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Tavistock Adult Depression Study (TADS): a randomised controlled trial of psychoanalytic psychotherapy for treatment-resistant/treatment-refractory forms of depression.

ABSTRACT: BACKGROUND: Long-term forms of depression represent a significant mental health problem for which there is a lack of effective evidence-based treatment. This study aims to produce findings about the effectiveness of psychoanalytic psychotherapy in patients with treatment-resistant/treatment-refractory depression and to deepen the understanding of this complex form of depression. METHODS/DESIGN INDEX GROUP: Patients with treatment resistant/treatment refractory depression. DEFINITION & INCLUSION CRITERIA: Current major depressive disorder, 2 years history of depression, a minimum of two failed treatment attempts, ?14 on the HRSD or ?21 on the BDI-II, plus complex personality and/or psycho-social difficulties. EXCLUSION CRITERIA: Moderate or severe learning disability, psychotic illness, bipolar disorder, substance dependency or receipt of test intervention in the previous two years. DESIGN: Pragmatic, randomised controlled trial with qualitative and clinical components. TEST INTERVENTION: 18 months of weekly psychoanalytic psychotherapy, manualised and fidelity-assessed using the Psychotherapy Process Q-Sort. CONTROL CONDITION: Treatment as usual, managed by the referring practitioner. RECRUITMENT: GP referrals from primary care. RCT MAIN OUTCOME: HRSD (with ?14 as remission). SECONDARY OUTCOMES: depression severity (BDI-II), degree of co-morbid disorders Axis-I and Axis-II (SCID-I and SCID-II-PQ), quality of life and functioning (GAF, CORE, Q-les-Q), object relations (PROQ2a), Cost-effectiveness analysis (CSRI and GP medical records). FOLLOW-UP: 2 years. Plus: a). Qualitative study of participants' and therapists' problem formulation, experience of treatment and of participation in trial. (b) Narrative data from semi-structured pre/post psychodynamic interviews to produce prototypes of responders and non-responders. (c) Clinical case-studies of sub-types of TRD and of change. DISCUSSION: TRD needs complex, long-term intervention and extended research follow-up for the proper evaluation of treatment outcome. This pushes at the limits of the design of randomised therapeutic trials. We discuss some of the consequent problems and suggest how they may be mitigated. TRIAL REGISTRATION: Current Controlled Trials ISRCTN40586372.

SUBMITTER: Taylor D

PROVIDER: S-EPMC3395560 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Tavistock Adult Depression Study (TADS): a randomised controlled trial of psychoanalytic psychotherapy for treatment-resistant/treatment-refractory forms of depression.

Taylor David D Carlyle Jo-anne JA McPherson Susan S Rost Felicitas F Thomas Rachel R Fonagy Peter P

BMC psychiatry 20120611

<h4>Background</h4>Long-term forms of depression represent a significant mental health problem for which there is a lack of effective evidence-based treatment. This study aims to produce findings about the effectiveness of psychoanalytic psychotherapy in patients with treatment-resistant/treatment-refractory depression and to deepen the understanding of this complex form of depression.<h4>Methods/design index group</h4>Patients with treatment resistant/treatment refractory depression.<h4>Definit ...[more]

PMID: 22686185

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Project description:ObjectiveTo examine the utility of psychotherapy in managing treatment resistant depression.Data sourcesPubMed, PsycInfo, Embase, Cochrane Registry of Controlled Clinical Trials, article bibliographies.Review methodsEligible articles had to be in English and include English-speaking adult outpatients from general medical or mental health clinics. Studies had to be randomized clinical trials (RCT) involving at least one of the following psychotherapy modalities: cognitive therapy, interpersonal therapy, or behavior therapy. Patients were considered treatment resistant if they reported partial or no remission following treatment with an adequate antidepressant dose for ≥ 6 weeks. Exclusion criteria included receiving psychotherapy at the time of recruitment, and/or comorbid psychiatric conditions unlikely to be treated outside of specialized mental health care (e.g., severe substance abuse). Due to heterogeneity in study designs, a summary estimate of effect was not calculated. Studies were critically analyzed and a qualitative synthesis was conducted.ResultsOf 941 original titles, 13 articles evaluating 7 unique treatment comparisons were included. Psychotherapy was examined as an augmentation to antidepressants in five studies and as substitution treatment in two studies. A total of 592 patients were evaluated (Mean age ~40 y; Females = 50-85%; Caucasians ≥ 75%). The STAR*D trial used an equipoise stratified randomization design; the remaining studies were RCTs. Compared to active management, two good quality trials showed similar benefit from augmenting antidepressants with psychotherapy; one fair quality and one poor quality trial showed benefit from psychotherapy augmentation; and one good and one poor trial found similar benefit from substituting psychotherapy for antidepressants. One fair quality trial showed lithium augmentation to be more beneficial than psychotherapy.ConclusionsReview demonstrates the utility of psychotherapy in managing treatment resistant depression. However, evidence is sparse and results are mixed. Given that quality trials are lacking, rigorous clinical trials are recommended to guide practice. In the interim, primary care providers should consider psychotherapy when treating patients with treatment resistant depression.

