Dataset Information

Effectiveness of Schema Therapy versus Cognitive Behavioral Therapy versus Supportive Therapy for Depression in Inpatient and Day Clinic Settings: A Randomized Clinical Trial.

ABSTRACT:

Introduction

Schema therapy (ST) reduces depressive symptoms, but clinical trials have not investigated its effectiveness for patients suffering from severe forms of depression and high rates of comorbidities. There is high demand for exploring and improving treatments for this patient group. The objective of the current study was to evaluate whether ST is more effective than individual supportive therapy (IST) and noninferior compared with cognitive behavioral therapy (CBT) in treating depression.

Methods

For this clinical trial, medicated patients were recruited in inpatient and day clinic settings. The major inclusion criteria were age between 18 and 75 years and primary diagnosis of depression without psychotic symptoms. A total of 292 participants were randomized to ST, CBT, or IST and received 7 weeks of psychotherapy (up to 14 individual and 14 group sessions). The primary outcome was change in depression severity after treatment measured by Beck Depression Inventory-II. Primary test for efficacy was superiority of ST over IST. Secondary test was noninferiority of ST compared with CBT. Multilevel modeling was conducted. The results at 6-month follow-up were explored.

Results

Across treatment, ST was not superior to IST. Secondary outcome analyses and completer analyses showed similar results. However, ST showed clinically relevant noninferiority compared with CBT.

Conclusion

ST for depression as part of a psychiatric care program showed clinical noninferiority compared to CBT, without being superior to IST. ST represents a potentially useful addition to the therapeutic repertoire for the treatment of depression but its efficacy, including long-term efficacy, should be evaluated further.

SUBMITTER: Kopf-Beck J

PROVIDER: S-EPMC10880804 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of Schema Therapy versus Cognitive Behavioral Therapy versus Supportive Therapy for Depression in Inpatient and Day Clinic Settings: A Randomized Clinical Trial.

Kopf-Beck Johannes J Müller Celina L CL Tamm Jeanette J Fietz Julia J Rek Nils N Just Leah L Spock Zoe Ilona ZI Weweck Katharina K Takano Keisuke K Rein Martin M Keck Martin E ME Egli Samy S

Psychotherapy and psychosomatics 20240104 1

<h4>Introduction</h4>Schema therapy (ST) reduces depressive symptoms, but clinical trials have not investigated its effectiveness for patients suffering from severe forms of depression and high rates of comorbidities. There is high demand for exploring and improving treatments for this patient group. The objective of the current study was to evaluate whether ST is more effective than individual supportive therapy (IST) and noninferior compared with cognitive behavioral therapy (CBT) in treating ...[more]

PMID: 38176391

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Project description:BackgroundMajor depressive disorder represents (MDD) a major cause of disability and disease burden. Beside antidepressant medication, psychotherapy is a key approach of treatment. Schema therapy has been shown to be effective in the treatment of psychiatric disorders, especially personality disorders, in a variety of settings and patient groups. Nevertheless, there is no evidence on its effectiveness for MDD in an inpatient nor day clinic setting and little is known about the factors that drive treatment response in such a target group.MethodsIn the current protocol, we outline OPTIMA (OPtimized Treatment Identification at the MAx Planck Institute): a single-center randomized controlled trial of schema therapy as a treatment approach for MDD in an inpatient and day clinic setting. Over the course of 7 weeks, we compare schema therapy with cognitive behavioral therapy and individual supportive therapy, conducted in individual and group sessions and with no restrictions regarding concurrent antidepressant medication, thus approximating real-life treatment conditions. N = 300 depressed patients are included. All study therapists undergo a specific training and supervision and therapy adherence is assessed. Primary outcome is depressive symptom severity as self-assessment (Beck Depression Inventory-II) and secondary outcomes are clinical ratings of MDD (Montgomery-Asberg Depression Rating Scale), recovery rates after 7 weeks according to the Munich-Composite International Diagnostic Interview, general psychopathology (Brief Symptom Inventory), global functioning (World Health Organization Disability Assessment Schedule), and clinical parameters such as dropout rates. Further parameters on a behavioral, cognitive, psychophysiological, and biological level are measured before, during and after treatment and in 2 follow-up assessments after 6 and 24 months after end of treatment.DiscussionTo our knowledge, the OPTIMA-Trial is the first to investigate the effectiveness of schema therapy as a treatment approach of MDD, to investigate mechanisms of change, and explore predictors of treatment response in an inpatient and day clinic setting by using such a wide range of parameters. Insights from OPTIMA will allow more integrative approaches of psychotherapy of MDD. Especially, the identification of intervention-specific markers of treatment response can improve evidence-based clinical decision for individualizing treatment.Trial registrationIdentifier on clinicaltrials.gov : NCT03287362 ; September, 12, 2017.

