scholarly journals Use of standardised outcome measures in adult mental health services

2006 ◽  
Vol 189 (4) ◽  
pp. 330-336 ◽  
Author(s):  
Mike Slade ◽  
Paul McCrone ◽  
Elizabeth Kuipers ◽  
Morven Leese ◽  
Sharon Cahill ◽  
...  

BackgroundRoutine use of standardised outcome measures is not universal.AimsTo evaluate the effectiveness of standardised outcome assessment.MethodA randomised controlled trial, involving 160 representative adult mental health patients and paired staff (ISRCTN16971059). The intervention group (n=101) (a) completed monthly postal questionnaires assessing needs, quality of life, mental health problem severity and therapeutic alliance, and (b) received 3-monthly feedback. The control group (n=59) received treatment as usual.ResultsThe intervention did not improve primary outcomes of patient-rated unmet need and of quality of life. Other subjective secondary outcome measures were also not improved. The intervention reduced psychiatric inpatient days (3.5 v. 16.4 mean days, bootstrapped 95% CI 1.6-25.7), and hence service use costs were £2586 (95% CI 102-5391) less for intervention-group patients. Net benefit analysis indicated that the intervention was cost-effective.ConclusionsRoutine use of outcome measures as implemented in this study did not improve subjective outcomes, but was associated with reduced psychiatric inpatient admissions.

2021 ◽  
Vol 12 ◽  
Author(s):  
Tianye Hu ◽  
Hantong Hu ◽  
Feng Chen ◽  
Bin Jiang ◽  
Fengfei Shen ◽  
...  

Introduction: With a high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect the quality of life of patients, but it remains difficult to manage by current treatment options. Acupuncture may be a potential treatment option for VM prophylaxis, but the currently available evidence is still uncertain. Therefore, this trial aims to evaluate the efficacy and safety of acupuncture for VM prophylaxis.Methods: This is a 28-week parallel, randomized, controlled clinical trial including 4 weeks of baseline, 8 weeks of treatment, and 16 weeks of follow-up. A total of 72 participants will be randomly assigned to two groups. The participants will receive acupuncture in the experimental group, while the participants in the control group will be treated with venlafaxine. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in doses of rescue medication, anxiety level, depression level, and quality of life per 4 weeks from baseline. Adverse events will be recorded for safety evaluation.Discussion: This study will investigate the efficacy and safety of acupuncture for VM prophylaxis. The results will contribute to determining whether acupuncture can serve as an optional treatment strategy for treating VM.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT0464088.


10.2196/15001 ◽  
2020 ◽  
Vol 22 (6) ◽  
pp. e15001
Author(s):  
Sarah MacLean ◽  
Daniel J Corsi ◽  
Sadie Litchfield ◽  
Julia Kucharski ◽  
Kira Genise ◽  
...  

Background Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression. Objective We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (The Journal) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks. Methods We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9). Results A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was −3.6 (SD 6.6) in the intervention group and −3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t91=−0.37; P=.72, 95% CI −3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t84=−2.73; P=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in The Journal and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in The Journal, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ21=6.3; P=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention. Conclusions The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective. Trial Registration ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733


2019 ◽  
Author(s):  
Sarah MacLean ◽  
Daniel J. Corsi ◽  
Sadie Litchfield ◽  
Julia Kucharski ◽  
Kira Genise ◽  
...  

BACKGROUND Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression. OBJECTIVE We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (<i>The Journal</i>) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks. METHODS We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9). RESULTS A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was −3.6 (SD 6.6) in the intervention group and −3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t<sub>91</sub>=−0.37; <i>P</i>=.72, 95% CI −3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t<sub>84</sub>=−2.73; <i>P</i>=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in <i>The Journal</i> and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in <i>The Journal</i>, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ<sup>2</sup><sub>1</sub>=6.3; <i>P</i>=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention. CONCLUSIONS The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective. CLINICALTRIAL ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733


2012 ◽  
Vol 92 (11) ◽  
pp. 1395-1410 ◽  
Author(s):  
Margaret Schenkman ◽  
Deborah A. Hall ◽  
Anna E. Barón ◽  
Robert S. Schwartz ◽  
Pamela Mettler ◽  
...  

