Than Treatment As Usual Research Articles

Psychotherapies for generalized anxiety disorder in adults: systematic review and network meta-analysis of randomized-controlled trials

IntroductionGeneralized anxiety disorder (GAD) is one of the most common mental disorders in adults. Psychotherapies are among the most recommended treatment choices for GAD, but which should be considered as first-line treatment still needs to be clarified.ObjectivesTo examine the most effective and accepted psychotherapy for GAD both in the short and long-term, via a network meta-analysis.MethodsWe searched MEDLINE, Embase, PsycINFO, and the Cochrane Register of Controlled Trials – CENTRAL, from database inception to January 1st, 2023, to find randomized controlled trials (RCTs) of psychotherapies for GAD. Eight psychotherapies (behaviour therapy, cognitive-behaviour therapy, cognitive restructuring, psychoeducation, psychodynamic therapy, relaxation therapy, supportive psychotherapy, and third-wave CBTs) were compared with each other and two control conditions (treatment as usual, waiting list). We followed Cochrane standards when extracting data and assessing data quality and used PRISMA guidelines for the reporting. We conducted random-effects model pairwise and network meta-analyses. We assessed risk of bias of individual studies through the second version of the Cochrane’s Risk of Bias tool and used the Confidence in Network Meta-Analysis (CINeMA) to rate certainty of evidence for meta-analytical results. Severity of GAD symptoms and acceptability of the psychotherapies were our outcomes of interest.ResultsWe analysed data from 66 RCTs. Effect size estimates on data from 5,597 participants suggest third wave cognitive-behavioural therapies (standardized mean differences [SMDs] =-0.78; 95%CI=-1.19 to -0.37; certainty=moderate), cognitive-behavioural therapy (CBT) (SMD=-0.68; 95%CI=-1.05 to -0.32 certainty=moderate), and relaxation therapy (SMD=-0.54; 95%CI=-1.04 to -0.05; certainty=low) reduced generalized anxiety symptoms more than treatment as usual (TAU). Relative risks for all-cause discontinuation signalled no differences compared with TAU for all psychotherapies. When excluding studies at high risk of bias, relaxation therapy lost its superiority over TAU. When considering anxiety severity at three to twelve months after completion of the intervention only CBT remained significantly more efficacious than TAU (SMD=-0.58; 95%CI=-0.93 to -0.23).Image:ConclusionsGiven the evidence for both acute and long-term efficacy, CBT may represent the reasonable first-line psychological treatment for GAD. Third-wave CBT and relaxation therapy have short-term efficacy and may also be offered. Results from this investigation should inform patients, clinicians, and guidelines. This project is funded by the European Union’s HORIZON EUROPE research programme under grant agreement No 101061648.Disclosure of InterestNone Declared

CLEAR – clozapine in early psychosis: study protocol for a multi-centre, randomised controlled trial of clozapine vs other antipsychotics for young people with treatment resistant schizophrenia in real world settings

BackgroundClozapine is an antipsychotic drug with unique efficacy, and it is the only recommended treatment for treatment-resistant schizophrenia (TRS: failure to respond to at least two different antipsychotics). However, clozapine is also associated with a range of adverse effects which restrict its use, including blood dyscrasias, for which haematological monitoring is required. As treatment resistance is recognised earlier in the illness, the question of whether clozapine should be prescribed in children and young people is increasingly important. However, most research to date has been in older, chronic patients, and evidence regarding the efficacy and safety of clozapine in people under age 25 is lacking. The CLEAR (CLozapine in EARly psychosis) trial will assess whether clozapine is more effective than treatment as usual (TAU), at the level of clinical symptoms, patient rated outcomes, quality of life and cost-effectiveness in people below 25 years of age. Additionally, a nested biomarker study will investigate the mechanisms of action of clozapine compared to TAU.Methods and designThis is the protocol of a multi-centre, open label, blind-rated, randomised controlled effectiveness trial of clozapine vs TAU (any other oral antipsychotic monotherapy licenced in the British National Formulary) for 12 weeks in 260 children and young people with TRS (12–24 years old).Aim and objectivesThe primary outcome is the change in blind-rated Positive and Negative Syndrome Scale scores at 12 weeks from baseline. Secondary outcomes include blind-rated Clinical Global Impression, patient-rated outcomes, quality of life, adverse effects, and treatment adherence. Patients will be followed up for 12 months and will be invited to give consent for longer term follow-up using clinical records and potential re-contact for further research. For mechanism of action, change in brain magnetic resonance imaging (MRI) biomarkers and peripheral inflammatory markers will be measured over 12 weeks.DiscussionThe CLEAR trial will contribute knowledge on clozapine effectiveness, safety and cost-effectiveness compared to standard antipsychotics in young people with TRS, and the results may guide future clinical treatment recommendation for early psychosis.Trial registrationISRCTN Number: 37176025, IRAS Number: 1004947.Trial statusIn set-up. Protocol version 4.0 01/08/23. Current up to date protocol available here: https://fundingawards.nihr.ac.uk/award/NIHR131175#/.

