Using the TIDieR Checklist to Standardize the Description of a Functional Strength Training Intervention for the Upper Limb After Stroke.

BACKGROUND AND PURPOSE: Published reports of intervention in randomized controlled trials are often poorly described. The Template for Intervention Description and Replication (TIDieR) checklist has been recently developed to improve the reporting of interventions. The aim of this article is to describe a therapy intervention used in the stroke rehabilitation trial, "Clinical Efficacy of Functional Strength Training for Upper Limb Motor Recovery Early After Stroke: Neural Correlates and Prognostic Indicators" (FAST-INdICATE), using TIDieR. METHODS: The functional strength training intervention used in the FAST-INdICATE trial was described using TIDieR so that intervention can be replicated by both clinicians, who may implement it in practice, and researchers, who may deliver it in future research. The usefulness of TIDieR in the context of a complex stroke rehabilitation intervention was then discussed. RESULTS AND DISCUSSION: The TIDieR checklist provided a systematic way of describing a treatment intervention used in a clinical trial of stroke rehabilitation. Clarification is needed regarding several aspects of the TIDieR checklist, including in which section to report about the development of the intervention in pilot studies, results of feasibility studies; overlap between training and procedures for assessing fidelity; and where to publish supplementary material so that it remains in the public domain. CONCLUSIONS: TIDieR is a systematic way of reporting the intervention delivered in a clinical trial of a complex intervention such as stroke rehabilitation. This approach may also have value for standardizing intervention in clinical practice.Video abstract available for more insights from the authors (see Supplemental Digital Content 1, http://links.lww.com/JNPT/A131).

Cognitive Biases Questionnaire for psychosis.

OBJECTIVE: The Cognitive Biases Questionnaire for psychosis (CBQp) was developed to capture 5 cognitive distortions (jumping to conclusions, intentionalising, catastrophising, emotional reasoning, and dichotomous thinking), which are considered important for the pathogenesis of psychosis. Vignettes were adapted from the Cognitive Style Test (CST),(1) relating to "Anomalous Perceptions" and "Threatening Events" themes. METHOD: Scale structure, reliability, and validity were investigated in a psychosis group, and CBQp scores were compared with those of depressed and healthy control samples. RESULTS: The CBQp showed good internal consistency and test-retest reliability. The 5 biases were not independent, with a 2-related factor scale providing the best fit. This structure suggests that the CBQp assesses a general thinking bias rather than distinct cognitive errors, while Anomalous Perception and Threatening Events theme scores can be used separately. Total CBQp scores showed good convergent validity with the CST, but individual biases were not related to existing tasks purporting to assess similar reasoning biases. Psychotic and depressed populations scored higher than healthy controls, and symptomatic psychosis patients scored higher than their nonsymptomatic counterparts, with modest relationships between CBQp scores and symptom severity once emotional disorders were partialled out. Anomalous Perception theme and Intentionalising bias scores showed some specificity to psychosis. CONCLUSIONS: Overall, the CBQp has good psychometric properties, although it is likely that it measures a different construct to existing tasks, tentatively suggested to represent a bias of interpretation rather than reasoning, judgment or decision-making processes. It is a potentially useful tool in both research and clinical arenas.

How Disorder-Specific are Depressive Attributions? A Comparison of Individuals with Depression, Post-Traumatic Stress Disorder and Healthy Controls.

Depressed individuals tend to assign internal, stable, and global causes to negative events. The present study investigated the specificity of this effect to depression and compared depressive attributional styles of individuals with major depression (MD), post-traumatic stress disorder (PTSD), and healthy controls. We indexed attributional style using the depressive attributions questionnaire in 164 participants. Additionally, we assessed appraisals characteristic of PTSD using the post-traumatic cognitions inventory (PTCI), depressive rumination, trauma history, and depression and PTSD symptom severity. Individuals with MD endorsed a depressive attributional style to a greater extent than both individuals with PTSD, who were not depressed, and healthy controls. Depressive attributional style was associated with the severity of depressive and PTSD symptoms, number and distress of traumatic experiences, frequency of rumination, and post-traumatic cognitions. Depressive attributions and PTCI appraisals independently predicted MD and PTSD symptom severity. They may thus be useful in predicting MD and PTSD, and should be targeted in psychological treatments of these conditions.

Reactivity of affect and self-esteem during remission in bipolar affective disorder: an experimental investigation.

