ABSTRACT
BACKGROUND: While existing psychological treatments for depression are effective for many, a significant proportion of depressed individuals do not respond to current approaches and few remain well over the long-term. Anhedonia (a loss of interest or pleasure) is a core symptom of depression which predicts a poor prognosis but has been neglected by existing treatments. Augmented Depression Therapy (ADepT) has been co-designed with service users to better target anhedonia alongside other features of depression. This mixed methods pilot trial aims to establish proof of concept for ADepT and to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost-effectiveness of ADepT, compared to an evidence-based mainstream therapy (Cognitive Behavioural Therapy; CBT) in the acute treatment of depression, the prevention of subsequent depressive relapse, and the enhancement of wellbeing. METHODS: We aim to recruit 80 depressed participants and randomise them 1:1 to receive ADepT (15 weekly acute and 5 booster sessions in following year) or CBT (20 weekly acute sessions). Clinical and health economic assessments will take place at intake and at 6-, 12-, and 18-month follow-up. Reductions in PHQ-9 depression severity and increases in WEMWBS wellbeing at 6-month assessment (when acute treatment should be completed) are the co-primary outcomes. Quantitative and qualitative process evaluation will assess mechanism of action, implementation issues, and contextual moderating factors. To evaluate proof of concept, intake-post effect sizes and the proportion of individuals showing reliable and clinically significant change on outcome measures in each arm at each follow-up will be reported. To evaluate feasibility and acceptability, we will examine recruitment, retention, treatment completion, and data completeness rates and feedback from patients and therapists about their experience of study participation and therapy. Additionally, we will establish the cost of delivery of ADepT. DISCUSSION: We will proceed to definitive trial if any concerns about the safety, acceptability, feasibility, and proof of concept of ADepT and trial procedures can be rectified, and we recruit, retain, and collect follow-up data on at least 60% of the target sample. TRIAL REGISTRATION: ISCRTN85278228, registered 27/03/2017.
ABSTRACT
BACKGROUND: This study examined the effects of a universal stress management program (Learn Young, Learn Fair) on stress, coping, anxiety and depression in fifth and sixth grade children. METHODS: Fifty-two schools (1467 children) participated in a clustered randomized controlled trial. Data was collected in the fall of 2002, the spring of 2003, and the winter of 2004. Given the nested structure of the design mixed (multilevel) regression analyses were applied. RESULTS: Positive effects were found for emotion-focused coping at posttest (p < .01) and increased stress awareness at both time points. At posttest a decrease in problem solving was found (p < .01). After correcting for mediation by stress awareness the results showed that the program significantly reduced stress symptoms (p = .05) and anxiety (p = .01) at posttest. Effect sizes varied from small to large. CONCLUSIONS: Universal prevention programs that address stress and coping in children are warranted given the high prevalence of stress in children and the relationship between stress, on the one hand, and health complaints and pathology, on the other. Such programs are expected to be particularly salient for children with an increased sensitivity to stress and inadequate coping styles (e.g., diathesis-stress model). The results indicate that the school-based program 'Learn Young, Learn Fair' may be a valuable program for reducing stress in children.