Piloting building early sentences therapy for pre-school children with low language abilities: An examination of efficacy and the role of sign as an active ingredient.

Early intervention is recommended for pre-school children with low language. However, few robustly evaluated language interventions for young children exist. Furthermore, in many interventions the theoretical underpinnings are underspecified and the 'active ingredients' of the interventions not tested. This paper presents a quasi-experimental study to test the efficacy and examine the active ingredients of Building Early Sentences Therapy (BEST): an intervention based on usage-based theory designed to support young children to understand and produce two-, three- and four-clause element sentences. BEST manipulates the input children hear to support them to harness the cognitive mechanisms hypothesized in usage-based theories to promote the development of abstract linguistic representations. One such input manipulation is the use of signing alongside verbal input signalling both content and morphology of target sentences. To examine whether (1) BEST is more efficacious than treatment as usual (TAU); and (2) signing of content and morphology is an active ingredient of the intervention. A quasi-experimental study recruited children aged 3;5-4;5 years from 13 schools. Schools were assigned to receive either BEST with sign, BEST without sign or TAU. The TAU group received their usual classroom provision. Across arms schools were matched with respect to classroom oral language environment and indices of deprivation. Participants were 48 children (28 boys) with expressive and/or receptive language abilities ≤ 16th centile measured using the New Reynell Developmental Language Scales (NRDLS). Outcomes gathered by researchers blind to treatment arm were NRDLS production and comprehension standard scores and measures of production of targeted sentence structures. Primary outcomes indicate that BEST with sign was significantly more efficacious than TAU with respect to NRDLS production standard score, but not comprehension. The advantage for production was maintained at follow-up. BEST without sign was significantly more efficacious than TAU on measures of targeted vocabulary, sentence structure and morphology. The results from this quasi-experimental study provide evidence for the efficacy of a usage-based intervention on expressive language outcomes for preschool children with low language abilities. There is also evidence to support the inclusion of sign as an active ingredient, and so efforts to train interventionists in its use are worthwhile. Patterns of findings across outcomes suggest signing of content and morphology may support the development of abstract linguistic representations and accelerate language learning. Given these positive results and the scale of this study, a fully powered randomized controlled trial is warranted. What is already known on the subject Robust language skills are crucial for positive social, emotional, academic and economic outcomes across the lifespan. There is a paucity of robustly evaluated interventions for preschool children with language difficulties. The development of such interventions is crucial for ameliorating language difficulties and promoting positive educational and psychosocial outcomes. What this study adds to the existing knowledge This paper evaluates BEST, a novel usage-based language intervention targeting children with language difficulties in the early years. Findings indicate that a usage-based intervention is efficacious for treating language difficulties. In particular, BEST benefited expressive language development, bringing benefits to both treated and untreated language structures and improving standard scores. The role of sign as an active ingredient is also supported. Further evaluation is warranted. What are the practical and clinical implications of this work? Findings suggest that BEST may be effective for targeting children who have been identified as having language difficulties. In particular, expressive language may be improved when the intervention is delivered as it was originally manualized, including a signing system to represent content and grammatical morphology. More broadly, these findings also provide preliminary evidence that the use of a signing system does not hinder oral language development in children with language difficulties and may conversely support their expressive language. Future research exploring the role and underpinning mechanisms of sign in language intervention is warranted.

Innovative strategies for the management of common mental disorders

Abstract Innovations such as computerized/internet-based interventions are taking centre stage in the management of common mental disorders. For example, computer-assisted cognitive behavior therapy (CCBT) has been proposed as a method for improving access to effective psychotherapy, reducing cost, and increasing the convenience and efficiency of treatment for depression. Results from our own research suggest that CCBT may have significantly greater effects on depressive symptoms than treatment as usual (TAU) in primary care patients with depression. Our study population included people with lower income and lack of internet access who typically have been underrepresented or not included in earlier investigations of CCBT; hence, results suggest that this form of treatment can be acceptable and useful in diverse primary care settings.

