Treatment as usual

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Effectiveness of a brief psychoeducational group intervention for relatives on the course of disease in patients after inpatient depression treatment compared with treatment as usual – study protocol of a multisite randomised controlled trial

Effectiveness of a brief psychoeducational group intervention for relatives on the course of disease in patients after inpatient depression treatment compared with treatment as usual – study protocol of a multisite randomised controlled trial

Background: Relapses and rehospitalisations are common after acute inpatient treatment in depressive disorders. Interventions for stabilising treatment outcomes are urgently needed. Psychoeducational group interventions for relatives were shown to be suitable for improving the course of disease in schizophrenia and bipolar disorders. A small Japanese monocentre randomised controlled trial also showed promising results for depressive disorders. However, the evidence regarding psychoeducation for relatives of patients with depressive disorders is unclear. Methods/Design: The study is conducted as a two-arm multisite randomised controlled trial to evaluate the incremental effect of a brief psychoeducational group intervention for relatives as a maintenance treatment on the course of disease compared to treatment as usual. Primary outcome is the estimated number of depression-free-days in patients within one year after discharge from inpatient treatment. 180 patients diagnosed with unipolar depressive disorders as well as one key relative per patient will be included during inpatient treatment and randomly allocated to the conditions at discharge. In the intervention group, relatives will participate in a brief psychoeducational group intervention following the patient ’ s discharge. The intervention consists of four group sessions lasting 90 to 120 min each. Every group session contains informational parts as well as structured training in problem-solving. In both study conditions, patients will receive treatment as usual. Patients as well as relatives will be surveyed by means of questionnaires at discharge and three, six, nine and twelve months after discharge. In addition to the primary outcome, several patient-related and relative-related secondary outcomes will be considered and health economics will be investigated.
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Adhesive capsulitis of the shoulder, treatment with corticosteroid, corticosteroid with distension or treatment as usual; a randomised controlled trial in primary care

Adhesive capsulitis of the shoulder, treatment with corticosteroid, corticosteroid with distension or treatment as usual; a randomised controlled trial in primary care

Patients in the steroid alone group (IS) received Tri- amcinolone 20 mg injection, with Lidocaine 10 mg/ml 3 ml and a total of 4 ml solution. Those in the distension group (ISD) also received steroid and Lidocaine (Triam- cinolone 20 mg, 3 ml Lidocaine), but with additional physiological Sodium chloride 9 mg/ml, comprising a total volume from 8 ml and upwards to 20 ml. Limiting factors for injected volume were difficulty in further in- jection and/or increasing pain during injection. Injection to IS and ISD groups were given after inclusion on day 1, after 7, 17, and 31 days from the start. Adherence to planned intervention was assessed continuously by one of the authors (SPS). Patients receiving treatment-as- usual (TAU) were informed about the possibilities of optional conservative treatment, such as physiotherapy or pain medication other than corticosteroid injections or per oral corticosteroid medication until 61 days after inclusion.
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Integrated treatment vs  treatment as usual for recent onset schizophrenia; 12 year follow up on a randomized controlled trial

Integrated treatment vs treatment as usual for recent onset schizophrenia; 12 year follow up on a randomized controlled trial

Significantly fewer patients receiving IT (11 of 28 pa- tients in the IT group and 12 of 17 in the TAU group) were involuntary hospitalized. This is an important finding and should have implications in planning of ser- vices for patients with schizophrenia. There were, how- ever, no difference in the number of days they were involuntary admitted. No significant differences were found between groups receiving integrated treatment or treatment-as-usual with respect to number of inpatient days, number of patients admitted to psychiatric wards, number of admissions to psychiatric wards, use of out- patient coercion or number of outpatient contacts over a period of 12 years. Although median time to readmis- sion was considerably longer for the IT group, this dif- ference did not reach statistical significance (possibly because of the sample size). Given that no effects on hospitalization were found in the first two years, these findings might not be surprising and limited conclu- sions can be drawn given that only 45 patients were in- cluded in the analyzes.
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A randomised controlled trial of the clinical and cost effectiveness of a contingency management intervention compared to treatment as usual for reduction of cannabis use and of relapse in early psychosis (CIRCLE): a study protocol for a randomised contro

