Trial Outcomes & Findings for Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD) (NCT NCT00076245)
NCT ID: NCT00076245
Last Updated: 2014-06-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
61 participants
Primary outcome timeframe
Post-treatment
Results posted on
2014-06-25
Participant Flow
Participant milestones
| Measure |
1 Light Therapy
Light Therapy: Light therapy will involve exposure to bright light twice a day.
|
2 Cognitive Behavioral Therapy
Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
|
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.
|
4 Control
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
16
|
15
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD)
Baseline characteristics by cohort
| Measure |
1 Light Therapy
n=16 Participants
Light Therapy: Light therapy will involve exposure to bright light twice a day.
|
2 Cognitive Behavioral Therapy
n=15 Participants
Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
|
3 Light Therapy Plus Cognitive Behavioral Therapy
n=15 Participants
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.
|
4 Control
n=15 Participants
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
45.9 years
STANDARD_DEVIATION 15.5 • n=7 Participants
|
43.0 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
45.0 years
STANDARD_DEVIATION 5.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
48 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
15 participants
n=4 Participants
|
61 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Post-treatmentThe 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.
Outcome measures
| Measure |
1 Light Therapy
n=16 Participants
Light Therapy: Light therapy will involve exposure to bright light twice a day.
|
2 Cognitive Behavioral Therapy
n=15 Participants
Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
|
3 Light Therapy Plus Cognitive Behavioral Therapy
n=15 Participants
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.
|
4 Control
n=15 Participants
|
|---|---|---|---|---|
|
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
|
13.3 units on a scale
Standard Deviation 11.1
|
8.3 units on a scale
Standard Deviation 5.8
|
22.6 units on a scale
Standard Deviation 8.4
|
PRIMARY outcome
Timeframe: Post-treatmentDichotomous Remission Status (remitted or not) at post-treatment
Outcome measures
| Measure |
1 Light Therapy
n=16 Participants
Light Therapy: Light therapy will involve exposure to bright light twice a day.
|
2 Cognitive Behavioral Therapy
n=15 Participants
Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
|
3 Light Therapy Plus Cognitive Behavioral Therapy
n=15 Participants
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.
|
4 Control
n=15 Participants
|
|---|---|---|---|---|
|
Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD)
|
8 participants
|
6 participants
|
11 participants
|
3 participants
|
Adverse Events
1 Light Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 Light Therapy Plus Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
4 Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kelly J. Rohan, Ph.D.
Department of Psychology, University of Vermont
Phone: 802-656-0798
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place