The effects of music listening and art production on negative mood: A randomized, controlled trial

A large literature now exists to examine the effects of music listening on negative mood. However, few studies both isolate music as the active ingredient in mood improvement and compare music to a placebo condition designed to reduce demand effects. In the present study, 60 adult participants recruited from the local community were randomly assigned to one of four conditions: music listening + art production (drawing), music listening + art sorting, no music + art production, or no music + art sorting. By giving participants in all four groups an “arts” task, we intended to equate expectations of improvement and thereby better rule out demand effects as a source of group differences. Self-report measures of negative mood were collected before and after the 10 min intervention period. Participants in the two music listening conditions showed greater mood enhancement compared to the two non-music conditions. However, there were no significant effects of the art conditions (production vs. sorting). These results document that music listening has specific efficacy in enhancing mood even when expectations of improvement are equated across groups.     

A randomised controlled trial of cognitive behaviour therapy for psychosis in a routine clinical service

Peters E, Landau S, McCrone P, Cooke M, Fisher P, Steel C, Evans R, Carswell K, Dawson K, Williams S, Howard A, Kuipers E. A randomised controlled trial of cognitive behaviour therapy for psychosis in a routine clinical service. Objective: To evaluate cognitive behaviour therapy for psychosis (CBTp) delivered by non‐expert therapists, using CBT relevant measures. Method: Participants (N = 74) were randomised into immediate therapy or waiting list control groups. The therapy group was offered 6 months of therapy and followed up 3 months later. The waiting list group received therapy after waiting 9 months (becoming the delayed therapy group). Results: Depression improved in the combined therapy group at both the end of therapy and follow‐up. Other significant effects were found in only one of the two therapy groups (positive symptoms; cognitive flexibility; uncontrollability of thoughts) or one of the two time points (end of therapy: general symptoms, anxiety, suicidal ideation, social functioning, resistance to voices; follow‐up: power beliefs about voices, negative symptoms). There was no difference in costs between the groups. Conclusion: The only robust improvement was in depression. Nevertheless, there were further encouraging but modest improvements in both emotional and cognitive variables, in addition to psychotic symptoms.     

Randomised controlled trial of a treatment adherence programme for prisoners with mental health problems in Spain

The prevalence of psychiatric disorders is high among prisoners, who often need psychotropic medication, but compliance with treatment is often poor. This combination leads to poorer prisoner‐patient health and increased health costs.The aim of this study was to test the impact of a treatment adherence programme (TAP) on medication adherence and subjective well‐being among prisoners with mental health problems. We conducted a randomised controlled trial of a treatment adherence programme compared with treatment as usual (TAU) among 183 prisoners with mental health problems. Those in the TAP group showed greater treatment adherence and reported better subjective well‐being with medication than those in the TAU group. We conclude that the treatment adherence of prisoners who require medication for mental health problems may be improved through specific intervention programmes. This could make a positive contribution to individual health and well‐being.     

Efficacy of group psychotherapy for posttraumatic stress disorder: Systematic review and meta-analysis of randomized controlled trials

Objective: The present meta-analysis evaluates the efficacy of group psychotherapy for post-traumatic stress disorder (PTSD) in adults directly compared to no treatment or active treatments examined in randomized controlled trials (RCTs). Method: Electronic databases were searched for eligible studies. Effects on PTSD symptoms, depression, and anxiety were extracted. Between- and within-group effect sizes (Hedges’ g) were calculated using a random-effects model. Data were adjusted to account for dependencies among observations in groups. Results: Twenty RCTs were included comprising 2244 individuals. Results showed significant effects of group psychotherapy in reducing symptoms of PTSD compared to no-treatment control groups (k?=?13; g?=?0.70; 95% CI: 0.41; 0.99). No significant differences in efficacy were found between group psychotherapy and other active treatments (k?=?8; g?=?0.13; 95% CI: ?0.16; 0.42). Moderator analyses confirmed gender and trauma type as important moderators of within-treatment effects for PTSD. Conclusions: Group treatments are associated with improvements in symptoms of PTSD. Particularly, the efficacy of exposure-based cognitive-behavioral group therapy (group CBT) is empirically well demonstrated. Still little is known about the effects of group treatment approaches other than CBT and the comparative efficacy to alternative treatments such as individual therapy or pharmacotherapy.

Clinical or Methodological Significance of this Article: This review provides an empirical base for group therapy as a viable treatment alternative for future PTSD practice guidelines. Although less is known about its comparative efficacy to alternative PTSD treatments such as individual therapy or pharmacotherapy, sufficient evidence exists to recommend group therapy (particularly exposure-based group CBT) for those who might not be able to access alternative treatments. Trauma type and gender proved to be important moderators of group treatment outcome. The results further indicate that the evidence base of recommendations for group therapy in current international treatment guidelines needs to be updated.     