BACKGROUND: Bipolar affective disorder (BPAD) is characterised by a lifelong vulnerability to develop episodes of depressed or elevated mood in response to stressful life events involving achievement or failure. We hypothesised that this latent vulnerability can manifest as reactivity of affect and self-esteem to experimentally induced experiences of success and failure and is shaped by history of childhood adversity. METHODS: Twenty-four people with remitted BPAD and twenty-four healthy controls underwent anagram-solving tasks designed to generate experiences of success and failure in two separate sessions. Positive and negative affect and implicit and explicit self-esteem were measured before and after each task. Early adversity was measured by Childhood Trauma Questionnaire. RESULTS: People with BPAD showed larger reactivity of affect and explicit self-esteem in response to experimental success and failure than did healthy controls. There were no significant differences in reactivity of implicit self-esteem. History of childhood trauma predicted increased affective reactivity to failure but not to success. LIMITATIONS: We used a convenience sample. CONCLUSIONS: The present experimental paradigm reveals reactivity of affect and self-esteem as features of BPAD, which are present even during good remission and thus are accessible as targets of interventions aiming at relapse prevention. Differential associations with childhood adversity indicate aetiological heterogeneity, with reactivity to failure influenced by early trauma and reactivity to success driven by other mechanisms.

Prospective evaluation of specialist inpatient treatment for refractory affective disorders.

BACKGROUND: Little data exist to inform the treatment of severe and resistant affective disorders. We report here the effectiveness of specialist multimodal inpatient treatment for refractory affective disorders. METHODS: Prospective evaluation of 225 consecutive patients admitted to the National Affective Disorders Unit between 2001 and 2008. RESULTS: Patients were highly treatment-resistant: most had already received ECT, lithium augmentation and over 10 prior treatment trials. Even so, sequential assessment with the Hamilton Depression Rating Scale found that 69% showed a clinical response (≥ 50% reduction in Hamilton score) to intensive therapy during admission; 50% continued to sustain a full response and 71% at least a partial response on discharge. Patients' self-ratings (57% very much or much improved, 24% slightly improved) and relative and referrer reports (75% and 68% respectively rated patients as improved) gave similar levels of improvement. LIMITATIONS: This was an observational study, without any untreated control group. The generalisability of the findings is limited by the highly specialised nature of the unit. CONCLUSIONS: Most patients with depression highly resistant to prior treatment respond to specialist and intensive multimodal inpatient therapy.

Intrusive memories and images in bipolar disorder.

Modifying intrusive memories and images is a powerful intervention in depression and anxiety disorders, but little is known about the presence of these intrusions in bipolar disorder. A semi-structured interview was administered to 29 euthymic patients with bipolar disorder, requiring them to report the intrusive memories and images recalled from their most recent episode of euthymia, depression and hypomania. Euthymia was characterised by intrusive memories of the past, which were less distressing than the memories experienced in depressed states. In addition to intrusive memories, depression was associated with vivid images focussed on death and suicide. Intrusive memories were rare in hypomanic states, which instead were characterised by vivid, enjoyable images of future events. Behaviours and emotions in different bipolar states may be amplified by characteristic intrusive memories and images, suggesting novel opportunities for therapeutic intervention. For example, intrusive images may be particularly important prodromal indicators and hence require greater emphasis in relapse-prevention programmes. Rescripting that incorporates negative elements into overly positive images may also be valuable in minimising the extent of hypomanic episodes.

Subregional hippocampal deformations in major depressive disorder.

BACKGROUND: Hippocampal atrophy is a well reported feature of major depressive disorder, although the evidence has been mixed. The present study sought to examine hippocampal volume and subregional morphology in patients with major depressive disorder, who were all medication-free and in an acute depressive episode of moderate severity. METHODS: Structural magnetic resonance imaging scans were acquired in 37 patients (mean age 42 years) and 37 age, gender and IQ-matched healthy individuals. Hippocampal volume and subregional structural differences were measured by manual tracings and identification of homologous surface points to the central core of each hippocampus. RESULTS: Both right (P=0.001) and left (P=0.005) hippocampal volumes were reduced in patients relative to healthy controls (n=37 patients and n=37 controls), while only the right hippocampus (P=0.016) showed a reduced volume in a subgroup of first-episode depression patients (n=13) relative to healthy controls. Shape analysis localised the subregional deformations to the subiculum and CA1 subfield extending into the CA2-3 subfields predominantly in the tail regions in the right (P=0.017) and left (P=0.011) hippocampi. LIMITATIONS: As all patients were in an acute depressive episode, effects associated with depressive state cannot be distinguished from trait effects. CONCLUSIONS: Subregional hippocampal deficits are present early in the course of major depression. The deformations may reflect structural correlates underlying functional memory impairments and distinguish depression from other psychiatric disorders.