BackgroundExercise confers short-term benefits for individuals with Parkinson disease (PD).ObjectiveThe purpose of the study was to compare short- and long-term responses among 2 supervised exercise programs and a home-based control exercise program.DesignThe 16-month randomized controlled exercise intervention investigated 3 exercise approaches: flexibility/balance/function exercise (FBF), supervised aerobic exercise (AE), and home-based exercise (control).SettingThis study was conducted in outpatient clinics.PatientsThe participants were 121 individuals with PD (Hoehn & Yahr stages 1–3).InterventionsThe FBF program (individualized spinal and extremity flexibility exercises followed by group balance/functional training) was supervised by a physical therapist. The AE program (using a treadmill, bike, or elliptical trainer) was supervised by an exercise trainer. Supervision was provided 3 days per week for 4 months, and then monthly (16 months total). The control group participants exercised at home using the National Parkinson Foundation Fitness Counts program, with 1 supervised, clinic-based group session per month.MeasurementsOutcomes, obtained by blinded assessors, were determined at 4, 10, and 16 months. The primary outcome measures were overall physical function (Continuous Scale—Physical Functional Performance [CS-PFP]), balance (Functional Reach Test [FRT]), and walking economy (oxygen uptake [mL/kg/min]). Secondary outcome measures were symptom severity (Unified Parkinson's Disease Rating Scale [UPDRS] activities of daily living [ADL] and motor subscales) and quality of life (39-item Parkinson's Disease Quality of Life Scale [PDQ-39]).ResultsOf the 121 participants, 86.8%, 82.6%, and 79.3% completed 4, 10, and 16 months, respectively, of the intervention. At 4 months, improvement in CS-PFP scores was greater in the FBF group than in the control group (mean difference=4.3, 95% confidence interval [CI]=1.2 to 7.3) and the AE group (mean difference=3.1, 95% CI=0.0 to 6.2). Balance was not different among groups at any time point. Walking economy improved in the AE group compared with the FBF group at 4 months (mean difference=−1.2, 95% CI=−1.9 to −0.5), 10 months (mean difference=−1.2, 95% CI=−1.9 to −0.5), and 16 months (mean difference=−1.7, 95% CI=−2.5 to −1.0). The only secondary outcome that showed significant differences was UPDRS ADL subscale scores: the FBF group performed better than the control group at 4 months (mean difference=−1.47, 95% CI=−2.79 to −0.15) and 16 months (mean difference=−1.95, 95% CI=−3.84 to −0.08).LimitationsAbsence of a non-exercise control group was a limitation of the study.ConclusionsFindings demonstrated overall functional benefits at 4 months in the FBF group and improved walking economy (up to 16 months) in the AE group.


10.2196/26814 ◽  
2021 ◽  
Vol 8 (12) ◽  
pp. e26814
Author(s):  
J Carola Pérez ◽  
Olga Fernández ◽  
Cristián Cáceres ◽  
Álvaro E Carrasco ◽  
Markus Moessner ◽  
...  

Background Internet-based interventions promise to enhance the accessibility of mental health care for a greater number of people and in more remote places. Their effectiveness has been shown for the prevention and treatment of various mental disorders. However, their potential when delivered as add-on to conventional treatment (ie, blended care) is less clear. Objective The aim of this study is to study the effectiveness of an internet intervention (ASCENSO) implemented in addition to face-to-face treatment as usual (TAU) for depression. Methods A 2-arm, parallel-group, randomized controlled trial was conducted in an outpatient private mental health care center in Chile. In all, 167 adults, diagnosed with major depressive disorder, without severe comorbidities, and with internet access, were included. Eighty-four participants were assigned to the intervention group and received medical and psychological TAU from the mental health center plus access to the ASCENSO online platform. The control group (n=83) received only TAU. The ASCENSO platform includes psycho-educational information, depressive symptom monitoring and feedback, and managing emergencies based on the principles of cognitive behavioral therapy. Emergency management was mental health provider–assisted. TAU includes access to primary care physicians and psychiatrists, to a brief individual psychotherapy, and to medication when needed. The baseline questionnaires were administered in person, and 6- and 9-months assessments were conducted online. Depression symptoms and quality of life were measured by self-administered questionnaires, and treatment adherence was determined via the Mental Health Center’s internal records. The usage of ASCENSO was assessed by server logs. Reduction on depressive symptomatology was considered as the primary outcome of the intervention and quality of life as a secondary outcome. Results Of the 84 participants in the intervention group, 5 participants (6%) never accessed the online platform. Of the remaining 79 participants who accessed ASCENSO, 1 (1%, 1/79) did not answer any of the symptom questionnaire, and most participants (72/79, 91%) answered the monitoring questionnaires irregularly. The ASCENSO intervention implemented in addition to face-to-face care did not improve the outcome of the usual care delivered at the mental health center, either in terms of reduction of depressive symptoms (F2,6087= 0.48; P=.62) or in the improvement of quality of life (EQ-5D-3L: F2,7678=0.24; P=.79 and EQ-VAS: F2,6670= 0.13; P=.88). In contrast, for the primary (F2,850=78.25; P<.001) and secondary outcomes (EQ-5D-3L: F2,1067=37.87; EQ-VAS: F2,4390= 51.69; P<.001) in both groups, there was an improvement from baseline to 6 months (P<.001), but there was no change at 9 months. In addition, no effects on adherence to or use of TAU were found. Finally, the dropout rate for the face-to-face treatment component was 54% (45/84) for the intervention group versus 39% (32/83) for the control group (P=.07). Conclusions The fact that the adjunctive access to ASCENSO did not improve outcome could be due to both the rather high effectiveness of TAU and to patients’ limited use of the online platform. Trial Registration ClinicalTrials.gov NCT03093467; https://clinicaltrials.gov/ct2/show/NCT03093467


