Mental Health Impairment
Conditions
Brief summary
The purpose of the project is to investigate whether an intervention program with vitamin D supplementation is able to improve the biology of stress resilience as well as subjective well-being in individuals with antisocial behavior problems (forensic inpatients).
Detailed description
This is a randomized control trial looking at the effects of vitamin D supplements on mental health in a group of forensic inpatients. More specific the effects of vitamin D will be investigated in relation to underlying biological mechanisms associated with resilience (e.g., serotonin, cortisol, heart rate variability and executive functioning), but also subjective well-being such as sleep quality, anxiety, depression, self-reported resilience and physical activity. About 100 participants will be randomized to an intervention group (vitamin D) or a control group (placebo). The intervention will last for 3-4 months. Pre-test will start in October/November 2017 and post-test in April/May 2018.
Interventions
DIETARY_SUPPLEMENTVitamin D
Vitamin D (40µg/day) will be compared with placebo
DIETARY_SUPPLEMENTPlacebo
120 mg olive oil
Sponsors
Wisconsin Department of Health and Family Services
Haukeland University Hospital
National Institute of Nutrition and Seafood Research, Norway
University of Bergen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Double blind
Intervention model description
Pre and post-test design
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with intelligence quotient \> 70 will be invited.
Exclusion criteria
* Patients with intelligence quotient \<70 will be excluded. * Patients already taking vitamin D. * Patients with psychotic disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in heart rate variability from pre-test (baseline) to post-test (after 4 months) | 5 minutes of baseline, during the cognitive testing (up to 60 minutes) and 5 minutes of recovery (at both pre and post test) | — |
| Change in vitamin D level in blood from pre-test (baseline) to post-test (after 4 months) | Time for blood sample: about 10-15 minutes (at both pre and post test) | Measured from blood sample |
| Change in serotonin from pre-test (baseline) to post-test (after 4 months) | Time for blood sample: about 10-15 minutes (at both pre and post test) | Measured form blood sample |
| Change in total cholesterol from pre-test (baseline) to post-test (after 4 months) | Time for blood sample: about 10-15 minutes (at both pre and post test) | Measured from blood sample |
| Change in lipoproteins from pre-test (baseline) to post-test (after 4 months) | Time for blood sample: about 10-15 minutes (at both pre and post test) | Measured from blood sample |
| Change in triglycerides from pre-test (baseline) to post-test (after 4 months) | Time for blood sample: about 10-15 minutes (at both pre and post-test) | Measured from blood sample |
| Change in cortisol from pre-test (baseline) to post-test (after 4 months) | 7 samples over 24 hours (at both pre and post-test) | Saliva |
| Change in performance on working memory tasks (N-back) from pre-test (baseline) to post-test (after 4 months) | About 8-10 minutes (at both pre and post-test) | Computerized cognitive task |
| Change in performance on Tower of Hanoi Task from pre-test (baseline) to post-test (after 4 months) | About 10-15 minutes (at bot pre and post-test) | Computerized cognitive task |
| Change in performance on Tower of London Task from pre-test (baseline) to post-test (after 4 months) | About 10-15 minutes (at both pre and post test) | Computerized cognitive task |
| Change in performance on Iowa Gambling Task from pre-test (baseline) to post-test (after 4 months) | About 15-20 minutes (at both pre and post test) | Computerized cognitive task |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in post-traumatic stress symptoms (Impact of event scale -Revised) from pre-test (baseline) to post-test (after 4 months) | About 5-10 minutes (at both pre and post-test) | — |
| Change in self-reported depression (Beck Depression Inventory) from pre-test (baseline) to post-test (after 4 months) | About 5-10 minutes (at both pre and post-test) | — |
| Change in sleep from pre-test (baseline) to post-test (after 4 months) | One week before intervention and one week after intervention (i.e., pre and post-test) | Measured by Ambulatory Monitoring System together with a sleep log |
| Change on Epworth Sleepiness Scale from pre-test (baseline) to post-test (after 4 months) | About 5-10 minutes (at both pre and post-test) | — |
| Houston Non-Exercise Questionnaire | The physical activity log will be filled out weekly over the course of the study period (i.e., 24 -28 weeks) and estimated time per week is 10 minutes. | The log consists of weekly recording of various activity levels. |
| Change in self-reported state and trait anxiety (STAI questionnaire) from pre-test (baseline) to post-test (after 4 months) | About 10 minutes (at both pre and post-test) | — |
| Change in self-reported resilience (Connor-Davidson Resilience Scale 25) from pre-test (baseline) to post-test (after 4 months) | About 5 minutes (at both pre and post-test) | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Childhood Trauma Questionnaire | About 10 minutes (only at pre-test) | — |
| Iodine (test 2) | About 2-3 minutes | Urin |
| Iodine (test 1) | About 2-3 minutes | Urin |
Countries
United States
Outcome results
None listed