Seasonal Affective DisorderPhase 1NCT00076245
Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD)
A Phase 1 study testing Light Therapy and Cognitive behavioral therapy (CBT) in people with Seasonal Affective Disorder and Depression, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial summary
This study will assess the effectiveness of cognitive behavioral therapy (CBT) in treating seasonal affective disorder (SAD), commonly called the "winter blues." Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Affective Disorder, Depression
- What is being tested?
- Light Therapy and Cognitive behavioral therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Nov 2005
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of seasonal affective disorder (SAD)
- Willing and able to participate in the study procedures
Who cannot join
- Major psychological diagnoses other than SAD
- Current psychological or psychiatric treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Uniformed Services University of the Health Sciences (USUHS)
Bethesda, Maryland, 20814-4799
About this study
Official title: Cognitive Behavioral Approaches to Seasonal Depression
This study will assess the effectiveness of cognitive behavioral therapy (CBT) in treating seasonal affective disorder (SAD), commonly called the "winter blues."
Read the 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.
- Conditions
- Seasonal Affective Disorder, Depression
- Being tested
- Light Therapy, Cognitive behavioral therapy (CBT)
- Keywords
- Phototherapy
- Medical subject headings
- Seasonal Affective Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light TherapyBehavioural
Light therapy will involve exposure to bright light twice a day.
Cognitive behavioral therapy (CBT)Behavioural
CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
| Study group | Role | What they receive |
|---|---|---|
| 1 Light therapy | Experimental | Not described Receives: Behavioral: Light Therapy |
| 2 Cognitive behavioral therapy | Experimental | Not described Receives: Behavioral: Cognitive behavioral therapy (CBT) |
| 3 Light therapy plus cognitive behavioral therapy | Experimental | Not described Receives: Behavioral: Light Therapy; Behavioral: Cognitive behavioral therapy (CBT) |
| 4 Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2004 (estimated)
- Study startNov 2002
- Primary completionFeb 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Seasonal Affective DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kelly Rohan, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Investigators
- Kelly J. Rohan, PhD, Principal investigator, Uniformed Services University of the Health Sciences (USUHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076245
- Sponsor's protocol ID
- R03MH065946
- Other IDs
- R03MH065946, DSIR AT-AS
- Status last verified
- Jun 2014
- First submitted
- 16 Jan 2004
- Last updated
- 25 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Approaches to Seasonal Depression
- ClinicalTrials.gov ID
- NCT00076245
- Acronym / sponsor ID
- R03MH065946
- Conditions
- Seasonal Affective Disorder, Depression
- Keywords
- Phototherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2002
- Primary completion
- Feb 2004 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 19 Jan 2004 (estimated)
- Results
- Posted 25 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 Light therapy | Experimental | Behavioral: Light Therapy |
| 2 Cognitive behavioral therapy | Experimental | Behavioral: Cognitive behavioral therapy (CBT) |
| 3 Light therapy plus cognitive behavioral therapy | Experimental | Behavioral: Light Therapy, Behavioral: Cognitive behavioral therapy (CBT) |
| 4 Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of seasonal affective disorder (SAD)
- Willing and able to participate in the study procedures
Key exclusion criteria (2 listed)
- Major psychological diagnoses other than SAD
- Current psychological or psychiatric treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light TherapyLight therapy will involve exposure to bright light twice a day. | Behavioural | 1 Light therapy, 3 Light therapy plus cognitive behavioral therapy |
| Cognitive behavioral therapy (CBT)CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week. | Behavioural | 2 Cognitive behavioral therapy, 3 Light therapy plus cognitive behavioral therapy |
Primary outcome
Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version
Time frame: 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)
Time frame: Post-treatment
Dichotomous Remission Status (remitted or not) at post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Society for Light Therapy and Biological Rhythms \[SLTBR\]Link provided by the sponsor.
- Association for Behavioral and Cognitive Therapies \[ABCT\]Link provided by the sponsor.
Related trials for Seasonal Affective Disorder
Not yet recruiting
Treating Seasonal Depression With Daylight
Depression
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Cohort of Patients Suffering From Major Depressive Episode With Evaluation of Sleep, Circadian Rhythms and Psychiatric Disorders
Major Depressive Episode
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Virtual Reality Digital Therapeutics for Seasonal Affective Disorder
Seasonal Affective Disorder (SAD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly J. Rohan, PhD principal investigator
Uniformed Services University of the Health Sciences (USUHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Light Therapy and Cognitive behavioral therapy (CBT) in people with Seasonal Affective Disorder and Depression, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (time frame: Post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2014.