessive Compulsive Scale-Observer-Rated (Y-BOCS-OR) at 3, 6, and 12 months. Secondary outcomes included health-related quality of life, depression, anxiety, and functioning. At 3 months, guided self-help demonstrated modest benefits over the waiting list in reducing OCD symptoms (adjusted mean difference = -1.91, 95% CI -3.27 to -0.55). These effects did not reach a prespecified level of "clinically significant benefit." cCBT did not demonstrate significant benefit (adjusted mean difference = -0.71, 95% CI -2.12 to 0.70). At 12 months, neither guided self-help nor cCBT led to differences in OCD symptoms. Early access to low-intensity interventions led to significant reductions in uptake of high-intensity CBT over 12 months; 86% of the patients allocated to the waiting list for high-intensity CBT started treatment by the end of the trial, compared to 62% in supported cCBT and 57% in guided self-help. These reductions did not compromise longer-term patient outcomes. Data suggested small differences in satisfaction at 3 months, with patients more satisfied with guided self-help than supported cCBT. A significant issue in the interpretation of the results concerns the level of access to high-intensity CBT before the primary outcome assessment.ConclusionsWe have demonstrated that providing low-intensity interventions does not lead to clinically significant benefits but may reduce uptake of therapist-led CBT.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN) Registry ISRCTN73535163.
| S-EPMC5486961 | biostudies-literature
Project description:BackgroundInnovative moments (IMs), defined as moments in psychotherapy when patients' problematic patterns change toward more elaborated and adaptive patterns, have been shown to be associated with a clinical change in patients with depression. Thus, far IMs have been studied in face-to-face settings but not in telephone-based cognitive-behavioral therapy (t-CBT). This study investigates whether IMs occur in t-CBT and examines the association between IMs and symptom improvement, and reconceptualization and symptom improvement.MethodsThe therapy transcripts of n = 10 patients with mild to moderate depression (range: 7-11 sessions, in total 94 sessions) undergoing t-CBT were qualitatively and quantitatively analyzed. Symptom severity (Patient Health Questionnaire-9) and IMs (levels and proportions) were assessed for each therapy session. Hierarchical linear models were used to test the prediction models.ResultsThe rating of IMs was shown to be feasible and reliable using the Innovative Moments Coding System (IMCS) (84.04% agreement in words coded), which is indicative of the applicability of the concept of IMs in t-CBT. Only reconceptualization IMs were shown to have a predictive value for treatment success (R2 = 0.05, p = 0.01).DiscussionThe results should be interpreted with caution due to the exploratory nature of this study. Due to the telephone setting, it was necessary to adapt the IMCS. Nonetheless, the extent of IMs identified in the low-intensity t-CBT investigated was comparable to IMs in face-to-face therapy. Further studies are needed to clarify the association between IMs and treatment success as a change process, especially for low-intensity treatments.
| S-EPMC10409642 | biostudies-literature
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.
| S-EPMC7217821 | biostudies-literature
Project description:IntroductionOne in eight women suffer from depression during pregnancy. Currently, low-intensity brief treatment based on cognitive behavioural therapy (CBT) is the only talking treatment widely available in the National Health Service (NHS) for mild and moderate depression. CBT involves identifying and changing unhelpful negative thoughts and behaviours to improve mood. Mothers in our patient advisory groups requested greater treatment choice. Interpersonal counselling (IPC) is a low-intensity version of interpersonal therapy. It may have important advantages during pregnancy over CBT because it targets relationship problems, changes in role and previous losses (eg, miscarriage). We aim to compare CBT and IPC for pregnant women with depression in a feasibility study.Methods and analysisA two-arm non-blinded randomised feasibility study of 60 women will be conducted in two UK localities. Women with depression will be identified through midwife clinics and ultrasound scanning appointments and randomised to receive six sessions of IPC or CBT. In every other way, these women will receive usual care. Women thought to have severe depression will be referred for more intensive treatment. After 12 weeks, we will measure women's mood, well-being, relationship satisfaction and use of healthcare. Women, their partners and staff providing treatments will be interviewed to understand whether IPC is an acceptable approach and whether changes should be introduced before applying to run a larger trial.Several groups of patients with depression during pregnancy have contributed to our study design. A patient advisory group will meet and advise us during the study.Ethics and disseminationStudy results will inform the design of a larger multicentre randomised controlled trial (RCT). Our findings will be shared through public engagement events, papers and reports to organisations within the NHS. National Research Ethics Service Committee approved the study protocol.Trial registration numberISRCTN11513120.
