Folate Augmentation of Treatment – Evaluation for Depression (FolATED): protocol of a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Clinical depression is common, debilitating and treatable; one in four people experience it during their lives. The majority of sufferers are treated in primary care and only half respond well to active treatment. Evidence suggests that folate may be a useful adjunct to antidepressant treatment: 1) patients with depression often have a functional folate deficiency; 2) the severity of such deficiency, indicated by elevated homocysteine, correlates with depression severity, 3) low folate is associated with poor antidepressant response, and 4) folate is required for the synthesis of neurotransmitters implicated in the pathogenesis and treatment of depression.</p> <p>Methods/Design</p> <p>The primary objective of this trial is to estimate the effect of folate augmentation in new or continuing treatment of depressive disorder in primary and secondary care. Secondary objectives are to evaluate the cost-effectiveness of folate augmentation of antidepressant treatment, investigate how the response to antidepressant treatment depends on genetic polymorphisms relevant to folate metabolism and antidepressant response, and explore whether baseline folate status can predict response to antidepressant treatment.</p> <p>Seven hundred and thirty patients will be recruited from North East Wales, North West Wales and Swansea. Patients with moderate to severe depression will be referred to the trial by their GP or Psychiatrist. If patients consent they will be assessed for eligibility and baseline measures will be undertaken.</p> <p>Blood samples will be taken to exclude patients with folate and B12 deficiency. Some of the blood taken will be used to measure homocysteine levels and for genetic analysis (with additional consent). Eligible participants will be randomised to receive 5 mg of folic acid or placebo. Patients with B12 deficiency or folate deficiency will be given appropriate treatment and will be monitored in the 'comprehensive cohort study'. Assessments will be at screening, randomisation and 3 subsequent follow-ups.</p> <p>Discussion</p> <p>If folic acid is shown to improve the efficacy of antidepressants, then it will provide a safe, simple and cheap way of improving the treatment of depression in primary and secondary care.</p> <p>Trial registration</p> <p>Current controlled trials ISRCTN37558856</p

Effectiveness of treatment for alcohol problems: findings of the randomised UK Alcohol Treatment Trial (UKATT)

Objective To compare the effectiveness of social behaviour and network therapy, a new treatment for alcohol problems, with that of the proved motivational enhancement therapy. Design Pragmatic randomised trial Setting Seven treatment sites around Birmingham, Cardiff, and Leeds. Participants. 742 clients with alcohol problems; 689 (93.0%) were interviewed at three months and 617 (83.2%) at 12 months. Interventions Social behaviour and network therapy and motivational enhancement therapy. Main outcome measures Changes in alcohol consumption, alcohol dependence, and alcohol related problems over 12 months. Results Both groups reported substantial reductions in alcohol consumption, dependence, and problems, and better mental health related quality of life over 12 months. Between groups we found only one significant difference in outcome, probably due to chance: the social network group showed significantly better physical health at three months. Non-significant differences at 12 months in the motivational group relative to the social network group included: the number of drinks consumed per drinking day had decreased by an extra 1.1 (95% confidence interval −1.0 to 3.2); scores on the Leeds dependence questionnaire had improved by an extra 0.6 (−0.7 to 2.0); scores on the alcohol problems questionnaire had improved by an extra 0.5 (−0.4 to 1.4); but the number of days abstinent from drinking had increased by 1.2% less (−4.5% to 6.9%). Conclusion The novel social behaviour and network therapy for alcohol problems did not differ significantly in effectiveness from the proved motivational enhancement therapy

Effectiveness of treatment for alcohol problems: Findings of the randomised United Kingdom Alcohol Treatment Trial (UKATT)

Objective: To compare the effectiveness of social behaviour and network therapy, a new treatment for alcohol problems, with that of the proved motivational enhancement therapy. Design: Pragmatic randomised trial. Setting: Seven treatment sites around Birmingham, Cardiff, and Leeds. Participants: 742 clients with alcohol problems; 689 (93.0%) were interviewed at three months and 617 (83.2%) at 12 months. Interventions: Social behaviour and network therapy and motivational enhancement therapy. Main outcome measures: Changes in alcohol consumption, alcohol dependence, and alcohol related problems over 12 months. Results: Both groups reported substantial reductions in alcohol consumption, dependence, and problems, and better mental health related quality of life over 12 months. Between groups we found only one significant difference in outcome, probably due to chance: the social network group showed significantly better physical health at three months. Non-significant differences at 12 months in the motivational group relative to the social network group included: the number of drinks consumed per drinking day had decreased by an extra 1.1 (95% confidence interval -1.0 to 3.2); scores on the Leeds dependence questionnaire had improved by an extra 0.6 (-0.7 to 2.0); scores on the alcohol problems questionnaire had improved by an extra 0.5 (-0.4 to 1.4); but the number of days abstinent from drinking had increased by 1.2% less (-4.5% to 6.9%). Conclusion: The novel social behaviour and network therapy for alcohol problems did not differ significantly in effectiveness from the proved motivational enhancement therapy