Internet-based cognitive and behavioural therapies for post-traumatic stress disorder (PTSD) in adults.

BACKGROUND: Therapist-delivered trauma-focused psychological therapies are effective for post-traumatic stress disorder (PTSD) and have become the accepted first-line treatments. Despite the established evidence-base for these therapies, they are not always widely available or accessible. Many barriers limit treatment uptake, such as the number of qualified therapists available to deliver the interventions; cost; and compliance issues, such as time off work, childcare, and transportation, associated with the need to attend weekly appointments. Delivering Internet-based cognitive and behavioural therapy (I-C/BT) is an effective and acceptable alternative to therapist-delivered treatments for anxiety and depression. OBJECTIVES: To assess the effects of I-C/BT for PTSD in adults. SEARCH METHODS: We searched MEDLINE, Embase, PsycINFO and the Cochrane Central Register of Controlled Trials to June 2020. We also searched online clinical trial registries and reference lists of included studies and contacted the authors of included studies and other researchers in the field to identify additional and ongoing studies. SELECTION CRITERIA: We searched for RCTs of I-C/BT compared to face-to-face or Internet-based psychological treatment, psychoeducation, wait list, or care as usual. We included studies of adults (aged over 16 years), in which at least 70% of the participants met the diagnostic criteria for PTSD, according to the Diagnostic and Statistical Manual (DSM) or the International Classification of Diseases (ICD). DATA COLLECTION AND ANALYSIS: Two review authors independently assessed abstracts, extracted data, and entered data into Review Manager 5. The primary outcomes were severity of PTSD symptoms and dropouts. Secondary outcomes included diagnosis of PTSD after treatment, severity of depressive and anxiety symptoms, cost-effectiveness, adverse events, treatment acceptability, and quality of life. We analysed categorical outcomes as risk ratios (RRs), and continuous outcomes as mean differences (MD) or standardised mean differences (SMDs), with 95% confidence intervals (CI). We pooled data using a fixed-effect meta-analysis, except where heterogeneity was present, in which case we used a random-effects model. We independently assessed the included studies for risk of bias and we evaluated the certainty of available evidence using the GRADE approach; we discussed any conflicts with at least one other review author, with the aim of reaching a unanimous decision. MAIN RESULTS: We included 13 studies with 808 participants. Ten studies compared I-C/BT delivered with therapist guidance to a wait list control. Two studies compared guided I-C/BT with I-non-C/BT. One study compared guided I-C/BT with face-to-face non-C/BT. There was substantial heterogeneity among the included studies. I-C/BT compared with face-to-face non-CBT Very low-certainty evidence based on one small study suggested face-to-face non-CBT may be more effective than I-C/BT at reducing PTSD symptoms post-treatment (MD 10.90, 95% CI 6.57 to 15.23; studies = 1, participants = 40). There may be no evidence of a difference in dropout rates between treatments (RR 2.49, 95% CI 0.91 to 6.77; studies = 1, participants = 40; very low-certainty evidence). The study did not measure diagnosis of PTSD, severity of depressive or anxiety symptoms, cost-effectiveness, or adverse events. I-C/BT compared with wait list Very low-certainty evidence showed that, compared with wait list, I-C/BT may be associated with a clinically important reduction in PTSD post-treatment (SMD -0.61, 95% CI -0.93 to -0.29; studies = 10, participants = 608). There may be no evidence of a difference in dropout rates between the I-C/BT and wait list groups (RR 1.25, 95% CI 0.97 to 1.60; studies = 9, participants = 634; low-certainty evidence). I-C/BT may be no more effective than wait list at reducing the risk of a diagnosis of PTSD after treatment (RR 0.53, 95% CI 0.28 to 1.00; studies = 1, participants = 62; very low-certainty evidence). I-C/BT may be associated with a clinically important reduction in symptoms of depression post-treatment (SMD -0.51, 95% CI -0.97 to -0.06; studies = 7, participants = 473; very low-certainty evidence). Very low-certainty evidence also suggested that I-C/BT may be associated with a clinically important reduction in symptoms of anxiety post-treatment (SMD -0.61, 95% CI -0.89 to -0.33; studies = 5, participants = 345). There were no data regarding cost-effectiveness. Data regarding adverse events were uncertain, as only one study reported an absence of adverse events. I-C/BT compared with I-non-C/BT There may be no evidence of a difference in PTSD symptoms post-treatment between the I-C/BT and I-non-C/BT groups (SMD -0.08, 95% CI -0.52 to 0.35; studies = 2, participants = 82; very low-certainty evidence). There may be no evidence of a difference between dropout rates from the I-C/BT and I-non-C/BT groups (RR 2.14, 95% CI 0.97 to 4.73; studies = 2, participants = 132; I² = 0%; very low-certainty evidence). Two studies found no evidence of a difference in post-treatment depressive symptoms between the I-C/BT and I-non-C/BT groups (SMD -0.12, 95% CI -0.78 to 0.54; studies = 2, participants = 84; very low-certainty evidence). Two studies found no evidence of a difference in post-treatment symptoms of anxiety between the I-C/BT and I-non-C/BT groups (SMD 0.08, 95% CI -0.78 to 0.95; studies = 2, participants = 74; very low-certainty evidence). There were no data regarding cost-effectiveness. Data regarding adverse effects were uncertain, as it was not discernible whether adverse effects reported were attributable to the intervention. AUTHORS' CONCLUSIONS: While the review found some beneficial effects of I-C/BT for PTSD, the certainty of the evidence was very low due to the small number of included trials. This review update found many planned and ongoing studies, which is encouraging since further work is required to establish non-inferiority to current first-line interventions, explore mechanisms of change, establish optimal levels of guidance, explore cost-effectiveness, measure adverse events, and determine predictors of efficacy and dropout.