Culturally sensitive stepped care for adolescent refugees: efficacy and cost–utility of a multicentric randomized controlled trial

Adolescent refugees and asylum seekers (ARAS) are highly vulnerable to mental health problems. Stepped care models (SCM) and culturally sensitive therapies offer promising treatment approaches to effectively provide necessary medical and psychological support. To our knowledge, we were the first to investigate whether a culturally sensitive SCM will reduce symptoms of depression and PTSD in ARAS more effectively and efficiently than treatment as usual (TAU). We conducted a multicentric, randomized, controlled and rater-blinded trial across Germany with ARAS between the ages of 14 to 21 years. Participants (N = 158) were stratified by their level of depressive symptom severity and then equally randomized to either SCM or TAU. Depending on their severity level, SCM participants were allocated to tailored interventions. Symptom changes were assessed for depression (PHQ) and PTSD (CATS) at four time points, with the primary end point at post-intervention after 12 weeks. Based on an intention-to-treat sample, we used a linear mixed model approach for the main statistical analyses. Further evaluations included cost–utility analyses, sensitivity analyses, follow-up-analyses, response and remission rates and subgroup analysis. We found a significant reduction of PHQ (d = 0.52) and CATS (d = 0.27) scores in both groups. However, there was no significant difference between SCM and TAU. Cost–utility analyses indicated that SCM generated greater cost–utility when measured as quality-adjusted life years compared to TAU. Subgroup analysis revealed different effects for the SCM interventions depending on the outcome measure. Although culturally sensitive, SCMs did not prove to be more effective in symptom change and represent a more cost-effective treatment alternative for mentally burdened ARAS. Our research contributes to the optimization of clinical productivity and the improvement of therapeutic care for ARAS. Disorder-specific interventions should be further investigated.

Comparative efficacy of psychosocial interventions for opioid-dependent people receiving methadone maintenance treatment: A network meta-analysis.

To estimate the efficacy of multiple psychosocial interventions for opioid-dependent people receiving methadone maintenance treatment (MMT). Systematic review and network meta-analysis of randomized controlled trials (RCTs) reporting the effect of psychosocial intervention for opioid-dependent people receiving MMT in outpatient clinics. We searched multiple data sources (Medline, Embase, Web of Science, PsycINFO and Cochrane Library) from inception to January 2022, finding 21 RCTs evaluating a total of 2862 people with opioid dependence receiving MMT. The primary outcome was the opioid-positive rate (assessed by urinalysis) and the secondary outcome was treatment discontinuation (the number of patients who terminated the study for any reason). We performed random-effects Bayesian meta-analysis. We used relative ranking using surface under the cumulative ranking method and certainty of evidence using grading of recommendations, assessment, development and evaluations. Cognitive-behavioral therapy (CBT) [odds ratio (OR) =0.66, 95% credible interval (CI) =0.66-0.96; low certainty] and educational and behavioral counseling (EBC) (OR =0.28, 95% CI =0.12-0.25; high certainty) were more effective than treatment as usual (TAU) in efficacy. In terms of treatment discontinuation, at the end of the follow-up period there was no statistical significance among psychosocial interventions. According to the ranking probabilities, EBC might be the most effective treatment and behavioral couples' therapy (BCT) might be the best discontinuation treatment. Educational and behavioral counseling and cognitive-behavioral therapy appear to be the most effective psychosocial interventions for opioid-dependent people receiving methadone maintenance treatment.

Effect of Computer-Assisted Cognitive Behavior Therapy vs Usual Care on Depression Among Adults in Primary Care

