scholarly journals Self-blame in major depression: a randomised pilot trial comparing fMRI neurofeedback with self-guided psychological strategies

2021 ◽  
pp. 1-11
Author(s):  
Tanja Jaeckle ◽  
Steven C. R. Williams ◽  
Gareth J. Barker ◽  
Rodrigo Basilio ◽  
Ewan Carr ◽  
...  
Keyword(s):  
Psychological Intervention ◽  
Pilot Trial ◽  
Treatment Resistance ◽  
Self Esteem ◽  
Opposite Pattern ◽  
Treatment As Usual ◽  
Self Blame ◽  
Secondary Analyses ◽  
Randomised Controlled ◽  
Other Blame

Abstract Background Overgeneralised self-blame and worthlessness are key symptoms of major depressive disorder (MDD) and have previously been associated with self-blame-selective changes in connectivity between right superior anterior temporal lobe (rSATL) and subgenual frontal cortices. Another study showed that remitted MDD patients were able to modulate this neural signature using functional magnetic resonance imaging (fMRI) neurofeedback training, thereby increasing their self-esteem. The feasibility and potential of using this approach in symptomatic MDD were unknown. Method This single-blind pre-registered randomised controlled pilot trial probed a novel self-guided psychological intervention with and without additional rSATL-posterior subgenual cortex (BA25) fMRI neurofeedback, targeting self-blaming emotions in people with insufficiently recovered MDD and early treatment-resistance (n = 43, n = 35 completers). Participants completed three weekly self-guided sessions to rebalance self-blaming biases. Results As predicted, neurofeedback led to a training-induced reduction in rSATL-BA25 connectivity for self-blame v. other-blame. Both interventions were safe and resulted in a 46% reduction on the Beck Depression Inventory-II, our primary outcome, with no group differences. Secondary analyses, however, revealed that patients without DSM-5-defined anxious distress showed a superior response to neurofeedback compared with the psychological intervention, and the opposite pattern in anxious MDD. As predicted, symptom remission was associated with increases in self-esteem and this correlated with the frequency with which participants employed the psychological strategies in daily life. Conclusions These findings suggest that self-blame-rebalance neurofeedback may be superior over a solely psychological intervention in non-anxious MDD, although further confirmatory studies are needed. Simple self-guided strategies tackling self-blame were beneficial, but need to be compared against treatment-as-usual in further trials. https://doi.org/10.1186/ISRCTN10526888

scholarly journals Self-blaming emotions in major depression: a randomised pilot trial comparing fMRI neurofeedback training with self-guided psychological strategies (NeuroMooD)

2019 ◽  
Author(s):  
Tanja Jaeckle ◽  
Steven C.R. Williams ◽  
Gareth J. Barker ◽  
Rodrigo Basilio ◽  
Ewan Carr ◽  
...  
Keyword(s):  
Symptom Severity ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Psychological Intervention ◽  
Pilot Trial ◽  
Self Esteem ◽  
Primary Outcome Measure ◽  
Neurofeedback Training ◽  
Self Blame ◽  
Clinical Potential