Stratification of the risk of bipolar disorder recurrences in pregnancy and postpartum.

BACKGROUND: Pregnancy and childbirth are a period of high risk for women with bipolar disorder and involve difficult decisions particularly about continuing or stopping medications.AimsTo explore what clinical predictors may help to individualise the risk of perinatal recurrence in women with bipolar disorder. METHOD: Information was gathered retrospectively by semi-structured interview, questionnaires and case-note review from 887 women with bipolar disorder who have had children. Clinical predictors were selected using backwards stepwise logistic regression, conditional permutation random forests and reinforcement learning trees. RESULTS: Previous perinatal history of affective psychosis or depression was the most significant predictor of a perinatal recurrence (odds ratio (OR) = 8.5, 95% CI 5.04-14.82 and OR = 3.6, 95% CI 2.55-5.07 respectively) but even parous women with bipolar disorder without a previous perinatal mood episode were at risk following a subsequent pregnancy, with 7% developing postpartum psychosis. CONCLUSIONS: Previous perinatal history of affective psychosis or depression is the most important predictor of perinatal recurrence in women with bipolar disorder and can be used to individualise risk assessments.Declaration of interestNone.

Internet-based cognitive and behavioural therapies for post-traumatic stress disorder (PTSD) in adults.

BACKGROUND: Therapist-delivered trauma-focused psychological therapies are an effective treatment for post-traumatic stress disorder (PTSD). These have become the accepted first-line treatments for the disorder. Despite the established evidence-base for these therapies, they are not always widely available or accessible. Many barriers limit treatment uptake, such as the limited number of qualified therapists to deliver the interventions, cost, and compliance issues, such as time off work, childcare, and transportation, associated with the need to attend weekly appointments. Delivering cognitive behavioural therapy (CBT) on the Internet is an effective and acceptable alternative to therapist-delivered treatments for anxiety and depression. However, fewer Internet-based therapies have been developed and evaluated for PTSD, and uncertainty surrounds the efficacy of Internet-based cognitive and behavioural therapy (I-C/BT) for PTSD. OBJECTIVES: To assess the effects of I-C/BT for PTSD in adults. SEARCH METHODS: We searched the Cochrane Common Mental Disorders Group's Specialised Register (CCMDCTR) to June 2016 and identified four studies meeting the inclusion criteria. The CCMDCTR includes relevant randomised controlled trials (RCT) from MEDLINE, Embase, and PsycINFO. We also searched online clinical trial registries and reference lists of included studies, and contacted researchers in the field to identify additional and ongoing studies. We ran an update search on 1 March 2018, and identified four additional completed studies, which we added to the analyses along with two that were previously awaiting classification. SELECTION CRITERIA: We searched for RCTs of I-C/BT compared to face-to-face or Internet-based psychological treatment, psychoeducation, wait list or care as usual. We included studies of adults (aged over 16 years or over), in which at least 70% of the participants met the diagnostic criteria for PTSD, according to the Diagnostic and Statistical Manual (DSM) or the International Classification of Diseases (ICD). DATA COLLECTION AND ANALYSIS: We entered data into Review Manager 5 software. We analysed categorical outcomes as risk ratios (RRs), and continuous outcomes as mean differences (MD) or standardised mean differences (SMDs), with 95% confidence intervals (CI). We pooled data with a fixed-effect meta-analysis, except where heterogeneity was present, in which case we used a random-effects model. Two review authors independently assessed the included studies for risk of bias; any conflicts