Efficacy of pharmacogenetic (PGx)-guided antidepressant treatment on functional outcomes and quality of life in adults with anxiety and affective disorders: A systematic review and meta-analysis.

A Brief Behavioral Intervention Targeting Mental Health Risk Factors for Vascular Disease: A Pilot Study

Mindfulness in sex therapy and intimate relationships: a feasibility and randomized controlled pilot study in a cross-diagnostic group

Long-term effects of rent supplements and mental health support services on housing and health outcomes of homeless adults with mental illness: extension study of the At Home/Chez Soi randomised controlled trial

BackgroundLittle information is available about whether the use of self-assessment instruments in primary care affects depression course and outcome. The purpose was to evaluate whether using a depression self-rating scale in recurrent person-centred GP consultations affected depression severity, quality of life, medication use, and sick leave frequency.MethodsPatients in the intervention group met their GP regularly at least 4 times during the 3 months intervention. In addition to treatment as usual (TAU), patients completed a self-assessment instrument (Montgomery-Asberg Depression Rating Scale) on each occasion, and then GPs used the completed instrument as the basis for a person-centred discussion of changes in depression symptoms. The control group received TAU. Frequency of visits in the TAU arm was the result of the GPs’ and patients’ joint assessments of care need in each case.Depression severity was measured with Beck Depression Inventory-II (BDI-II), quality of life with EQ-5D, and psychological well-being with the General Health Questionnaire-12 (GHQ-12). Data on sick leave, antidepressant and sedatives use, and care contacts were collected from electronic patient records. All variables were measured at baseline and 3, 6, and 12 months. Mean intra-individual changes were compared between the intervention and TAU group.ResultsThere were no significant differences between the intervention and control group in depression severity reduction or remission rate, change in quality of life, psychological well-being, sedative prescriptions, or sick leave during the whole 12-month follow-up. However, significantly more patients in the intervention group continued antidepressants until the 6 month follow-up (86/125 vs 78/133, p < 0.05).ConclusionsWhen GPs used a depression self-rating scale in recurrent consultations, patients more often continued antidepressant medication according to guidelines, compared to TAU patients. However, reduction of depressive symptoms, remission rate, quality of life, psychological well-being, sedative use, sick leave, and health care use 4-12 months was not significantly different from the TAU group. These findings suggest that frequent use of depression rating scales in person-centred primary care consultations has no further additional effect on patients’ depression or well-being, sick leave, or health care use.Trial registrationClinicalTrials.gov Identifier: NCT01402206. Registered June 27 2011(retrospectively registered).

Objective: Internet-delivered cognitive behavioral therapy (ICBT) is recommended as an efficient treatment alternative for depression in primary care. However, only few previous studies have been conducted at primary care centers (PCCs). We evaluated long-term effects of ICBT treatment for depression compared to treatment as usual (TAU) in primary care settings.Design: Randomized controlled trial.Setting: Patients were enrolled at16 PCCs in south-west Sweden.Participants: Patients attending PCCs and diagnosed with depression (n = 90).Interventions: Patients were assessed by a primary care psychologist/psychotherapist and randomized to ICBT or TAU. The ICBT included an ICBT program consisting of seven modules and weekly therapist e-mail or telephone support during the 3-month treatment period.Main outcome measures: Questionnaires on depressive symptoms (BDI-II), quality of life (EQ-5D) and psychological distress (GHQ-12) were administered at baseline, with follow-ups at 3, 6 and 12 months. Antidepressants and sedatives use, sick leave and PCC contacts were registered.Results: Intra-individual change in depressive symptoms did not differ between the ICBT group and the TAU group during the treatment period or across the follow-up periods. At 3-month follow-up, significantly fewer patients in ICBT were on antidepressants. However, the difference leveled out at later follow-ups. There were no differences between the groups concerning psychological distress, sick leave or quality of life, except for a larger improvement in quality of life in the TAU group during the 0- to 6-month period.Conclusions: ICBT with weekly minimal therapist support in primary care can be equally effective as TAU among depressed patients also over a 12-month period.Clinical trial registration: The trial was registered in the Swedish Registry, researchweb.org, ID number 30511.

