A randomized controlled trial of the use of self-help materials in addition to standard general practice treatment of depression compared to standard treatment alone

2005 ◽  
Vol 36 (3) ◽  
pp. 325-333 ◽  
Author(s):  
PAUL SALKOVSKIS ◽  
KATHARINE RIMES ◽  
DEBORAH STEPHENSON ◽  
GERALD SACKS ◽  
JAN SCOTT
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Social Adjustment ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Control Group ◽  
Global Functioning ◽  
Randomized Controlled ◽  
Self Help ◽  
Treatment Of Depression

Background. The purpose of the study was to examine whether the addition of a brief individual self-help package to standard primary-care treatment of depression with antidepressants is associated with any additional improvements in clinical outcome.Method. Individuals with major depressive disorder who were prescribed an antidepressant were recruited through their general practitioner (GP) and allocated randomly to standard treatment alone or standard treatment plus self-help. Assessments of symptoms, social adjustment, global functioning, satisfaction with treatment and knowledge about the management of the disorder were completed at three time points over 26 weeks.Results. One hundred and twelve individuals agreed to participate and 96 met criteria for inclusion in the randomized controlled trial. Subjects in both treatment conditions improved substantially over the study period; the mean Beck Depression Inventory (BDI) score fell from 27·3 to 13·9 in the intention-to-treat analysis. There were no between group differences in outcome on any of the primary outcome measures, nor did these approach even marginal significance. Patients and GPs were highly satisfied with the self-help programme, and the intervention as compared to the control group reported significantly greater improvements in knowledge about depression and satisfaction with information received about depression.Conclusions. An individualized self-help package improved perceived knowledge about depression but did not have identifiable effects on outcome when offered to patients treated in primary care. The study was sufficiently well powered to detect relatively small effects.

scholarly journals Effectiveness of Supported Self-Help in Recurrent Depression: A Randomized Controlled Trial in Primary Care

2017 ◽  
Vol 86 (4) ◽  
pp. 220-230 ◽  
Author(s):  
Karolien E.M. Biesheuvel-Leliefeld ◽  
Sandra M.A. Dijkstra-Kersten ◽  
Digna J.F. van Schaik ◽  
Harm W.J. van Marwijk ◽  
Filip Smit ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Recurrent Depression ◽  
Randomized Controlled ◽  
Self Help

scholarly journals Team approach to polypharmacy evaluation and reduction: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Dee Mangin ◽  
Larkin Lamarche ◽  
Gina Agarwal ◽  
Hoan Linh Banh ◽  
Naomi Dore Brown ◽  
...  
Keyword(s):  
Older Adults ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Clinical Pathway ◽  
Controlled Trial ◽  
Primary Objective ◽  
Control Group ◽  
Team Approach ◽  
Potentially Inappropriate Medications ◽  
Randomized Controlled

Abstract Background Polypharmacy in older adults can be associated with negative outcomes including falls, impaired cognition, reduced quality of life, and general and functional decline. It is not clear to what extent these are reversible if the number of medications is reduced. Primary care does not have a systematic approach for reducing inappropriate polypharmacy, and there are few, if any, approaches that account for the patient’s priorities and preferences. The primary objective of this study is to test the effect of TAPER (Team Approach to Polypharmacy Evaluation and Reduction), a structured operationalized clinical pathway focused on reducing inappropriate polypharmacy. TAPER integrates evidence tools for identifying potentially inappropriate medications, tapering, and monitoring guidance and explicit elicitation of patient priorities and preferences. We aim to determine the effect of TAPER on the number of medications (primary outcome) and health-related outcomes associated with polypharmacy in older adults. Methods We designed a multi-center randomized controlled trial, with the lead implementation site in Hamilton, Ontario. Older adults aged 70 years or older who are on five or more medications will be eligible to participate. A total of 360 participants will be recruited. Participants will be assigned to either the control or intervention arm. The intervention involves a comprehensive multidisciplinary medication review by pharmacists and physicians in partnership with patients. This review will be focused on reducing medication burden, with the assumption that this will reduce the risks and harms of polypharmacy. The control group is a wait list, and control patients will be given appointments for the TAPER intervention at a date after the final outcome assessment. All patients will be followed up and outcomes measured in both groups at baseline and 6 months. Discussion Our trial is unique in its design in that it aims to introduce an operationalized structured clinical pathway aimed to reduce polypharmacy in a primary care setting while at the same time recording patient’s goals and priorities for treatment. Trial registration Clinical Trials.gov NCT02942927. First registered on October 24, 2016.

