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Study protocol for a randomised controlled trial of cognitive processing therapy for post-traumatic stress disorder among Japanese patients: the Safety, Power, Intimacy, Esteem, Trust (SPINET) study.

ABSTRACT: INTRODUCTION:Cognitive processing therapy (CPT) is widely regarded as a safe and effective first-line treatment for individuals with post-traumatic stress disorder (PTSD); however, no comparative studies have been conducted to examine the treatment outcomes in an Asian population. The aim of the present trial is to investigate the efficacy of CPT (individual format) as a treatment for PTSD in a population of Japanese patients. METHODS AND ANALYSIS:A 16-week, single-centre, assessor-masked, randomised, parallel-group superiority trial has been designed to compare the efficacy of CPT in conjunction with treatment as usual (mostly pharmacotherapy and clinical monitoring) versus treatment as usual alone. The Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) will be our primary outcome measure of the post-traumatic stress symptoms at 17 weeks, whereas the PTSD Checklist for DSM-5 and determination of the operationally defined responder status will be used to assess the secondary outcomes. An estimated sample size of 29 participants in each group will be required to detect an expected effect size of 1.4 (95% CI 0.85 to 1.95). ETHICS AND DISSEMINATION:The institutional review board at the National Center of Neurology and Psychiatry in Japan approved this study. The results of this clinical trial will be presented at conferences and disseminated through publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER:UMIN000021670 (registered on 1 April 2016).

SUBMITTER: Ito M

PROVIDER: S-EPMC5734443 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Study protocol for a randomised controlled trial of cognitive processing therapy for post-traumatic stress disorder among Japanese patients: the Safety, Power, Intimacy, Esteem, Trust (SPINET) study.

Ito Masaya M Horikoshi Masaru M Resick Patricia A PA Katayanagi Akiko A Miyamae Mitsuhiro M Takagishi Yuriko Y Takebayashi Yoshitake Y Kanie Ayako A Hirabayashi Naotsugu N Furukawa Toshiaki A TA

BMJ open 20170630 6

<h4>Introduction</h4>Cognitive processing therapy (CPT) is widely regarded as a safe and effective first-line treatment for individuals with post-traumatic stress disorder (PTSD); however, no comparative studies have been conducted to examine the treatment outcomes in an Asian population. The aim of the present trial is to investigate the efficacy of CPT (individual format) as a treatment for PTSD in a population of Japanese patients.<h4>Methods and analysis</h4>A 16-week, single-centre, assesso ...[more]

PMID: 28667201

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Project description:Introduction Post-traumatic stress disorder (PTSD) is associated with hippocampal system structural and functional impairments. Neurobiological models of PTSD posit that contextual memory for traumatic events is impaired due to hippocampal system dysfunction whilst memory of sensory details is enhanced due to amygdalar impact on sensory cortices. If hippocampal system dysfunction is a core feature of PTSD, then non-traumatic hippocampal-dependent cognitive functions such as scene construction, spatial processing, and memory should also be impaired in individuals with PTSD. Methods Forty-six trauma survivors, half diagnosed with PTSD, performed two tasks that involved spatial processing. The first was a scene construction task which requires conjuring-up spatially coherent multimodal scenarios, completed by all participants. Twenty-six participants (PTSD: n = 13) also completed a navigation task in a virtual environment, and underwent structural T1, T2 and diffusion-tensor MRI to quantify gray and white matter integrity. We examined the relationship between spatial processing, neural integrity, and symptom severity in a multiple factor analysis. Results Overall, patients with PTSD showed impaired performance in both tasks compared to controls. Scenes imagined by patients were less vivid, less detailed, and generated less sense of presence; importantly they had disproportionally reduced spatial coherence between details. Patients also made more errors during virtual navigation. Two components of the multiple factor analysis captured group differences. The first component explained 25% of the shared variance: participants that constructed less spatially coherent scenes also made more navigation errors and had reduced white matter integrity to long association tracts and tracts connecting the hippocampus, thalamus, and cingulate. The second component explained 20% of the variance: participants who generated fewer scene details, with less spatial coherence between them, had smaller hippocampal, parahippocampal and isthmus cingulate volumes. These participants also had increased white matter integrity to the right hippocampal cingulum bundle. Conclusion Our results suggest that patients with PTSD are impaired at imagining even neutral spatially coherent scenes and navigating through a complex spatial environment. Patients that showed reduced spatial processing more broadly had reduced hippocampal systems volumes and abnormal white matter integrity to tracts implicated in multisensory integration.

