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Negative and Positive Affect Regulation in a Transdiagnostic Internet-Based Protocol for Emotional Disorders: Randomized Controlled Trial.
Díaz-García, A, González-Robles, A, García-Palacios, A, Fernández-Álvarez, J, Castilla, D, Bretón, JM, Baños, RM, Quero, S, Botella, C
Journal of medical Internet research. 2021;(2):e21335
Abstract
BACKGROUND Emotional disorders (EDs) are among the most prevalent mental disorders. Existing evidence-based psychological treatments are not sufficient to reduce the disease burden of mental disorders. It is therefore essential to implement innovative solutions to achieve a successful dissemination of psychological treatment protocols, and in this regard, the use of information and communication technologies such as the internet can be very useful. Furthermore, the literature suggests that not everyone with an ED receives the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which attempts to address the underlying processes common to EDs. Most of these transdiagnostic interventions focus primarily on downregulating negative affectivity (NA), and less attention has been paid to strengths and the upregulation of positive affectivity, despite its importance for well-being and mental health. OBJECTIVE This study aims to evaluate the efficacy of a transdiagnostic internet-based treatment for EDs in a community sample. METHODS A 3-armed randomized controlled trial was conducted. A total of 216 participants were randomly assigned to a transdiagnostic internet-based protocol (TIBP), a TIBP+ positive affect (PA) component, or a waiting list (WL) control group. The treatment protocol contained core components mainly addressed to downregulate NA (ie, present-focused emotional awareness and acceptance, cognitive flexibility, behavioral and emotional avoidance patterns, and interoceptive and situational exposure) as well as a PA regulation component to promote psychological strengths and enhance well-being. Data on depression, anxiety, quality of life, neuroticism and extraversion, and PA/NA before and after treatment were analyzed. Expectations and opinions of treatment were also analyzed. RESULTS Within-group comparisons indicated significant pre-post reductions in the two experimental conditions. In the TIBP+PA condition, the effect sizes were large for all primary outcomes (d=1.42, Beck Depression Inventory [BDI-II]; d=0.91, Beck Anxiety Inventory [BAI]; d=1.27, Positive and Negative Affect Schedule-Positive [PANAS-P]; d=1.26, Positive and Negative Affect Schedule-Negative [PANAS-N]), whereas the TIBP condition yielded large effect sizes for BDI-II (d=1.19) and PANAS-N (d=1.28) and medium effect sizes for BAI (d=0.63) and PANAS-P (d=0.69). Between-group comparisons revealed that participants who received one of the two active treatments scored better at posttreatment than WL participants. Although there were no statistically significant differences between the two intervention groups on the PA measure, effect sizes were consistently larger in the TIBP+PA condition than in the standard transdiagnostic protocol. CONCLUSIONS Overall, the findings indicate that EDs can be effectively treated with a transdiagnostic intervention via the internet, as significant improvements in depression, anxiety, and quality of life measures were observed. Regarding PA measures, promising effects were found, but more research is needed to study the role of PA as a therapeutic component. TRIAL REGISTRATION ClinicalTrials.gov NCT02578758; https://clinicaltrials.gov/ct2/show/NCT02578758. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-017-1297-z.
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Improved Glycemic Control in Adults With Serious Mental Illness and Diabetes With a Behavioral and Educational Intervention.
Schnitzer, K, Cather, C, Thorndike, AN, Potter, K, Freudenreich, O, MacLaurin, S, Vilme, M, Dechert, A, Wexler, D, Evins, AE
Psychiatric services (Washington, D.C.). 2020;(7):730-733
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OBJECTIVE The purpose of this study was to evaluate a 16-week, reverse-integrated care (bringing primary care interventions/services into the psychiatric setting) behavioral and educational group intervention for individuals with serious mental illness and diabetes. METHODS The primary outcome was change in glycated hemoglobin (HbA1c). Secondary outcomes included body mass index (BMI), blood pressure, lipid levels, physical activity, diabetes knowledge, and self-care. RESULTS Thirty-five participants attended at least one group and were included in a modified intent-to-treat analysis. From baseline to week 16, HbA1c improved, from 7.5±1.6 to 7.1±1.4, p=0.01, and BMI improved, from 33.3±3.8 to 32.9±4.1, p<0.001, as did measures of diabetes knowledge and self-care. One-year follow-up in a subset of participants showed no evidence of rebound in HbA1c. CONCLUSIONS This 16-week behavioral and educational group intervention resulted in improvements in glycemic control, BMI, diabetes knowledge, and self-care. The results warrant larger-scale, controlled trial testing of this intervention to improve diabetes-related health outcomes in those with serious mental illness.
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Preventive effect of dexmedetomidine on postictal delirium after electroconvulsive therapy: A randomised controlled study.