| S-EPMC6701625 | biostudies-literature
Project description:IntroductionThe 1 year prevalence of depression in adolescents is about 2%. Treatment with antidepressant medication is not recommended for initial treatment in young people due to concerns over high side effects, poor efficacy and addictive potential. Evidence suggests that cognitive behaviour therapy (CBT) is an effective treatment for depression and is currently one of the main treatment options recommended in adolescents. Given the affinity young people have with information technology they may be treated effectively, more widely and earlier in their illness evolution using computer-administered CBT (CCBT). Currently little is known about the clinical and resource implications of implementing CCBT within the National Health Service for adolescents with low mood/depression. We aim to establish the feasibility of running a fully powered randomised controlled trial (RCT).Methods and analysisAdolescents aged 12-18 with low mood/depression, (scoring ≥20 on the Mood and Feelings Questionnaire (MFQ)), will be approached to participate. Consenting participants will be randomised to either a CCBT programme (Stressbusters) or accessing selected websites providing information about low mood/depression. The primary outcome measure will be the Beck Depression Inventory (BDI). Participants will also complete generic health measures (EQ5D-Y, HUI2) and resource use questionnaires to examine the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline, 4 and 12-month follow-ups. Progress and risk will be monitored via the MFQ administered at each treatment session. The acceptability of a CCBT programme to adolescents; and the willingness of clinicians to recruit participants and of participants to be randomised, recruitment rates, attrition rates and questionnaire completion rates will be collected for feasibility analysis. We will estimate 'numbers needed' to plan a fully powered RCT of clinical and cost-effectiveness.Ethics and disseminationThe current trial protocol received a favourable ethical opinion from Leeds (West) Research and Ethics Committee. (Reference: 10/H1307/137).Trial registration numberISRCTN31219579.
| S-EPMC4216856 | biostudies-literature
Project description:BackgroundLow-intensity cognitive behavioural therapy (LICBT) has been recommended as a primary intervention in the tiered care for mild to moderate generalised anxiety disorder. However, LICBT for generalised anxiety disorder are markedly diverse and efficacy data on various outcomes have not been systematically reviewed. This meta-analysis aimed to synthesise effect sizes of three NICE-recommended LICBT for generalised anxiety disorder: non-facilitated self-help, guided self-help, and psychoeducational groups.MethodsA systematic literature review of randomised controlled trials (RCTs) examining LICBT for generalised anxiety disorder in the last 23 years (2000-2023) was conducted. Efficacy data for anxiety, depression, and worry outcomes were separately meta-analysed. The study was reported following the PRISMA guidelines.ResultsThe systematic review identified 12 RCTs out of 1205 papers. The three meta-analyses consisted of 12 (anxiety), 11 (depression), and 9 (worry) effect sizes respectively, including total sample sizes of 1201 (anxiety), 1164 (depression), and 908 (worry). The adjusted effect sizes for reductions in anxiety (g = -0.63), depression (g = -0.48), and worry (g = -0.64) were all in the medium range, favouring LICBT over control conditions. Between-study heterogeneity was significant on anxiety and worry, with no specific moderators identified by meta-regression.ConclusionsLICBT has shown promise as an effective and efficient treatment modality for individuals with generalised anxiety disorder. Future research comparing various LICBT subtypes and treatment components will further inform clinical practice.Trial registrationThis systematic review protocol has been registered with the International Prospective Register of Systematic Reviews (PROSPERO; record ID CRD42021285590).
