A randomized controlled trial of a psychoeducational group program for unipolar depression in adults in Norway (NCT00319540).
Ontology highlight
ABSTRACT:
SUBMITTER: Dalgard OS
PROVIDER: S-EPMC1538590 | biostudies-literature | 2006 Jun
REPOSITORIES: biostudies-literature
Publications
A randomized controlled trial of a psychoeducational group program for unipolar depression in adults in Norway (NCT00319540).
Clinical practice and epidemiology in mental health : CP & EMH 20060628
<h4>Background</h4>Coping with Depression Course (CWD) has shown to be effective in the treatment of depression. However, there are very few randomized controlled trials on unipolar depression in adults.<h4>Aims</h4>To test the effect of a modified CWD on unipolar depression in a randomized controlled trial design in adults.<h4>Methods</h4>Participants were recruited through mass media, tested by BDI and clinical interview, and randomized into intervention group (N = 81) and control group (N = 7 ...[more]
Similar Datasets
Project description:Major 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.We 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.If 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.This trial is registered under number 2015-A00249-40 (PURE clinical trial: NCT02501226 ) (June 30th, 2015).
| S-EPMC4650332 | biostudies-literature
Project description:This randomized controlled trial examined the impact of a psychoeducational group program on the mental well-being of unit-based nurse leaders, specifically nurse managers and assistant nurse managers. The program was developed around the themes of resilience, insight, self-compassion, and empowerment to fight burnout and enhance purposeful adaptive coping to reduce distress and improve mental wellbeing. The sample included 77 unit-based nurse leaders. Outcomes included post-traumatic growth, resilience, insight, self-compassion, empowerment, perceived stress, burnout, and job satisfaction. Paired samples t-tests and repeated measures ANOVA tests were conducted to compare outcomes at baseline to the follow-up timepoints of endpoint, one-month follow-up, three-month follow-up, and six-month follow-up. The intervention group participants showed significant improvement in post-traumatic growth between baseline and all follow-up timepoints compared to the waitlist control group. Among intervention group participants, there were also significant improvements in self-reflection and insight, self-compassion, psychological empowerment, and compassion satisfaction, as well as significant reductions in perceived stress, burnout, and secondary traumatic stress. This study extends existing evidence that this psychoeducational group program can be an effective intervention for improving and protecting mental wellbeing. Among nurse leaders, it can reduce stress and burnout and improve post-traumatic growth, self-reflection and insight, self-compassion, psychological empowerment, and compassion satisfaction.
| S-EPMC10252280 | biostudies-literature
Project description:BACKGROUND: Minor depression is almost twice as common in primary care (PC) as major depression. Despite the high prevalence, few evidence-based algorithms exist for managing patients with minor depression or patients presenting solely with distress. OBJECTIVES: The aim of this study was to test the effectiveness of a telephone-based close monitoring program to manage PC patients with minor depression or distress. DESIGN: Subjects were randomly assigned to either the control arm (usual care; UC) or the intervention arm (close monitoring; CM). We hypothesized that those randomized to CM would exhibit less depression and be less likely to have symptoms progress to the point of meeting diagnostic criteria. SUBJECTS: Overall, 223 PC subjects with minor depression or distress consented to participation in this trial. MEASUREMENTS: At baseline, subjects completed a telephone-based evaluation comprised of validated diagnostic assessments of depression and other MH disorders. Outcomes were assessed at six months utilizing this same battery. Chart reviews were conducted to track care received, such as prescribed antidepressants and MH and primary care visits. RESULTS: Subjects in the CM arm exhibited fewer psychiatric diagnoses than those in the UC arm (chi(2) = 4.04, 1 df, p = 0.04). In addition, the intervention group showed improved overall physical health (SF-12 PCS scores) (M = 45.1, SD = 11.8 versus M = 41.5, SD = 12.4) (chi(2) = 5.90, 1 df, p = .02). CONCLUSIONS: Those randomized to CM exhibited less MH problems at the conclusion of the trial, indicating that the close monitoring program is effective, feasible and valuable. The findings of this study will allow us to enhance clinical care and support the integration of mental health services and primary care.