Venlafaxine versus nortriptyline in the treatment of elderly depressed inpatients: a randomised, double-blind, controlled trial

BACKGROUND: The majority of the trials in the elderly are outpatient trials which excluded psychotic patients and patients with common comorbid physical disorders. Consequently information is lacking about the more complex cases of elderly depressed patients, as found in inpatient wards. OBJECTIVE: To evaluate the effectiveness of two antidepressants, venlafaxine and nortriptyline, in a clinically representative sample of elderly depressed inpatients. METHOD: A 12-week, double blind, randomised, controlled trial in 81 elderly inpatients from one centre. All patients fulfilled DSM-IV criteria for major depression and were assessed using the Montgomery Asberg Depression Rating Scale, the Hamilton Depression Rating Scale, the Geriatric Depression Scale, the Clinical Global Improvement and the Symptom, sign, and Side-effect Checklist. RESULTS: Overall, remission was achieved by 26 (32.1%) of the patients. There was no statistically significant difference in the number of patients achieving remission on the MADRS between venlafaxine (11 out of 40 patients) and nortriptyline (15 out of 41 patients; p = 0.381) or in any of the secondary outcome variables. The number and severity of side-effects was not statistically different between both treatment groups and most side effects were mild or moderate in intensity. CONCLUSIONS: In elderly inpatients with severe depression, venlafaxine and nortriptyline appeared to be equally effective and equally well tolerated.     

Positive PsychoTherapy in ABI Rehab (PoPsTAR): A pilot randomised controlled trial

Psychological distress is common following acquired brain injury (ABI), but the evidence base for psychotherapeutic interventions is small and equivocal. Positive psychotherapy aims to foster well-being by increasing experiences of pleasure, engagement and meaning. In this pilot trial, we investigated the feasibility and acceptability of brief positive psychotherapy in adults with ABI and emotional distress. Participants were randomised to brief positive psychotherapy plus usual treatment, or usual treatment only. Brief positive psychotherapy was delivered over eight individual out-patient sessions, by one research psychologist. A blinded assessor administered the Depression Anxiety Stress Scales (DASS-21) and the Authentic Happiness Inventory (AHI) at 5, 9 and 20 weeks post-baseline. Of 27 participants randomised (median age 57; 63% male; 82% ischaemic stroke survivors; median 5.7 months post-injury), 14 were assigned to positive psychotherapy, of whom 8 completed treatment. The intervention was feasible to deliver with excellent fidelity, and was acceptable to participants. Retention at 20 weeks was 63% overall. A full-scale trial would need to retain n?=?39 per group to end-point, to detect a significant difference in change scores on the DASS-21 Depression scale of 7 points (two-tailed alpha?=?.05, power?=?.80). Trials including an active control arm would require larger sample sizes. We conclude that a full-scale trial to investigate efficacy is warranted.     

A randomised controlled trial of cognitive behaviour therapy vs treatment as usual in the treatment of mild to moderate late life depression

OBJECTIVES: This study provides an empirical evaluation of Cognitive Behaviour Therapy (CBT) alone vs Treatment as usual (TAU) alone (generally pharmacotherapy) for late life depression in a UK primary care setting. METHOD: General Practitioners in Fife and Glasgow referred 114 Participants to the study with 44 meeting inclusion criteria and 40 participants providing data that permitted analysis. All participants had a diagnosis of mild to moderate Major Depressive Episode. Participants were randomly allocated to receive either TAU alone or CBT alone. RESULTS: Participants in both treatment conditions benefited from treatment with reduced scores on primary measures of mood at end of treatment and at 6 months follow-up from the end of treatment. When adjusting for differences in baseline scores, gender and living arrangements, CBT may be beneficial in levels of hopelessness at 6 months follow-up. When evaluating outcome in terms of numbers of participants meeting Research Diagnostic Criteria for depression, there were significant differences favouring the CBT condition at the end of treatment and at 3 months follow-up after treatment. CONCLUSIONS: CBT alone and TAU alone produced significant reductions in depressive symptoms at the end of treatment and at 6 months follow-up. CBT on its own is shown to be an effective treatment procedure for mild to moderate late life depression and has utility as a treatment alternative for older people who cannot or will not tolerate physical treatment approaches for depression.     