Project description:Importance:Electroconvulsive therapy (ECT) is a highly effective treatment for depression but is infrequently used owing to stigma, uncertainty about indications, adverse effects, and perceived high cost. Objective:To assess the cost-effectiveness of ECT compared with pharmacotherapy/psychotherapy for treatment-resistant major depressive disorder in the United States. Design, Setting, and Participants:A decision analytic model integrating data on clinical efficacy, costs, and quality-of-life effects of ECT compared with pharmacotherapy/psychotherapy was used to simulate depression treatment during a 4-year horizon from a US health care sector perspective. Model input data were drawn from multiple meta-analyses, randomized trials, and observational studies of patients with depression. Where possible, data sources were restricted to US-based studies of nonpsychotic major depression. Data were analyzed between June 2017 and January 2018. Interventions:Six alternative strategies for incorporating ECT into depression treatment (after failure of 0-5 lines of pharmacotherapy/psychotherapy) compared with no ECT. Main Outcomes and Measures:Remission, response, and nonresponse of depression; quality-adjusted life-years; costs in 2013 US dollars; and incremental cost-effectiveness ratios. Strategies with incremental cost-effectiveness ratios of $100 000 per quality-adjusted life-year or less were designated cost-effective. Results:Based on the Sequenced Treatment Alternatives to Relieve Depression trial, we simulated a population with a mean (SD) age of 40.7 (13.2) years, and 62.2% women. Over 4 years, ECT was projected to reduce time with uncontrolled depression from 50% of life-years to 33% to 37% of life-years, with greater improvements when ECT is offered earlier. Mean health care costs were increased by $7300 to $12 000, with greater incremental costs when ECT was offered earlier. In the base case, third-line ECT was cost-effective, with an ICER of $54 000 per quality-adjusted life-year. Third-line ECT remained cost-effective in a range of univariate, scenario, and probabilistic sensitivity analyses. Incorporating all input data uncertainty, we estimate a 74% to 78% likelihood that at least 1 of the ECT strategies is cost-effective and a 56% to 58% likelihood that third-line ECT is the optimal strategy. Conclusions and Relevance:For US patients with treatment-resistant depression, ECT may be an effective and cost-effective treatment option. Although many factors influence the decision to proceed with ECT, these data suggest that, from a health-economic standpoint, ECT should be considered after failure of 2 or more lines of pharmacotherapy/psychotherapy.

Project description:BackgroundAlthough psychotherapy is one of the most efficacious and effective treatments for depression, limited accessibility to trained providers markedly limits access to care. In an attempt to overcome this obstacle, several platforms seeking to provide these services using digital modalities (eg, video, text, and chat) have been developed. However, the use of these modalities individually poses barriers to intervention access and acceptability. Multimodal platforms, comprising those that allow users to select from a number of available modalities, may be able to provide a solution to these concerns.ObjectiveWe aimed to investigate the preliminary effectiveness of providing psychotherapy through a multimodal digital psychotherapy platform. In addition, we aimed to examine differential responses to intervention by gender, self-reported physical health status, and self-reported financial status, as well as how prior exposure to traditional face-to-face psychotherapy affected the effectiveness of a multimodal digital psychotherapy intervention. Finally, we aimed to examine the dose-response effect.MethodsData were collected from a total of 318 active users of BetterHelp, a multimodal digital psychotherapy platform. Data on physical health status, financial status, and prior exposure to psychotherapy were obtained using self-report measures. Effectiveness was determined by the extent of symptom severity change, which was measured using the Patient Health Questionnaire at Time 1 (time of enrollment) and Time 2 (3 months after enrollment). Intervention dosage was measured as the sum of individual therapist-user interactions across modalities.ResultsDepression symptom severity was significantly reduced after the use of the multimodal digital psychotherapy intervention (P<.001). Individuals without prior traditional psychotherapy experience revealed increased improvement after intervention (P=.006). We found no significant dose-response effect of therapy, nor significant differences in outcomes across gender, self-reported financial status, and self-reported physical health status.ConclusionsUsers of BetterHelp experienced significantly reduced depression symptom severity after engaging with the platform. Study findings suggest that this intervention is equally effective across gender, self-reported financial status, and self-reported physical health status and particularly effective for individuals without a history of psychotherapy. Overall, study results suggest that multimodal digital psychotherapy is a potentially effective treatment for adult depression; nevertheless, experimental trials are needed. We discuss directions for future research.