BackgroundHand oedema is a common consequence of hand trauma or surgery. There are numerous methods to reduce hand oedema but lack high-quality evidence to support best practice. The primary objective of this pilot trial was to assess study feasibility when comparing treatments for subacute hand oedema after trauma.MethodsA parallel two-arm pilot randomised controlled trial was conducted in the hand therapy department at a regional hospital in Norfolk between October 2017 and July 2018. Patients were eligible if 18 years or over, referred to hand therapy with subacute hand oedema. Randomisation was on a 1:1 basis to treatment as usual (TAU) (compression, elevation and massage) or trial treatment (TT) (kinesiology tape, elevation and massage). One blinded assessor completed all assessments (prior to randomisation, 4 and 12 weeks later). Data on study feasibility, adherence and acceptability of treatments were collected. The primary outcome measure was hand volume (volumetry). Patient-rated severity (0–5 Likert scale), hand health profile of the Patient Evaluation Measure (PEM) and quality of life (EQ-5D-5L) were also recorded.ResultsForty-five patients were screened for eligibility and 26 consented and were randomised with 13 patients in each treatment arm. Twelve participants were lost to follow-up leaving 7 participants in each group included in the analysis. Assessor blinding was maintained in 64% of participants (9/14). Total mean acceptability scores, out of 100, were higher for TAU (87.9) than TT (76.1). Health resource use results showed TT was marginally cheaper (~£2 per patient) than TAU.Individual adherence ranged between 39 and 100%, with higher levels of overall adherence seen in the TAU group. Four participants (28%) reported adverse effects (TT group n = 3, TAU group n = 1).ConclusionThis pilot trial has identified that modifications are required in order to make a full-scale trial feasible. They include a formal assessment of treatment fidelity, research staff assisting with screening and recruitment of participants and multiple blinded assessors at each study site. Whilst not designed as an efficacy trial, it should be acknowledged that the small sample size and high loss to follow-up meant very small numbers were included in the final analysis resulting in wide confidence intervals and therefore low precision in parameter estimates.Trial registrationInternational Standard Randomised Controlled Trial Number: 94083271. Date of registration 16th August 2017.Trial fundingNational Institute for Health Research Trainees Co-ordinating Centre (TCC); Grant Codes: CDRF-2014-05-064

Introduction: Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that frequently persists into adulthood. Pharmacotherapies are effective but have side effects and dropout risks. Videoconference-based cognitive behavioral therapy (vCBT) has emerged as a promising intervention, particularly for improving treatment accessibility. This study aimed to evaluate the efficacy of vCBT in adults with ADHD compared to treatment-as-usual (TAU) using a randomized, assessor-blinded, controlled trial design. Methods: Thirty participants (aged 18–65 years) with ADHD were randomly assigned to either the 12-session individual vCBT intervention as an adjunct to TAU or TAU group. The primary outcome was the change in the total score on the ADHD Rating Scale-IV (ADHD-RS-IV) with adult prompts by a blinded assessor at 12 weeks from baseline. Secondary outcomes included self-reported measures of ADHD symptoms using the Conners’ Adult ADHD Rating-Self-Report, quality of life (QOL) using the Euro QOL 5 Dimension-5 Level, functional impairment using the Sheehan Disability Scale, depression, anxiety, and self-esteem. Results: All of the participants received pharmacotherapy. Participants in the vCBT group (n = 15) demonstrated a significantly greater reduction in ADHD-RS-IV total score than those in the TAU group (vCBT −9.02 vs. TAU 0.84, p = 0.0007, effect size −1.46). Significant improvements in self-reported inattention, hyperactivity, impulsivity, QOL, and work/school performance were observed in favor of vCBT. Conclusion: This study highlights the efficacy of vCBT as a viable and accessible intervention for adults with ADHD, particularly in reducing core symptoms and enhancing QOL and functional outcomes. vCBT is an important alternative treatment, especially for patients who remain symptomatic after pharmacotherapy.