2020 ◽  
pp. 088626052094815
Author(s):  
Diksha Sapkota ◽  
Kathleen Baird ◽  
Amornrat Saito ◽  
Pappu Rijal ◽  
Debra Anderson

Survivors of domestic and family violence (DFV) report poorer quality of life and worsening mental health. This study evaluated the effect of a counseling and education intervention on the mental health and help-seeking behaviors among pregnant women living with DFV. A parallel pilot randomized controlled trial was performed among 140 pregnant women attending an antenatal clinic of a tertiary hospital of Nepal. Using computer-generated random numbers, participants were randomized to the intervention group (a counseling session, an information booklet about DFV, and contact details of the counselor) or a control group (usual care plus a booklet containing contact details of local DFV support services). Outcome measures included mental health, quality of life (QOL), self-efficacy, social support, and safety planning behaviors. Analyses followed intention-to-treat, using the generalized estimating equation model. Intervention participants showed significant improvements in anxiety (β = −3.24, p < .001) and depression (β = −3.16, p < .001) at postintervention. Such improvements were also sustained at follow-up assessment ( p < .001). Significant group and time interaction for QOL, social support, use of safety behaviors, and self-efficacy ( p < .05) revealed a greater increase in these outcome measures among intervention participants at both follow-up assessments compared with the control group. This pilot integrated intervention showed promising outcomes in improving the mental health, social support, and the use of safety behaviors among women with DFV. This intervention could be incorporated into regular antenatal care as a strategy to identify and support victims of DFV. Larger controlled trials with longer follow-up are needed to support and expand on the current findings regarding the effectiveness of a psychosocial intervention targeting victims of DFV in resource-constrained settings.


Author(s):  
Anna María Pálsdóttir ◽  
Marie Gudmundsson ◽  
Patrik Grahn

People with neurological disorders suffer from poor mobility, poor balance, fatigue, isolation and monotonous everyday activities. Studies show that equine-assisted interventions can improve their mobility and balance, but could these kinds of interventions also increase participants’ activity repertoire and self-assessed health, and reduce their fatigue? The study was conducted as a prospective, controlled study with three cohorts followed for one year: intervention group (n = 14), control group Passive (n = 29), and control group Active (n = 147). Participants in the study were affected by neurological disease or injury that limited their opportunities for an active everyday life. The intervention group lacked regular activities outside the home before the intervention, which consisted of riding once a week, led by a certified therapist. Control group Passive lacked regular activities outside the home, while control group Active had several activities outside the home per week. Primary outcome measures were activity repertoire measured with Occupational Value Assessment questionnaire. Secondary outcome measures were global self-assessed health measured with EuroQol-VAS and fatigue measured with Shirom-Melamed Burnout Questionnaire. The intervention group’s activity repertoire and self-assessed health increased significantly compared to both baseline and the control groups. Equine-assisted interventions could help to improve the perceived value of everyday occupations and quality of life, as well as break isolation and increase the activity repertoire of people with neurological disorders.


2015 ◽  
Vol 8 (4) ◽  
pp. 179-192
Author(s):  
Andrea Louise Fielder ◽  
Antonina Mikocka-Walus ◽  
Stacey McCallum ◽  
Benjamin Stewart ◽  
Pasquale Alvaro ◽  
...  