AbstractBackgroundOvergeneralised self-blame and worthlessness are key symptoms of major depressive disorder (MDD) and were previously associated with self-blame-selective changes in connectivity between right superior anterior temporal lobe (rSATL) and subgenual frontal areas. In a previous study, remitted MDD patients successfully modulated guilt-selective rSATL-subgenual cingulate connectivity using real-time functional magnetic resonance imaging (rtfMRI) neurofeedback training, thereby increasing their self-esteem. The feasibility and potential of using this approach in symptomatic MDD were unknown.MethodsThis single-blind pre-registered randomised controlled pilot trial tested the clinical potential of a novel self-guided psychological intervention with and without additional rSATL-posterior subgenual cortex (SC) rtfMRI neurofeedback, targeting self-blaming emotions in insufficiently recovered people with MDD and early treatment-resistance (n=43, n=35 completers). Following a diagnostic baseline assessment, patients completed three self-guided sessions to rebalance self-blaming biases and a post-treatment assessment. The fMRI neurofeedback software FRIEND was used to measure rSATL-posterior SC connectivity, while the BDI-II was administered to assess depressive symptom severity as a primary outcome measure.ResultsBoth interventions were demonstrated to be safe and beneficial, resulting in a mean reduction of MDD symptom severity by 46% and response rates of more than 55%, with no group difference. Secondary analyses, however, revealed a differential response on our primary outcome measure between MDD patients with and without DSM-5 defined anxious distress. Stratifying by anxious distress features was investigated, because this was found to be the most common subtype in our sample. MDD patients without anxious distress showed a higher response to rtfMRI neurofeedback training compared to the psychological intervention, with the opposite pattern found in anxious MDD. We explored potentially confounding clinical differences between subgroups and found that anxious MDD patients were much more likely to experience anger towards others as measured on our psychopathological interview which might play a role in their poorer response to neurofeedback. In keeping with the hypothesis that self-worth plays a key role in MDD, improvement on our primary outcome measure was correlated with increases in self-esteem after the intervention and this correlated with the frequency with which participants employed the strategies to tackle self-blame outside of the treatment sessions.ConclusionsThese findings suggest that self-blame-selective rtfMRI neurofeedback training may be superior over a solely psychological intervention in non-anxious MDD, although further confirmatory studies are needed. The self-guided psychological intervention showed a surprisingly high clinical potential in the anxious MDD group which needs further confirmation compared versus treatment-as-usual. Future studies need to investigate whether self-blame-selective rSATL-SC connectivity changes are irrelevant in anxious MDD, which could explain their response being better to the psychological intervention without interfering neurofeedback.https://doi.org/10.1186/ISRCTN10526888

scholarly journals Effectiveness of hypnosis for pain management and promotion of health-related quality-of-life among people with haemophilia: a randomised controlled pilot trial

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Ana Cristina Paredes ◽  
Patrício Costa ◽  
Susana Fernandes ◽  
Manuela Lopes ◽  
Manuela Carvalho ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Management ◽  
Pilot Trial ◽  
Pain Interference ◽  
Health Related Quality ◽  
Treatment As Usual ◽  
Related Quality ◽  
Health Related ◽  
Randomised Controlled

Abstract Joint deterioration and associated chronic pain are common among people with haemophilia (PWH), having an impact on quality-of-life. Though non-pharmacological strategies are recommended, psychological interventions to promote pain control and quality-of-life have scarcely been tested in haemophilia. This randomised controlled pilot trial aimed to assess feasibility, acceptability and effectiveness of hypnosis for pain management and promotion of health-related quality-of-life (HRQoL) among PWH. Twenty adults were randomised either to four weekly hypnosis sessions plus treatment-as-usual (experimental group; EG) or treatment-as-usual only (control group; CG). Participants completed sociodemographic and clinical assessment, measures of pain, HRQoL and emotional distress before (T1) and after (T2) intervention. Changes were analysed by calculating the differences between T1 and T2, and the groups were compared through independent-sample t tests (or chi-squared). Retention rates (90%) and analysis of patient satisfaction showed good acceptability and feasibility of the intervention. The EG (n = 8) had a higher reduction on pain interference than the CG (n = 10) (d = −0.267). A higher improvement on HRQoL (EQ-5D index: d = 0.334; EQ-5D VAS: d = 1.437) and a tendency towards better haemophilia-related quality-of-life (A36-Hemofilia QoL) were also evident in the EG. This is the first study showing the effectiveness of hypnosis to reduce pain interference and promote HRQoL among PWH.

scholarly journals Brief psychological intervention after self-harm: randomised controlled trial from Pakistan

2014 ◽  
Vol 204 (6) ◽  
pp. 462-470 ◽  
Author(s):  
Nusrat Husain ◽  
Salahuddin Afsar ◽  
Jamal Ara ◽  
Hina Fayyaz ◽  
Raza ur Rahman ◽  
...  
Keyword(s):  
Suicide Ideation ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Healthcare Utilisation ◽  
Coping Resources ◽  
Secondary Outcome ◽  
University Hospitals ◽  
Treatment As Usual ◽  
Self Harm ◽  
Randomised Controlled