Project description:BackgroundA third of patients diagnosed with major depressive disorder (MDD) experience treatment-resistant depression (TRD). Relatively few pharmacological agents have established efficacy for TRD. Therefore, the evaluation of novel treatments for TRD is a pressing priority. Statins are pleiotropic agents and preclinical studies as well as preliminary clinical trials have suggested that these drugs may have antidepressant properties.AimsTo report on a protocol for a 12-week, randomised, double-blind, placebo-controlled trial of add-on treatment with simvastatin for patients meeting DSM-5 criteria for MDD who have failed to respond to at least two adequate trials with approved antidepressants. The trial has been registered with Clinicaltrials.gov in (ClinicalTrials.gov identifier: NCT03435744).MethodAfter screening and randomisation to the two parallel arms of the trial, 75 patients will receive simvastatin and 75 patients will receive placebo as adjuncts to treatment as usual. The primary outcome is change in Montgomery-Åsberg Depression Rating Scale scores from baseline to week 12 and secondary outcomes include changes in scores on the 24-item Hamilton Rating Scale for Depression, the Clinical Global Impression scale, the 7-item Generalized Anxiety Disorder scale and change in body mass index from baseline to week 12. Assessments will take place at screening, baseline, and weeks 2, 4, 8 and 12. Checklists for adverse effects will be undertaken at each visit. Simvastatin (20 mg) will be given once daily. Other secondary outcomes include C-reactive protein and plasma lipids measured at baseline and week 12.ResultsThis trial will assess simvastatin's efficacy and tolerability as an add-on treatment option for patients with TRD and provide insights into its putative mechanisms of action.ConclusionsAs the first trial investigating the use of simvastatin as an augmentation strategy in patients with TRD, if the results indicate that adjuvant simvastatin is efficacious in reducing depressive symptoms, it will deliver immediate clinical benefit.Declaration of interestI.B.C. and N.H. have given lectures and advice to Eli Lilly, Bristol Myers Squibb, Lundbeck, Astra Zeneca and Janssen pharmaceuticals for which they or their employing institution have been reimbursed. R.R. and M.M.H. have received educational grants and support for academic meetings from Pfizer, Roche, Novartis and Nabiqasim. A.H.Y. has been commissioned to provide lectures and advice to all major pharmaceutical companies with drugs used in affective and related disorders. A.H.Y. has undertaken investigator-initiated studies from Astra Zeneca, Eli Lilly, Lundbeck and Wyeth. None of the companies have a financial interest in this research.

Project description:BACKGROUND:Recent scientific studies have suggested that climbing/bouldering is effective in alleviating depression when the comparison group was a waitlist control group, even when physical activity and other therapeutic approaches were controlled for. In the present study, we aimed to investigate the effectiveness of a manualised psychotherapeutic bouldering intervention for depressed individuals, compared with an active control group performing physical exercise alone. METHODS:In a multicentre randomised controlled intervention trial, 133 outpatients with depression were assigned to either a bouldering psychotherapy (BPT) group or a home-based supervised exercise programme (EP). Severity of depression as the primary outcome was assessed at baseline and directly after a ten-week intervention period using the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary outcomes included anxiety, coping skills, self-esteem, body image, and interpersonal sensitivity. We applied t-tests to test for differences within the groups (t0 vs. t1) and between the BPT and the EP and a multiple regression analysis with the post-intervention MADRS score as the dependent variable. The robustness of estimates was investigated with a sensitivity analyses. RESULTS:Patients in the BPT group showed a significantly larger decrease in depression scores compared with the EP on the MADRS (drop of 8.4 vs. 3.0 points, p?=?.002, Cohen's d?=?0.55). In the confounder-adjusted regression analyses, group allocation was found to be the only significant predictor of the post-intervention MADRS score (??=?-?5.60, p?=?.001) besides the baseline MADRS score. Further significant differences in change scores between the BPT and the EP were found for anxiety (p?=?.046, d?=?0.35), body image (p?=?.018, d?=?0.42), and global self-esteem (p?=?.011, d?=?0.45). CONCLUSIONS:The study provides evidence that the manualised BPT is not only effective in alleviating depressive symptoms but even goes beyond the effect of mere physical exercise. Based on these findings, the BPT should be considered as a complementary therapeutic approach. TRIAL REGISTRATION:Trial identification number: ISRCTN12457760: Study KuS (Klettern und Stimmung - Climbing and Mood) combined boulder and psychotherapy against depression, registered retrospectively on July 26th, 2017.

Dataset Information

Tavistock Adult Depression Study (TADS): a randomised controlled trial of psychoanalytic psychotherapy for treatment-resistant/treatment-refractory forms of depression.

Publications

Tavistock Adult Depression Study (TADS): a randomised controlled trial of psychoanalytic psychotherapy for treatment-resistant/treatment-refractory forms of depression.

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