Qiu, Z, Zhou, S, Zhang, M, Guo, N, Huang, P, Xiang, P, Hei, Z, Li, X
European journal of anaesthesiology. 2020;(1):5-13
Abstract
BACKGROUND Postictal delirium (PID) is a relatively common complication following electroconvulsive therapy (ECT). OBJECTIVE We investigated whether prophylactic dexmedetomidine administration would safely decrease the incidence of PID in psychiatric patients after ECT. DESIGN A randomised, double-blind, placebo-controlled trial. PATIENTS A total of 223 patients undergoing ECT were randomly allocated to two groups. INTERVENTIONS Patients received 0.5 μg kg dexmedetomidine (Dex group, n=111) or 0.9% sodium chloride (Con group, n=112) before ECT. Propofol was used for anaesthesia and succinylcholine for muscle relaxation. The incidence of PID was measured using the Confusion Assessment Method for the Intensive Care Unit. MAIN OUTCOME MEASURES The percentage of patients who were diagnosed with PID at any ECT session during the whole treatment. RESULTS PID occurred in 76 (67.9%) of 112 patients given saline (0.9% sodium chloride), and in 49 (44.1%) of 111 patients given dexmedetomidine during the whole treatment. There was a significant difference in the incidence of PID between two groups (P < 0.001). Post hoc analyses showed that the incidence of PID was significantly lower in the Dex group than in the Con group from the first to the seventh ECT session (P < 0.005). There were no significant differences in seizure duration or recovery time between the two groups. Heart rate and mean arterial pressure in the Dex group were significantly lower than in the Con group at 0, 5 and 15 min after electrical stimulation. No patients developed bradycardia, hypotension or respiratory depression during recovery. CONCLUSION Pretreatment with dexmedetomidine leads to a significant reduction in the incidence of PID with no respiratory depressant effect. Dexmedetomidine might be considered an effective method for the prevention of PID post-ECT. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR-IOR-17012306.
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The role of serious mental illness in motivation, participation and adoption of health behavior change among obese/sedentary Latino adults.
Jimenez, DE, Thomas, L, Bartels, SJ
Ethnicity & health. 2019;(8):889-896
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Objective: Serious mental illness (SMI; e.g. schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder, severe major depressive disorder, and psychotic disorders) and Latino ethnicity can produce a compounded health disparity, placing individuals at particularly high risk for excess morbidity and premature mortality. In this study we sought to identify the role of SMI in motivation, participation, and adoption of health behavior change among overweight Latino adults. Design: Qualitative, semi-structured interviews were conducted with 20 overweight Latinos with SMI who were enrolled in a randomized trial evaluating the effectiveness of a motivational health promotion intervention adapted for persons with SMI, In SHAPE. The interviews explored the complicated role having an SMI had in the lives of the Latino participants. Results: SMI had both positive and negative impact on Latino participants' health behaviors. The nature of their mental illness along with medication side effects (e.g. lethargy, weight gain, etc.) negatively impacted their ability to making lasting health behavior change. However, the regular appointments with various specialists provided them with structure that they otherwise would have lacked and gave them a reason to get out of the house. Conclusions: This exploratory research provides insight into the experience of overweight Latinos with SMI and the ways in which SMI impacts their participation in health behavior change. An understanding of the positive and negative effects of SMI on health behavior change will inform the development of health promotion interventions targeted at Latinos with SMI.
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'Walk this way': results from a pilot randomised controlled trial of a health coaching intervention to reduce sedentary behaviour and increase physical activity in people with serious mental illness.
Williams, J, Stubbs, B, Richardson, S, Flower, C, Barr-Hamilton, L, Grey, B, Hubbard, K, Spaducci, G, Gaughran, F, Craig, T
BMC psychiatry. 2019;(1):287
Abstract
BACKGROUND Cardiovascular disease (CVD) is the leading cause of premature death among people with serious mental illness (SMI). Sedentary behaviour (SB) is an independent risk factor for CVD and mortality and people with SMI are highly sedentary. We developed a health coaching intervention called 'Walk this Way' to reduce SB and increase physical activity (PA) in people with SMI and conducted a pilot randomised controlled trial (RCT) to test its feasibility and acceptability. METHODS We randomised people with SMI from three community mental health teams into either the WTW intervention or treatment as usual. The WTW intervention lasted 17 weeks and included an initial education session, fortnightly coaching, provision of pedometers and access to a weekly walking group. Objective SB and PA were measured with accelerometers. Cardiometabolic risk factors and wellbeing measures were collected. RESULTS We recruited 40 people of whom 33 (82.5%) were followed up. 13/20 (65%) of participants allocated to the coaching intervention completed it. In the intervention group SB decreased by 56 min and total PA increased by 32 min per day on average which was sustained 6 months later. There was no change in PA or SB in the control group. When interviewed, participants in the intervention found the intervention helpful and acceptable. No adverse events were reported from the intervention. CONCLUSIONS The intervention was feasible and acceptable to participants. Preliminary results were encouraging with improvement seen in both SB and PA. A larger study is needed to assess the effectiveness of the intervention and address any implementation challenges. TRIAL REGISTRATION ISRCTN Registry identifier: ISRCTN37724980 , retrospectively registered 25 September 2015.
