Dataset Information

Efficacy of a dilemma-focused intervention for unipolar depression: study protocol for a multicenter randomized controlled trial.

ABSTRACT:

Background

Depression is one of the more severe and serious health problems because of its morbidity, disabling effects and for its societal and economic burden. Despite the variety of existing pharmacological and psychological treatments, most of the cases evolve with only partial remission, relapse and recurrence.Cognitive models have contributed significantly to the understanding of unipolar depression and its psychological treatment. However, success is only partial and many authors affirm the need to improve those models and also the treatment programs derived from them. One of the issues that requires further elaboration is the difficulty these patients experience in responding to treatment and in maintaining therapeutic gains across time without relapse or recurrence. Our research group has been working on the notion of cognitive conflict viewed as personal dilemmas according to personal construct theory. We use a novel method for identifying those conflicts using the repertory grid technique (RGT). Preliminary results with depressive patients show that about 90% of them have one or more of those conflicts. This fact might explain the blockage and the difficult progress of these patients, especially the more severe and/or chronic. These results justify the need for specific interventions focused on the resolution of these internal conflicts. This study aims to empirically test the hypothesis that an intervention focused on the dilemma(s) specifically detected for each patient will enhance the efficacy of cognitive behavioral therapy (CBT) for depression.

Design

A therapy manual for a dilemma-focused intervention will be tested using a randomized clinical trial by comparing the outcome of two treatment conditions: combined group CBT (eight, 2-hour weekly sessions) plus individual dilemma-focused therapy (eight, 1-hour weekly sessions) and CBT alone (eight, 2-hour group weekly sessions plus eight, 1-hour individual weekly sessions).

Method

Participants are patients aged over 18 years meeting diagnostic criteria for major depressive disorder or dysthymic disorder, with a score of 19 or above on the Beck depression inventory, second edition (BDI-II) and presenting at least one cognitive conflict (implicative dilemma or dilemmatic construct) as assessed using the RGT. The BDI-II is the primary outcome measure, collected at baseline, at the end of therapy, and at 3- and 12-month follow-up; other secondary measures are also used.

Discussion

We expect that adding a dilemma-focused intervention to CBT will increase the efficacy of one of the more prestigious therapies for depression, thus resulting in a significant contribution to the psychological treatment of depression.

Trial registration

ISRCTN92443999; ClinicalTrials.gov Identifier: NCT01542957.

SUBMITTER: Feixas G

PROVIDER: S-EPMC3659066 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature

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Publications

Efficacy of a dilemma-focused intervention for unipolar depression: study protocol for a multicenter randomized controlled trial.

Feixas Guillem G Bados Arturo A García-Grau Eugeni E Montesano Adrián A Dada Gloria G Compañ Victoria V Aguilera Mari M Salla Marta M Soldevilla Joan Miquel JM Trujillo Adriana A Paz Clara C Botella Lluís L Corbella Sergi S Saúl-Gutiérrez Luis Angel LA Cañete José J Gasol Miquel M Ibarra Montserrat M Medeiros-Ferreira Leticia L Soriano José J Ribeiro Eugénia E Caspar Franz F Winter David D

Trials 20130517

<h4>Background</h4>Depression is one of the more severe and serious health problems because of its morbidity, disabling effects and for its societal and economic burden. Despite the variety of existing pharmacological and psychological treatments, most of the cases evolve with only partial remission, relapse and recurrence.Cognitive models have contributed significantly to the understanding of unipolar depression and its psychological treatment. However, success is only partial and many authors ...[more]