| S-EPMC2518035 | biostudies-other
Project description:Studies show the effectiveness of group psychoeducation in reducing symptoms in people with depression. However, few controlled studies that have included aspects of personal care and healthy lifestyle (diet, physical exercise, sleep) together with cognitive-behavioral techniques in psychoeducation are proven to be effective.The objective of this study is to assess the effectiveness of a psychoeducational program, which includes aspects of personal care and healthy lifestyle, in patients with mild/moderate depression symptoms in Primary Care (PC).In a randomized, controlled trial, 246 participants over 20 years old with ICD-10 major depression were recruited through nurses/general practitioners at 12 urban Primary Care Centers (PCCs) in Barcelona. The intervention group (IG) (n=119) received a group psychoeducational program (12 weekly, 1.5 h sessions led by two nurses) and the control group (CG) (n=112) received usual care. Patients were assessed at baseline and at, 3, 6 and 9 months. The main outcome measures were the BDI, EQ-5D and remission based upon the BDI.231 randomized patients were included, of whom 85 had mild depression and 146 moderate depression. The analyses showed significant differences between groups in relation to remission of symptoms, especially in the mild depression group with a high rate of 57% (p=0.009) at post-treatment and 65% (p=0.006) at 9 month follow up, and only showed significant differences on the BDI at post-treatment (p=0.016; effect size Cohen's d'=.51) and at 6 and 9 month follow-up (p= 0.048; d'=.44).In the overall and moderate sample, the analyses only showed significant differences between groups on the BDI at post-treatment, p=0.02 (d'=.29) and p=0.010 (d'=.47), respectively.The psychoeducation group improved significantly on the EQ-5D at short and long-term.This psychoeducational intervention is a short and long-term effective treatment for patients with mild depression symptoms. It results in a high remission rate, is recommended in PC and can be carried out by nurses with previous training. In moderate patients, group psychoeducation is effective in the short-term.Clinical Trials.gov identifier NCT00841737.
| S-EPMC3551665 | biostudies-literature
Project description:The N-methyl-D-aspartate (NMDA) receptor antagonist ketamine is associated with rapid but transient antidepressant effects in patients with treatment resistant unipolar depression (TRD). Based on work suggesting that ketamine and lithium may share overlapping mechanisms of action, we tested lithium compared to placebo as a continuation strategy following ketamine in subjects with TRD. Participants who met all eligibility criteria and showed at least an initial partial response to a single intravenous infusion of ketamine 0.5?mg/kg were randomized under double-blind conditions to lithium or matching placebo before receiving an additional three infusions of ketamine. Subsequent to the ketamine treatments, participants remained on lithium or placebo during a double-blind continuation phase. The primary study outcome was depression severity as measured by the Montgomery-Åsberg Depression Rating Scale compared between the two groups at Study Day 28, which occurred ~2 weeks following the final ketamine of four infusions. Forty-seven participants with TRD were enrolled in the study and underwent an initial ketamine infusion, of whom 34 participants were deemed to have at least a partial antidepressant response and were eligible for randomization. Comparison between treatment with daily oral lithium (n?=?18) or matching placebo (n?=?16) at the primary outcome showed no difference in depression severity between groups (t32?=?0.11, p?=?0.91, 95% CI [-7.87, 8.76]). There was no difference between lithium and placebo in continuing the acute antidepressant response to ketamine. The identification of a safe and effective strategy for preventing depression relapse following an acute course of ketamine treatment remains an important goal for future studies.