A randomised controlled trial of the clinical and cost effectiveness of a contingency management intervention compared to treatment as usual for reduction of cannabis use and of relapse in early psychosis (CIRCLE): a study protocol for a randomised controlled trial

recognised to have a substantial evidence base in some contexts and its adoption in the UK is advocated by the National Institute for Health and Care Excellence (NICE) guidance as a treatment for substance or alcohol misuse. However, there is currently little published data testing its effectiveness for reducing cannabis use in early psychosis. Methods: CIRCLE is a two-arm, rater-blinded randomised controlled trial (RCT) investigating the clinical and cost- effectiveness of a CM intervention for reducing cannabis use among young people receiving treatment from UK Early Intervention in Psychosis (EIP) services. EIP service users ( n = 544) with a recent history of cannabis use will be recruited. The experimental group will receive 12 once-weekly CM sessions, and a voucher reward if urinalysis shows that they have not used cannabis in the previous week. Both the experimental and the control groups will be offered an Optimised Treatment as Usual (OTAU) psychoeducational package targeting cannabis use. Assessment interviews will be performed at consent, at 3 months, and at 18 months. The primary outcome is time to relapse, defined as admission to an acute mental health service. Secondary outcomes include proportion of cannabis-free urine samples during the intervention period, severity of positive psychotic symptoms, quality-adjusted life years, and engagement in work or education.
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Protocol for a proof of concept randomized controlled trial of cognitive behavioural therapy for adult ADHD as a supplement to treatment as usual, compared with treatment as usual alone

Protocol for a proof of concept randomized controlled trial of cognitive behavioural therapy for adult ADHD as a supplement to treatment as usual, compared with treatment as usual alone

The current study therefore aims to develop and eval- uate a collaborative, formulation-based approach to trea- ting adult ADHD. A group of individuals receiving CBT combined with treatment as usual for adults with ADHD will be compared with a group receiving treatment as usual only, employing a randomized design. Detailed cognitive-behavioural assessments as well as informa- tion about cognitions and behaviours from a measure developed in a concurrent study will inform the con- tent of the intervention. Therapists will also have ac- cess to a range of skills-based approaches, as have been used in previous studies, as and when indicated by the formulation, and a treatment manual is being produced which will be updated iteratively.
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A randomized controlled trial comparing Circle of Security Intervention and treatment as usual as interventions to increase attachment security in infants of mentally ill mothers: Study Protocol

A randomized controlled trial comparing Circle of Security Intervention and treatment as usual as interventions to increase attachment security in infants of mentally ill mothers: Study Protocol

Methods/Design: This randomized controlled clinical trial tests whether promoting attachment security in infancy with the Circle of Security (COS) Intervention will result in a higher rate of securely attached children compared to treatment as usual (TAU). Furthermore, we will determine whether the distributions of securely attached children are moderated or mediated by variations in maternal sensitivity, mentalizing, attachment representations, and psychopathology obtained at baseline and at follow-up. We plan to recruit 80 mother-infant dyads when infants are aged 4-9 months with 40 dyads being randomized to each treatment arm. Infants and mothers will be reassessed when the children are 16-18 months of age. Methodological aspects of the study are systematic recruitment and randomization, explicit inclusion and exclusion criteria, research assessors and coders blinded to treatment allocation, advanced statistical analysis, manualized treatment protocols and assessments of treatment adherence and integrity. Discussion: The aim of this clinical trial is to determine whether there are specific effects of an attachment-based intervention that promotes attachment security in infants. Additionally, we anticipate being able to utilize data on maternal and child outcome measures to obtain preliminary indications about potential moderators of the intervention and inform hypotheses about which intervention may be most suitable when offered in a clinical psychiatric outpatient context.
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The ACCESS study a Zelen randomised controlled trial of a treatment package including problem solving therapy compared to treatment as usual in people who present to hospital after self harm: study protocol for a randomised controlled trial

The ACCESS study a Zelen randomised controlled trial of a treatment package including problem solving therapy compared to treatment as usual in people who present to hospital after self harm: study protocol for a randomised controlled trial

Methods: We propose to use a double consent Zelen design where participants are randomised prior to giving consent to enrol a large representative cohort of patients. The main outcome will be hospital attendance following repetition of self-harm, in the 12 months after recruitment with secondary outcomes of self reported self-harm, hopelessness, anxiety, depression, quality of life, social function and hospital use at three months and one year. Discussion: A strength of the study is that it is a pragmatic trial which aims to recruit large numbers and does not exclude people if English is not their first language. A potential limitation is the analysis of the results which is complex and may underestimate any effect if a large number of people refuse their consent in the group randomised to problem solving therapy as they will effectively cross over to the treatment as usual group. However the primary analysis is a true intention to treat analysis of everyone randomised which includes both those who consent and do not consent to participate in the study. This provides information about how the intervention will work in practice in a representative population which is a major advance in this study compared to what has been done before.
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Te Ira Tangata: A Zelen randomised controlled trial of a treatment package including problem solving therapy compared to treatment as usual in Maori who present to hospital after self harm