Effect and safety of sertraline for treat posttraumatic stress disorder: a multicenter randomised controlled study

Objective: Although several previous studies have examined the efficacy of sertraline in the treatment of posttraumatic stress disorder (PTSD), none involved Chinese PTSD patients. This study aimed to evaluate sertraline efficacy and adverse events in Chinese patients with PTSD over 12 weeks.

Methods: In total, 72 PTSD patients were randomly assigned to receive sertraline (135?mg daily) or a placebo for 12 weeks. Impact of Event Scale-Revised subscores constituted the primary outcome, with Clinical Global Impression Scale-Severity scores and adverse events as secondary outcomes.

Results: Sixty-five subjects completed the study, and their data were included in the final analysis. Sertraline showed greater efficacy in enhancing Impact of Event Scale-Revised and Clinical Global Impression Scale-Severity scores at 6 and 12 weeks relative to that of the placebo. The most common adverse event was nausea, which occurred in 12 (33.3%) and 8 (22.2%) patients in the sertraline and placebo groups, respectively. No sertraline-related deaths were recorded.

Conclusions: In summary, we demonstrated that 12 weeks of sertraline was efficacious and well-tolerated in Chinese patients with PTSD.     

A randomised controlled trial into the effects of food on ADHD

The aim of this study is to assess the efficacy of a restricted elimination diet in reducing symptoms in an unselected group of children with Attention deficit/hyperactivity disorder (ADHD). Dietary studies have already shown evidence of efficacy in selected subgroups. Twenty-seven children (mean age 6.2) who all met the DSM-IV criteria for ADHD, were assigned randomly to either an intervention group (15/27) or a waiting-list control group (12/27). Primary endpoint was the clinical response, i.e. a decrease in the symptom scores by 50% or more, at week 9 based on parent and teacher ratings on the abbreviated ten-item Conners Scale and the ADHD-DSM-IV Rating Scale. The intention-to-treat analysis showed that the number of clinical responders in the intervention group was significantly larger than that in the control group [parent ratings 11/15 (73%) versus 0/12 (0%); teacher ratings, 7/10 (70%) versus 0/7 (0%)]. The Number of ADHD criteria on the ADHD Rating Scale showed an effect size of 2.1 (cohen’s d) and a scale reduction of 69.4%. Comorbid symptoms of oppositional defiant disorder also showed a significantly greater decrease in the intervention group than it did in the control group (cohens’s d 1.1, scale reduction 45.3%). A strictly supervised elimination diet may be a valuable instrument in testing young children with ADHD on whether dietary factors may contribute to the manifestation of the disorder and may have a beneficial effect on the children’s behaviour.     

Two years of continued early treatment for recent-onset schizophrenia: a randomised controlled study

OBJECTIVE: This random-controlled study evaluated benefits derived from continued integrated biomedical and psychosocial treatment for recent-onset schizophrenia. METHOD: Fifty cases of schizophrenia of less than 2 years duration were allocated randomly to integrated or standard treatment (ST) for 2 years. ST comprised optimal pharmacotherapy and case management, while IT also included cognitive-behavioural family treatment, that incorporated skills training, cognitive-behavioural strategies for residual psychotic and non-psychotic problems and home-based crisis management. Psychopathology, functioning, hospitalisation and suicidal behaviours were assessed two monthly and a composite index, reflecting overall clinical outcome was derived. RESULTS: IC proved superior to ST in reducing negative symptoms, minor psychotic episodes and in stabilising positive symptoms, but did not reduce hospital admissions or major psychotic recurrences. The composite index showed that significantly more IC patients (53%) had excellent 2-year outcomes than ST (25%). CONCLUSION: Evidence-based treatment achieves greater clinical benefits than pharmacotherapy and case management alone for recent-onset schizophrenia.     

Improved word comprehension in Global aphasia using a modified semantic feature analysis treatment

Limited research has investigated treatment of single word comprehension in people with aphasia, despite numerous studies examining treatment of naming deficits. This study employed a single case experimental design to examine efficacy of a modified semantic feature analysis (SFA) therapy in improving word comprehension in an individual with Global aphasia, who presented with a semantically based comprehension impairment. Ten treatment sessions were conducted over a period of two weeks. Following therapy, the participant demonstrated improved comprehension of treatment items and generalisation to control items, measured by performance on a spoken word picture matching task. Improvements were also observed on other language assessments (e.g. subtests of WAB-R; PALPA subtest 47) and were largely maintained over a period of 12 weeks without further therapy. This study provides support for the efficacy of a modified SFA therapy in remediating single word comprehension in individuals with aphasia with a semantically based comprehension deficit.     