were discussed with a third author, with the aim of reaching a unanimous decision. MAIN RESULTS: We included 10 studies with 720 participants in the review. Eight of the studies compared I-C/BT delivered with therapist guidance to a wait list control. Two studies compared guided I-C/BT with I-non-C/BT. There was considerable heterogeneity among the included studies.Very low-quality evidence showed that, compared with wait list, I-C/BT may be associated with a clinically important reduction in PTSD post-treatment (SMD -0.60, 95% CI -0.97 to -0.24; studies = 8, participants = 560). However, there was no evidence of a difference in PTSD symptoms when follow-up was less than six months (SMD -0.43, 95% CI -1.41 to 0.56; studies = 3, participants = 146). There may be little or no difference in dropout rates between the I-C/BT and wait list groups (RR 1.39, 95% CI 1.03 to 1.88; studies = 8, participants = 585; low-quality evidence). I-C/BT was no more effective than wait list at reducing the risk of a diagnosis of PTSD after treatment (RR 0.53, 95% CI 0.28 to 1.00; studies = 1, participants = 62; very low-quality evidence). I-C/BT may be associated with a clinically important reduction in symptoms of depression both post-treatment (SMD -0.61, 95% CI -1.17 to -0.05; studies = 5, participants = 425; very low-quality evidence). Very low-quality evidence also suggested that I-C/BT may be associated with a clinically important reduction in symptoms of anxiety post-treatment (SMD -0.67, 95% CI -0.98 to -0.36; studies = 4, participants = 305), and at follow-up less than six months (MD -12.59, 95% CI -20.74 to -4.44; studies = 1, participants = 42; very low-quality evidence). The effects of I-C/BT on quality of life were uncertain (SMD 0.60, 95% CI 0.08 to 1.12; studies = 2, participants = 221; very low-quality evidence).Two studies found no difference in PTSD symptoms between the I-C/BT and I-non-C/BT groups when measured post-treatment (SMD -0.08, 95% CI -0.52 to 0.35; studies = 2, participants = 82; very low-quality evidence), or when follow-up was less than six months (SMD 0.08, 95% CI -0.41 to 0.57; studies = 2, participants = 65; very low-quality evidence). However, those who received I-C/BT reported their PTSD symptoms were better at six- to 12-month follow-up (MD -8.83, 95% CI -17.32 to -0.34; studies = 1, participants = 18; very low-quality evidence). Two studies found no difference in depressive symptoms between the I-C/BT and I-non-C/BT groups when measured post-treatment (SMD -0.12, 95% CI -0.78 to 0.54; studies = 2, participants = 84; very low-quality evidence) or when follow-up was less than six months (SMD 0.20, 95% CI -0.31 to 0.71; studies = 2, participants = 61; very low-quality evidence). However, those who received I-C/BT reported their depressive symptoms were better at six- to 12-month follow-up (MD -8.34, 95% CI -15.83 to -0.85; studies = 1, participants = 18; very low-quality evidence). Two studies found no difference in symptoms of anxiety between the I-C/BT and I-non-C/BT groups when measured post-treatment (SMD 0.08, 95% CI -0.78 to 0.95; studies = 2, participants = 74; very low-quality evidence) or when follow-up was less than six months (SMD -0.16, 95% CI -0.67 to 0.35; studies = 2, participants = 60; very low-quality evidence). However, those who received I-C/BT reported their symptoms of anxiety were better at six- to 12-month follow-up (MD -8.05, 95% CI -15.20 to -0.90; studies = 1, participants = 18; very low-quality evidence).None of the included studies reported on cost-effectiveness or adverse events. AUTHORS' CONCLUSIONS: While the review found some beneficial effects of I-C/BT for PTSD, the quality of the evidence was very low due to the small number of included trials. Further work is required to: establish non-inferiority to current first-line interventions, explore mechanisms of change, establish optimal levels of guidance, explore cost-effectiveness, measure adverse events, and determine predictors of efficacy and dropout.