Project description:BackgroundThe past few decades saw considerable advances in research and dissemination of evidence-based psychotherapies, yet available treatment resources are not able to meet the high need for care for individuals suffering from depression or anxiety. Blended care psychotherapy, which combines the strengths of therapist-led and internet interventions, can narrow this gap and be clinically effective and efficient, but has rarely been evaluated outside of controlled research settings.ObjectiveThis study evaluated the effectiveness of a blended care intervention (video-based cognitive behavior therapy and internet intervention) under real-world conditions.MethodsThis is a pragmatic retrospective cohort analysis of 385 participants with clinical range depression and/or anxiety symptoms at baseline, measured using Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7), who enrolled in blended care psychotherapy treatment. Participants resided in the United States and had access to the blended care intervention as a mental health benefit offered through their employers. Levels of depression and anxiety were tracked throughout treatment. Hierarchical linear modeling was used to examine the change in symptoms over time. The effects of age, gender, and providers on participants' symptom change trajectories were also evaluated. Paired sample t-tests were also conducted, and rates of positive clinical change and clinically significant improvement were calculated.ResultsThe average depression and anxiety symptoms at 6 weeks after the start of treatment were 5.94 and 6.57, respectively. There were significant linear effects of time on both symptoms of depression and anxiety (β=-.49, P<.001 and β=-.64, P<.001). The quadratic effect was also significant for both symptoms of depression and anxiety (β=.04, P<.001 for both), suggesting a decelerated decrease in symptoms over time. Approximately 73% (n=283) of all 385 participants demonstrated reliable improvement, and 83% (n=319) recovered on either the PHQ-9 or GAD-7 measures. Large effect sizes were observed on both symptoms of depression (Cohen d=1.08) and of anxiety (d=1.33).ConclusionsVideo blended care cognitive behavioral therapy interventions can be effective and efficient in treating symptoms of depression and anxiety in real-world conditions. Future research should investigate the differential and interactive contribution of the therapist-led and digital components of care to patient outcomes to optimize care.

Project description:BACKGROUND:Major depression is a world-wide problem that can be treated with various forms of psychotherapy. There is strong research support for treating major depression using cognitive behavior therapy delivered in the format of guided self-help via the Internet (ICBT). Recent research also suggests that psychodynamic psychotherapy can be delivered as guided self-help via the Internet (IPDT) and that it seem to be as effective as ICBT for mild to moderate depression. However, no head-to-head comparison between the two treatments exists. In the field of Internet interventions it is largely unexplored if treatment preference affects outcome and adherence. METHODS:Participants were allocated to IPDT or ICBT based on their stated preference. More than half of the participants preferred ICBT (N = 30) over IPDT (N = 14). Differences in efficacy between treatments were explored. Correlations between strength of preference and treatment outcome, adherence to treatment and completion of the whole treatment program were explored. Data were collected before and after treatment, as well as in a 7-month follow-up. RESULTS:During the treatment period, both programs performed equally well in reducing symptoms. More participants who received IPDT completed the entire program. At follow-up, mixed-effects models showed that participants who chose ICBT improved more in terms of quality of life. The ICBT group also had a significant increase in participants who recovered from their depression from post-treatment to follow-up. Exploratory analyses indicated that strength of preference was correlated with adherence to treatment and completion of the whole program, and long-term outcome for the ICBT group. CONCLUSIONS:Few differences were found during the acute treatment phase, but the long-term effects are in favor of ICBT. Strength of preference for treatment seems to have a predictive value. Further research comparing the efficacy of ICBT and IPDT, and the effects of preference matching and strength of preference, is warranted. TRIAL REGISTRATION:This trial is a continuation of the study registered as NCT01324050 at Clinicaltrials.gov.