Depression is a common disorder that may go untreated or receive suboptimal care in primary care settings. Computer-assisted cognitive behavior therapy (CCBT) has been proposed as a method for improving access to effective psychotherapy, reducing cost, and increasing the convenience and efficiency of treatment for depression. To evaluate whether clinician-supported CCBT is more effective than treatment as usual (TAU) in primary care patients with depression and to examine the feasibility and implementation of CCBT in a primary care population with substantial numbers of patients with low income, limited internet access, and low levels of educational attainment. This randomized clinical trial included adult primary care patients from clinical practices at the University of Louisville who scored 10 or greater on the Patient Health Questionnaire-9 (PHQ-9) and were randomly assigned to CCBT or TAU for 12 weeks of active treatment. Follow-up assessments were conducted 3 and 6 months after treatment completion. Enrollment occurred from June 24, 2016, to May 13, 2019. The last follow-up assessment was conducted on January 30, 2020. CCBT included use of the 9-lesson computer program Good Days Ahead, along with as many as 12 weekly telephonic support sessions of approximately 20 minutes with a master's level therapist, in addition to TAU, which consisted of the standard clinical management procedures at the primary care sites. TAU was uncontrolled, but use of antidepressants and psychotherapy other than CCBT was recorded. The primary outcome measure (PHQ-9) and secondary outcome measures (Automatic Thoughts Questionnaire for negative cognitions, Generalized Anxiety Disorder-7, and the Satisfaction with Life Scale for quality of life) were administered at baseline, 12 weeks, and 3 and 6 months after treatment completion. Satisfaction with treatment was assessed with the Client Satisfaction Questionnaire-8. The sample of 175 patients was predominately female (147 of 174 [84.5%]) and had a high proportion of individuals who identified as racial and ethnic minority groups (African American, 44 of 162 patients who reported [27.2%]; American Indian or Alaska Native, 2 [1.2%]; Hispanic, 4 [2.5%]; multiracial, 14 [8.6%]). An annual income of less than $30 000 was reported by 88 of 143 patients (61.5%). Overall, 95 patients (54.3%) were randomly assigned to CCBT and 80 (45.7%) to TAU. Dropout rates were 22.1% for CCBT (21 patients) and 30.0% for TAU (24 patients). An intent-to-treat analysis found that CCBT led to significantly greater improvement in PHQ-9 scores than TAU at posttreatment (mean difference, -2.5; 95% CI, -4.5 to -0.8; P = .005) and 3 month (mean difference, -2.3; 95% CI, -4.5 to -0.8; P = .006) and 6 month (mean difference, -3.2; 95% CI, -4.5 to -0.8; P = .007) follow-up points. Posttreatment response and remission rates were also significantly higher for CCBT (response, 58.4% [95% CI, 46.4-70.4%]; remission, 27.3% [95% CI, 16.4%-38.2%]) than TAU (response, 33.1% [95% CI, 20.7%-45.5%]; remission, 12.0% [95% CI, 3.3%- 20.7%]). In this randomized clinical trial, CCBT was found to have significantly greater effects on depressive symptoms than TAU in primary care patients with depression. Because the study population included people with lower income and lack of internet access who typically have been underrepresented or not included in earlier investigations of CCBT, results suggest that this form of treatment can be acceptable and useful in diverse primary care settings. Additional studies with larger samples are needed to address implementation procedures that could enhance the effectiveness of CCBT and to examine potential factors associated with treatment outcome. ClinicalTrials.gov Identifier: NCT02700009.

Cost effectiveness of therapist delivered cognitive behavioural therapy and web-based self-management in irritable bowel syndrome: the ACTIB randomised trial

BackgroundTelephone therapist delivered CBT (TCBT) and web-based CBT (WCBT) have been shown to be significantly more clinically effective than treatment as usual (TAU) at reducing IBS symptom severity and impact at 12 months in adults with refractory IBS. In this paper we assess the cost-effectiveness of the interventions.MethodsParticipants were recruited from 74 general practices and three gastroenterology centres in England. Interventions costs were calculated, and other service use and lost employment measured and costed for one-year post randomisation. Quality-adjusted life years (QALYs) were combined with costs to determine cost-effectiveness of TCBT and WCBT compared to TAU.ResultsTCBT cost £956 more than TAU (95% CI, £601–£1435) and generated 0.0429 more QALYs. WCBT cost £224 more than TAU (95% CI, − £11 to £448) and produced 0.029 more QALYs. Compared to TAU, TCBT had an incremental cost per QALY of £22,284 while the figure for WCBT was £7724. After multiple imputation these ratios increased to £27,436 and £17,388 respectively. Including lost employment and informal care, TCBT had costs that were on average £866 lower than TAU (95% CI, − £1133 to £2957), and WCBT had costs that were £1028 lower than TAU (95% CI, − £448 to £2580).ConclusionsTCBT and WCBT resulted in more QALYs and higher costs than TAU. Complete case analysis suggests both therapies are cost-effective from a healthcare perspective. Imputation for missing data reduces cost-effectiveness but WCTB remained cost-effective. If the reduced societal costs are included both interventions are likely to be more cost-effective.Trial registration ISRCTN44427879 (registered 18.11.13).

A network meta-analysis of psychosocial interventions for refugees and asylum seekers with PTSD

IntroductionRefugees and asylum seekers are vulnerable to common mental disorders, including post-traumatic stress disorder (PTSD). Using a network meta-analysis (NMA) approach, the present systematic review compared and ranked psychosocial interventions...

Community-Based Rehabilitation for Persons with Severe Mental Illness in a Rural Community of Karnataka: Methodology of a Randomized Controlled Study.