Objectives The purpose of this study was to assess feasibility and acceptability of a stroke-specific mindfulness-based intervention called Helping Ease Anxiety and Depression after Stroke (HEADS: UP). Method This study was a mixed-methods pilot randomized controlled trial comparing HEADS: UP to treatment as usual (TAU). HEADS: UP is a 9-week mindfulness intervention for stroke survivors. UK (United Kingdon)-based stroke survivors were recruited and attended HEADS: UP Online. Psychological functioning outcomes measures and other data were collected online at pre-intervention (Week 0), post-intervention (Week 9), and follow-up (months 3 and 6). Participants were randomized 1:1 to either HEADS: UP or TAU. Results Sixty-two participants completed baseline questionnaires and were randomized to HEADS: UP (n = 30) or TAU (n = 32). Retention rates were as follows: HEADS: UP (n = 25, 83.30%) versus TAU (n = 25, 78.10%) at post-intervention, HEADS: UP (n = 24, 80%) versus TAU (n = 26, 81.30%) at 3-month follow-up, and HEADS: UP (n = 20, 66.70%) versus TAU (n = 25, 78.10%) at 6-month follow-up. The mean age for HEADS: UP was 56.0 years versus 56.80 for TAU. The HEADS: UP group was 30% male, while the TAU group was 56% male. Depression Anxiety Stress Scales (DASS)-21 total mean score for HEADS: UP improved in the direction of expected effect (baseline 46.20, SD (standard deviation) = 24.00; post-intervention 24.00, SD = 16.10) indicating recovery versus no reliable change for TAU (baseline 36.10, SD = 18.70; post-intervention 31.60, SD = 20.40). HEADS: UP and TAU scores continued to improve over time. Between-group effect sizes (Cohen’s d) at post-intervention were large for BAI (Beck Anxiety Inventory) (d = 0.91), DASS-21 total (d = 0.89), and BDI (Beck Depression Inventory)-II (d = 0.86), highlighting the potential of HEADS: UP for improving depression and anxiety symptoms. At the six-month follow-up, the attrition rate was higher in the HEADS: UP group (33.30%) compared with TAU (21.90%). Conclusions HEADS: UP is feasible and acceptable and has potential to improve depression and anxiety symptoms for stroke survivors. Preregistration ClinicalTrials.gov: NCT04985838.

Background: Relapses do not only add psychological burden to the individuals, their friends and families, but also are costly to the government and the health-care system. Thus, relapse prevention is a major concern and goes along with the primary goal of any treatment: remission of positive and also negative symptoms within functional recovery. The Remission in Schizophrenia Working Group (RSWG) defines remission as mild or less severe symptoms for a period of at least 6 months. Besides medication, relapse prevention became an important treatment goal for psychosocial intervention. Since years, study data support evidence for successful relapse prevention of psycho-educative and family therapy approaches, but little is known about any impact Cognitive Remediation Therapy (CRT) has. Methods: The purpose of this study was to investigate whether additional CRT could prevent relapses compared to treatment as usual (TAU). The CRT approach of choice was the Integrated Neurocognitive Therapy (INT) developed in our lab. INT is a group approach consisting of 4 modules including intervention on all neuro- and social cognitive domains defined by the MATRICS initiative as well as educational and stress reduction tasks. A total of 56 stabilized schizophrenia outpatients according to DSM-IV participated in the study and were randomly allocated to INT or TAU. Patients showed mild or no symptoms according to RSWG criteria in PANSS at study intake. A relapse was defined as an increase of symptoms in any of the RSGW areas for remission to a level of moderate or higher symptom severity. Assessments including e.g. PANSS, GAF and cognitive tests was administered before and after therapy (30 biweekly sessions) and at a 1-year follow-up. Results: Highly significant results support evidence for relapse prevention of INT compared to TAU during therapy. This effect could be maintained during the 1-year follow-up period: 76% of the patients in the INT group and 46% in the TAU group did not relapse. This primary outcome was in line with significant improvements in negative symptoms, psychosocial functioning (GAF) and in the cognitive domains of speed, executive functioning and emotion processing at the follow-up favoring INT compared to TAU. Conclusion: These data on INT intervention support evidence for an impact of CRT in relapse prevention. The further outcome results seem to be in accordance with empirical integrated models suggesting a mediation role of social cognition and negative symptoms between neurocognition and functional outcome. The successful INT intervention in negative symptoms and social cognition may help to improve the functional outcome and to prevent relapse.

The effectiveness of community mental health services with respect to enhancing empowerment among patients with severe mental illness (SMI) has rarely been investigated. In this multicenter trial the effectiveness of a community mental health intervention (acronym: GBV) added to treatment as usual (TAU) compared to TAU alone was investigated. In a randomized controlled multicenter trial with twelve sites spread across Germany, people living with SMI aged 18-82 years were investigated over 24 months. The trial was conducted from 2020 to 2023, a time period affected by the Covid-19 pandemic. The intervention was delivered by multiprofessional GBV teams based on the Functional Assertive Community Treatment (FACT) program and was supplemented by strategies that increase the degree of self-determination. The primary outcome was measured by the Assessment of Empowerment in Patients with Affective and Schizophrenic Disorders (EPAS). Difference in difference (DiD) effect sizes were estimated on an intention-to-treat basis. A total of 929 persons with SMI were randomly assigned to the GBV plus TAU intervention (n = 470) or to TAU alone (n = 459). The dropout rate over 24 months amounted to 28%. DiD effect sizes over 24 months indicate significant treatment effects for empowerment (d = 0.27; 95% CI = 0.14 0.40). Serious adverse events (SAE) were reported for 15 (3.2%) participants in the GBV + TAU vs. 17 (3.7%) in the TAU group. The addition of GBV to TAU, for patients with SMI, can be recommended as an effective measure to improve key psychosocial outcomes in mental health care settings across Germany. German Clinical Trial Register, DRKS00019086. Registered on 3 January 2020, https://drks.de/search/de/trial/DRKS00019086 .