BackgroundSelf-harm is a major risk factor for completed suicide.AimsTo determine the efficacy of a brief psychological intervention – culturally adapted manual-assisted problem-solving training (C-MAP) – delivered following an episode of self-harm compared with treatment as usual (TAU).MethodThe study was a randomised controlled assessor-masked clinical trial (trial registration: ClinicalTrials.gov NCT01308151). All patients admitted after an episode of self-harm during the previous 7 days to the participating medical units of three university hospitals in Karachi, Pakistan, were included in the study. A total of 250 patients were screened and 221 were randomly allocated to C-MAP plus treatment as usual (TAU) or to TAU alone. All patients were assessed at baseline, at 3 months (end of intervention) and at 6 months after baseline. The primary outcome measure was reduction in suicidal ideation at 3 months. The secondary outcome measures included hopelessness, depression, coping resources and healthcare utilisation.ResultsA total of 108 patients were randomised to the C-MAP group and 113 to the TAU group. Patients in the C-MAP group showed statistically significant improvement on the Beck Scale for Suicide Ideation and Beck Hopelessness Inventory, which was sustained at 3 months after the completion of C-MAP. There was also a significant reduction in symptoms of depression compared with patients receiving TAU.ConclusionsThe positive outcomes of this brief psychological intervention in patients attempting self-harm are promising and suggest that C-MAP may have a role in suicide prevention.

scholarly journals T44. 12-MONTH FOLLOW UP OF METABOLIC MEASURES FOLLOWING A RANDOMISED CONTROLLED TRIAL OF TREATMENT OF CLOZAPINE ASSOCIATED OBESITY AND DIABETES WITH EXENATIDE (CODEX)

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S248-S248
Author(s):  
Dan Siskind ◽  
Anthony Russell ◽  
Steve Kisely
Keyword(s):  
Weight Loss ◽  
Fasting Glucose ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Glycated Haemoglobin ◽  
Open Label ◽  
Treatment As Usual ◽  
Obesity And Diabetes ◽  
Randomised Controlled

Abstract Background Clozapine is associated with high rates of obesity and type 2 diabetes (T2DM). Exenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, can counter clozapine-associated GLP-1 dysregulation. Our randomized, controlled (RCT), open-label, pilot trial of once-weekly extended-release subcutaneous exenatide or treatment as usual (TAU) for 24 weeks (n=28), found 6/14 people on exenatide achieved >5% weight loss vs 1/14 receiving usual care (P = .029). Compared with TAU, participants on exenatide had greater mean weight loss body mass index (BMI) reduction, and reduced fasting glucose and glycated haemoglobin (HbA1c) levels. Methods We followed up CODEX trial participants at 12 months following the end of the trial. We collected information on weight, BMI, waist circumference, blood pressure, fasting glucose, HbA1c, and use of metformin. The primary outcome of interest was change in weight. Change in these parameters from trial baseline to 12 months post endpoint and trial endpoint to 12 months post endpoint was compared between those formerly in the exenatide and TAU arms. Results There were no significant differences between baseline and 12-months post endpoint for any of the variables. Data from endpoint to 12-month follow up point showed significantly greater increases among the former exenatide group compared to the former TAU group for weight, BMI, and proportion with >5% weight gain. Stratifying the dataset by whether participants were on metformin six months after the end of the trial did not alter the overall results. Discussion There were significant increases in weight and BMI in the 12 months post endpoint for the former exenatide group, however there were no significant differences in weight and BMI between baseline and 12-month post endpoint. This is in keeping with other GLP-1RA studies. This information suggests the need for continued use of exenatide among people on clozapine who have achieved weight loss.

Psychological interventions as an alternative and add-on to antidepressant medication to prevent depressive relapse: systematic review and meta-analysis

2020 ◽  
pp. 1-8
Author(s):  
Josefien Johanna Froukje Breedvelt ◽  
Maria Elisabeth Brouwer ◽  
Mathias Harrer ◽  
Maria Semkovska ◽  
David Daniel Ebert ◽  
...  
Keyword(s):  
Psychological Intervention ◽  
Meta Analysis ◽  
Antidepressant Medication ◽  
Cochrane Library ◽  
Psychological Interventions ◽  
Relapse Risk ◽  
Increased Risk ◽  
Antidepressant Use ◽  
Randomised Controlled ◽  
Risk Of Relapse