Background:Task shifting has been recommended as a strategy to reach out to persons with mental illness and bridge the treatment gap. There is a need to explore task-shifting using existing health staff like Accredited Social Health Activists (ASHAs).Aim and Context:ASHAs are involved in ongoing community-based rehabilitation (CBR) program run with a public–private partnership over the last 5 years at Jagaluru Taluk (an administrative block) in Davanagere district (Karnataka, India). This article aims to summarize a randomized controlled trial (RCT) to examine whether CBR delivered by ASHAs is more effective than treatment as usual (TAU) control group in reducing disability associated with severe mental illness (SMI).Method:A group of proactive ASHAs is already working with us for a follow-up of persons with SMI. For the study, we would allocate areas that are currently not being covered proactively by ASHAs randomly in a 1:1 ratio via computer-generated randomization list to receive either ASHAs delivered CBR arm or TAU control group. A sample size of about 100 in each arm is enough to identify an effect size of 0.5 in total IDEAS score between the intervention and control arms with a power of 90% and an alpha of 0.05. We use the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement to describe the methods of the trial.Result:The study has been approved by the institute ethics committee and registered with CTRI (CTRI/2019/08/020585 dated 6th August 2019). The recruitment of subjects is ongoing. The patients will be followed up for 1 year and assessed. The trial is funded by the Indian Council of Medical Research, Government of India.Discussion:The results of the study will be helpful from a public health perspective in delivering cost-effective and replicable CBR for persons with SMI through ASHAs. If the model turns successful, this could be expanded throughout the state/country. This would go a long way in bridging the huge treatment gap.

Effectiveness and moderators of individual cognitive behavioral therapy versus treatment as usual in clinically depressed adolescents: a randomized controlled trial

We examined if manualized cognitive behavioral therapy (CBT) was more effective than Treatment As Usual (TAU) for clinically depressed adolescents within routine care. This multisite Randomized controlled trail included 88 clinically depressed adolescents (aged 12–21 years) randomly assigned to CBT or TAU. Multiple assessments (pre-, post treatment and six-month follow-up) were done using semi-structured interviews, questionnaires and ratings and multiple informants. The primary outcome was depressive or dysthymic disorder based on the KSADS. Completers, CBT (n = 19) and TAU (n = 26), showed a significant reduction of affective diagnoses at post treatment (76% versus 76%) and after six months (90% versus 79%). Intention-to-treat analyses on depressive symptoms showed that 41.6% within CBT and 31.8% within the TAU condition was below clinical cut-off at post treatment and after six-months, respectively 61.4% and 47.7%. No significant differences in self-reported depressive symptoms between CBT and TAU were found. No prediction or moderation effects were found for age, gender, child/parent educational level, suicidal criteria, comorbidity, and severity of depression. We conclude that CBT did not outperform TAU in clinical practice in the Netherlands. Both treatments were found to be suitable to treat clinically referred depressed adolescents. CBT needs further improvement to decrease symptom levels below the clinical cut-off at post treatment.

Telephone-based cognitive behavioral therapy for depression in Parkinson disease: A randomized controlled trial.

ObjectiveTo determine whether, for patients with depression and Parkinson disease (PD), telephone-based cognitive-behavioral treatment (T-CBT) alleviates depressive symptoms significantly more than treatment as usual (TAU), we conducted a randomized controlled trial to evaluate the efficacy of a 10-session T-CBT intervention for depression in PD, compared to TAU.MethodsSeventy-two people with PD (PWP) were randomized to T-CBT + TAU or TAU only. T-CBT tailored to PWPs’ unique needs was provided weekly for 3 months, then monthly during 6-month follow-up. CBT targeted negative thoughts (e.g., “I have no control”; “I am helpless”) and behaviors (e.g., social withdrawal, excessive worry). It also trained care partners to help PWP practice healthy habits. Blind raters assessed outcomes at baseline, midtreatment, treatment end, and 1 and 6 months post-treatment. Analyses were intent to treat.ResultsT-CBT outperformed TAU on all depression, anxiety, and quality of life measures. The primary outcome (Hamilton Depression Rating Scale score) improved significantly in T-CBT compared to TAU by treatment end. Mean improvement from baseline was 6.53 points for T-CBT and −0.27 points for TAU (p < 0.0001); gains persisted over 6-month follow-up (p < 0.0001). Improvements were moderated by a reduction in negative thoughts in the T-CBT group only, reflecting treatment target engagement.ConclusionsT-CBT may be an effective depression intervention that addresses a significant unmet PD treatment need and bypasses access barriers to multidisciplinary, evidence-based care.Clinicaltrials.gov identifierNCT02505737.Classification of evidenceThis study provides Class I evidence that for patients with depression and PD, T-CBT significantly alleviated depressive symptoms compared to usual care.

Effectiveness of cognitive-behavioural therapy for depression in advanced cancer: CanTalk randomised controlled trial.

