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| ID | Type | Description | Link |
|---|---|---|---|
| R03MH065946 | U.S. NIH Grant/Contract | View source | |
| DSIR AT-AS |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Light therapy | Experimental |
| |
| 2 Cognitive behavioral therapy | Experimental |
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| 3 Light therapy plus cognitive behavioral therapy | Experimental |
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| 4 Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light Therapy | Behavioral | Light therapy will involve exposure to bright light twice a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly J. Rohan, PhD | Uniformed Services University of the Health Sciences (USUHS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniformed Services University of the Health Sciences (USUHS) | Bethesda | Maryland | 20814-4799 | United States |
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| Label | URL |
|---|---|
| Association for Behavioral and Cognitive Therapies \[ABCT\] | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Light Therapy | Light Therapy: Light therapy will involve exposure to bright light twice a day. |
| FG001 | 2 Cognitive Behavioral Therapy | Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week. |
| FG002 | 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. |
| FG003 | 4 Control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Light Therapy | Light Therapy: Light therapy will involve exposure to bright light twice a day. |
| BG001 | 2 Cognitive Behavioral Therapy | Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Post-treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Light Therapy | Light Therapy: Light therapy will involve exposure to bright light twice a day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly J. Rohan, Ph.D. | Department of Psychology, University of Vermont | 802-656-0798 | kelly.rohan@uvm.edu |
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| ID | Term |
|---|---|
| D016574 | Seasonal Affective Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Cognitive behavioral therapy (CBT) | Behavioral | CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week. |
|
| BG002 | 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. |
| BG003 | 4 Control |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
|
| OG002 | 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. |
| OG003 | 4 Control |
|
|
| 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 | Posted | Number | participants | Post-treatment |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | 2 Cognitive Behavioral Therapy | Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week. | 0 | 15 | 0 | 15 |
| EG002 | 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. | 0 | 15 | 0 | 15 |
| EG003 | 4 Control | 0 | 15 | 0 | 15 |
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| D001519 |
| Behavior |