| S-EPMC6784998 | biostudies-literature
Project description:Although several face-to-face programs are dedicated to informal caregivers of persons with dementia, they are not always accessible to overburdened or isolated caregivers. Based on a face-to-face intervention program, we adapted and designed a Web-based fully automated psychoeducational program (called Diapason) inspired by a cognitive approach.This study aimed to evaluate through a pilot unblinded randomized controlled trial the efficacy and acceptability of a Web-based psychoeducational program for informal caregivers of persons with Alzheimer's disease (PWAD) based on a mixed methods research design.We recruited and randomized offline 49 informal caregivers of a PWAD in a day care center in Paris, France. They either received the Web-based intervention and usual care for 3 months (experimental group, n=25) or only usual care (control group, n=24). Caregivers' perceived stress (PSS-14, primary outcome), self-efficacy, burden, perceived health status, and depression (secondary outcomes) were measured during 3 face-to-face on-site visits: at baseline, at the end of the program (month 3), and after follow-up (month 6). Additionally, semistructured interviews were conducted with experimental group caregivers at month 6 and examined with thematic analysis.Intention-to-treat analysis did not show significant differences in self-perceived stress between the experimental and control groups (P=.98). The experimental group significantly improved their knowledge of the illness (d=.79, P=.008) from baseline to month 3. Of the 25 participants allocated to the experimental group, 17 (71%) finished the protocol and entirely viewed at least 10 of 12 online sessions. On average, participants used the website 19.72 times (SD 12.88) and were connected for 262.20 minutes (SD 270.74). The results of the satisfaction questionnaire showed that most participants considered the program to be useful (95%, 19/20), clear (100%, 20/20), and comprehensive (85%, 17/20). Significant correlations were found between relationship and caregivers' program opinion (P=.01). Thus, positive opinions were provided by husbands and sons (3/3), whereas qualified opinions were primarily reported by daughters (8/11). Female spouses expressed negative (2/3) or neutral opinions (1/3). Caregivers expected more dynamic content and further interaction with staff and peers.In this study, quantitative results were inconclusive owing to small sample size. Qualitative results indicated/showed little acceptance of the program and high expectations from caregivers. Caregivers did not rule out their interest in this kind of intervention provided that it met their needs. More dynamic, personalized, and social interventions are desirable. Our recruitment issues pointed out the necessity of in-depth studies about caregivers' help-seeking behaviors and readiness factors.Clinicaltrials.gov NCT01430286; http://clinicaltrials.gov/ct2/show/NCT01430286 (Archived by WebCite at http://www.webcitation/6KxHaRspL).
| S-EPMC4468784 | biostudies-literature
Project description:BackgroundSuicide prevention after a recent suicide attempt remains a major issue for clinicians. Indeed, these patients are at risk of new attempts and also less prone to interact with mental health services. As psychoeducation-based interventions are strongly recommended for patients with severe or chronic disorders and poor adherence, we developed the first French program of suicide psychoeducation (PEPSUI).MethodsWe started a large multicenter randomized controlled trial in outpatients who attempted suicide in the last year (i.e., current suicidal behavior disorder) to assess the feasibility, acceptability, and effectiveness of a 10-week psychoeducational program (PEPSUI group: scientific information on suicidal behavior, and third-wave cognitive behavioral therapies) compared with a 10-week relaxation program (control condition), in a naturalistic setting. Here, we present the qualitative part of this study. Participants in both groups completed a narrative interview with questions on their general impressions about the therapy process and outcomes, specific areas of change in their life since inclusion, and knowledge and perceptions about suicide and mental health services. Interviews were audiotaped, transcribed, and coded using inductive and deductive thematic analysis with a constant comparative approach. Participants were consecutively included until data saturation.ResultsThe interviews of 18 patients (n=10 in the PEPSUI group, and n=8 in the relaxation group) were analyzed. Qualitative analyses revealed some common points, and many differences between groups that are relevant for suicide prevention. Patients in both groups were satisfied with the programs. Group modality and therapeutic alliance with the instructors were considered useful in both groups. Participation was related to improved perception of mental health units (particularly in the PEPSUI group). Both groups reported the acquisition of stress management skills and distress tolerance. Relaxation was an easy way to survive stress. Conversely, the PEPSUI program had deeper implications for daily life through effective positioning towards internal events (thoughts and emotions) as a consequence of mindfulness-derived practices, enhancement of value-based commitments, improvement of the meaning in life and internal locus of control, increased contact with the present moment, use of a matrix (a decision-making tool), and acquisition of scientific knowledge on suicidal behavior.ConclusionThrough specific processes for targeting suicidal risk and reducing the stigma, the PEPSUI program may represent a promising intervention for suicide prevention.
