Depression Clinical Trial
Official title:
A Randomized-controlled Pilot Study to Evaluate the Efficacy of a Fasting Mimicking Diet Added to Functional Therapy for Depression
Verified date | August 2019 |
Source | Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Depression has to be considered as a systematic illness involving the whole body, it is often associated with low-grade inflammation and alterations of the microbiome. In this regard, an unhealthy diet increases the risk of the onset of this disorder, therefore an integrated treatment including a healthy diet could be more effective. The aim of our study were to verify the efficacy of a structured FT program, delivered in individual setting, for patients with depression (PSY group), and to verify whether the association of a FMD protocol with the structured FT program significantly improves clinical outcomes (PSY-FMD group). After a psychiatric, psychological and anthropometric assessment, depressed patients were randomly assigned to psychotherapy and diet (PSY-FMD) or just psychotherapy (PSY). PSY-FMD participants received 20 individual sessions of Functional Psychotherapy. Each session attended twice a week for the first 8 weeks and once a week for the remaining 4. Furthermore, they received a nutritional consultation and prescription of a Fasting Mimicking Diet. PSY group received just the psychotherapy protocol and the nutritional consultation. All patients were retested at the end of the treatment and at follow-up 3 months after the last session. In both groups was highlighted a strong effectiveness of treatments on depression, self-esteem and quality of life. In the PSY-FMD group compared to PSY a significant effect was found on the improvement of self-esteem and quality of life. Furthermore, a significant reduction of BMI was found in the PSY-FMD group. The current study supports the effectiveness of the combination of psychotherapy with a fasting mimicking diet in adult depressed patients.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 27, 2019 |
Est. primary completion date | May 23, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - a score at the Beck Depression Inventory - II (BDI-II) over than 13 at the time of initial assessment; - age from 18 to 60 years old; - seeking treatment for mood problems; - not involved in a concurrent treatment; - without any psychopharmacological treatment for depression in the previous 12 months; - without any practice of yoga or meditation; Exclusion Criteria: - a current or lifetime diagnosis of psychotic disorders, borderline, schizotypal, or antisocial personality disorder, active suicidal ideation with a plan, eating disorders, bipolar disorder, primary anxiety disorder - a past or present of drug abuse or drug addiction (excluding nicotine) - chronic inflammation diseases - eating disorders - IQ less than 65 - BMI less than 18.5 or more than 30 - severe hepatic failure - serious infections (such as HIV, hepatitis B and C) - cancer in the previous 6 months - regular use of anti-inflammatory drugs for more than 15 days/month |
Country | Name | City | State |
---|---|---|---|
Italy | Unit of Psychiatry | Palermo |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo | Centro Studi Psicoterapia Neo-Funzionale, University of Palermo |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | severity of depressive symptoms measured by the second version of the Beck-Depression-Inventory (BDI-II) | change of depression symptoms (measured through Beck Depression Inventory -II). Total score from 0 to 63. Higher values represent worst depression symptoms | end of the treatment (three months) and three months later (follow-up) | |
Secondary | self-esteem measured by the Basic Self-Esteem Scale | change of self-esteem (measured through Basic Self-Esteem Scale). Percentiles scores were used (from 0 to 100). Higher values indicate a better self-esteem | end of the treatment (three months) and three months later (follow-up) | |
Secondary | quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF) | change of Quality of Life (measured through World Health Organization Quality of Life BREF). Subscales: physical health, psychological health, social relationships, and environment. Score from 0 to 100. Higher values represent a better quality of life in each area | end of the treatment (three months) and three months later (follow-up) |
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