The efficacy of nutraceuticals in the treatment of chronic insomnia
Not Applicable
Completed
- Conditions
- Treatment of patients suffering from chronic insomnia and anxiety states.Mental and Behavioural Disorders
- Registration Number
- ISRCTN85501054
- Lead Sponsor
- Sapienza University of Rome
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
Patients suffering from chronic insomnia according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders and the third edition of the International Classification of Sleep Disorders (DSM-V), associated with a state of anxiety.
Exclusion Criteria
1. Major depressive disorders
2. Substance abuse disorders
3. Pregnancy
4. Unstable clinical status
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measured at baseline and week four:<br>1. The Pittsburgh Sleep Quality Index (PSQI)<br>2. STAI-Y1 (anxiety)
- Secondary Outcome Measures
Name Time Method 1. PSQI at baseline and eight weeks<br>2. STAI-Y2 at baseline and eight weeks<br>3. Beck Depression Inventory (BDI) at four and eight weeks<br>4. Fatigue Severity Scale (FSS) at four and eight weeks<br>5. Depression and Anxiety Scale Short form – 21 (DASS-21) at four and eight weeks<br>6. Patient global impression of improvement - severity (PGI-S) at four and eight weeks<br>7. Rapid Stress Assessment (RSA) at four and eight weeks<br>8. Insomnia Severity Index at four and eight weeks <br>9. General health (SF-36) at four and eight weeks