Te Ira Tangata: A Zelen randomised controlled trial of a treatment package including problem solving therapy compared to treatment as usual in Maori who present to hospital after self harm

The study, due to report its findings in 2012, tests the effectiveness of a complex package of interventions in the management of Maori who present to hospital with intentional self-harm. It uses a novel design to try and overcome the problems of previous trials which have recruited small numbers of unrepresentative people. A strength of the study is that it is a pragmatic trial which aims to demonstrate the importance of a comprehensive approach to culture in assessment and treatment. A potential limitation is the analysis of the results which is complex and may underestimate any effect on the sec- ondary outcomes if a large number of people refuse their consent in the group randomised to problem sol- ving therapy as they will effectively cross over to the treatment as usual group. Another potential issue is col- lecting a high enough proportion of completed rating scales at follow up.
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Activation therapy for the treatment of inpatients with depression – protocol for a randomised control trial compared to treatment as usual

Activation therapy for the treatment of inpatients with depression – protocol for a randomised control trial compared to treatment as usual

One justification for cognitive activation (CA) is to attempt to reverse neurobiological abnormalities in depression. Neu- roimaging studies in depression suggest there is decreased recruitment of executive control networks, including regions such as the dorsolateral prefrontal cortex (DLPFC) [49]. Siegle et al. [50] examined the utility of repeated practise on two tasks hypothesised to activate DLPFC, in outpatients with severe depression. Fifteen patients received six cognitive training sessions, utilising these tasks, over a 2 week period, while seven received care as usual. The cognitive training group showed significantly decreased self-rated depression score and reduced rumination. Six patients completed func- tional magnetic resonance imaging (fMRI) before and after cognitive training, with preliminary evidence of increased ac- tivity in the DLPFC. The study therefore presents prelimin- ary evidence of clinical efficacy and concomitant expected biological changes. In a later replication, patients undergoing intensive day hospital treatment for depression, who received similar intensive cognitive training, required only 30% as many days of intensive day hospital treatment in the subse- quent year as a service control group who did not receive this intervention [51].
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Design paper: The CapOpus trial: A randomized, parallel group, observer blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis

Design paper: The CapOpus trial: A randomized, parallel group, observer blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis

A randomized trial showed that the combination of cog- nitive behavioral therapy, motivational interviewing [see [21]], and family involvement had a significant positive effect on level of functioning, psychotic symptoms, and duration of periods of cannabis-abstinence, compared with regular treatment [22]. This finding has been sup- ported by two reviews, concluding that positive evidence exists for integrated treatment with motivational inter- views, cognitive behavioral therapy (individual or group- based), and a harm-reduction approach [23,24]. Group- based treatments are arguably less expensive, and in a lit- erature review, Weiss et al. concluded that specialized group therapy could reinforce the effect of an existing treatment [25]. However, there is currently insufficient evidence to show that group-based interventions for can- nabis use are superior to individual treatment [26,27]. Similarly, authors of a recent Cochrane review concluded that insufficient evidence exists to show that any psycho- social treatment method for comorbid schizophrenia and substance abuse is superior to others [28].
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An open-label study of algorithm-based treatment versus treatment-as-usual for patients with schizophrenia

An open-label study of algorithm-based treatment versus treatment-as-usual for patients with schizophrenia

A fair interpretation of the results of this study appears to be that ALGO compares well to TAU, rendering ALGO a rational approach and a topic of further scrutiny. In TAU, ten patients received treatment, which was – in essence – the same with our algorithm (see Results). Altogether, the treat- ment results of these 35 patients (25 from the ALGO group and ten from the TAU group), which are shown in Table S2 and are equivalent to a 27% reduction of the total PANSS score over the treatment period, could serve as an indicator of the overall usefulness of our algorithm in these symptomatic patients (see Suzuki 36 for past evidence on the PANSS/BPRS
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Cost and cost effectiveness of treatment as usual in drug misuse services

Cost and cost effectiveness of treatment as usual in drug misuse services

All of the service providers were found to have made a positive response to help seekers and all delivered statistically significant health and social gains. Broadly speaking, treatment took people out of the criminal justice system, with highly significant public sector cost savings, and got people into health and social care systems, with some additional public sector cost. The size of the treatment effect was similar to that found in other areas of healthcare and within the NICE approved cost limit. The key findings were:

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The effect of financial incentives on patients’ motivation for treatment: results of “Money for Medication,” a randomised controlled trial

The effect of financial incentives on patients’ motivation for treatment: results of “Money for Medication,” a randomised controlled trial