Pharmacotherapy for post-traumatic stress disorder: systematic review and meta-analysis.

BACKGROUND: Pharmacological treatment is widely used for post-traumatic stress disorder (PTSD) despite questions over its efficacy. AIMS: To determine the efficacy of all types of pharmacotherapy, as monotherapy, in reducing symptoms of PTSD, and to assess acceptability. METHOD: A systematic review and meta-analysis of randomised controlled trials was undertaken; 51 studies were included. RESULTS: Selective serotonin reuptake inhibitors were found to be statistically superior to placebo in reduction of PTSD symptoms but the effect size was small (standardised mean difference -0.23, 95% CI -0.33 to -0.12). For individual pharmacological agents compared with placebo in two or more trials, we found small statistically significant evidence of efficacy for fluoxetine, paroxetine and venlafaxine. CONCLUSIONS: Some drugs have a small positive impact on PTSD symptoms and are acceptable. Fluoxetine, paroxetine and venlafaxine may be considered as potential treatments for the disorder. For most drugs there is inadequate evidence regarding efficacy for PTSD, pointing to the need for more research in this area.

Clinical audit research and evaluation of motor neuron disease (CARE-MND): a national electronic platform for prospective, longitudinal monitoring of MND in Scotland.

Objectives: Launched in 1989, the Scottish Motor Neuron Disease Register (SMNDR) has provided a resource for prospective clinical data collection. However, in 2015 we aimed to evolve a system to allow: i) A patient-centered approach to care based on recognized standards, ii) Harmonized data sharing between Scottish health professionals in "real-time", iii) Regular audit of care to facilitate timely improvements in service delivery, and iv) Patient participation in a diverse range of observational and interventional research studies including clinical trials. Methods: We developed a standardized national electronic data platform-Clinical Audit Research and Evaluation of MND (CARE-MND) which integrates clinical audit and research data fields. Data completion pre- and post-CARE-MND were compared, guided by recently published National Institute for Clinical Excellence (NICE) recommendations. Statistical difference in data capture between time periods was assessed using Z-test of proportions. Results: Data field completion for the historical 2011-2014 period ranged from 4 to 95%; median 50%. CARE-MND capture ranged from 32 to 98%; median 87%. 15/17 fields were significantly more complete post-CARE-MND (p < 0.001). All MND nurse/allied health specialists in Scotland use the CARE-MND platform. Management of MND in Scotland is now coordinated through a standardized template. Conclusions: Through CARE-MND, national audits of MND care and interventions have been possible, leading to protocols for harmonized service provision. Stratification of the MND population is facilitating participation in observational and interventional studies. CARE-MND can act as a template for other neurological disorders.