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Increasing physical activity and healthy diet in outpatients with mental disorders: a randomized-controlled evaluation of two psychological interventions.
Petzold, MB, Mumm, JLM, Bischoff, S, Große, J, Plag, J, Brand, R, Ströhle, A
European archives of psychiatry and clinical neuroscience. 2019;(5):529-542
Abstract
INTRODUCTION While physical activity (PA) can play an important role in the treatment of mental disorders (MD), large proportions of patients with MD do not meet PA recommendations. The aim of this trial was to evaluate whether structured psychological intervention (MoVo-LISA) is effective in helping outpatients with MD to increase their level of PA. As active control group (CG) we modified MoVo-LISA to target healthy diet behavior. METHODS N = 83 outpatients with MD (F1-F4) were randomized to the two conditions. PA (self-report and accelerometry), dietary behavior, social-cognitive determinants of health behavior change, psychiatric symptoms and health-related quality of life were assessed at baseline, 1 and 12 weeks after the intervention. RESULTS Significant time*group interaction effects for objectively measured PA, dietary behavior and fruit and vegetable consumption indicated differential effects of the interventions on these outcomes. PA increased in the MoVo-LISA group (IG) from baseline to follow-up while it decreased in CG. IG showed a significant higher level of objectively measured PA at follow-up compared to CG. Dietary behavior and fruit and vegetable consumption significantly increased from baseline to follow-up in CG, but not IG. IG showed a significant increase in some, but not all social cognitive determinants of health behavior change. CONCLUSIONS MoVo-LISA is effective in helping outpatients with MD to increase their level of PA in short- and mid-term. The used intervention strategies are effective for the promotion of healthy diet in patients with MD as well.
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Changing the obesogenic environment to improve cardiometabolic health in residential patients with a severe mental illness: cluster randomised controlled trial.
Looijmans, A, Stiekema, APM, Bruggeman, R, van der Meer, L, Stolk, RP, Schoevers, RA, Jörg, F, Corpeleijn, E
The British journal of psychiatry : the journal of mental science. 2017;(5):296-303
Abstract
BackgroundFor patients with severe mental illness (SMI) in residential facilities, adopting a healthy lifestyle is hampered by the obesity promoting (obesogenic) environment.AimsTo determine the effectiveness of a 12-month lifestyle intervention addressing the obesogenic environment with respect to diet and physical activity to improve waist circumference and cardiometabolic risk factors v. care as usual (Dutch Trial Registry: NTR2720).MethodIn a multisite cluster randomised controlled pragmatic trial, 29 care teams were randomised into 15 intervention (365 patients) and 14 control teams (371 patients). Intervention staff were trained to improve the obesogenic environment.ResultsWaist circumference decreased 1.51 cm (95% CI -2.99 to -0.04) in the intervention v. control group after 3 months and metabolic syndrome z-score decreased 0.22 s.d. (95% CI -0.38 to -0.06). After 12 months, the decrease in waist circumference was no longer statistically significantly different (-1.28 cm, 95% CI -2.79 to 0.23, P=0.097).ConclusionsTargeting the obesogenic environment of residential patients with SMI has the potential to facilitate reduction of abdominal adiposity and cardiometabolic risk, but maintaining initial reductions over the longer term remains challenging.
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A Randomized, Controlled Multisite Study of Behavioral Interventions for Veterans with Mental Illness and Antipsychotic Medication-Associated Obesity.