Reflective testing – A randomized controlled trial in primary care patients

2020 ◽  
pp. 000456322096837
Author(s):  
Wytze P Oosterhuis ◽  
Wilhelmine PHG Verboeket-van de Venne ◽  
Cees TBM van Deursen ◽  
Henri EJH Stoffers ◽  
Bernadette AC van Acker ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
General Practitioners ◽  
Medical Records ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Test Results ◽  
Randomized Controlled ◽  
Primary Care Patients

Background Reflective testing, i.e. interpreting, commenting on and, if necessary, adding tests in order to aid the diagnostic process in a meaningful and efficient manner, is an extra service provided by laboratory medicine. However, there have been no prospective randomized controlled trials investigating the value of reflective testing in patient management. Methods In this trial, primary care patients were randomly allocated to an intervention group, where general practitioners received laboratory tests results as requested as well as add-on test results with interpretative comments where considered appropriate by the laboratory specialist, or to a control group, where general practitioners only received the laboratory test results requested. Patients’ medical records were evaluated with a follow-up period of six months. For both groups, the primary outcome measures, i.e. both intended action and actual management action, were blindly assessed by an independent expert panel as adequate, neutral or inadequate. Results In 226 of the 270 cases (84%), reflective testing was considered to be useful for the patient. In the intervention group ( n = 148), actual management by the general practitioner was scored as adequate ( n = 104; 70%), neutral ( n = 29; 20%) or not adequate ( n = 15; 10%). In the control group ( n = 122), these numbers were 57 (47%), 37 (30%) and 28 (23%). This difference was statistically significant ( P < 0.001). Conclusion This randomized controlled trial showed a positive effect of reflective testing in primary care patients on the adequacy of their management, as documented in medical records.

scholarly journals Evaluation of the Effectiveness of a Psychoeducational Intervention in Treatment-Naïve Patients with Antidepressant Medication in Primary Care: A Randomized Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
R. Casañas ◽  
R. Catalán ◽  
R. Penadés ◽  
J. Real ◽  
S. Valero ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Antidepressant Medication ◽  
Psychoeducational Intervention ◽  
Control Group ◽  
Intention To Treat ◽  
Symptoms Of Depression ◽  
Randomized Controlled ◽  
Treatment Naïve

Background. There is evidence supporting the effectiveness of psychoeducation (PE) in patients with symptoms of depression in primary care (PC), but very few studies have assessed this intervention in antidepressant-naïve patients. The aim of this study is to assess the effectiveness of a PE program in these patients, since the use of antidepressant (AD) medication may interfere with the effects of the intervention.Methods. 106 participants were included, 50 from the PE program (12 weekly 1.5-hour sessions) and 56 from the control group (CG) that received the usual care. Patients were assessed at baseline and at 3, 6, and 9 months. The main outcome measures were the Beck Depression Inventory (BDI) and remission based on the BDI. The analysis was carried out on an intention-to-treat basis.Results. The PE program group showed remission of symptoms of 40% (P=0.001) posttreatment and 42% (P=0.012) at 6 months. The analysis only showed significant differences in the BDI score posttreatment (P=0.008; effect size Cohen’sd′=0.55).Conclusions. The PE intervention is an effective treatment in the depressive population not treated with AD medication. Before taking an AD, psychoeducational intervention should be considered.

scholarly journals A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness

10.2196/16629 ◽  
2020 ◽  
Vol 22 (5) ◽  
pp. e16629 ◽  
Author(s):  
Aikaterini Kassavou ◽  
Venus Mirzaei ◽  
James Brimicombe ◽  
Simon Edwards ◽  
Efthalia Massou ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Clinical Effectiveness ◽  
Control Group ◽  
Randomized Controlled

Background The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated. Objective This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored. Methods This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement. Results A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t116=2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI −7.423 to 6.301), and hemoglobin A1c was 4.5 mmol/mol (95% CI −13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction. Conclusions Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149.

Self-Help for Social Anxiety: Randomized Controlled Trial Comparing a Mindfulness and Acceptance-Based Approach With a Control Group

2019 ◽  
Vol 50 (4) ◽  
pp. 696-709 ◽  
Author(s):  
Nancy L. Kocovski ◽  
Jan E. Fleming ◽  
Rebecca A. Blackie ◽  
Meagan B. MacKenzie ◽  
Alison L. Rose
Keyword(s):  
Randomized Controlled Trial ◽  
Social Anxiety ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Self Help

scholarly journals A Brief Mindfulness-Based Intervention for Primary Care Physicians: A Pilot Randomized Controlled Trial

2016 ◽  
Vol 12 (1) ◽  
pp. 83-91 ◽  
Author(s):  
David A. Schroeder ◽  
Elizabeth Stephens ◽  
Dharmakaya Colgan ◽  
Matthew Hunsinger ◽  
Dan Rubin ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Primary Care Physicians ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
Patient Reported ◽  
The Impact

Primary care physicians experience high rates of burnout, which results in diminished quality of life, poorer quality of care, and workforce attrition. In this randomized controlled trial, our primary aim was to examine the impact of a brief mindfulness-based intervention (MBI) on burnout, stress, mindfulness, compassion, and resilience among physicians. A total of 33 physicians completed the baseline assessment and were randomized to the Mindful Medicine Curriculum (MMC; n = 17) or waitlist control group (n = 16). Participants completed self-report measures at baseline, post-MBI, and 3-month follow-up. We also analyzed satisfaction with doctor communication (DCC) and overall doctor rating (ODR) data from patients of the physicians in our sample. Participants in the MMC group reported significant improvements in stress (P < .001), mindfulness (P = .05), emotional exhaustion (P = .004), and depersonalization (P = .01) whereas in the control group, there were no improvements on these outcomes. Although the MMC had no impact on patient-reported DCC or ODR, among the entire sample at baseline, DCC and ODR were significantly correlated with several physician outcomes, including resilience and personal achievement. Overall, these findings suggest that a brief MBI can have a positive impact on physician well-being and potentially enhance patient care.

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