A Phase 1 interventional study of Light Therapy and Cognitive behavioral therapy (CBT) in Seasonal Affective Disorder and Depression, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-25.
Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine · Phase 1, Interventional, and Treatment
This study will assess the effectiveness of cognitive behavioral therapy (CBT) in treating seasonal affective disorder (SAD), commonly called the "winter blues."
SAD is a condition in which people experience depression as a result of seasonal variations in sunlight. Although light therapy is a common treatment for SAD, a large proportion of people with SAD are resistant to this treatment. CBT is effective for nonseasonal depressive disorders, but its use for SAD has not been thoroughly explored. This study will determine whether CBT, alone and combined with light therapy, is as effective as light therapy alone in reducing SAD symptoms.
Participants in this study will be randomly assigned to light therapy, CBT, a combination of light therapy and CBT, or a control group (no therapy) for 6 weeks. CBT will be conducted twice a week; light therapy will be conducted twice a day. Assessments will be made before, during, and after the study treatment. Depression scales, questionnaires, and behavioral tasks will be used to assess the depressive symptoms of participants. A 6-month and 1-year follow-up visit will also be conducted. During the follow-up visits, participants will be interviewed and will complete a questionnaire and a survey.
31 studies on the registry are indexed under Seasonal Affective Disorder; 2 are open to participants now.
This study's enrollment of 61 is close to the median of 60 across 25 interventional studies indexed under Seasonal Affective Disorder.
Browse Seasonal Affective Disorder studies →Henry M. Jackson Foundation for the Advancement of Military Medicine is the lead sponsor of 85 studies on the registry; 18 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Behavioral: Light Therapy
Behavioral: Cognitive behavioral therapy (CBT)
Behavioral: Light Therapy · Behavioral: Cognitive behavioral therapy (CBT)
Light therapy will involve exposure to bright light twice a day.
CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version
The Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcome. Range of scores is 0 to 73. Generally, a score of 20 or higher is the cutoff for clinical depression.
Time frame: Post-treatment
Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD)
Dichotomous Remission Status (remitted or not) at post-treatment
Time frame: Post-treatment
| Milestone | 1 Light Therapy | 2 Cognitive Behavioral Therapy | 3 Light Therapy Plus Cognitive Behavioral Therapy | 4 Control |
|---|---|---|---|---|
| Started | 16 | 15 | 15 | 15 |
| Completed | 16 | 15 | 15 | 14 |
| Not completed | 0 | 0 | 0 | 1 |
The Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcome. Range of scores is 0 to 73. Generally, a score of 20 or higher is the cutoff for clinical depression.
| units on a scale | 1 Light Therapy | 2 Cognitive Behavioral Therapy | 3 Light Therapy Plus Cognitive Behavioral Therapy | 4 Control |
|---|---|---|---|---|
| Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version | 13.6 ± 8.8 | 13.3 ± 11.1 | 8.3 ± 5.8 | 22.6 ± 8.4 |
Dichotomous Remission Status (remitted or not) at post-treatment
| participants | 1 Light Therapy | 2 Cognitive Behavioral Therapy | 3 Light Therapy Plus Cognitive Behavioral Therapy | 4 Control |
|---|---|---|---|---|
| Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD) | 8 | 6 | 11 | 3 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1 Light Therapy | — | 0/16 (0%) | 0/16 (0%) |
| 2 Cognitive Behavioral Therapy | — | 0/15 (0%) | 0/15 (0%) |
| 3 Light Therapy Plus Cognitive Behavioral Therapy | — | 0/15 (0%) | 0/15 (0%) |
| 4 Control | — | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | 1 Light Therapy | 2 Cognitive Behavioral Therapy | 3 Light Therapy Plus Cognitive Behavioral Therapy | 4 Control | Total |
|---|---|---|---|---|---|
| Mean | 47.6 ± 9.7 | 45.9 ± 15.5 | 43.0 ± 12.8 | 43.3 ± 7.7 | 45.0 ± 5.8 |
| Sex: Female, Male(Participants) | 1 Light Therapy | 2 Cognitive Behavioral Therapy | 3 Light Therapy Plus Cognitive Behavioral Therapy | 4 Control | Total |
|---|---|---|---|---|---|
| Female | 14 | 15 | 14 | 12 | 55 |
| Male | 2 | 0 | 1 | 3 | 6 |
| Race/Ethnicity, Customized(participants) | 1 Light Therapy | 2 Cognitive Behavioral Therapy | 3 Light Therapy Plus Cognitive Behavioral Therapy | 4 Control | Total |
|---|---|---|---|---|---|
| White | 13 | 11 | 12 | 12 | 48 |
| Asian | 0 | 1 | 2 | 0 | 3 |
| African American | 2 | 2 | 1 | 2 | 7 |
| Hispanic | 1 | 0 | 0 | 1 | 2 |
| Other | 0 | 1 | 0 | 0 | 1 |
| Region of Enrollment(participants) | 1 Light Therapy | 2 Cognitive Behavioral Therapy | 3 Light Therapy Plus Cognitive Behavioral Therapy | 4 Control | Total |
|---|---|---|---|---|---|
| United States | 16 | 15 | 15 | 15 | 61 |
The record gives a start of Nov 2002, a primary completion of Feb 2004 and a completion of Nov 2005. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2014, 10 years 4 months after primary completion.
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This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Henry M. Jackson Foundation for the Advancement of Military Medicine