What metrics of harm are being captured in clinical trials involving talking treatments for young people? A systematic review of registered studies on the ISRCTN

Hayes, Daniel; Za’ba, Nur

doi:10.1002/capr.12407

Cited by 10 publications

(5 citation statements)

References 42 publications

(55 reference statements)

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“…Our findings indicate that TM is a relatively well-tolerated and feasible intervention for survivors of domestic violence, with participants reporting few adverse events, most of which were mild and transient in nature. While worsening of symptoms and/or the manifestation of psychosomatic adverse effects are not uncommon with psychological and meditative therapies (Muschalla et al, 2020;Schermuly-Haupt et al, 2018;Taylor et al, 2022), reporting of adverse events to psychological therapies (including TM) is largely inadequate (Condon et al, 2021;Hayes & Za'ba, 2022). The few clinical studies that have purposefully measured adverse events to TM (Leach et al, 2015) have similarly reported psychosomatic adverse events to TM, though the intensity and frequency of events reported in our study was relatively lower.…”

Section: Discussionmentioning

confidence: 58%

Transcendental Meditation for Women Affected by Domestic Violence: A Pilot Randomised, Controlled Trial

Leach

Lorenzon²

2023

J Fam Viol

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Purpose Domestic and family violence is a major public health issue impacting one in three women worldwide. The implications of such violence are considerable. Transcendental Meditation® (TM) represents a promising treatment option for women impacted by domestic violence given its demonstrable effects on mental and trauma-related symptoms. This study set out to compare the effectiveness of TM to group support, on quality of life, perceived stress and mood in female survivors of domestic violence. Methods This 16-week pilot randomised controlled trial recruited women from metropolitan Adelaide, who survived any type of domestic violence in their lifetime. Outcomes included health-related quality of life, severity of depression, anxiety and perceived stress, symptoms of post-traumatic stress disorder, and subjective experience. Data were analysed by intention-to-treat using linear mixed-effects models. Results Forty-two women were randomly assigned to the TM (n = 21) and support (n = 21) groups. Adjusting for random effects, TM was shown to be significantly more effective than support at improving Australian Quality of Life (AQoL-8D) utility scores (p = .011), and Depression Anxiety and Stress Scale (DASS-21) severity scores for depression (p = .029), anxiety (p = .017) and stress (p = .021) over the 16 weeks. There was no statistically significant time-group interaction effect for PTSD Checklist for DSM-5 (PCL-5) total symptom severity scores. Conclusions TM is shown to have promising effects on quality of life, perceived stress and mood among women exposed to domestic violence, suggesting that it may represent an effective alternative to group support. Trial Registration ACTRN12620000467932 (09/04/2020).

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Section: Discussionmentioning

confidence: 58%

Transcendental Meditation for Women Affected by Domestic Violence: A Pilot Randomised, Controlled Trial

Leach

Lorenzon²

2023

J Fam Viol

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“…In time, all studies assessing school-based mental health interventions should measure and report cases of symptom deterioration and other adverse effects as standard, as happens with clinical trials. 9 More importantly, it should become standard to have a plan of what to do with adolescents who deteriorate during these interventions – for example, to conduct follow-up assessments and offer group or individual interventions as necessary. When there is an evidence base demonstrating which individuals are more likely to experience harm from school interventions, then more tailored, effective support can be offered.…”

Section: Discussionmentioning

confidence: 99%

“…It has long been recognised that the psychological therapies on which interventions are based can cause harm in a minority of individuals, including adolescents. 8 , 9 There is also an established body of literature demonstrating harms from public health interventions. 4 As school-based mental health interventions similarly aim to change adolescents’ thoughts, feelings or behaviours, it is reasonable that this too might have negative effects for some individuals.…”

Section: The Problem With School Mental Health Interventionsmentioning

confidence: 99%

Do no harm: can school mental health interventions cause iatrogenic harm?

Foulkes

Stringaris²

2023

BJPsych Bull

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In recent years, there have been extensive efforts in secondary schools to prevent, treat and raise awareness of adolescent mental health problems. For some adolescents, these efforts are essential and will lead to a reduction in clinical symptoms. However, it is also vital to assess whether, for others, the current approach might be causing iatrogenic harm. A growing body of quantitative research indicates that some aspects of school-based mental health interventions increase distress or clinical symptoms, relative to control activities, and qualitative work indicates that this may be partly due to the interventions themselves.

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“…Despite CBT’s historical promotion as the ‘gold standard’, a growing body of literature is critical of this perspective. This literature argues that claims about CBT’s superiority lack thorough assessment and fail to acknowledge potential harms or iatrogenic effects (Castro Batic and Hayes, 2020; Hayes and Za’ba, 2021; Lilienfeld, 2007; Parry et al., 2016). In addition, there is increasing evidence that CBT may not be the most suitable approach and can even be potentially harmful for certain marginalized communities, such as autistic individuals (Babb et al., 2022), who are overrepresented in eating disorder populations (Huke et al., 2013).…”

Section: Introductionmentioning

confidence: 99%

Is cognitive behavioral therapy more effective than pharmacotherapy for binge spectrum disorders? A systematic review and meta-analysis

Samara,

Michou,

Lappas

et al. 2024

Aust N Z J Psychiatry

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Objectives: Binge spectrum disorders are prevalent worldwide. Psychiatric and medical comorbidities are common, and societal costs are significant. Evidence-based treatment remains underutilized. Cognitive behavioral therapy is the recommended first-line treatment, but pharmacotherapy may be easier to access. Interventions: Meta-analytic evidence directly comparing cognitive behavioral therapy with pharmacotherapy is lacking. We aimed to compare the effects of cognitive behavioral therapy interventions with any pharmacological treatment for binge spectrum disorders. We searched PubMed, Embase, CENTRAL, ClinicalTrials.gov and reference lists for randomized controlled trials comparing cognitive behavioral therapy with any pharmacotherapy for bulimia nervosa/binge eating disorder and performed pairwise meta-analytic evaluations. Primary Outcomes: Primary outcomes are remission and frequency of binges. Secondary outcomes are frequency of purges, response, eating disorder psychopathology, weight/body mass index, depression, anxiety, quality of life and dropouts. Results: Eleven randomized controlled trials comparing cognitive behavioral therapy with fluoxetine/imipramine/desipramine/methylphenidate/sibutramine were identified ( N = 531). Cognitive behavioral therapy was superior to antidepressants in terms of remission, frequency of binges and eating disorder psychopathology. There were no statistically significant differences for any of the individual cognitive behavioral therapy vs drug comparisons in terms of response/depression/anxiety/weight/quality of life/dropouts. Cognitive behavioral therapy was not superior to sibutramine/methylphenidate for the primary outcomes. Conclusions: Data are scarce, comparisons underpowered and, considering the inherent methodological limitations of psychotherapy trials, questions arise regarding the presumed superiority of cognitive behavioral therapy. Further research is needed.

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What metrics of harm are being captured in clinical trials involving talking treatments for young people? A systematic review of registered studies on the ISRCTN

Abstract: This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Cited by 10 publications

References 42 publications

Transcendental Meditation for Women Affected by Domestic Violence: A Pilot Randomised, Controlled Trial

Transcendental Meditation for Women Affected by Domestic Violence: A Pilot Randomised, Controlled Trial

Do no harm: can school mental health interventions cause iatrogenic harm?

Is cognitive behavioral therapy more effective than pharmacotherapy for binge spectrum disorders? A systematic review and meta-analysis

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