Therapist-assisted online psychological therapies differing in trauma focus for post-traumatic stress disorder (STOP-PTSD): a UK-based, single-blind, randomised controlled trial.

BACKGROUND: Many patients are currently unable to access psychological treatments for post-traumatic stress disorder (PTSD), and it is unclear which types of therapist-assisted internet-based treatments work best. We aimed to investigate whether a novel internet-delivered cognitive therapy for PTSD (iCT-PTSD), which implements all procedures of a first-line, trauma-focused intervention recommended by the UK National Institute for Health and Care Excellence (NICE) for PTSD, is superior to internet-delivered stress management therapy for PTSD (iStress-PTSD), a comprehensive cognitive behavioural treatment programme focusing on a wide range of coping skills. METHODS: We did a single-blind, randomised controlled trial in three locations in the UK. Participants (≥18 years) were recruited from UK National Health Service (NHS) Improving Access to Psychological Therapies (IAPT) services or by self-referral and met DSM-5 criteria for PTSD to single or multiple events. Participants were randomly allocated by a computer programme (3:3:1) to iCT-PTSD, iStress-PTSD, or a 3-month waiting list with usual NHS care, after which patients who still met PTSD criteria were randomly allocated (1:1) to iCT-PTSD or iStress-PTSD. Randomisation was stratified by location, duration of PTSD (<18 months or ≥18 months), and severity of PTSD symptoms (high vs low). iCT-PTSD and iStress-PTSD were delivered online with therapist support by messages and short weekly phone calls over the first 12 weeks (weekly treatment phase), and three phone calls over the next 3 months (booster phase). The primary outcome was the severity of PTSD symptoms at 13 weeks after random assignment, measured by self-report on the PTSD Checklist for DSM-5 (PCL-5), and analysed by intention-to-treat. Safety was assessed in all participants who started treatment. Process analyses investigated acceptability and compliance with treatment, and candidate moderators and mediators of outcome. The trial was prospectively registered with the ISRCTN registry, ISRCTN16806208. FINDINGS: Of the 217 participants, 158 (73%) self-reported as female, 57 (26%) as male, and two (1%) as other; 170 (78%) were White British, 20 (9%) were other White, six (3%) were Asian, ten (5%) were Black, eight (4%) had a mixed ethnic background, and three (1%) had other ethnic backgrounds. Mean age was 36·36 years (SD 12·11; range 18-71 years). 52 (24%) participants met self-reported criteria for ICD-11 complex PTSD. Fewer than 10% of participants dropped out of each treatment group. iCT-PTSD was superior to iStress-PTSD in reducing PTSD symptoms, showing an adjusted difference on the PCL-5 of -4·92 (95% CI -8·92 to -0·92; p=0·016; standardised effect size d=0·38 [0·07 to 0·69]) for immediate allocations and -5·82 (-9·59 to -2·04; p=0·0027; d=0·44 [0·15 to 0·72]) for all treatment allocations. Both treatments were superior to the waiting list for PCL-5 at 13 weeks (d=1·67 [1·23 to 2·10] for iCT-PTSD and 1·29 [0·85 to 1·72] for iStress-PTSD). The advantages in outcome for iCT-PTSD were greater for participants with high dissociation or complex PTSD symptoms, and mediation analyses showed both treatments worked by changing negative meanings of the trauma, unhelpful coping, and flashback memories. No serious adverse events were reported. INTERPRETATION: Trauma-focused iCT-PTSD is effective and acceptable to patients with PTSD, and superior to a non-trauma-focused cognitive behavioural stress management therapy, suggesting that iCT-PTSD is an effective way of delivering the contents of CT-PTSD, one of the NICE-recommended first-line treatments for PTSD, while reducing therapist time compared with face-to-face therapy. FUNDING: Wellcome Trust, UK National Institute for Health and Care Research Oxford Health Biomedical Research Centre.

The Relationship Between Working Alliance and Symptom Improvement in Cognitive Therapy for Posttraumatic Stress Disorder.

Background: Working alliance has been shown to predict outcome of psychological treatments in multiple studies. Conversely, changes in outcome scores have also been found to predict working alliance ratings. Objective: To assess the temporal relationships between working alliance and outcome in 230 patients receiving trauma-focused cognitive behavioral treatment for posttraumatic stress disorder (PTSD). Methods: Ratings of working alliance were made by both the patient and therapist after sessions 1, 3, and 5 of a course of Cognitive Therapy for PTSD (CT-PTSD). Autoregressive, cross-lagged panel models were used to examine whether working alliance predicted PTSD symptom severity at the next assessment point and vice versa. Linear regressions tested the relationship between alliance and treatment outcome. Results: Both patients' and therapists' working alliance ratings after session 1 predicted PTSD symptom scores at the end of treatment, controlling for baseline scores. At each assessment point, higher therapist working alliance was associated with lower PTSD symptoms. Crossed-lagged associations were found for therapist-rated alliance, but not for patient-rated alliance: higher therapists' alliance ratings predicted lower PTSD symptom scores at the next assessment point. Similarly, lower PTSD symptoms predicted higher therapist working alliance ratings at the next assessment point. Ruminative thinking was negatively related to therapists' alliance ratings. Conclusions: Working alliance at the start of treatment predicted treatment outcome in patients receiving CT-PTSD and may be an important factor in setting the necessary conditions for effective treatment. For therapists, there was a reciprocal relationship between working alliance and PTSD symptom change in their patients during treatment, suggesting that their alliance ratings predicted symptom change, but were also influenced by patients' symptom change.

