None listed
Conditions
Brief summary
We aim to investigate the efficacy and cost-efficacy of dietary improvement in the treatment of Major Depressive Episodes (MDE) using a randomised controlled trial.
Interventions
After a screening visit, participants will be randomly allocated to either a dietary intervention group or a social support control condition. The intervention will consist of 3 weekly educational and counselling sessions, targeting diet, followed by 4 two-weekly booster sessions. In each of the sessions, background information as well as strategies to address dietary change and adherence will be presented. At the commencement, each participant will be provided with a sample meal plan and select
After a screening visit, participants will be randomly allocated to either a dietary intervention group or a social support control condition. The intervention will consist of 3 weekly educational and counselling sessions, targeting diet, followed by 4 two-weekly booster sessions. In each of the sessions, background information as well as strategies to address dietary change and adherence will be presented. At the commencement, each participant will be provided with a sample meal plan and selected ingredients: oil, margarine and, nuts (e.g. walnuts as high in n-3 PUFA) for snacks (over the duration of the study). Examples of portions of fish and lean cuts of meat will also be provided. Sessions will be one on one, face to face and approximately 1 hour in length.
Sponsors
Barwon Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged 18 or over; have the capacity to consent to the study and to follow its instructions and procedures; fulfil the DSM-IV-TR diagnostic criteria for Major Depressive Disorder, Single Episode or Recurrent, as well as scoring 18 or over on the MADRS at the time of entry into the study. Antidepressant therapy is not an inclusion criterion; however, those on antidepressant therapy need to have been on the same treatment for at least two weeks prior to randomisation. Habitual diet quality will be assessed at screening using the validated Dietary Screening Tool (DST), and only those below the predetermined cutoff (less than 60= categorized as “at risk”) will be eligible for the study
Exclusion criteria
A concurrent diagnosis of bipolar I or II disorder; two or more failed trials of antidepressant therapy for the current major depressive episode; known or suspected clinically unstable systemic medical disorder; pregnancy or breastfeeding; commencement of new psychotherapy; current participation in an intervention targeting diet or exercise; a primary clinical diagnosis of a personality disorder or a current substance use disorder on structured interview.
Outcome results
None listed