Depression is one of the most common mental disorders in people with advanced cancer. Although cognitive-behavioural therapy (CBT) has been shown to be effective for depression in people with cancer, it is unclear whether this is the case for people with advanced cancer and depression. We sought to determine whether CBT is more clinically effective than treatment as usual (TAU) for treating depression in people with advanced cancer (trial registration number ISRCTN07622709). A multi-centre, parallel-group single-blind randomised controlled trial comparing TAU with CBT (plus TAU). Participants (n = 230) with advanced cancer and depression were randomly allocated to (a) up to 12 sessions of individual CBT or (b) TAU. The primary outcome measure was the Beck Depression Inventory-II (BDI-II). Secondary outcome measures included the Patient Health Questionnaire-9, the Eastern Cooperative Oncology Group Performance Status, and Satisfaction with Care. Multilevel modelling, including complier-average intention-to-treat analysis, found no benefit of CBT. CBT delivery was proficient, but there was no treatment effect (-0.84, 95% CI -2.76 to 1.08) or effects for secondary measures. Exploratory subgroup analysis suggested an effect of CBT on the BDI-II in those widowed, divorced or separated (-7.21, 95% CI -11.15 to -3.28). UK National Institute for Health and Care Excellence (NICE) guidelines recommend CBT for treating depression. Delivery of CBT through the Improving Access to Psychological Therapies (IAPT) programme has been advocated for long-term conditions such as cancer. Although it is feasible to deliver CBT through IAPT proficiently to people with advanced cancer, this is not clinically effective. CBT for people widowed, divorced or separated needs further exploration. Alternate models of CBT delivery may yield different results.

Cost-effectiveness of Housing First Intervention With Intensive Case Management Compared With Treatment as Usual for Homeless Adults With Mental Illness

In the At Home/Chez Soi trial for homeless individuals with mental illness, the scattered-site Housing First (HF) with Intensive Case Management (ICM) intervention proved more effective than treatment as usual (TAU). To evaluate the cost-effectiveness of the HF plus ICM intervention compared with TAU. This is an economic evaluation study of data from the At Home/Chez Soi randomized clinical trial. From October 2009 through July 2011, 1198 individuals were randomized to the intervention (n = 689) or TAU (n = 509) and followed up for as long as 24 months. Participants were recruited in the Canadian cities of Vancouver, Winnipeg, Toronto, and Montreal. Participants with a current mental disorder who were homeless and had a moderate level of need were included. Data were analyzed from 2013 through 2019, per protocol. Scattered-site HF (using rent supplements) with off-site ICM services was compared with usual housing and support services in each city. The analysis was performed from the perspective of society, with days of stable housing as the outcome. Service use was ascertained using questionnaires. Unit costs were estimated in 2016 Canadian dollars. Of 1198 randomized individuals, 795 (66.4%) were men and 696 (58.1%) were aged 30 to 49 years. Almost all (1160 participants, including 677 in the HF group and 483 in the TAU group) contributed data to the economic analysis. Days of stable housing were higher by 140.34 days (95% CI, 128.14-153.31 days) in the HF group. The intervention cost $14 496 per person per year; reductions in costs of other services brought the net cost down by 46% to $7868 (95% CI, $4409-$11 405). The incremental cost-effectiveness ratio was $56.08 (95% CI, $29.55-$84.78) per additional day of stable housing. In sensitivity analyses, adjusting for baseline differences using a regression-based method, without altering the discount rate, caused the largest change in the incremental cost-effectiveness ratio with an increase to $60.18 (95% CI, $35.27-$86.95). At $67 per day of stable housing, there was an 80% chance that HF was cost-effective compared with TAU. The cost-effectiveness of HF appeared to be similar for all participants, although possibly less for those with a higher number of previous psychiatric hospitalizations. In this study, the cost per additional day of stable housing was similar to that of many interventions for homeless individuals. Based on these results, expanding access to HF with ICM appears to be warranted from an economic standpoint. isrctn.org Identifier: ISRCTN42520374.

Supported self-help to prevent relapse or recurrence of depression: Who benefits most?

BackgroundThis study aimed to identify subgroups for whom supported self-help preventive cognitive therapy (S-PCT) is more (cost)effective than treatment as usual (TAU) in preventing relapse and recurrence of major depression. MethodsWe conducted a randomized controlled trial in which 248 remitted, recurrently depressed participants were randomized to S-PCT (n = 124) or TAU (n = 124). Clinical outcome was relapse or recurrence of major depressive disorder (SCID-I). We tested the moderating effects on relapse or recurrence of age, gender, education level, residual depressive symptoms, number of previous episodes, age of onset, antidepressant medication, somatization, and self-efficacy with logistic regression analyses adjusted for baseline values of depressive symptoms. We examined moderating effects on costs using linear regression analyses adjusted for baseline costs. A stratified cost-effectiveness analysis was performed to tease out differences in cost-effectiveness between subgroups. ResultsWe found no moderating effect on relapse or recurrence for any of the potential moderators. For costs, the number of previous depressive episodes was identified as a moderator. At a willingness-to-pay of 16,000€, the probability that S-PCT was cost-effective compared to TAU was 95% for participants with 2–3 episodes and 11% for participants with ≥4 episodes. LimitationsParticipants and counselors were not blinded. The study was primarily designed to assess the (cost)effectiveness of S-PCT and not to conduct moderation analyses. ConclusionsS-PCT was effective in preventing relapse or recurrence of depressive disorders in a broad range of participants, but is more likely to be cost-effective in participants with 2–3 episodes than ≥4 episodes. This indicates that S-PCT can best be offered to participants with fewer previous depressive episodes.