A randomised controlled trial of therapist-assisted online psychological therapies for posttraumatic stress disorder (STOP-PTSD): trial protocol.

BACKGROUND: Over the last few decades, effective psychological treatments for posttraumatic stress disorder (PTSD) have been developed, but many patients are currently unable to access these treatments. There is initial evidence that therapist-assisted internet-based psychological treatments are effective for PTSD and may help increase access, but it remains unclear which of these treatments work best and are most acceptable to patients. This randomised controlled trial will compare a trauma-focussed and a nontrauma-focussed therapist-assisted cognitive behavioural Internet treatment for PTSD: Internet-delivered cognitive therapy for PTSD (iCT-PTSD) and internet-delivered stress management therapy (iStress-PTSD). METHODS/DESIGN: The study is a single-blind, randomised controlled trial comparing iCT-PTSD, iStress-PTSD and a 13-week wait-list condition, with an embedded process study. Assessors of treatment outcome will be blinded to trial arm. Two hundred and seventeen participants who meet DSM-5 criteria for PTSD will be randomly allocated by a computer programme to iCT-PTSD, iStress-PTSD or wait-list at a 3:3:1 ratio. The primary assessment point is at 13 weeks, and further assessments are taken at 6, 26, 39 and 65 weeks. The primary outcome measure is the severity of PTSD symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5). Secondary measures of PTSD symptoms are the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the Impact of Event Scale-Revised (IES-R). Other symptoms and well-being will be assessed with the Patient Health Questionnaire (PHQ-9), Generalised Anxiety Disorder Scale (GAD-7), WHO (Five) Well-Being Index, Work and Social Adjustment Scale (WSAS), Endicott Quality of Life Scale (QoL), and Insomnia Sleep Index (ISI). Health economics analyses will consider quality of life, productivity, health resource utilisation, employment status and state benefits, and treatment delivery costs. Process analyses will investigate candidate mediators and moderators of outcome. Patient experience will be assessed by interview and questionnaire. DISCUSSION: This study will be the first to compare the efficacy of a trauma-focussed and nontrauma-focussed therapist-assisted online cognitive behavioural treatment for people with posttraumatic stress disorder. TRIAL REGISTRATION: ISRCTN16806208. Registered prospectively on 5 January 2018.

Cognitive processes associated with sudden gains in cognitive therapy for posttraumatic stress disorder in routine care.

OBJECTIVE: Although most studies investigating sudden gains in treatments for posttraumatic stress disorder (PTSD) report a positive association between sudden gains and outcomes at the end of treatment, less is known about sudden gains in routine clinical care and the processes involved in their occurrence. This study investigated changes in cognitive factors (negative appraisals, trauma memory characteristics) before, during, and after sudden gains in PTSD symptom severity. METHOD: Two samples (N1 = 248, N2 = 234) of patients who received trauma-focused cognitive therapy for PTSD in routine clinical care were analyzed. Mahalanobis distance matching, including the propensity score, was used to compare patients with sudden gains and similar patients without sudden gains. Estimates from both samples were meta-analyzed to obtain pooled effects. RESULTS: Patients with sudden gains (n1 = 76, n2 = 87) reported better treatment outcomes in PTSD symptom severity, depression, and anxiety at the end of therapy and follow-up than those without sudden gains. No baseline predictors of sudden gains could be reliably identified. During sudden gains, those with sudden gains had greater changes in both cognitive factors than matched patients. Meta-analyses of the two samples showed that negative appraisals had already decreased in the session prior to sudden gains compared with matched patients. CONCLUSIONS: The pooled estimates suggest that changes in negative trauma-related appraisals precede sudden gains in PTSD symptoms. The results suggest that interventions that promote change in appraisals may also facilitate sudden gains in therapy. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Cognitive paths from trauma to posttraumatic stress disorder: a prospective study of Ehlers and Clark's model in survivors of assaults or road traffic collisions.

BACKGROUND: Individual differences in cognitive responses to trauma may represent modifiable risk factors that could allow early identification, targeted early treatment and possibly prevention of chronic posttraumatic stress disorder (PTSD). Ehlers and Clark's cognitive model of PTSD suggests that negative appraisals, disjointed trauma memories, and unhelpful coping strategies maintain PTSD. These are thought to be influenced by cognitive processing during trauma. The aim of this study was to test this model prospectively with path analyses. METHODS: Participants (N = 828) were recruited from an emergency department following injury in a violent assault or road traffic collision and 700 participated in the 6-month assessments. Cognitive processing was assessed shortly after the event, negative appraisals, disjointed memories, and unhelpful coping strategies at 1 month, persistent PTSD symptom severity at 6 months, and early PTSD symptom severity at 2 weeks. RESULTS: Cognitive variables, with trauma type and gender, explained 52% of the variance in PTSD symptom severity at 6 months. Including early symptom severity in the model did not explain more variance (53%). Early PTSD symptom severity, with trauma type and gender, only predicted 40%. Negative appraisals and disjointed memories predicted persistent symptom severity both directly and indirectly via unhelpful strategies. Peritraumatic processing predicted persistent symptom severity mainly indirectly. The effects of trauma type and gender were fully mediated by the cognitive factors. CONCLUSIONS: The results are consistent with theoretically derived predictions and support cognitive factors as indicators of risk for chronic PTSD and as a target for the treatment and prevention of PTSD.