| S-EPMC10763350 | biostudies-literature
Project description:BackgroundInternet-delivered cognitive behavioral therapy (ICBT) is an effective treatment that can overcome barriers to mental health care. Various research groups have suggested that unguided ICBT (ie, ICBT without therapist support) and other eHealth interventions can be designed to enhance user engagement and thus outcomes. The persuasive systems design framework captures most design recommendations for eHealth interventions, but there is little empirical evidence that persuasive design is related to clinical outcomes in unguided ICBT.ObjectiveThis study aims to provide an updated meta-analysis of randomized controlled trials of unguided ICBT for depression and anxiety, describe the frequency with which various persuasive design principles are used in such interventions, and use meta-regression to explore whether a greater number of persuasive design elements predicts efficacy in unguided ICBT for depression and anxiety.MethodsWe conducted a systematic review of 5 databases to identify randomized controlled trials of unguided ICBT for depression and anxiety. We conducted separate random effects meta-analyses and separate meta-regressions for depression and anxiety interventions. Each meta-regression included 2 steps. The first step included, as a predictor, whether each intervention was transdiagnostic. For the meta-regression of ICBT for depression, the first step also included the type of control condition. The number of persuasive design principles identified for each intervention was added as a predictor in the second step to reveal the additional variance in effect sizes explained by persuasive design.ResultsOf the 4471 articles we identified in our search, 46 (1.03%) were eligible for inclusion in our analyses. Our meta-analyses showed effect sizes (Hedges g) ranging from 0.22 to 0.31 for depression interventions, depending on the measures taken to account for bias in the results. We found a mean effect size of 0.45 (95% CI 0.33-0.56) for anxiety interventions, with no evidence that the results were inflated by bias. Included interventions were identified as using between 1 and 13 persuasive design principles, with an average of 4.95 (SD 2.85). The meta-regressions showed that a greater number of persuasive design principles predicted greater efficacy in ICBT for depression (R2 change=0.27; B=0.04; P=.02) but not anxiety (R2 change=0.05; B=0.03; P=.17).ConclusionsThese findings show wide variability in the use of persuasive design in unguided ICBT for depression and anxiety and provide preliminary support for the proposition that more persuasively designed interventions are more efficacious, at least in the treatment of depression. Further research is needed to clarify the role of persuasive design in ICBT.
| S-EPMC8120424 | biostudies-literature
Project description:BACKGROUND:Depression has serious personal, family and economic consequences. It is estimated that it will cost £12.15 billion to the economy each year in England by 2026. Improving access to psychological therapies (IAPT) is the National Health Service talking therapies service in England for adults experiencing anxiety or depression. Over 1 million people are referred to IAPT every year, over half experiencing depression. Where symptoms of depression are mild to moderate, people are typically offered cognitive behavioural therapy (CBT) self-help (CBT-SH) supported by a psychological well-being practitioner. The problem is that over half of people who complete treatment for depression in IAPT remain depressed despite receiving National Institute of Health and Care Excellent recommended treatment. Furthermore, less than half of IAPT service users complete treatment. This study seeks to investigate the effectiveness of an alternative to CBT-SH. Mindfulness-based cognitive therapy (MBCT) differs from CBT in focus, approach and practice, and may be more effective with a higher number of treatment completions. METHODS/DESIGN:This is a definitive randomised controlled trial comparing supported MBCT self-help (MBCT-SH) with CBT-SH for adults experiencing mild to moderate depression being treated in IAPT services. We will recruit 410 participants experiencing mild to moderate depression from IAPT services and randomise these to receive either an MBCT-based self-help workbook or a CBT-based self-help workbook. Participants will be asked to complete their workbook within 16?weeks, with six support sessions with a psychological well-being practitioner. The primary outcome is depression symptom severity on treatment completion. Secondary outcomes are treatment completion rates and measures of generalized anxiety, well-being, functioning and mindfulness. An exploratory non-inferiority analysis will be conducted in the event the primary hypothesis is not supported. A semi-structured interview with participants will guide understanding of change processes. DISCUSSION:If the findings from this randomised controlled trial demonstrate that MBCT-SH is more effective than CBT-SH for adults experiencing depression, this will provide evidence for policy makers and lead to changes to clinical practice in IAPT services, leading to greater choice of self-help treatment options and better outcomes for service users. If the exploratory non-inferiority analysis is conducted and this indicates non-inferiority of MBCT-SH in comparison to CBT-SH this will also be of interest to policy makers when seeking to increase service user choice of self-help treatment options for depression. TRIAL REGISTRATION:Current Controlled Trial registration number: ISRCTN 13495752. Registered on 31 August 2017 (www.isrctn.com/ISRCTN13495752).
| S-EPMC7199325 | biostudies-literature