Project description:BackgroundGeriatric rehabilitation is a multidisciplinary intervention that promotes functional recovery in older adults. Our objective was to assess the efficacy of geriatric rehabilitation in inpatient and geriatric day hospital settings.MethodsWe searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, PsycINFO, PEDro and AgeLine from inception to September 30, 2022 for randomized controlled trials (RCTs) including older adults (age ≥ 65 years) undergoing geriatric rehabilitation (inpatient or day hospital) with a usual care comparator group. Primary outcome measures included mortality, long-term care home (LTCH) admission, and functional status. Secondary outcomes included discharge/remaining at home, functional improvement, length of stay, cognition, mood, and quality of life. Records were screened, abstracted and assessed for risk of bias (Cochrane Risk of Bias [RoB] 2) by two reviewers independently. We conducted a random effects meta-analysis to summarize risk ratios (RR, dichotomous outcomes) and standardized mean differences (SMD, continuous outcomes).ResultsOf the 5304 records screened, 29 studies (7999 patients) met eligibility criteria. There were 23 RCTs of inpatient geriatric rehabilitation (6428 patients) and six of geriatric day hospital (1571 patients) reporting outcomes of mortality (26 studies), LTCH admission (22 studies), functional status (19 studies), length of stay (18 studies), cognition (5 studies), mood (5 studies) and quality of life (6 studies). The primary outcome of mortality at longest follow up was lower in the rehabilitation group (RR 0.84, 95% confidence interval [CI] 0.76 to 0.93, I2 = 0%). LTCH admission was lower in the rehabilitation group at longest follow up (RR 0.86, 95% CI 0.75 to 0.98, I2 = 8%). Functional status was better in the rehabilitation group at longest follow up (SMD 0.09, 95% CI 0.02 to 0.16, I2 = 24%). Cognition was improved in the rehabilitation group (mean difference of mini-mental status exam score 0.97, 95% CI 0.35 to 1.60, I2 = 0%). No difference was found for patient length of stay, mood, or quality of life.ConclusionsGeriatric rehabilitation in inpatient and day hospital settings reduced mortality, LTCH admission, and functional impairment. Future studies should explore implementation of this intervention for older adults.Review registrationPROSPERO: CRD42022345078.