A treatment schedule of conventional physical therapy provided to enhance upper limb sensorimotor recovery after stroke: expert criterion validity and intra-rater reliability.

BACKGROUND: Inadequate description of treatment hampers progress in stroke rehabilitation. OBJECTIVE: To develop a valid, reliable, standardised treatment schedule of conventional physical therapy provided for the paretic upper limb after stroke. DESIGN, SETTING AND PARTICIPANTS: Eleven neurophysiotherapists participated in the established methodology: semi-structured interviews, focus groups and piloting a draft treatment schedule in clinical practice. Different physiotherapists (n=13) used the treatment schedule to record treatment given to stroke patients with mild, moderate and severe upper limb paresis. Rating of adequacy of the treatment schedule was made using a visual analogue scale (0 to 100mm). Mean (95% confidence interval) visual analogue scores were calculated (expert criterion validity). For intra-rater reliability, each physiotherapist observed a video tape of their treatment and immediately completed a treatment schedule recording form on two separate occasions, 4 to 6 weeks apart. The Kappa statistic was calculated for intra-rater reliability. RESULTS: The treatment schedule consists of a one-page A4 recording form and a user booklet, detailing 50 treatment activities. Expert criterion validity was 79 (95% confidence interval 74 to 84). Intra-rater Kappa was 0.81 (P<0.001). CONCLUSION: This treatment schedule can be used to document conventional physical therapy in subsequent clinical trials in the geographical area of its development. Further work is needed to investigate generalisability beyond this geographical area.

A multidimensional tool to quantify treatment resistance in depression: the Maudsley staging method.

OBJECTIVE: Treatment resistance is a common clinical phenomenon in depression. However, current unitary models of staging fail to represent its complexity. We aimed to devise a model to stage treatment-resistant depression, taking into account the core factors contributing to treatment failure. METHOD: We reviewed the literature to identify factors consistently associated with treatment resistance. We also analyzed data from a subgroup of patients discharged from a specialist inpatient unit for whom adequate data were obtainable. RESULTS: We present a points-based staging model incorporating 3 factors: treatment, severity of illness, and duration of presenting episode. In this model, the rating of symptom severity ranges from subsyndromal depression (score 1) to severe syndromal depression with psychosis (score 5). Antidepressant treatment is rated on a 5-point subscale based on number of medications used, while duration of the presenting episode is rated on a 3-point subscale. The overall level of resistance estimated using this model varies from minimal resistance (score of 3) to severe resistance (score of 15). The rating system allows the overall severity of treatment resistance to be summarized either as a single numeric score or under a single descriptive category. It may also be possible to specify categories (mild, moderate, and severe) based on severity of resistance. Analysis of inpatient data indicates that the factors incorporated in the model and the model itself have some predictive validity. CONCLUSION: This staging model has reasonable face and predictive validity and may have better utility in staging treatment resistance than currently available methods.

What happens to patients with treatment-resistant depression? A systematic review of medium to long term outcome studies.

BACKGROUND: Treatment-resistant depression (TRD) is relatively common and accounts for a large proportion of the overall burden caused by depression. We conducted a systematic review of outcome studies of TRD in order to summarise findings on the longer term outcome of TRD and make recommendations. METHODS: Studies were identified through MEDLINE (1960--June Week 1 2008), EMBASE (1974--June Week 1 2008) and PsycINFO (1967--June Week 1 2008) searches. We included studies that followed adults with highly probable TRD for a minimum of 6 months. Statistical analyses were conducted on selected outcome variables whenever possible. Methodological heterogeneity of studies prohibited formal meta-analysis. RESULTS: We identified nine outcome studies with a total of 1279 participants and follow-up duration of between 1 and 10 years. In the short term, TRD was highly recurrent with as many as 80% of those requiring multiple treatments relapsing within a year of achieving remission. For those with a more protracted illness, the probability of recovery within 10 years was about 40%. TRD was also associated with poorer quality of life and increased mortality. LIMITATIONS: Included primary studies were heterogeneous. CONCLUSIONS: TRD is associated with poorer clinical outcome, particularly among those who require multiple antidepressant medications. The main limitations of the review arise from the variability in recruitment procedures, definitions and outcome assessments of the original studies. We recommend further follow-up studies of carefully identified samples in order to gain a more detailed understanding of this domain of depression and plan effective interventions.