Background After remission, antidepressants are often taken long term to prevent depressive relapse or recurrence. Whether psychological interventions can be a viable alternative or addition to antidepressants remains unclear. Aims To compare the effectiveness of psychological interventions as an alternative (including delivered when tapering antidepressants) or addition to antidepressants alone for preventing depressive relapse. Method Embase, PubMed, the Cochrane Library and PsycINFO were searched from inception until 13 October 2019. Randomised controlled trials (RCTs) with previously depressed patients in (partial) remission where preventive psychological interventions with or without antidepressants (including tapering) were compared with antidepressant control were included. Data were extracted independently from published trials. A random-effects meta-analysis on time to relapse (hazard ratio, HR) and risk of relapse (risk ratio, RR) at the last point of follow-up was conducted. PROSPERO ID: CRD42017055301. Results Among 11 included trials (n = 1559), we did not observe an increased risk of relapse for participants receiving a psychological intervention while tapering antidepressants versus antidepressants alone (RR = 1.02, 95% CI 0.84–1.25; P = 0.85). Psychological interventions added to antidepressants significantly reduced the risk of relapse (RR = 0.85, 95% CI 0.74–0.97; P = 0.01) compared with antidepressants alone. Conclusions This study found no evidence to suggest that adding a psychological intervention to tapering increases the risk of relapse when compared with antidepressants alone. Adding a psychological intervention to antidepressant use reduces relapse risk significantly versus antidepressants alone. As neither strategy is routinely implemented these findings are relevant for patients, clinicians and guideline developers.

scholarly journals M.I.C.E—Mental Health Intervention for Children with Epilepsy: a randomised controlled, multi-centre clinical trial evaluating the clinical and cost-effectiveness of MATCH-ADTC in addition to usual care compared to usual care alone for children and young people with common mental health disorders and epilepsy—study protocol

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sophie D. Bennett ◽  
◽  
J. Helen Cross ◽  
Anna E. Coughtrey ◽  
Isobel Heyman ◽  
...  
Keyword(s):  
Mental Health ◽  
Young People ◽  
Usual Care ◽  
Psychological Intervention ◽  
Mental Health Disorders ◽  
Long Term Conditions ◽  
Children And Young People ◽  
Health Disorders ◽  
Randomised Controlled

Abstract Background Mental health disorders in the context of long-term conditions in children and young people are currently overlooked and undertreated. Evidence-based psychological treatments for common childhood mental health disorders (anxiety, depression and disruptive behaviour disorders) have not been systematically evaluated in young people with epilepsy despite their high prevalence in this population. The aim of this multi-site randomised controlled trial is to determine the clinical and cost-effectiveness of adding a modular psychological intervention to usual care for the mental health disorders in comparison to assessment-enhanced usual care alone. Methods In total, 334 participants aged 3–18 years attending epilepsy services will be screened for mental health disorders with the Strengths and Difficulties Questionnaire (SDQ) and the diagnostic Development and Wellbeing Assessment (DAWBA). Those identified as having a mental health disorder and consenting to the trial will be randomised to either receive up to 22 sessions of the modular psychological intervention (MATCH-ADTC) delivered over the telephone over 6 months by non-mental health professionals in addition to usual care or to assessment-enhanced usual care alone. Outcomes will be measured at baseline, 6 months and 12 months post-randomisation. It is hypothesised that MATCH-ADTC plus usual care will be superior to assessment-enhanced usual care in improving emotional and behavioural symptoms. The primary outcome is the SDQ reported by parents at 6 months. Secondary outcomes include parent-reported mental health measures such as the Revised Children’s Anxiety and Depression Scale, quality of life measures such as the Paediatric Quality of Life Inventory and physical health measures such as the Hague Seizure Severity Scale. Outcome assessors will be blinded to group assignment. Qualitative process evaluations and a health economic evaluation will also be completed. Discussion This trial aims to determine whether a systematic and integrated approach to the identification and treatment of mental health disorders in children and young people with epilepsy is clinically and cost-effective. The findings will contribute to policies and practice with regard to addressing mental health needs in children and young people with other long-term conditions. Trial registration ISRCTN ISRCTN57823197. Registered on 25 February 2019.

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