| S-EPMC7561374 | biostudies-literature
Project description:The goal of this study is to evaluate feasibility and estimate effect sizes of omega-3 fatty acids (?3), individual-family psychoeducational psychotherapy (PEP), their combination, and moderating effects of maternal depression and psychosocial stressors in youth with depression. In a pilot 2 × 2 randomized controlled trial, 72 youth (ages 7-14; 57% Caucasian, 57% male) with major depression, dysthymia, or depression not otherwise specified were randomized to 12 weeks of ?3, PEP+placebo, ?3+PEP, or placebo. ?3 versus placebo was double-masked. Evaluators masked to condition assessed depressive severity at baseline (randomization) and at 2, 4, 6, 9, and 12 weeks using the Children's Depression Rating Scale-Revised. Side effects were either absent or mild. PEP was administered with 74% fidelity. Remission was 77%, ?3+PEP; 61%, PEP+placebo; 44%, ?3; 56%, placebo. Intent-to-treat analyses found small to medium effects of combined treatment (d = .29) and ?3 monotherapy (d = .42), but negligible effect for PEP+placebo (d < .10), all compared to placebo alone. Relative to placebo, youth with fewer social stressors responded better to ?3 (p = .04), PEP (p = .028), and their combination (p = .035), and those with maternal depression responded better to PEP (p = .020) than did those without maternal depression. Remission rates were favorable compared to other studies of psychotherapy and comparable to an existing randomized controlled trial of ?3; results warrant further evaluation in a larger sample. ?3 was well tolerated. Active treatments show significantly more placebo-controlled depression improvement in the context of maternal depression and fewer stressors, suggesting that they may benefit depression with a more endogenous than environmental origin.
| S-EPMC6066443 | biostudies-literature
Project description:Postpartum depression is a disease with a prevalence of 20% that has deleterious consequences not only for the mother but also for the baby and can cause delays in physical, social and cognitive development. In this context, the European Union Committee on Public Health has declared it essential that preventative measures are taken by centres providing care for women with a multidisciplinary approach. PROGEA is a multicentre, single-blind randomized, 3-year, longitudinal clinical trial aiming to evaluate the efficacy of a psychoeducational programme in preventing postpartum depression in at-risk women, based on a range of clinical variables, and explore prognostic factors. This paper describes the methods and rationale behind the study.We will study women receiving treatment as usual plus a psychoeducation cognitive behavioural therapy (CBT)-based intervention and a control group receiving only treatment as usual. The sample will be recruited from an incidental sampling of pregnant women in two health regions. We will recruit 600 women in the third trimester of pregnancy who consent to take part in the study. Almost half of the women, about 280, would be expected to have some risk factors for postpartum depression. All those found to have risk factors will be evaluated, and we estimate that a quarter will be classified as at-risk of developing postpartum depression as measured with the Edinburgh Postnatal Depression Scale. This subset will be randomly allocated to receive treatment as usual with or without the CBT intervention. Six sessions of CBT (1 individual and 5 group) will be offered by a psychologist.Findings from this study will be used to design a definitive study that will examine the clinical and cost-effectiveness of the CBT-based intervention in improving the mood of women in the postpartum period.ClinicalTrials.gov Identifier: NCT02323152 ; Date: December 2014.
| S-EPMC5237273 | biostudies-literature
Project description:OBJECTIVE:We sought to test our a priori hypothesis that depressed patients with diabetes in practices implementing a depression management program would have a decreased risk of mortality compared with depressed patients with diabetes in usual-care practices. RESEARCH DESIGN AND METHODS:We used data from the multisite, practice-randomized, controlled Prevention of Suicide in Primary Care Elderly: Collaborative Trial (PROSPECT), with patient recruitment from May 1999 to August 2001, supplemented with a search of the National Death Index. Twenty primary care practices participated from the greater metropolitan areas of New York City, New York; Philadelphia, Pennsylvania; and Pittsburgh, Pennsylvania. In all, 584 participants identified though a two-stage, age-stratified (aged 60-74 or >or=75 years) depression screening of randomly sampled patients and classified as depressed with complete information on diabetes status are included in these analyses. Of the 584 participants, 123 (21.2%) reported a history of diabetes. A depression care manager worked with primary care physicians to provide algorithm-based care. Vital status was assessed at 5 years. RESULTS:After a median follow-up of 52.0 months, 110 depressed patients had died. Depressed patients with diabetes in the intervention category were less likely to have died during the 5-year follow-up interval than depressed diabetic patients in usual care after accounting for baseline differences among patients (adjusted hazard ratio 0.49 [95% CI 0.24-0.98]). CONCLUSIONS:Older depressed primary care patients with diabetes in practices implementing depression care management were less likely to die over the course of a 5-year interval than depressed patients with diabetes in usual-care practices.
| S-EPMC2803110 | biostudies-literature