Methods: This study was part of Money for Medication, a multicentre, open-label, randomised controlled trial, which demonstrated the positive effects of financial incentives on antipsychotic depot compliance. Three mental healthcare institutions in Dutch secondary psychiatric care services participated. Eligible patients were aged 18 – 65 years, had been diagnosed with schizophrenia or another psychotic disorder, had been prescribed antipsychotic depot medication or had an indication to start using depot medication, and were participating in outpatient treatment. For 12 months, patients were randomly assigned either to treatment as usual (control group) or to treatment as usual plus a financial reward for each depot of medication received ( € 30 per month if fully compliant; intervention group). They were followed up for 6 months, during which time no monetary rewards were offered for taking antipsychotic medication. To assess treatment motivation after 0, 12 and 18 months, interviews were conducted using a supplement to the Health of the Nation Outcome Scales (HoNOS) and the Treatment Entry Questionnaire (TEQ).
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Heterogeneity In Major Depression: Influence On Treatment Outcomes And Processes-Outcome Relations

Heterogeneity In Major Depression: Influence On Treatment Outcomes And Processes-Outcome Relations

prognosis. The studies presented in the dissertation aimed to explore how heterogeneity in depression may moderate treatment effects and process-outcome relations. In study 1, a prognostic index (PI) was developed and treatment differences along the PI were explored in a sample of patients (N = 622) randomized to treatment as usual (TAU) or stepped care starting with brief therapy (BT) or with cognitive-behavioral therapy (CBT). The PI comprised five variables: unemployment status, depression severity, hostility, sleep problems, and lower positive emotionality, all of which predicted a lower likelihood of recovery. For patients whose PI indicated a high likelihood of recovery (73% of the sample), recovery rates were similarly high across the treatments. Among patients whose PI indicated a lower likelihood of recovery, patients in the CBT condition experienced a substantially higher recovery rate (65%) than patients in TAU (40%) or BT (44%). In study 2, variability in the predictive relationship between the therapeutic alliance and depressive symptom change was explored in a sample of patients receiving cognitive therapy (CT) for depression (N = 60). The alliance predicted outcome in the subgroup of clients with 0–2 prior episodes (r = .52), but not in those with 3 or more prior episodes (r = -.02). In study 3, these findings were replicated in an independent sample of patients receiving CBT for depression, but they did not extend to patients in a psychodynamic therapy condition. Taken together, these findings suggest that there may be identifiable subgroups of patients for whom factors common to all treatments will promote symptom change. By contrast, complementary subgroups, such as those with poorer prognoses or more recurrent histories of depression, may reveal differences in the efficacies of treatments and their active mechanisms.
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Return to Work and Painkiller Medication after Rehabilitation for Subacute Back Conditions—A 2 Year Follow Up

Return to Work and Painkiller Medication after Rehabilitation for Subacute Back Conditions—A 2 Year Follow Up

Gender is an important issue in LBP. In our study women accounted for 75% of the sample but linear regression failed to indicate a significant relationship between outcome and gender. In a very large sample in Norway (Hagen, 1998) the estimated overall 1-year incidence was 2.2%. It was significantly higher for women (2.7%) than for men (1.9%). Lifting activities in house holding, heels and pregnancy are significant risk factors. Indeed, an increased risk of relapse exists in case of jobs re- quiring lifting, pulling or pushing objects >25 lbs. Prolonged periods of standing or walking may have the same effect. Risks are, in general, greater in women, for a first ever episode of LBP (Heymans, 2005; Macfarlane, 1997). On the other hand, differences of outcome after therapy still exist. A full-time be- havioural medicine program was particularly effective in fe- males, whereas rehabilitating men had no significant effect on either health or costs (Jensen, 2005). In men significantly better results for full RTW were found for light multidisciplinary treatment compared with treatment as usual, but no differences were found between extensive multidisciplinary treatment and
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Cost effectiveness of family psychoeducation to prevent relapse in major depression: Results from a randomized controlled trial

Cost effectiveness of family psychoeducation to prevent relapse in major depression: Results from a randomized controlled trial

To evaluate the depressive state, we administered the Hamilton Rating Scale for Depression (HAM-D) [12] and the Beck Depression Inventory (BDI) [13] before interven- tion and after 9 months. The treating psychiatrist, who was blinded to the intervention status, administered the HAM-D. The BDI-II was filled in by the patient himself. When the treating psychiatrist who was blinded to the allocated intervention recognized the re-emergence of a major depressive episode according to the DSM-IV in the course of the bi-weekly visits constituting the treatment as usual, the patient was referred to an independent psych- iatrist who also was kept blind to the intervention group and who administered the HAM-D and BDI. Relapse/ recurrence was declared when the diagnostic threshold for a major depressive episode as specified in the DSM- IV was met according to the interview by this inde- pendent psychiatrist. The number of depression-free days up to the relapse/recurrence was taken as the unit of effectiveness.
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Cognitive-Behavioral Therapy for Anxiety in Children With High-Functioning Autism: A Meta-analysis