Sub-types of safety behaviours and their effects on social anxiety disorder.

Cognitive models suggest that social anxiety disorder (SAD) is maintained through the use of safety behaviours. Previous reports propose that these safety behaviours can be subdivided into two main categories: avoidance and impression management. Study 1 investigates whether certain safety behaviours are specific to SAD. The social behaviour questionnaire was administered to individuals with SAD (N = 106), post-traumatic stress disorder (N = 28) and non-patient controls (N = 59). A factor analysis (N = 164) replicated the previously reported avoidance and impression management subtypes. Scores for both subtypes were significantly higher in individuals with SAD than in individuals with post-traumatic stress disorder or non-patient controls. Study 2 investigated the causal role of such safety behaviours using an experimental design in a non-clinical population (N = 96). Pairs of participants each engaged in two conversations. In one of the conversations, a randomly selected participant performed either avoidance or impression management safety behaviours. In the other conversation, neither participant was instructed to use safety behaviours. Each participant rated their own anxiety and performance as well as rating the other person. Videos of the conversations were also rated. Both types of safety behaviour increased anxiety in the person performing the safety behaviour. The avoidance subtype also had broader effects on the other person that were largely absent from the impression management subtype. Taken together the studies provide support for the distinction between safety behaviour subtypes and have implications for the treatment of SAD.

Night-time rumination in PTSD: development and validation of a brief measure.

Background: Pre-sleep cognitive activity and arousal have long been implicated in the maintenance of insomnia. However, despite high comorbidity between insomnia and posttraumatic stress disorder (PTSD), pre-sleep thoughts in PTSD and their associations with disturbed sleep, have not yet been investigated. Objective: This study presents the development and preliminary validation of a brief self-report measure of the content of trauma-related pre-sleep thoughts: the Trauma Thoughts before Sleep Inventory (TTSI). Methods: Participants (N = 285) were recruited online into five groups: three groups with clinical symptoms, 1) PTSD; 2) depression without PTSD; 3) insomnia without depression or PTSD; and two healthy control groups 4) nontrauma-exposed controls; 5) trauma-exposed controls. The questionnaire was administered at baseline, and for a subsample (n = 157) again one week later to assess test-retest reliability. At baseline, participants also completed questionnaires of sleep quality, PTSD and depression symptoms, and insomnia-related thoughts. Results: The TTSI had good reliability and validity; it discriminated participants with PTSD from those with depression and insomnia, those with depression from insomnia, and correlated with existing measures of pre-sleep thoughts, self-reported pre-sleep arousal and poor sleep. Conclusions: The results support the utility of the TTSI for measuring thoughts that keep people with PTSD awake, although replication in an independent clinical sample is required.

Antecedentes: La actividad cognitiva y la excitación previa al sueño han estado implicadas durante mucho tiempo en el mantenimiento del insomnio. Sin embargo, a pesar de la alta comorbilidad entre el insomnio y el trastorno de estrés postraumático (TEPT), los pensamientos previos al sueño en el trastorno de estrés postraumático y sus asociaciones con trastornos del sueño, aún no se han investigado.Objetivo: Este estudio presenta el desarrollo y la validación preliminar de una escala breve de autoreporte del contenido de los pensamientos previos al sueño relacionados con el trauma: El Inventario de Pensamientos Traumáticos Previos al Sueño (IPTPS).Métodos: Los participantes (N = 285) fueron reclutados en línea y se dividieron en cinco grupos: tres grupos con síntomas clínicos, 1) TEPT; 2) depresión sin TEPT; 3) insomnio sin depresión o TEPT; y dos grupos de control sanos 4) controles no expuestos a traumas; 5) Controles expuestos al trauma. El cuestionario se administró al inicio del estudio y para una submuestra (n = 157) nuevamente una semana después, para evaluar la confiabilidad test-retest. Al inicio, los participantes también completaron cuestionarios de calidad del sueño, trastorno de estrés postraumático y depresión, y pensamientos relacionados con el insomnio.Resultados: El IPTPS tuvo buena confiabilidad y validez; discriminó a los participantes con TEPT de aquellos con depresión e insomnio, aquellos con depresión de los con insomnio y se correlacionó con las medidas existentes de los pensamientos previos al sueño y auto-reporte de activación previa al sueño y mala calidad de sueño.Conclusiones: Los resultados apoyan la utilidad del IPTPS para medir pensamientos que mantienen despiertas a las personas con TEPT, aunque se requiere la replicación en una muestra clínica independiente.