Use of Health Technologies for Low Back Pain in the Military Health System

Low back pain (LBP) is a widespread condition that poses specific occupational risks for active-duty military personnel. Barriers to treatment are also greater for military personnel and veterans. The authors conducted a review of the literature to identify technology solutions to help offset barriers to treatment for military personnel and veterans. Researchers conducted a PubMed search using subject headings and natural language terms and phrases. Three research psychologists screened abstracts and full text articles. After application of exclusion criteria, 28 key articles on treatment of LBP leveraging technology were included. There is evidence in medical literature for the efficacy of health technology in the treatment of LBP. Telehealth can be effective in reducing pain levels, and more convenient and cost-effective than treatment as usual (TAU). Smartphone and mobile apps are effective for managing LBP by providing self-management tools and tracking methods. Internet-based programs are highly accessible, cost-effective, and less stigmatized than TAU. Wearable technologies, such as biofeedback and electronic sensors, are effective for reducing pain and improve physical rehabilitation assessment and treatment for chronic LBP. Findings for emerging technologies are reviewed and discussed. Considerable evidence exists for incorporating technology into treatment programs for LBP. The most promising technologies were as follows: telehealth, internet-based programs, and mobile apps. Benefits of using technology in treatment programs included not only reduction in pain symptoms, but also enabling self-management, allowing anonymous participation, portability of treatment, and cost effectiveness.

Dialectical behaviour therapy and 12‐step programmes for substance use disorder: A systematic review and meta‐analysis

AbstractBackgroundResearch on dialectical behaviour therapy (DBT) or 12‐step programmes has shown inconclusive results; no systematic review has directly compared the two.ObjectivesThe goals of this meta‐analytic review were to assess if DBT is more effective than treatment as usual (TAU) and if DBT is more effective than 12‐step programmes (including twelve‐step facilitation [TSF] and self‐help groups like Alcoholics Anonymous) for substance use disorder (SUD).MethodsWe searched for randomised controlled trials (RCTs) and extracted data on the following outcomes: reduction in substance use, retention in treatment, severity of substance dependence/abuse and severity of mental health symptoms. Studies involved adult (&gt;18 years) women with SUD, according to DSM‐5 or the equivalent diagnoses in DSM‐IV. Three RCTs met the inclusion criteria and contained appropriate data for meta‐analysis (75 participants).ResultsNo significant effects of DBT have been found compared to 12‐step programmes. Comparing DBT with TAU, we found a beneficial short‐term (1 RCT, n = 12, SMD = −0.84; 95% CI [−1.64, −0.04]) and long‐term (2 RCTs, n = 29, SMD = −1.26; 95% CI [−2.13, −0.40]) effect of DBT on severity of substance use.ConclusionsDespite the limited evidence of the present review, contextual evidence supports DBT and 12‐step programmes. RCTs with larger sample sizes are needed to better elucidate the impact of both treatments on SUD and facilitate the comparison between DBT and 12 steps programmes.

Managing suicidality within specialized care: A randomized controlled trial

BackgroundSuicide prevention is a core task in mental health services. Our objective was to determine whether Collaborative Assessment and Management of Suicidality (CAMS) reduced suicidal thoughts and behaviors and mental health distress more effectively than treatment as usual (TAU) in a heterogeneous patient population within specialized mental health care services. MethodsIn this observer-blinded pragmatic randomized controlled trial participants who scored 13 or above on Beck's Scale for Suicide Ideation-Current (BSSI-C) were included from seven in- and outpatient units. Primary outcome was suicidal ideation (BSSI-C). Secondary outcomes were mental health distress measured by the Outcome Questionnaire–45, and suicidal behaviors measured by the Suicide Attempt Self-Injury Count. Patients were assessed at baseline and after 6 and 12 months. ResultsThe final intent-to-treat analyses included 78 participants (mean age 35.9 years, SD = 14.5, 41 females). The majority were depressed (65%), had a secondary diagnosis (73%) and 32% suffered from borderline personality disorder or borderline traits. After 6 months, CAMS participants reported lower levels of suicidal ideation compared to TAU (β = −4.29, 95% CI = −8.32 to −0.27, p = .036). Larger changes in mental health distress were observed for CAMS participants after 6 months (β = −11.87, 95% CI = −22.99 to −0.76, p = .036) and 12 months (β = −13.70, 95% CI = −24.88 to −2.51, p = .017). LimitationsThe modest sample size rendered the trial unable to detect small between-group differences. ConclusionsCAMS reduced suicidal ideation and mental health distress more efficiently than TAU in a heterogeneous patient population within specialized care.

