Predicting Effectiveness of Light Treatment for Winter Seasonal Affective Disorder
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Predicting Light Treatment's Effectiveness on Reducing Depression and Cardiovascular Risk in Seasonal Affective Disorder|
- Hamilton rating scale for depressional seasonal affective disorder (SIGH SAD) [ Time Frame: Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks ]
- Hunger questionnaire [ Time Frame: Measured daily for 6 weeks ]
- Three factor eating questionnaire [ Time Frame: Measured weekly for 6 weeks ]
- Sleep log [ Time Frame: Measured weekly for 6 weeks ]
- Food craving questionnaire [ Time Frame: Measured daily for 6 weeks ]
- Side effects questionnaire [ Time Frame: Measured weekly for 6 weeks ]
- Adherence questionnaire [ Time Frame: Measured weekly for 6 weeks ]
- Profile of Mood States [ Time Frame: Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks ]
- Beck Depression Inventory-II (BDI) [ Time Frame: Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks ]
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||September 2015|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Participants will be given a 1-hour lab test of bright light treatment, then the bright light treatment for 6 weeks.
Device: Bright light
One hour of exposure to bright light daily upon awakening for 6 weeks.
Other Name: Brite light III light box (Apollo) 10,000 lux.
Participants will be given a 1-hour treatment of the red light placebo, then the bright light treatment for 6 weeks.
Device: Red light placebo
One hour of exposure to red light.
Other Name: Dim red light box (Apollo) 50 lux.
The winter subtype of seasonal affective disorder (SAD) is characterized by episodes of major depression in the fall and winter, with remission of these episodes in the spring and summer. SAD disrupts the lives of millions of Americans, who experience symptoms such as restless agitation, increased appetite and weight gain, and reduced energy and motivation. Bright light treatment, while shown to be effective in improving SAD in 75% of cases, only causes a full remission in 50% of cases. If doctors had a diagnostic tool to determine which patients would respond to bright light therapy, they could make better decisions about whether to prescribe bright light as treatment. This study will examine a possible diagnostic tool—a single, 1-hour bright light session—for predicting improvement in SAD symptoms over an extended course of bright light treatment. Additionally, because many symptoms of SAD (like weight gain and sedentary lifestyle) correspond to cardiovascular risk, this study will examine whether bright light treatment correlates with improved cardiovascular health.
Participants with SAD will be randomly assigned to first receive a 1-hour session of either bright light or the placebo, red light. Then all participants will switch and receive a 1-hour session of the other type of light. Red light has been accepted as a placebo in previous SAD studies because it does not suppress melatonin or shift circadian rhythms. Before and after each light session, participants will have their SAD symptoms evaluated in a clinical interview and self-report measure. After these two light sessions, all participants will receive instructions for administering bright light treatment on their own at home. For the next 6 weeks, participants will administer the bright light to themselves for 1 hour every morning. Every week they will undergo clinical interviews by phone and will mail in self-report measures, some completed daily and some weekly, to the researchers. The participants will have checkups and interviews in person on Weeks 4 and 6. At the two time periods, SAD symptoms and indicators of cardiovascular risk, such as appetite and sleep loss, will be evaluated. The participant responses to bright light and red light at the initial session will be compared with the participant responses to the subsequent 6-week treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742365
|Principal Investigator:||Teodor T. Postolache, MD||University of Maryland|