Purpose – The purpose of this paper is to test the effectiveness of a self-directed cognitive behavioural therapy (CBT) booklet allowing immediate access to treatment for anxiety during alcohol use disorder (AUD) interventions. Design/methodology/approach – Parallel pilot randomised controlled trial: 69 individuals in AUD treatment, continued to receive treatment alone (control: n=29) or in addition, a self-directed, four week CBT booklet to manage anxiety (intervention: n=40). Primary outcome measures were changes in state (SAnx) and trait anxiety (TAnx) at four weeks. Secondary outcome measures were changes in adaptive (ACop), maladaptive (MCop) coping and quality of life (QoL, physical (PHQoL), psychological (PSQoL), social (SQoL), environment (EQoL)) at four weeks. Findings – Participants had significantly higher SAnx (p < 0.01) and TAnx (p < 0.01) baseline scores compared to the general population. There were no statistically significant group changes in SAnx or TAnx (p > 0.05). Control group allocation predicted improvement in ACop (p < 0.01), MCop (p < 0.05), PHQoL (p < 0.01), PSQoL (p < 0.05) and SQoL (p < 0.01); CBT group allocation predicted improvement in EQoL (p=0.05). All effect sizes were small to moderate (Cohen’s d < 0.50). Percentage of book completion did not determine changes in anxiety, coping or quality of life. Originality/value – A four week self-directed CBT booklet did not significantly reduce anxiety during AUD treatment. Larger sample sizes will determine the most suitable treatment delivery mode for this type of CBT.


2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Ming-Yu Si ◽  
Wei-Jun Xiao ◽  
Chen Pan ◽  
Hao Wang ◽  
Yi-Man Huang ◽  
...  

Abstract Background COVID-19 can lead to increased psychological symptoms such as post-traumatic stress disorder (PTSD), depression, and anxiety among patients with COVID-19. Based on the previous mindfulness-based interventions proved to be effective, this protocol reports a design of a randomized controlled trial aiming to explore the efficacy and possible mechanism of a mindful living with challenge (MLWC) intervention developed for COVID-19 survivors in alleviating their psychological problems caused by both the disease and the pandemic. Methods In April 2021, more than 1600 eligible participants from Hubei Province of China will be assigned 1:1 to an online MLWC intervention group or a waitlist control group. All participants will be asked to complete online questionnaires at baseline, post-program, and 3-month follow-up. The differences of mental health status (e.g. PTSD) and physical symptoms including fatigue and sleeplessness between the COVID-19 survivors who receiving the online MLWC intervention and the control group will be assessed. In addition, the possible mediators and moderators of the link between the MLWC intervention and target outcomes will be evaluated by related verified scales, such as the Five Facets Mindfulness Questionnaire. Data will be analyzed based on an intention-to-treat approach, and SPSS software will be used to perform statistical analysis. Discussion The efficacy and potential mechanism of MLWC intervention in improving the quality of life and psychological status of COVID-19 survivors in China are expected to be reported. Findings from this study will shed light on a novel and feasible model in improving the psychological well-being of people during such public health emergencies. Trial registration Chinese Clinical Trial Registry (ChiCTR), ChiCTR2000037524; Registered on August 29, 2020, http://www.chictr.org.cn/showproj.aspx?proj=60034.


Medicina ◽  
2021 ◽  
Vol 57 (2) ◽  
pp. 122
Author(s):  
Marta Pérez-Rodríguez ◽  
Saleky García-Gómez ◽  
Javier Coterón ◽  
Juan José García-Hernández ◽  
Javier Pérez-Tejero

Background and objectives: Acquired brain injury (ABI) is the first cause of disability and physical activity (PA) is a key element in functional recovery and health-related quality of life (HRQoL) during the subacute and chronic phases. However, it is necessary to develop PA programs that respond to the heterogeneity and needs of this population. The aim of this study was to assess the effectiveness of a PA program on the HRQoL in this population. Materials and Methods: With regard to recruitment, after baseline evaluations, participants were assigned to either the intervention group (IG, n = 38) or the control group (CG, n = 35). Functional capacity, mood, quality of life and depression were measured pre- and post-intervention. The IG underwent the “Physical Activity and Sport for Acquired Brain Injury” (PASABI) program, which was designed to improve HRQoL (1-h sessions, two to four sessions/week for 18 weeks). The CG underwent a standard rehabilitation program without PA. Results: Results for the IG indicated significant differences and large effect sizes for the physical and mental dimensions of quality of life, as well as mood and functional capacity, indicating an increase in HRQoL. No significant differences were found for the CG across any variables. Conclusions: The PASABI program was feasible and beneficial for improving physiological and functionality variables in the IG. The wide range of the activities of the PASABI program allow its application to a large number of people with ABI, promoting health through PA, especially in the chronic phase.


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