Project description:ObjectivesWomen's decision-making power is a dimension of empowerment and is crucial for better physical and psychosocial outcomes of mothers. Suchana, a large-scale development programme in Bangladesh, actively provided social interventions on behaviour change communication to empower women belonging to the poorest social segment. This paper aims to assess the impact of the Suchana intervention on various indicators related to women's decision-making power.Design, setting and participantsThe evaluation design was a cluster randomised pre-post design with two cross-sectional surveys conducted among beneficiary women with at least one child aged <23 months from randomly selected poor or very poor beneficiary households in Sylhet division.Outcome measureDecision-making indicators included food purchases, major household purchases, food preparation, children's healthcare as well as women's own healthcare and visiting family and relatives.ResultsOur findings suggest that 45% of women were able to make decisions on food purchases, 25% on major household purchases, 78% on food preparation, 59% on children's healthcare, 51% on their own healthcare and 43% on visiting family and relatives at baseline in the intervention group, whereas the results were almost the same in the control group. In contrast, at the endline survey, the respective proportions were 75%, 56%, 87%, 80%, 77% and 67% in the intervention group, which were significantly improved when compared with the control group. The prevalence of those outcome indicators were 64%, 41%, 80%, 71%, 68% and 56%, respectively, in the control group. As per multiple logistic regression analysis and structural equation modelling, the Suchana intervention had a substantial influence on the latent variable of women's decision-making power.ConclusionIn terms of food purchases, major household purchases, children's healthcare, their own healthcare and visiting family and relatives, the Suchana intervention favourably influenced the decision-making power of rural women living in a vulnerable region of Bangladesh.Trial registration numberRIDIE-STUDY-ID-5d5678361809b.

Project description:BackgroundPost-traumatic stress disorder (PTSD) is a distressing and disabling condition that affects significant numbers of children and adolescents. Youth exposed to multiple traumas (eg, abuse, domestic violence) are at particular risk of developing PTSD. Cognitive therapy for PTSD (CT-PTSD), derived from adult work, is a theoretically informed, disorder-specific form of trauma-focused cognitive-behavioural therapy. While efficacious for child and adolescent single-event trauma samples, its effectiveness in routine settings with more complex, multiple trauma-exposed youth has not been established. The Delivery of Cognitive Therapy for Young People after Trauma randomised controlled trial (RCT) examines the effectiveness of CT-PTSD for treating PTSD following multiple trauma exposure in children and young people in comparison with treatment as usual (TAU).Methods/designThis protocol describes a two-arm, patient-level, single blind, superiority RCT comparing CT-PTSD (n=60) with TAU (n=60) in children and young people aged 8-17 years with a diagnosis of PTSD following multiple trauma exposure. The primary outcome is PTSD severity assessed using the Children's Revised Impact of Event Scale (8-item version) at post-treatment (ie, approximately 5 months post-randomisation). Secondary outcomes include structured interview assessment for PTSD, complex PTSD symptoms, depression and anxiety, overall functioning and parent-rated mental health. Mid-treatment and 11-month and 29-month post-randomisation assessments will also be completed. Process-outcome evaluation will consider which mechanisms underpin or moderate recovery. Qualitative interviews with the young people, their families and their therapists will be undertaken. Cost-effectiveness of CT-PTSD relative to TAU will be also be assessed.Ethics and disseminationThis trial protocol has been approved by a UK Health Research Authority Research Ethics Committee (East of England-Cambridge South, 16/EE/0233). Findings will be disseminated broadly via peer-reviewed empirical journal articles, conference presentations and clinical workshops.Trial registrationISRCTN12077707. Registered 24 October 2016 (http://www.isrctn.com/ISRCTN12077707). Trial recruitment commenced on 1 February 2017. It is anticipated that recruitment will continue until June 2021, with 11-month assessments being concluded in May 2022.

Dataset Information

Study protocol for a randomised controlled trial of cognitive processing therapy for post-traumatic stress disorder among Japanese patients: the Safety, Power, Intimacy, Esteem, Trust (SPINET) study.

Publications

Study protocol for a randomised controlled trial of cognitive processing therapy for post-traumatic stress disorder among Japanese patients: the Safety, Power, Intimacy, Esteem, Trust (SPINET) study.

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