PMID: 23683841

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Project description:BackgroundMajor Depressive Disorder (MDD) is highly prevalent and was associated with greater morbidity, mortality (including suicide), and healthcare costs. By 2030, MDD will become the leading cause of disability in high-income countries. Notably, among patients with a previous experience of a major depressive episode, it was indeed estimated that up to 85 % of those patients will suffer from relapse. Two main factors were associated with a significantly higher risk of relapse: poor medication adherence and low self-efficacy in disease management. Interestingly, these issues could become the targets of psychoeducational programs for chronic diseases. Indded psychoeducational program for depression are recommended in international guidelines, but have not yet been proposed in France.Methods/designWe propose to evaluate the first French psychoeducational program for depression "ENVIE" in a multicenter randomized controlled trial. The group intervention will include 9 weekly sessions. Its aim is to educate patients on the latest knowledge on depression and effective treatments through didactic and interactive sessions. Patients will experiment the latest innovating psychological skills (from acceptance and commitment therapy) to cope with depressive symptoms and maintain motivation in behavioral activation. In total, 332 unipolar non-chronic (<2 years) outpatients with moderate to severe depression, without psychotic features, will be randomly allocated to the add-on ENVIE program (N = 166) or to a waiting list (N = 166). The follow-up will last 15 months and include 5 assessment visits. The primary endpoint will be the remission rate of the index episode at 15 months post-inclusion, defined by a Montgomery and Asberg Depression Rating Scale (MADRS) score ≤ 12 over an 8-week period, and without relapse during follow-up. We will also assess the response rate and relapse at 15 months post-inclusion, hospitalization rate and adherence to treatment during the follow-up period, quality of life and global functioning upon inclusion and at 9 and 15 months post inclusion.DiscussionIf the proposed trial shows the effectiveness of the intervention, but also an increased remission rate in depressed outpatients at 15-months post-inclusion, in addition to improved treatment adherence in patients, it will further promotes arguments in favor of a wide dissemination of psychoeducational programs for depression.Trial registrationThis trial is registered under number 2015-A00249-40 (PURE clinical trial: NCT02501226 ) (June 30th, 2015).

Project description:BACKGROUND:Cognitive behavioural therapy (CBT) is aimed to counteract cognitions and behaviours that are considered as dysfunctional. The aim of the study is to test whether the inclusion of a non-counteractive approach (dilemma-focused intervention, DFI) in combination with CBT group therapy will yield better short- and long-term outcomes than an intervention conducted entirely using CBT. METHOD:A total of 128 patients with depression and at least one cognitive conflict, of six health community centres in Barcelona, participated from November of 2011 to December of 2014 in seven weekly group CBT sessions and were then randomly allocated to either DFI or CBT (eight individual sessions each) by an independent researcher. Depressive symptoms were assessed with the Beck Depression Inventory-II at baseline, at the end of therapy and three- and twelve-month follow-ups. Therapists did not participate in any of the assessments nor in the randomisation of patients and evaluators were masked to group assignment. Both intention to treat and complete case analyses were performed using linear mixed models with random effects. FINDINGS:According to intention-to-treat analysis (F2, 179 = 0.69) and complete case analysis (F2, 146 = 0.88), both conditions similarly reduced the severity of symptoms across posttreatment assessments. For the 77 participants (CBTgroup +CBTindividual = 40; CBTgroup+DFIindividual = 37) that completed allocated treatment and one-year follow-up assessment, response and remission rates were relative higher for the DFI condition, however no significant differences were found between treatment conditions. The relapse rates were similar between treatment conditions (CBTgroup +CBTindividual = 7/20; CBTgroup+DFIindividual = 8/22). INTERPRETATION:Although using a counteractive approach across all the treatment sessions is quite effective, it does not seem to be necessary to produce significant improvement. DFI may be considered as an alternative, which could be included in a wider treatment for depression. TRIAL REGISTRATION:ClinicalTrials.gov; ID: NCT01542957.