Adjunctive lacosamide for partial-onset seizures: Efficacy and safety results from a randomized controlled trial

Purpose:   To evaluate the efficacy and safety of lacosamide (200 and 400 mg/day) when added to one to three concomitant antiepileptic drugs (AEDs) in patients with uncontrolled partial-onset seizures.
Methods:   This multicenter, double-blind, placebo-controlled trial randomized patients (age 16–70 years) with partial-onset seizures with or without secondary generalization to placebo, lacosamide 200, or lacosamide 400 mg/day. The trial consisted of an 8-week baseline, a 4-week titration, and a 12-week maintenance period.
Results:   Four hundred eighty-five patients were randomized and received trial medication. Among these, 87% were taking two or more concomitant AEDs. Median percent reduction in seizure frequency per 28 days from baseline to maintenance period (intent-to-treat, ITT) was 20.5% for placebo, 35.3% for lacosamide 200 mg/day (p   =   0.02), and 36.4% for 400 mg/day (p   =   0.03). In the per protocol population, the reductions were 35.3% for lacosamide 200 mg/day (p   =   0.04) and 44.9% for 400 mg/day (p   =   0.01) compared to placebo (25.4%). The 50% responder rate for lacosamide 400 mg/day (40.5%) was significant (p   =   0.01) over placebo (25.8%), but was not for 200 mg/day (35.0%). In the per protocol population, the 50% responder rate for lacosamide 400 mg/day (46.3%) was significant (p   <   0.01) compared with the placebo responder rate (27.5%). Dose-related adverse events (AEs) included dizziness, nausea, and vomiting. Clinically relevant changes in the mean plasma concentrations of commonly used AEDs were not observed.
Discussion:   Results of this trial demonstrated the efficacy and tolerability of adjunctive lacosamide 200 and 400 mg/day and support that lacosamide may be an advantageous option for the treatment of partial-onset seizures in patients with epilepsy.     

Efficacy and tolerability of venlafaxine in geriatric outpatients with major depression: a double-blind, randomised 6-month comparative trial with citalopram

BACKGROUND: The objectives of the study were to compare efficacy and tolerability of venlafaxine ER 75-150 mg/day with that of citalopram 10-20 mg/day in elderly patients with major depression according to DSM-IV criteria. METHODS: A randomised, double-blind, parallel group 6-month study. Efficacy was assessed by MADRS, CGI Global Improvement, CGI Severity of Illness and GDS-20 scores and safety by physical examinations, vital signs, adverse events and UKU side effect rating. Plasma levels of venlafaxine, its major metabolite O-desmethylvenlafaxine and citalopram were followed. RESULTS: One hundred and fifty-one male and female patients (64-89 years) were enrolled and 118 patients completed the study. Comparable improvements in MADRS, CGI Severity of Illness, CGI Global Improvement and GDS-20 were observed during venlafaxine and citalopram treatment. The MADRS remission rate was 19% for venlafaxine and 23% for citalopram. Side effects were common during both treatments but differed in tremor being more common during citalopram and nausea/vomiting during venlafaxine treatment. There were no clinically significant changes in blood pressure or body weight. CONCLUSION: The observed benefits of venlafaxine treatment in elderly patients with major depression were similar to those observed in younger adults as were reported adverse events and side effects. Treatment with venlafaxine ER was well tolerated and induced beneficial effects of similar magnitude as those of citalopram.     

Moderators,mediators and nonspecific predictors of outcome after cognitive rehabilitation of executive functions in a randomised controlled trial

Moderators, mediators and nonspecific predictors of treatment after cognitive rehabilitation of executive functions in a randomised controlled trial

Objective: To explore moderators, mediators and nonspecific predictors of executive functioning after cognitive rehabilitation in a randomised controlled trial, comparing Goal Management Training (GMT) with an active psycho-educative control-intervention, in patients with chronic acquired brain injury.

Methods: Seventy patients with executive dysfunction were randomly allocated to GMT (n?=?33) or control (n?=?37). Outcome measures were established by factor-analysis and included cognitive executive complaints, emotional dysregulation and psychological distress.

Results: Higher age and IQ emerged as nonspecific predictors. Verbal memory and planning ability at baseline moderated cognitive executive complaints, while planning ability at six-month follow-up mediated all three outcome measures. Inhibitory cognitive control emerged as a unique GMT specific mediator. A general pattern regardless of intervention was identified; higher levels of self-reported cognitive—and executive–symptoms of emotional dysregulation and psychological distress at six-month follow-up mediated less improvement across outcome factors.