Effects of conventional physical therapy and functional strength training on upper limb motor recovery after stroke: a randomized phase II study.

BACKGROUND: Functional training and muscle strength training may improve upper limb motor recovery after stroke. Combining these as functional strength training (FST) might enhance the benefit, but it is unclear whether this is better than conventional physical therapy (CPT). Comparing FST with CPT is not straightforward. OBJECTIVE: This study aimed at assessing the feasibility of conducting a phase III trial comparing CPT with FST for upper limb recovery. METHODS: Randomized, observer-blind, phase II trial. Subjects had upper limb weakness within 3 months of anterior circulation infarction. Subjects were randomized to CPT (no extra therapy), CPT + CPT, and CPT + FST. Intervention lasted 6 weeks. Primary outcome measure was the Action Research Arm Test (ARAT). Measurements were taken before treatment began, after 6 weeks of intervention, and 12 weeks thereafter. Attrition rate was calculated and differences between groups were interpreted using descriptive statistics. ARAT data were used to inform a power calculation. RESULTS: Thirty subjects were recruited (8% of people screened). Attrition rate was 6.7% at outcome and 40% at follow-up. At outcome the CPT + FST group showed the largest increase in ARAT score and this was above the clinically important level of 5.7 points. Median (interquartile range) increases were 11.5 (21.0) for CPT; 8.0 (13.3) for CPT + CPT; and 19.5 (22.0) for CPT + FST. The estimated sample size for an adequately powered subsequent phase III trial was 279 subjects at outcome. CONCLUSION: Further work toward a phase III clinical trial appears justifiable.

Neural responses to sad facial expressions in major depression following cognitive behavioral therapy.

BACKGROUND: Affective facial processing is an important component of interpersonal relationships. The neural substrate has been examined following treatment with antidepressant medication but not with psychological therapies. The present study investigated the neural correlates of implicit processing of sad facial expressions in depression pretreatment and posttreatment with cognitive behavioral therapy (CBT). METHODS: The patient group consisted of 16 medication-free subjects (mean age 40 years) with a DSM-IV diagnosis of acute unipolar major depression, and the comparison group were 16 matched healthy volunteers. Subjects participated in a prospective study with functional magnetic resonance imaging (fMRI) at weeks 0 and 16. During the fMRI scans, subjects performed an affect recognition task with facial stimuli morphed to display varying intensities of sadness. Patients received 16 sessions of CBT. Functional magnetic resonance imaging data were analyzed for the mean activation and differential response to variable intensity (load-response) of facial affect processing. RESULTS: During an acute depressive episode, patients showed elevated amygdala-hippocampal activity relative to healthy individuals. Baseline dorsal anterior cingulate activity in patients showed a significant relationship with subsequent clinical response. CONCLUSIONS: These data provide further support for elevated amygdala activity in depression and suggest that anterior cingulate activity may be a predictor of treatment response to both pharmacotherapy and CBT.

Rumination and attention in major depression.

Up until recently, it had been assumed that attentional biases for negative information do not exist in depression. However studies using post-conscious exposure durations have produced contradictory results. The limitations of common attentional tasks, suitability of stimulus materials and differences in stimulus duration times may have contributed to these inconsistencies. We aimed to address many of these issues and examine attentional responses in major depression at two post-conscious exposure times. We also investigated possible roles for rumination and distraction in increasing and lessening attentional biases for negative information. We used a fully controlled experimental design to test the effects of both induced and trait rumination and distraction on attention in patients with major depression and healthy controls. Attention was assessed using the dot-probe task. The findings revealed an attentional bias for negative information in depressed patients only at the longer post-conscious exposure duration. Furthermore although this bias was not influenced by either induced or trait distraction, it was related to trait rumination. Overall, the results showed that depression is associated with a strategic attentional bias towards negative information and that this bias is stronger in individuals who habitually ruminate.