Project description:BackgroundProblematic and pathological gambling have been linked to depression. Despite a high demand for treatment and negative financial consequences, only a small fraction of problematic and pathological gamblers seek professional help. The existing treatment gap could be narrowed by providing low-threshold, anonymous internet-based interventions. The aim of the present study was to examine the acceptance and efficacy of an online-intervention for depression ("Deprexis") in a sample of problematic and pathological slot-machine gamblers. We hypothesized that the intervention group would show a greater reduction in both depressive and gambling-related symptoms compared to a wait-list control group.MethodA total of 140 individuals with self-reported gambling and mood problems were randomly allocated either to the intervention group or to a wait-list control group. After 8 weeks, all participants were invited for re-assessment. The Patient Health Questionnaire - 9 (PHQ-9) served as the primary outcome assessment. Problematic gambling was measured with the Pathological Gambling Adaptation of Yale-Brown Obsessive Compulsive Scale (PG-YBOCS) and the South Oaks Gambling Screen (SOGS). The trial is registered with the German Registry for Clinical Studies (DRKS00013888).ResultsITT analyses showed that the intervention led to a significant reduction in depressive symptoms as well as gambling-related symptoms compared to the control group, with moderate to strong effect sizes. PP analyses failed to yield significant results due to high rates of non-completion and limited statistical power. Moderator analyses indicated that Deprexis was particularly beneficial in reducing problematic gambling for those scoring high on baseline gambling-related symptoms and for those who gamble due to loneliness.DiscussionResults of the present study suggest that Deprexis might be a useful adjunct to traditional interventions for the treatment of problematic gambling. The potential of internet-based interventions that are more targeted at issues specific to gambling should be evaluated in future studies.Trial registrationGerman Registry for Clinical Studies DRKS00013888.

Project description:BackgroundAdolescent depression is a significant public health concern; however, access to effective mental health care is limited. Digital therapeutics (DTx) can improve access to evidence-based interventions; however, their efficacy in adolescents is sparsely documented.ObjectiveThis study aims to examine the efficacy of a mobile app DTx versus an active control as an adjunct treatment for adolescent depression symptoms.MethodsAn internet-based open-label randomized control trial was conducted nationwide with a partial crossover design, and 168 adolescents aged 13 to 21 years with symptoms of depression were recruited between November 2020 and September 2021. Participants were randomized (1:1) to the cognitive behavioral therapy-based treatment app (Spark) or to a psychoeducational control app (control), which they would use for a duration of 5 weeks. The primary outcome was a between-group (Spark vs control) difference in the change in depression symptoms from baseline to postintervention, as measured by the Patient Health Questionnaire-8 (PHQ-8) using a linear mixed-effects analysis. The PHQ-8 ranges from 0 to 24, with scores of 5 to 9 indicating mild depression symptoms, scores of 10 to 14 indicating moderate symptoms, scores of 15 to 19 indicating moderately severe symptoms, and scores of 20 to 24 indicating severe symptoms. A minimal clinically important difference (5-point reduction between baseline and postintervention) in the Spark arm and group differences in remission and treatment response rates based on the PHQ-8 at postintervention were also investigated.ResultsA total of 160 participants were randomized, 80 in the Spark arm (mean age 16.89, SD 2.5 y) and 80 in the control arm (mean age 16.79, SD 2.59 y). Data from 121 participants (Spark: n=63; control: n=58) with moderate to severe (PHQ-8≥10) symptoms at baseline were included in the primary analyses following a modified intention-to-treat principle. A linear mixed-effect analysis revealed a nonsignificant difference between the study arms in depression symptom change over the intervention period. The Spark arm met a minimal clinically important difference threshold (mean -5.08, 95% CI -6.72 to -3.42). The remission rate in the Spark arm was significantly higher than that in the control arm (11/63, 17% vs 2/58, 3%; χ21=6.2; P=.01; false discovery rate-adjusted P=.03). The treatment response rates were not significantly different between the study arms (P=.07; false discovery rate-adjusted P=.16). Post hoc analyses including participants with mild to severe (PHQ-8 score ≥5) symptoms at baseline revealed promising evidence that Spark is effective in those with mild to severe symptoms.ConclusionsThere is initial evidence that a self-guided, cognitive behavioral therapy-based DTx intervention may effectively treat mild to severe depression symptoms in adolescents. DTx may improve access to mental health care for adolescents or serve as an important adjunct to the standard of care.Trial registrationClinicalTrials.gov NCT04524598; https://clinicaltrials.gov/study/NCT04524598.

