Improving mood with psychoanalytic and cognitive therapies (IMPACT): a pragmatic effectiveness superiority trial to investigate whether specialised psychological treatment reduces the risk for relapse in adolescents with moderate to severe unipolar depression: study protocol for a randomised controlled trial

Background Up to 70% of adolescents with moderate to severe unipolar major depression respond to psychological treatment plus Fluoxetine (20-50 mg) with symptom reduction and improved social function reported by 24 weeks after beginning treatment. Around 20% of non responders appear treatment resistant and 30% of responders relapse within 2 years. The specific efficacy of different psychological therapies and the moderators and mediators that influence risk for relapse are unclear. The cost-effectiveness and safety of psychological treatments remain poorly evaluated. Methods/Design Improving Mood with Psychoanalytic and Cognitive Therapies, the IMPACT Study, will determine whether Cognitive Behavioural Therapy or Short Term Psychoanalytic Therapy is superior in reducing relapse compared with Specialist Clinical Care. The study is a multicentre pragmatic effectiveness superiority randomised clinical trial: Cognitive Behavioural Therapy consists of 20 sessions over 30 weeks, Short Term Psychoanalytic Psychotherapy 30 sessions over 30 weeks and Specialist Clinical Care 12 sessions over 20 weeks. We will recruit 540 patients with 180 randomised to each arm. Patients will be reassessed at 6, 12, 36, 52 and 86 weeks. Methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, research assessors independent of treatment team and blind to randomization, analysis by intention to treat, data management using remote data entry, measures of quality assurance, advanced statistical analysis, manualised treatment protocols, checks of adherence and competence of therapists and assessment of cost-effectiveness. We will also determine whether time to recovery and/or relapse are moderated by variations in brain structure and function and selected genetic and hormone biomarkers taken at entry. Discussion The objective of this clinical trial is to determine whether there are specific effects of specialist psychotherapy that reduce relapse in unipolar major depression in adolescents and thereby costs of treatment to society. We also anticipate being able to utilise psychotherapy experience, neuroimaging, genetic and hormone measures to reveal what techniques and their protocols may work best for which patients.

A case study of the Tatweer school system in Saudi Arabia: the perceptions of leaders and teachers

School reform is a major concern in many countries that seek to improve their educational systems and enhance their performances. In consequence, many global schemes, theories, studies, attempts, and programmes have been introduced to promote education in recent years. Saudi Arabia is one of these countries that implemented educational change by introducing many initiatives. The Tatweer Programme is one of these initiatives and is considered as a major recent reform. The main purpose of this study is to investigate this reform in depth by examining the perceptions and experiences of the Tatweer leaders and teachers to find out which extent they have been enabled to be innovative, and to examine the types of leadership and decision-making that have been undertaken by such schools. This study adopted a qualitative case study that employed interviews, focus groups and documentary analysis. The design of the study has been divided into two phases; the first phase was the feasibility study and the second phase was the main study. The research sample of the feasibility study was head teachers, educational experts and Tatweer Unit’s members. The sample of the main study was three Tatweer schools, Tatweer Unit members and one official of Tatweer Project in Riyadh. The findings of this study identified the level of autonomy in managing the school; the Tatweer schools’ system is semi-autonomous when it comes to the internal management, but it lacks autonomy when it comes to staff appointment, student assessment, and curriculum development. In addition, the managerial work has been distributed through teams and members; the Excellence Team plays a critical role in school effectiveness leading an efficient change. Moreover, Professional Learning Communities have been used to enhance the work within Tatweer schools. Finally the findings show that there have been major shifts in the Tatweer schools’ system; the shifting from centralisation to semi-decentralisation; from the culture of the individual to the culture of community; from the traditional school to one focused on self-evaluation and planning; from management to leadership; and from an isolated school being open to society. These shifts have impacted positively on the attitudes of students, parents and staff.