Conclusions: The majority of treatment effects were nonspecific to intervention, probably underscoring the variables’ general contribution to outcome of cognitive rehabilitation interventions. Interventions targeting specific cognitive domains, such as attention or working memory, need to take into account the patients’ overall cognitive and emotional self-perceived functioning. Future studies should investigate the identified predictors further, and also consider other predictor candidates.     

A randomised controlled trial of the efficacy of supported employment

Hoffmann H, Jäckel D, Glauser S, Kupper Z. A randomised controlled trial of the efficacy of supported employment. Objective: Although numerous randomised controlled trials indicated the superiority of supported employment (SE), we still have too little evidence that SE is more effective than traditional vocational rehabilitation programmes (TVR) in Western European countries with highly developed social security and welfare systems, sophisticated rehabilitation programmes and high thresholds to the open labour market. The aim of this study is to prove the efficacy of SE in Switzerland. Method: Following a 2‐week intake assessment, 100 unemployed persons with stabilised severe mental illness (SMI) were randomly assigned to either the SE programme (n = 46) or to the most viable locally available TVR (n = 54). Follow‐up lasted 24 months. Results: After the first year, the rate of competitive employment reached a mean level of 48.2% in the SE group and of 18.5% in the TVR group. 58.7% of the SE group were ever competitively employed as opposed to 25.9% of the TVR group. In the second year, SE group participants were competitively employed for 24.5 weeks as compared with 10.2 in the TVR group. The groups showed no significant differences in the non‐vocational outcome criteria. Conclusion: The SE programme in Switzerland also proved more effective than TVR and seems to be applicable to the socio‐economic context of Western European countries.     

Cost effectiveness of the occupation-based approach for subacute stroke patients: result of a randomized controlled trial

Background and purpose: The cost effectiveness of occupational therapy for subacute stroke patients is unclear in the extant literature. Consequently, this study determined the cost effectiveness of the occupation-based approach using Aid for Decision-Making in Occupation Choice (ADOC) for subacute stroke patients compared with an impairment-based approach.

Methods: We conducted an economic evaluation from a societal perspective alongside a pilot randomized controlled trial, with a single blind assessor for participants in 10 subacute rehabilitation units in Japan. The intervention group received occupation-based goal setting using ADOC, with interventions focused on meaningful occupations. The control group received an impairment-based approach focused on restoring capacities. For both groups, occupational-therapy intervention was administered more than five times per week, for over 40 min each time, and they received physical and speech therapy prior to discharge. The main outcomes were quality-adjusted life years (QALYs) and total costs. Further, sensitivity analyses were performed to examine the influence of parameter uncertainty on the base case results.

Results: The final number of participants was 24 in each of the two groups. In terms of QALYs, the intervention group is significantly higher than the control group (p = 0.001, difference 95% CI: 0.002–0.008) and total costs are not statistically significant. Applying a willingness-to-pay threshold of JPY 5 million/QALY, the probability of the occupation-based approach using ADOC being cost effective was estimated to be 65.3%.

Conclusions: The results show that the occupation-based approach is associated with significantly improved QALYs and has potential cost effectiveness, compared with the impairment-based approach.     

Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial.

BACKGROUND: We tested whether transcranial magnetic stimulation (TMS) over the left dorsolateral prefrontal cortex (DLPFC) is effective and safe in the acute treatment of major depression. METHODS: In a double-blind, multisite study, 301 medication-free patients with major depression who had not benefited from prior treatment were randomized to active (n = 155) or sham TMS (n = 146) conditions. Sessions were conducted five times per week with TMS at 10 pulses/sec, 120% of motor threshold, 3000 pulses/session, for 4-6 weeks. Primary outcome was the symptom score change as assessed at week 4 with the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary outcomes included changes on the 17- and 24-item Hamilton Depression Rating Scale (HAMD) and response and remission rates with the MADRS and HAMD. RESULTS: Active TMS was significantly superior to sham TMS on the MADRS at week 4 (with a post hoc correction for inequality in symptom severity between groups at baseline), as well as on the HAMD17 and HAMD24 scales at weeks 4 and 6. Response rates were significantly higher with active TMS on all three scales at weeks 4 and 6. Remission rates were approximately twofold higher with active TMS at week 6 and significant on the MADRS and HAMD24 scales (but not the HAMD17 scale). Active TMS was well tolerated with a low dropout rate for adverse events (4.5%) that were generally mild and limited to transient scalp discomfort or pain. CONCLUSIONS: Transcranial magnetic stimulation was effective in treating major depression with minimal side effects reported. It offers clinicians a novel alternative for the treatment of this disorder.