Project description:IntroductionPoststroke depression is a serious and common complication of stroke, especially the ischemic poststroke depression. Antidepressants are used in poststroke depression, and acupuncture may be an alternative approach. However, the efficacy and mechanism of acupuncture for poststroke depression has not been confirmed.Methods/designThis is a multicenter, central-randomized, single-blind, sham-controlled clinical trial. We will allocate 208 subjects aged between 40 and 80 years old, diagnosed with initial poststroke depression (PSD) within 6 months to 2 groups randomly in a ratio of 1:1. Patients in the experimental group will be treated with traditional acupuncture and placebo pills, whereas the others in the control group will be treated with sham-acupoints acupuncture and antidepressant (fluoxetine hydrochloride tablets). All will be given acupuncture and/or medication treatment for 12 weeks, and then received 12-week follow-up. Patients will be evaluated with the 17-item Hamilton Depression Scale and Se1f-rating Depression Scale for depression state, National Institute of Health Stroke Scale for neurological deficit, Modified Barthel Index for activities of daily living, Treatment Emergent Symptom Scale for side effects of treatments, diagnosis and evaluation criteria of traditional Chinese medicine for stroke (try out) for curative effects of stroke, and clinical global impression for synthesize effect before and the 2nd, 4th, 8th, and 12th week of treatment, 24th week of follow-up. Study on mechanisms of acupuncture will be revealed through the diversity of brain metabolites (choline-containing compounds [Cho], N-acetylaspartate [NAA], myoinositol, glutamine and glutamate complex, creatine [Cr], Cho/Cr, Cho/NAA, Cr/NAA) in bilateral dorsolateral prefrontal cortex and anterior cingulate cortex monitored by proton magnetic resonance spectroscopy, and serum monoamine neurotransmitters (5-hydroxytryptamine, norepinephrine, dopamine) and cytokines (brain-derived neurotrophic factor [BDNF], interleukin [IL]-4, IL-6, IL-10, IL-18, IL-1β, tumor necrosis factor alpha) before and the 12th week of treatment. Baseline characteristics of patients will be summarized by groups and compared with chi-square for categorical variables, and 2-sample t tests or Wilcoxon rank-sum test for the continuous variables. Primary and secondary outcomes according to the measurement times are applicable to univariate repetitive measurement deviation analysis or 2-sample t tests, or Wilcoxon rank-sum test.ConclusionThe present research is designed to investigate efficacy and mechanism of traditional acupuncture therapy on ischemic PSD, also to explore the correlation between cerebra metabolic and serologic factors, and ischemic PSD. With this research, we are looking forward to find out an appropriate alternative nondrug therapy for PSD people to alleviate the adverse effects and drug dependence caused by antidepressants.

