Depression, Seasonal Affective Disorder
Conditions
Keywords
Phototherapy
Brief summary
This study will assess the effectiveness of cognitive behavioral therapy (CBT) in treating seasonal affective disorder (SAD), commonly called the winter blues.
Detailed description
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.
Interventions
BEHAVIORALLight Therapy
Light therapy will involve exposure to bright light twice a day.
BEHAVIORALCognitive behavioral therapy (CBT)
CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
Sponsors
National Institute of Mental Health (NIMH)
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of seasonal affective disorder (SAD) * Willing and able to participate in the study procedures
Exclusion criteria
* Major psychological diagnoses other than SAD * Current psychological or psychiatric treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version | Post-treatment | 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. |
| Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD) | Post-treatment | Dichotomous Remission Status (remitted or not) at post-treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1 Light Therapy Light Therapy: Light therapy will involve exposure to bright light twice a day. | 16 |
| 2 Cognitive Behavioral Therapy Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week. | 15 |
| 3 Light Therapy Plus Cognitive Behavioral Therapy Light Therapy: Light therapy will involve exposure to bright light twice a day.
Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week. | 15 |
| 4 Control | 15 |
| Total | 61 |
Baseline characteristics
| Characteristic | 1 Light Therapy | 2 Cognitive Behavioral Therapy | 3 Light Therapy Plus Cognitive Behavioral Therapy | 4 Control | Total |
|---|---|---|---|---|---|
| Age, Continuous | 47.6 years STANDARD_DEVIATION 9.7 | 45.9 years STANDARD_DEVIATION 15.5 | 43.0 years STANDARD_DEVIATION 12.8 | 43.3 years STANDARD_DEVIATION 7.7 | 45.0 years STANDARD_DEVIATION 5.8 |
| Race/Ethnicity, Customized African American | 2 participants | 2 participants | 1 participants | 2 participants | 7 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 2 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized Hispanic | 1 participants | 0 participants | 0 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Other | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 13 participants | 11 participants | 12 participants | 12 participants | 48 participants |
| Region of Enrollment United States | 16 participants | 15 participants | 15 participants | 15 participants | 61 participants |
| Sex: Female, Male Female | 14 Participants | 15 Participants | 14 Participants | 12 Participants | 55 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 1 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 Light Therapy | Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD) | 8 participants |
| 2 Cognitive Behavioral Therapy | Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD) | 6 participants |
| 3 Light Therapy Plus Cognitive Behavioral Therapy | Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD) | 11 participants |
| 4 Control | Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD) | 3 participants |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Light Therapy | Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version | 13.6 units on a scale | Standard Deviation 8.8 |
| 2 Cognitive Behavioral Therapy | Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version | 13.3 units on a scale | Standard Deviation 11.1 |
| 3 Light Therapy Plus Cognitive Behavioral Therapy | Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version | 8.3 units on a scale | Standard Deviation 5.8 |
| 4 Control | Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version | 22.6 units on a scale | Standard Deviation 8.4 |