Transcranial magnetic stimulation and muscle contraction to enhance stroke recovery: a randomized proof-of-principle and feasibility investigation.

OBJECTIVE: To explore the efficacy of repetitive transcranial magnetic stimulation (rTMS) and voluntary muscle contraction (VMC) to improve corticospinal transmission, muscle function, and purposeful movement early after stroke. METHODS: Factorial 2 x 2 randomized single-blind trial. SUBJECTS: n = 27, mean age 75 years, mean 27 days after middle cerebral artery infarct (24 subjects completed outcome measures). PROCEDURE: after baseline measurement (day 1), subjects were randomized to 1 of 4 groups. Treatment was given for the next 8 working days, and outcome was measured on day 10. INTERVENTIONS: (a) Real-rTMS + RealVMC, (b) Real-rTMS + PlaceboVMC, (c) Placebo-rTMS + RealVMC, and (d) Placebo-rTMS + PlaceboVMC. Real-rTMS consisted of 200 1-Hz stimuli at 120% motor threshold in 5 blocks of 40 separated by 3 minutes delivered to the lesioned hemisphere. Placebo-rTMS used a dummy coil. In RealVMC, the paretic elbow was repeatedly flexed/extended for 5 minutes. In PlaceboVMC, subjects viewed pairs of drawings of upper limbs and reported their likeness. OUTCOMES: frequency of motor-evoked potentials in biceps and triceps, muscle function (torque about elbow), and purposeful movement (Action Research Arm Test). ANALYSIS: group mean changes (outcome - baseline) were compared. RESULTS: In the Real-rTMS + RealVMC group, motor-evoked potential frequency increased 14% for biceps and 20% for triceps, whereas in the Placebo-rTMS + PlaceboVMC group, it decreased 12% for biceps and 6% for triceps. For other groups, there were changes of intermediate values. No meaningful differences were found for secondary outcomes. CONCLUSIONS: A positive trend for motor-evoked potential frequency was found for Real-rTMS + RealVMC, whereas a negative trend for motor-evoked potential frequency was found for Placebo-rTMS + PlaceboVMC.

Burden and marital and sexual satisfaction in the partners of bipolar patients.

OBJECTIVES: Bipolar disorder can be traumatic for both patients and patients' partners. Hence, partners' stress, burden, marital and sexual satisfactions are important areas to investigate. However, there have been problems with past attempts to identify the determinants of marital satisfaction in bipolar patients and their partners. The present study aimed to address these issues and provide an accurate description of relationship functioning in these couples. METHODS: The sample involved 37 partners of bipolar patients. A semi-structured interview assessed the impact of bipolar disorder on aspects of everyday functioning and partners' attributions for patients' disturbing behaviour. Standardized instruments assessed partners' sexual and marital satisfaction across the different affective states. RESULTS: Despite couples staying together, significant numbers of partners reported strain as a result of socioeconomic and household changes. More male partners reported premature ejaculation and female partners reported sexual infrequency when patients were depressed. Overall, partners were less sexually satisfied when the patient was ill. Marital disharmony was greater when patients were ill and worse during manic than depressed phases. Marital disharmony was also more likely when partners believed the patient could control their illness; they had increased domestic responsibilities; or were sexually dissatisfied. CONCLUSION: Reductions in sexual satisfaction during affective episodes may be the result of illness-related changes in sexual interest, responsiveness and affection. Partners who attribute control for the illness to the patient may use strategies to influence behaviour that disrupt marital harmony. Interventions involving education, problem-solving strategies and sex therapy components may help to reduce marital dissatisfaction.

Expressed emotion and attributions in the carers of patients with Alzheimer's disease: the effect on carer burden.

Burden of care, expressed emotion (EE), causal attributions, and salivary cortisol were assessed in 100 carers of patients with Alzheimer's disease. Forty-one carers were rated high EE, which was associated with higher scores of carer distress and strain, and greater reports of noncognitive features in the patient, but not with cortisol levels. High EE carers made more attributions personal to, and controllable by, the patient for negative events. Critical carers made more attributions of the patient's behavior that was idiosyncratic. Warmth toward the patient was associated with the opposite of this pattern. Overinvolved carers made attributions of the patient's behavior to causes external to the patient and internal to themselves. Cortisol levels were associated with self-reports of strain and distress.