Background: The innovative treatment model Improving Access to Psychological Therapies (IAPT) and its Norwegian adaptation, Prompt Mental Health Care (PMHC), have been evaluated by cohort studies only. Albeit yielding promising results, the extent to which these are attributable to the treatment thus remains unsettled. Objective: To investigate the effectiveness of the PMHC treatment compared to treatment as usual (TAU) at 6-month follow-up. Methods: A randomized controlled trial with parallel assignment was performed in two PMHC sites (Sandnes and Kristiansand) and enrolled clients between November 9, 2015 and August 31, 2017. Participants were 681 adults (aged ≥18 years) considered for admission to PMHC due to anxiety and/or mild to moderate depression (Patient Health Questionnaire [PHQ-9]/Generalized Anxiety Disorder scale [GAD-7] scores above cutoff). These were randomly assigned (70:30 ratio; n = 463 to PMHC, n = 218 to TAU) with simple randomization within each site with no further constraints. The main outcomes were recovery rates and changes in symptoms of depression (PHQ-9) and anxiety (GAD-7) between baseline and follow-up. Primary outcome data were available for 73/67% in PMHC/TAU. Sensitivity analyses based on observed patterns of missingness were also conducted. Secondary outcomes were work participation, functional status, health-related quality of life, and mental well-being. Results: A reliable recovery rate of 58.5% was observed in the PMHC group and of 31.9% in the TAU group, equaling a between-group effect size of 0.61 (95% CI 0.37 to 0.85, p < 0.001). The differences in degree of improvement between PMHC and TAU yielded an effect size of –0.88 (95% CI –1.23 to –0.43, p < 0.001) for PHQ-9 and –0.60 (95% CI –0.90 to –0.30, p < 0.001) for GAD-7 in favor of PMHC. All sensitivity analyses pointed in the same direction, with small variations in point estimates. Findings were slightly more robust for depressive than anxiety symptoms. PMHC was also more effective than TAU in improving all secondary outcomes, except for work participation (z = 0.415, p = 0.69). Conclusions: The PMHC treatment was substantially more effective than TAU in alleviating the burden of anxiety and depression. This adaptation of IAPT is considered a viable supplement to existing health services to increase access to effective treatment for adults who suffer from anxiety and mild to moderate depression. A potential effect on work participation needs further examination.

Objectives This preliminary study aimed to establish the feasibility of running an adapted Mindfulness Based Cognitive Therapy (MBCT) intervention for people with mild dementia and depression. It also aimed to conduct an exploratory analysis as to whether the MBCT intervention would lead to greater improvements in measures of depression, anxiety, quality of life and cognition, as compared to treatment as usual (TAU). Methods A single-blind, multisite, feasibility randomized controlled trial was used. People with dementia and depression were recruited from participating memory services. Twenty participants were randomized to either an adapted MBCT and TAU group (n = 10) or TAU (n = 10). Measures of depression, anxiety, quality of life (QOL), and cognition were assessed at baseline and follow-up. Results The intervention was feasible in terms of high attendance and low levels of attrition. It was not judged feasible to recruit enough participants within the recruitment time-frame. The MBCT group did not show significant improvements in depression, anxiety, QOL, and cognition at follow-up, as compared to TAU. Conclusion There is currently inadequate evidence to recommend this adapted MBCT intervention for people with dementia for the treatment of depression within memory services. The MBCT intervention needs redevelopment and piloting before further testing in an RCT.