Cognitive-Behavioral Therapy for Anxiety in Children With High-Functioning Autism: A Meta-analysis

Two reviewers independently evaluated the titles and abstracts of the located studies to determine eligibility for in- clusion in this meta-analysis using the following criteria: (1) included patient population with a primary diagnosis of ASD, (2) compared a group of patients receiving CBT for anxiety with a group of patients in a control condition (eg, waitlist, treatment as usual [TAU]), and (3) included at least 1 standardized measure of anxiety. Case studies, single- case designs, and qualitative case reports were not considered for this meta-analysis. We did not have an in- clusion criterion for the children ’ s level of cognitive functioning, but all studies included in this meta-analysis were conducted with subjects who had high- functioning ASD, de fi ned as IQ above 70. No published studies to our knowledge have evaluated CBT in children with ASD and IQ below 70.
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Enhancing inpatient psychotherapeutic treatment with online self help: study protocol for a randomized controlled trial

Enhancing inpatient psychotherapeutic treatment with online self help: study protocol for a randomized controlled trial

In addition to inpatient treatment (treatment as usual) consisting of individual and group psychotherapy, inte- grating body-oriented and creative psychotherapy interven- tions, as well as various adjunct treatments (for example, relaxation, patient education, exercising, therapeutic community) [20], participants in the intervention group receive access to a 12-week internet-based self-help treat- ment (deprexis®) that is described in detail elsewhere [21]. The self-help program consists of 10 modules, plus one introductory and one summary module. The modules combine cognitive and behavioral techniques with positive psychology, dream work and emotion-focused interven- tions. The contents of the modules are provided as a sim- ulated dialogue, explaining and illustrating concepts and techniques, engaging the user in exercises, and continu- ously asking for user feedback. Provision of subsequent content is tailored to the users’ responses. Participants can work through the program at their own pace, as modules are not gradually made available at a specific schedule [10]. If desired by the user, the program automatically delivers helpful comments or reminders on a daily basis by SMS or email.
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Assertive community treatment for elderly people with severe mental illness

Assertive community treatment for elderly people with severe mental illness

The study was carried out in the Netherlands by BavoEuropoort centre for mental healthcare in the greater Rotterdam area (1.3 million residents). BavoEur- opoort has 1,300 staff, who are employed at 32 sites in eleven municipalities. It provides treatment and gui- dance to people in whom complex psychiatric disorders are combined with problems in several life domains. It has various outpatient clinics and clinical settings for voluntary or involuntary admission. There are six ACT teams for patients who are difficult to engage in treat- ment. One of these teams focuses on elderly patients. BavoEuropoort also provides mental healthcare services for elderly people (55+) in their third and fourth stages of life who have mental health complaints and/or cogni- tive disorders.
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Acupuncture, or non directive counselling versus usual care for the treatment of depression: a pilot study

Acupuncture, or non directive counselling versus usual care for the treatment of depression: a pilot study

Depression is one of the most common reasons for con- sulting in primary care [1]. The economic burden of this health problem in the UK is estimated to be £9 billion per annum with £370 million being due to direct costs of treatment [2]. Despite these considerable costs, current pharmacological and psychological interventions options have limited acceptability and effectiveness. A recent sur- vey of London GPs found an "effectiveness gap" in the treatment of depression, an effectiveness gap being defined as an area of clinical practice in which GPs consid- ered available treatments as not fully effective [3]. Up to 33% of patients do not show an adequate response to pharmacological antidepressant treatment [4], and 30% do not adhere to their medication regime [1]. Patients have expressed the view that there is an over-reliance on prescribed antidepressant medications and that they are keen to have a range of possible treatment choices [5]. A significant number of individuals who are diagnosed and treated for depression also present with painful symp- toms, with prevalence estimates ranging from 43% to 65% [6]. A recent survey of 644 respondents conducted by the Depression Alliance found that 99% of people with depression have physical symptoms and 85% believe their "quality of life could be greatly improved if their aches and pains were managed effectively" [7]. GPs are optimally placed to manage these patients with both painful conditions and depression, but feel ill equipped to do so [6]. Patients with multiple painful symptoms and depression are less satisfied with their medical care than patients without mental disorders [8]. Evidence suggests that the presence of pain, particularly if it is severe, may be associated with a poor response to SSRIs [9].
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