Project description:BackgroundMalnutrition after hip fracture is associated with increased rehabilitation time, complications, and mortality. We assessed the effect of intensive 3 month nutritional intervention in elderly after hip fracture on length of stay (LOS).MethodsOpen-label, randomized controlled trial. Exclusion criteria: age < 55 years, bone disease, life expectancy < 1 year, bedridden, using oral nutritional supplements (ONS) before hospitalization, and cognitive impairment. Intervention: weekly dietetic consultation, energy-protein-enriched diet, and ONS (400 mL per day) for 3 months. Control: usual nutritional care. Primary outcome: total LOS in hospital and rehabilitation clinic, including readmissions over 6 months (Cox regression adjusted for confounders); hazard ratio (HR) < 1.0 reflects longer LOS in the intervention group. Secondary outcomes: nutritional and functional status, cognition, quality of life, postoperative complications (6 months); subsequent fractures and all-cause mortality (1 and 5 years). Effect modification by baseline nutritional status was also tested.ResultsOne hundred fifty-two patients were randomized (73 intervention, 79 control). Median total LOS was 34.0 days (range 4-185 days) in the intervention group versus control 35.5 days (3-183 days; plogrank = .80; adjusted hazard ratio (adjHR): 0.98; 95% CI: 0.68-1.41). Hospital LOS: 12.0 days (4-56 days) versus 11.0 days (3-115 days; p = .19; adjHR: 0.75; 95% CI: 0.53-1.06) and LOS in rehabilitation clinics: 19.5 days (0-174 days) versus 18.5 days (0-168 days; p = .82; adjHR: 1.04; 95% CI: 0.73-1.48). The intervention improved nutritional intake/status at 3, but not at 6 months, and did not affect any other outcome. No difference in intervention effect between malnourished and well-nourished patients was found.ConclusionsIntensive nutritional intervention after hip fracture improved nutritional intake and status, but not LOS or clinical outcomes. Paradigms underlying nutritional intervention in elderly after hip fracture may have to be reconsidered.

Project description:BackgroundDepression is a highly prevalent mental disorder with major public health effects globally. It impairs the quality of life and reduces the ability to work and function, leading to increasing costs of sick leaves and disability pensions. Current treatment strategies focus on biological and psychological pathways while understating the role of lifestyle factors. Epidemiological studies have shown convincing evidence of an inverse relationship between diet quality and depression. However, only limited data are available on the therapeutic effects of diet quality improvement on depression. Using a randomized controlled trial design, our primary aim is to investigate the effectiveness and cost-effectiveness of a behavioral nutrition group intervention compared to a social support intervention in the treatment of depression.MethodsParticipants (N=144, aged 20-65 years) with a diagnosis of moderate or severe depression recruited in collaboration with outpatient care units will be randomized into two arms: Food for Mind (FM) nutrition intervention (n=72) or Bring Good Mood (BGM) social support control group (n=72). Both arms will be provided with 6 group sessions over an 8-week period. FM involves improving diet quality by applying strength-based behavioral nutrition counseling and activities facilitated by a registered dietitian. The control arm comprises a befriending protocol. During the interventions, all participants will continue their treatment for depression as usual. Longitudinal data are collected at baseline, at 8 weeks, and at 6- and 12-month follow-ups. Depressive symptoms, diet quality, eating behavior, ability to work and function, and quality of life are assessed by self-reported questionnaires. A treatment expectancy questionnaire will be administered at baseline and an acceptability questionnaire at 8 weeks. The Center for Epidemiologic Studies Depression Scale is used as the primary endpoint at 1 year. The results will be analyzed with linear mixed-effects models. Economic evaluation includes both cost-effectiveness and cost-utility analysis. Two incremental cost-effectiveness ratios will be calculated to evaluate the incremental cost per QALY and the incremental cost per improvement in CES-D.DiscussionIf the intervention proves to be cost-effective and acceptable, it be can be implemented in healthcare to support the treatment of depression.Trial registrationClinicalTrials.gov NCT03904771 . Retrospectively registered on 5 April 2019.