This randomized controlled trial was performed to investigate whether placebo effects in chronic low back pain could be harnessed ethically by adding open-label placebo (OLP) treatment to treatment as usual (TAU) for 3 weeks. Pain severity was assessed on three 0- to 10-point Numeric Rating Scales, scoring maximum pain, minimum pain, and usual pain, and a composite, primary outcome, total pain score. Our other primary outcome was back-related dysfunction, assessed on the Roland-Morris Disability Questionnaire. In an exploratory follow-up, participants on TAU received placebo pills for 3 additional weeks. We randomized 97 adults reporting persistent low back pain for more than 3 months' duration and diagnosed by a board-certified pain specialist. Eighty-three adults completed the trial. Compared to TAU, OLP elicited greater pain reduction on each of the three 0- to 10-point Numeric Rating Scales and on the 0- to 10-point composite pain scale (P < 0.001), with moderate to large effect sizes. Pain reduction on the composite Numeric Rating Scales was 1.5 (95% confidence interval: 1.0-2.0) in the OLP group and 0.2 (-0.3 to 0.8) in the TAU group. Open-label placebo treatment also reduced disability compared to TAU (P < 0.001), with a large effect size. Improvement in disability scores was 2.9 (1.7-4.0) in the OLP group and 0.0 (-1.1 to 1.2) in the TAU group. After being switched to OLP, the TAU group showed significant reductions in both pain (1.5, 0.8-2.3) and disability (3.4, 2.2-4.5). Our findings suggest that OLP pills presented in a positive context may be helpful in chronic low back pain.

Background: The burden and economic consequences of depression are high, mostly due to its recurrent nature. Due to current budget and time restraints, a preventive, low- cost, accessible minimal intervention is much needed. In this study, we evaluated the effectiveness of a supported self-help preventive cognitive therapy (S-PCT) added to treatment as usual (TAU) in primary care, compared to TAU alone. Methods: We conducted a randomized controlled trial among 248 patients with a history of depression, currently in full or partial remission or recovery. Participants were randomized to TAU augmented with S-PCT (n = 124) or TAU alone (n = 124). S-PCT consisted of an 8-week self-help intervention, supported by weekly telephone guidance by a counselor. The intervention included a self-help book that could be read at home. The primary outcome was the incidence of relapse or recurrence and was assessed over the telephone by the Structured Clinical Interview for DSM-IV axis 1 disorders. Participants were observed for 12 months. Secondary outcomes were depressive symptoms, quality of life (EQ-5D and SF-12), comorbid psychopathology, and self-efficacy. These secondary outcomes were assessed by digital questionnaires. Results: In the S-PCT group, 44 participants (35.5%) experienced a relapse or recurrence, compared to 62 participants (50.0%) in the TAU group (incidence rate ratio = 0.71, 95% CI 0.52-0.97; risk difference = 14, 95% CI 2-24, number needed to treat = 7). Compared to the TAU group, the S-PCT group showed a significant reduction in depressive symptoms over 12 months (mean difference -2.18; 95% CI -3.09 to -1.27) and a significant increase in quality of life (EQ-5D) (mean difference 0.04; 95% CI 0.004-0.08). S-PCT had no effect on comorbid psychopathology, self-efficacy, and quality of life based on the SF-12. Conclusions: A supported self-help preventive cognitive therapy, guided by a counselor in primary care, proved to be effective in reducing the burden of recurrent depression.

Adoption of effective treatments for recurrent binge-eating disorders depends on the balance of costs and benefits. Using data from a recent randomized controlled trial, we conducted an incremental cost-effectiveness analysis (CEA) of a cognitive-behavioral therapy guided self-help intervention (CBT-GSH) to treat recurrent binge eating compared to treatment as usual (TAU). Participants were 123 adult members of an HMO (mean age = 37.2 years, 91.9% female, 96.7% non-Hispanic White) who met criteria for eating disorders involving binge eating as measured by the Eating Disorder Examination (C. G. Fairburn & Z. Cooper, 1993). Participants were randomized either to treatment as usual (TAU) or to TAU plus CBT-GSH. The clinical outcomes were binge-free days and quality-adjusted life years (QALYs); total societal cost was estimated using costs to patients and the health plan and related costs. Compared to those receiving TAU only, those who received TAU plus CBT-GSH experienced 25.2 more binge-free days and had lower total societal costs of $427 over 12 months following the intervention (incremental CEA ratio of -$20.23 per binge-free day or -$26,847 per QALY). Lower costs in the TAU plus CBT-GSH group were due to reduced use of TAU services in that group, resulting in lower net costs for the TAU plus CBT group despite the additional cost of CBT-GSH. Findings support CBT-GSH dissemination for recurrent binge-eating treatment.