Project description:BackgroundAbout one third of patients with depression are in a condition that can be termed as "difficult-to-treat". Some evidence suggests that difficult-to-treat depression is associated with a higher frequency of childhood trauma and comorbid personality disorders or accentuated features. However, the condition is understudied, and the effects of psychotherapy for difficult-to-treat depression are currently uncertain. The aim of this trial is to investigate the beneficial and harmful effects of 30 sessions of individual schema therapy versus treatment as usual for difficult-to-treat depression in the Danish secondary, public mental health sector.MethodsIn this randomized, multi-centre, parallel-group, superiority clinical trial, 129 outpatients with difficult-to-treat depression will be randomized (1:1) to 30 sessions of individual schema therapy or treatment as usual; in this context mainly group-based, short-term cognitive behaviour or psychodynamic therapy. The primary outcome is the change from baseline in depressive symptoms 12 months after randomization, measured on the observer-rated 6-item Hamilton Rating Scale for Depression. The secondary outcomes are health-related quality of life assessed with the European Quality of Life 5 Dimensions 5 Level Version, functional impairment assessed with the Work and Social Adjustment Scale, psychological wellbeing assessed with the WHO-5 Well-being Index, and negative effects of treatment assessed with the Negative Effects Questionnaire. Exploratory outcomes are improvement on patient self-defined outcomes, personal recovery, anxiety symptoms, anger reactions, metacognitive beliefs about anger, and perseverative negative thinking. Outcomes will be assessed at 6, 12, and 24 months after randomization; the 12-month time-point being the primary time-point of interest. Outcome assessors performing the depression-rating, data managers, statisticians, the data safety and monitoring committee, and conclusion makers for the outcome article will be blinded to treatment allocation and results. To assess cost-effectiveness of the intervention, a health economic analysis will be performed.DiscussionThis trial will provide evidence on the beneficial and harmful effects, as well as the cost-effectiveness of schema therapy versus treatment as usual for outpatients with difficult-to-treat depression. The results can potentially improve treatment for a large and understudied patient group.Trial registrationClinicalTrials.gov NCT05833087. Registered on 15th April 2023 (approved without prompts for revision on 27th April 2023).

Project description:BackgroundGiven the high prevalence of Cluster-C Personality Disorders (PDs) in clinical populations, disease burden, high societal costs and poor prognosis of comorbid disorders, a major gain in health care can be achieved if Cluster-C PDs are adequately treated. The only controlled cost-effectiveness study published so far found Individual Schema Therapy (IST) to be superior to Treatment as Usual (TAU). Group ST (GST) might improve cost-effectiveness as larger numbers can be treated in (>50%) less time compared to IST. However, to date there is no RCT supporting its (cost-) effectiveness. The overall aim of this study is to assess the evidence for GST for Cluster-C PDs and to improve treatment allocation for individual patients. Three main questions are addressed: 1) Is GST for Cluster-C PDs (cost-)effective compared to TAU? 2) Is GST for Cluster-C PDs (cost-) effective compared to IST? 3) Which patient-characteristics predict better response to GST, IST, or TAU?MethodsIn a multicenter RCT, the treatment conditions GST, IST, and TAU are compared in 378 Cluster-C PD patients within 10 sites. GST and IST follow treatment protocols and are completed within 1 year. TAU is the optimal alternative treatment available at the site according to regular procedures. Severity of the Cluster-C PD is the primary outcome, assessed with clinical interviews by independent raters blind for treatment. Functioning and wellbeing are important secondary outcomes. Assessments take place at week 0 (baseline), 17 (mid-GST), 34 (post-GST), 51 (post-booster sessions of GST), and 2 years (FU). Patient characteristics predicting better response to a specific treatment are studied, e.g., childhood trauma, autistic features, and introversion. A tool supporting patients and clinicians in matching treatment to patient will be developed. An economic evaluation investigates the cost-effectiveness and cost-utility from a societal perspective. A process evaluation by qualitative methods explores experiences of participants, loved ones and therapists regarding recovery, quality of life, and improving treatment.DiscussionThis study will determine the (cost-)effectiveness of treatments for Cluster-C PDs regarding treatment type as well as optimal matching of patient to treatment and deliver insight into which aspects help Cluster-C-PD patients recover and create a fulfilling life.Trial registrationDutch Trial Register: NL9209 . Registered on 28-01-2021.

Dataset Information

Effectiveness of Schema Therapy versus Cognitive Behavioral Therapy versus Supportive Therapy for Depression in Inpatient and Day Clinic Settings: A Randomized Clinical Trial.

Introduction

Methods

Results

Conclusion

Publications

Effectiveness of Schema Therapy versus Cognitive Behavioral Therapy versus Supportive Therapy for Depression in Inpatient and Day Clinic Settings: A Randomized Clinical Trial.

Similar Datasets

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