Cognitive-behavioural therapy for clozapine-resistant schizophrenia: the FOCUS RCT.

Clozapine (clozaril, Mylan Products Ltd) is a first-choice treatment for people with schizophrenia who have a poor response to standard antipsychotic medication. However, a significant number of patients who trial clozapine have an inadequate response and experience persistent symptoms, called clozapine-resistant schizophrenia (CRS). There is little evidence regarding the clinical effectiveness of pharmacological or psychological interventions for this population. To evaluate the clinical effectiveness and cost-effectiveness of cognitive-behavioural therapy (CBT) for people with CRS and to identify factors predicting outcome. The Focusing on Clozapine Unresponsive Symptoms (FOCUS) trial was a parallel-group, randomised, outcome-blinded evaluation trial. Randomisation was undertaken using permuted blocks of random size via a web-based platform. Data were analysed on an intention-to-treat (ITT) basis, using random-effects regression adjusted for site, age, sex and baseline symptoms. Cost-effectiveness analyses were carried out to determine whether or not CBT was associated with a greater number of quality-adjusted life-years (QALYs) and higher costs than treatment as usual (TAU). Secondary care mental health services in five cities in the UK. People with CRS aged ≥ 16 years, with an International Classification of Diseases, Tenth Revision (ICD-10) schizophrenia spectrum diagnoses and who are experiencing psychotic symptoms. Individual CBT included up to 30 hours of therapy delivered over 9 months. The comparator was TAU, which included care co-ordination from secondary care mental health services. The primary outcome was the Positive and Negative Syndrome Scale (PANSS) total score at 21 months and the primary secondary outcome was PANSS total score at the end of treatment (9 months post randomisation). The health benefit measure for the economic evaluation was the QALY, estimated from the EuroQol-5 Dimensions, five-level version (EQ-5D-5L), health status measure. Service use was measured to estimate costs. Participants were allocated to CBT (n = 242) or TAU (n = 245). There was no significant difference between groups on the prespecified primary outcome [PANSS total score at 21 months was 0.89 points lower in the CBT arm than in the TAU arm, 95% confidence interval (CI) -3.32 to 1.55 points; p = 0.475], although PANSS total score at the end of treatment (9 months) was significantly lower in the CBT arm (-2.40 points, 95% CI -4.79 to -0.02 points; p = 0.049). CBT was associated with a net cost of £5378 (95% CI -£13,010 to £23,766) and a net QALY gain of 0.052 (95% CI 0.003 to 0.103 QALYs) compared with TAU. The cost-effectiveness acceptability analysis indicated a low likelihood that CBT was cost-effective, in the primary and sensitivity analyses (probability < 50%). In the CBT arm, 107 participants reported at least one adverse event (AE), whereas 104 participants in the TAU arm reported at least one AE (odds ratio 1.09, 95% CI 0.81 to 1.46; p = 0.58). Cognitive-behavioural therapy for CRS was not superior to TAU on the primary outcome of total PANSS symptoms at 21 months, but was superior on total PANSS symptoms at 9 months (end of treatment). CBT was not found to be cost-effective in comparison with TAU. There was no suggestion that the addition of CBT to TAU caused adverse effects. Future work could investigate whether or not specific therapeutic techniques of CBT have value for some CRS individuals, how to identify those who may benefit and how to ensure that effects on symptoms can be sustained. Current Controlled Trials ISRCTN99672552. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 7. See the NIHR Journals Library website for further project information.

Improving the quality of life of care home residents with dementia: Cost-effectiveness of an optimized intervention for residents with clinically significant agitation in dementia

IntroductionTo examine whether an optimized intervention is a more cost-effective option than treatment as usual (TAU) for improving agitation and quality of life in nursing home residents with clinically significant agitation and dementia. MethodsA cost-effectiveness analysis within a cluster-randomized factorial study in 69 care homes with 549 residents was conducted. Each cluster was randomized to receive either the Well-being and Health for people with Dementia (WHELD) intervention or TAU for nine months. Health and social care costs, agitation, and quality of life outcomes were evaluated. ResultsImprovements in agitation and quality of life were evident in residents allocated to the WHELD intervention group. The additional cost of the WHELD intervention was offset by the higher health and social care costs incurred by TAU group residents (mean difference, £2103; 95% confidence interval, −13 to 4219). DiscussionThe WHELD intervention has clinical and economic benefits when used in residents with clinically significant agitation.