Project description:BackgroundDepression is a debilitating and costly disease for our society, especially in the case of treatment-resistant depression (TRD). Repetitive transcranial magnetic stimulation (rTMS) is an effective adjuvant therapy in treatment-resistant unipolar and non-psychotic depression. It can be applied according to two therapeutic strategies after an initial rTMS cure: a further rTMS cure can be performed at the first sign of relapse or recurrence, or systematic maintenance rTMS (M-rTMS) can be proposed. TMS adjuvant to treatment as usual (TAU) could improve long-term prognosis. However, no controlled study has yet compared the cost-effectiveness of these two additional rTMS therapeutic strategies versus TAU alone.Methods/designThis paper focuses on the design of a health-economic, prospective, randomized, double-blind, multicenter study with three parallel arms carried out in France. This study assesses the cost-effectiveness of the adjunctive and maintenance low frequency rTMS on the right dorsolateral prefrontal cortex versus TAU alone. A total of 318 patients suffering from a current TRD will be enrolled. The primary endpoint is to investigate the incremental cost-effectiveness ratio (ICER) (ratio costs / quality-adjusted life-years [QALY] measured by the Euroqol Five Dimension Questionnaire) over 12 months in a population of patients assigned to one of three arms: systematic M-rTMS for responders (arm A); additional new rTMS cure in case of mood deterioration among responders (arm B); and a placebo arm (arm C) in which responders are allocated in two subgroups: sham systematic M-rTMS and supplementary rTMS course in case of mood deterioration. ICER and QALYs will be compared between arm A or B versus arm C. The secondary endpoints in each three arms will be: ICER at 24 months; the cost-utility ratio analysis at 12 and 24 months; 5-year budget impact analysis; and prognosis factors of rTMS. The following criteria will be compared between arm A or B and arm C: rates of responders; remission and disease-free survival; clinical evolution; tolerance; observance; treatment modifications; hospitalization; suicide attempts; work stoppage; marital / professional statues; and quality of life at 12 and 24 months.DiscussionThe purpose of our study is to check the cost-effectiveness of rTMS and we will discuss its economic impact over time. In the case of significant decrease in the depression costs and expenditures associated with a good long-term prognosis (sustained response and remission) and tolerance, rTMS could be considered as an efficient treatment within the armamentarium for resistant unipolar depression.Trial registrationClinicalTrials.gov, NCT03701724. Registered on 10 October 2018. Protocol Amendment Version 2.0 accepted on 29 June 2019.

Project description:BackgroundPost-stroke depression (PSD) is one of the most common neuropsychiatric diseases in patients with stroke, and it can increase the disability rate, mortality, and recurrence rate of stroke. Currently, many clinical studies have indicated that traditional Chinese medicine (TCM), such as acupuncture and herbs, Western medicine, rehabilitation, repeated transcranial magnetic stimulation, and other treatment methods, are effective in treating PSD. However, no study has formulated a comprehensive treatment plan that integrates TCM, Western medicine, and rehabilitation for PSD. Thus, this trial aims to assess the efficacy and safety of integrative medicine for treating PSD.MethodsThis multicenter, prospective, randomized, controlled study aims to form a set of effective clinical treatment schemes that integrate TCM, Western medicine, and rehabilitation for PSD. A total of 202 participants recruited from four centers will be randomized into either the integrative medicine or standard care group. Standard care-basic treatment, general nursing care, and exercise therapy-will be provided to all participants. The integrative medicine group will also receive acupuncture, Chinese herbs, and repeated transcranial magnetic stimulation (rTMS). Participants will receive acupuncture and rTMS treatments five times per week for 4 weeks and will be administered Chinese herbs, basic treatment, general nursing care, and exercise therapy for 4 weeks. The primary outcomes include the Hamilton Depression Scale (HAMD), Self-Rating Depression Scale (SDS), and Activity of Daily Living Scale (ADL). And the secondary outcomes include the Montreal Cognitive Assessment Scale, the Fugl-Meyer Assessment (FMA) Scale, and the Pittsburgh Sleep Quality Index (PSQI). All outcome measures will be evaluated at baseline, week 4 (the end of the treatment courses), and week 8 (the end of follow-up). Safety assessments will be performed throughout the study.DiscussionThis study is expected to verify the efficacy and safety of integrative medicine for treating PSD, providing an evidence-based clinical reference for the future development of a standardized scheme.Clinical trial registrationClinicalTrials.gov, identifier: NCT05187975.

Dataset Information

Efficacy of a dilemma-focused intervention for unipolar depression: study protocol for a multicenter randomized controlled trial.

Background

Design

Method

Discussion

Trial registration

Publications

Efficacy of a dilemma-focused intervention for unipolar depression: study protocol for a multicenter randomized controlled trial.

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