Erickson, ZD, Kwan, CL, Gelberg, HA, Arnold, IY, Chamberlin, V, Rosen, JA, Shah, C, Nguyen, CT, Hellemann, G, Aragaki, DR, et al
Journal of general internal medicine. 2017;(Suppl 1):32-39
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BACKGROUND Weight gain and other metabolic sequelae of antipsychotic medications can lead to medication non-adherence, reduced quality of life, increased costs, and premature mortality. Of the approaches to address this, behavioral interventions are less invasive, cost less, and can result in sustained long-term benefits. OBJECTIVE We investigated behavioral weight management interventions for veterans with mental illness across four medical centers within the Veterans Affairs (VA) Healthcare System. DESIGN We conducted a 12-month, multi-site extension of our previous randomized, controlled study, comparing treatment and control groups. PARTICIPANTS Veterans (and some non-veteran women) diagnosed with mental illness, overweight (defined as having a BMI over 25), and required ongoing antipsychotic therapy. INTERVENTIONS One group received "Lifestyle Balance" (LB; modified from the Diabetes Prevention Program) consisting of classes and individual nutritional counseling with a dietitian. A second group received less intensive "Usual Care" (UC) consisting of weight monitoring and provision of self-help. MAIN MEASURES Participants completed anthropometric and nutrition assessments weekly for 8 weeks, then monthly. Psychiatric, behavioral, and physical assessments were conducted at baseline and months 2, 6, and 12. Metabolic and lipid laboratory tests were performed quarterly. KEY RESULTS Participants in both groups lost weight. LB participants had a greater decrease in average waist circumference [F(1,1244) = 11.9, p < 0.001] and percent body fat [F(1,1121) = 4.3, p = 0.038]. Controlling for gender yielded statistically significant changes between groups in BMI [F(1,1246) = 13.9, p < 0.001]. Waist circumference and percent body fat decreased for LB women [F(1,1243) = 22.5, p < 0.001 and F(1,1221) = 4.8, p = 0.029, respectively]. The majority of LB participants kept food and activity journals (92%), and average daily calorie intake decreased from 2055 to 1650 during the study (p < 0.001). CONCLUSIONS Behavioral interventions specifically designed for individuals with mental illness can be effective for weight loss and improve dietary behaviors. "Lifestyle Balance" integrates well with VA healthcare's patient-centered "Whole Health" approach. ClinicalTrials.gov identifier NCT01052714.
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Improvement in Body Image, Perceived Health, and Health-Related Self-Efficacy Among People With Serious Mental Illness: The STRIDE Study.
Yarborough, BJ, Leo, MC, Yarborough, MT, Stumbo, S, Janoff, SL, Perrin, NA, Green, CA
Psychiatric services (Washington, D.C.). 2016;(3):296-301
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OBJECTIVE The authors examined secondary outcomes of STRIDE, a randomized controlled trial that tested a weight-loss and lifestyle intervention for individuals taking antipsychotic medications. METHODS Hierarchical linear regression was used to explore the effects of the intervention and weight change at follow-up (six, 12, and 24 months) on body image, perceived health, and health-related self-efficacy. RESULTS Participants were 200 adults who were overweight and taking antipsychotic agents. Weight change × study arm interaction was associated with significant improvement in body image from baseline to six months. From baseline to 12 months, body image scores of intervention participants improved by 1.7 points more compared with scores of control participants; greater weight loss was associated with more improvement. Between baseline and 24 months, greater weight loss was associated with improvements in body image, perceived health, and health-related self-efficacy. CONCLUSIONS Participation in STRIDE improved body image, and losing weight improved perceived health and health-related self-efficacy.
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Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial.
Hanlon, C, Alem, A, Medhin, G, Shibre, T, Ejigu, DA, Negussie, H, Dewey, M, Wissow, L, Prince, M, Susser, E, et al
Trials. 2016;:76
Abstract
BACKGROUND Task sharing mental health care through integration into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. However, the effectiveness, acceptability, feasibility and sustainability of this service model for people with a severe mental disorder (SMD) have not been evaluated in a low-income country. METHODS/DESIGN A randomised, controlled, non-inferiority trial will be carried out in a predominantly rural area of Ethiopia. A sample of 324 people with SMD (diagnoses of schizophrenia, schizoaffective disorder, bipolar disorder or major depressive disorder) with an ongoing need for mental health care will be recruited from 1) participants in a population-based cohort study and 2) people attending a psychiatric nurse-led out-patient clinic. The intervention is a task-sharing model of locally delivered mental health care for people with SMD integrated into PHC delivered over 18 months. Participants in the active control arm will receive the established and effective model of specialist mental health care delivered by psychiatric nurses at an out-patient clinic within a centrally located general hospital. The hypothesis is that people with SMD who receive mental health care integrated into PHC will have a non-inferior clinical outcome, defined as a mean symptom score on the Brief Psychiatric Rating Scale, expanded version, of no more than six points higher, compared to participants who receive the psychiatric nurse-led service, after 12 months. The primary outcome is change in symptom severity. Secondary outcomes are functional status, relapse, service use costs, service satisfaction, drop-out and medication adherence, nutritional status, physical health care, quality of care, medication side effects, stigma, adverse events and cost-effectiveness. Sustainability and cost-effectiveness will be further evaluated at 18 months. Randomisation will be stratified by health centre catchment area using random permuted blocks. The outcome assessors and investigators will be masked to allocation status. DISCUSSION Evidence about the effectiveness of task sharing mental health care for people with SMD in a rural, low-income African country will inform the World Health Organisation's mental health Gap Action Programme to scale-up mental health care globally. TRIAL REGISTRATION NCT02308956 (ClinicalTrials.gov). Date of registration: 3 December 2014.