Seasonal Affective Disorder (SAD)NCT01714050
Cognitive-behavioral Therapy vs. Light Therapy for Preventing SAD Recurrence
A study testing Cognitive-Behavioral Therapy (CBT) and Light Therapy (LT) in people with Seasonal Affective Disorder (SAD) and Winter Depression, run by University of Vermont at 1 site in United States.
Trial summary
Major depression is a highly prevalent, chronic, and debilitating mental health problem with significant social cost that poses a tremendous economic burden. Winter seasonal affective disorder (SAD) is a subtype of recurrent major depression involving substantial depressive symptoms that adversely affect the family… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Affective Disorder (SAD), Winter Depression, Major Depressive Disorder, Recurrent, With Seasonal Pattern
- What is being tested?
- Cognitive-Behavioral Therapy (CBT) and Light Therapy (LT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- aged 18 or older
- meet DSM-IV criteria for Major Depression, Recurrent, with Seasonal Pattern
- meet Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD) criteria for a current SAD episode
Who cannot join
- past light therapy or cognitive-behavioral therapy for SAD
- presence of a comorbid Axis I disorder that requires immediate treatment
- acute and serious suicidal intent
- positive laboratory findings for hypothyroidism
- plans for major vacations or absences from the study area through March
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont, Psychology Department
Burlington, Vermont, 05405-0134
About this study
Official title: Cognitive-behavioral Therapy vs. Light Therapy for Preventing Seasonal Affective Disorder Recurrence
Major depression is a highly prevalent, chronic, and debilitating mental health problem with significant social cost that poses a tremendous economic burden. Winter seasonal affective disorder (SAD) is a subtype of recurrent major depression involving substantial depressive symptoms that adversely affect the family and workplace for about 5 months of each year during most years, beginning in young adulthood. This clinical trial is relevant to this public health challenge in seeking to develop and test a time-limited (i.e., acute treatment completed in a discrete period vs. daily treatment every fall/winter indefinitely), palatable cognitive-behavioral treatment with effects that endure beyond the cessation of acute treatment to prevent the annual recurrence of depression in SAD.
Aim (1) To compare the long-term efficacy of cognitive-behavioral therapy (CBT) and light therapy on depression recurrence status, symptom severity, and remission status during the next winter season (i.e., the next wholly new winter season after the initial winter of treatment completion), which we argue to be the most important time point for evaluating clinical outcomes following SAD intervention.
Read more
Hypothesis: CBT will be associated with a smaller proportion of depression recurrences, less severe symptoms, and a higher proportion of remissions than light therapy in the next winter. The study is designed to detect a clinically important difference between CBT and light therapy in depressive episode recurrences during the next winter, the primary endpoint, in an intent-to-treat analysis.
Aim (2) To compare the efficacy of CBT and light therapy on symptom severity and remission status at post-treatment (treatment endpoint).
Hypothesis: CBT and light therapy will not differ significantly on post-treatment outcomes.
Read the detailed description
Seasonal affective disorder (SAD) is a subtype of recurrent depression involving major depressive episodes during the fall and/or winter months that remit in the spring. SAD affects an estimated 5% of the U. S. population, over 14.5 million Americans. The central public health challenge in the management of SAD is prevention of winter depression recurrence. The established and best available treatment, light therapy, remits acute symptoms in 53% of SAD cases. However, long-term compliance with clinical practice guidelines recommending daily use of a light box from onset of first symptom through spontaneous springtime remission during every fall/winter season is poor. Time-limited alternative treatments with durable effects are needed to prevent the annual recurrence of these disabling symptoms. Our preliminary studies suggest that a novel, SAD-tailored cognitive-behavioral therapy (CBT) may be as efficacious as light therapy alone for acute SAD treatment and that CBT may have superior outcomes to light therapy during the next winter. During the next wholly new winter season following the initial winter of study treatment, the proportion of depression recurrences was significantly smaller in participants randomized to CBT (5.8%) or to CBT combined with light therapy (5.2%) than in participants randomized to light therapy alone (39.2%). As the next step in this programmatic line of intervention studies, the primary aim of the proposed project is to further test the efficacy of our CBT for SAD intervention against light therapy in a larger, more definitive randomized head-to-head comparison on next winter outcomes in an intent-to-treat (ITT) analysis using all randomized participants. This project is seeking to test for a clinically meaningful difference between CBT and light therapy on depression recurrence in the next winter (the primary outcome), thereby having the potential to impact clinical practice. The proposed work will go beyond our pilot studies in four ways: (1) This study will augment the generalizability of our prior pilot study data by relaxing the inclusion/exclusion criteria to allow for comorbid diagnoses and stable antidepressant medication use and by demonstrating the feasibility of training experienced community therapists to facilitate the CBT groups. (2) We will prospectively track recurrences and potential intervening variables that could affect outcome (e.g., new treatments, summer remission status) in the interim between treatment endpoint and the following winter. (3) This study includes a second annual winter followup to obtain preliminary data on the comparative effects of CBT vs. LT two winters after the initial winter of study treatment. (4) We will examine how potential modifiers influence the effects of CBT vs. LT, including demographic variables; baseline characteristics (e.g., depression severity, comorbidity, baseline medication status); and complete or incomplete summer remission status in the interim. If successful, this work will develop a novel treatment with important public health implications for winter depression prevention.
- Conditions
- Seasonal Affective Disorder (SAD), Winter Depression, Major Depressive Disorder, Recurrent, With Seasonal Pattern
- Being tested
- Cognitive-Behavioral Therapy (CBT), Light Therapy (LT)
- Keywords
- seasonal affective disorder, winter depression, cognitive-behavioral therapy, light therapy
- Medical subject headings
- Seasonal Affective Disorder, Depressive Disorder, Major, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Therapy (CBT)Behavioural
Light Therapy (LT)Device
SunRay (SunBox Company, Gaithersburg, MD)
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy (CBT) | Experimental | The CBT is a SAD-tailored version of Beck et al.'s (1979) cognitive therapy for depression called "Coping with the Seasons" (Rohan, 2008). The rationale addresses environmental changes, thoughts, and behaviors in SAD onset and maintenance. It seeks to change behaviors and thoughts to improve coping with winter. Behaviors that promote enjoyment in the winter are increased. Negative thoughts that interfere with self-esteem and negative thoughts about winter are identified and addressed. A relapse-prevention component addresses early identification of negative anticipatory thoughts about winter and SAD-related behavior changes, using the CBT skills learned to cope with subsequent winter seasons, and development of a personalized relapse-prevention plan. The CBT sessions are administered twice a week over 6 weeks (total of 12 sessions) with 4-8 participants per group. The CBT is led by one of three licensed Ph.D.-level psychologists working on the project. Receives: Behavioral: Cognitive-Behavioral Therapy (CBT) |
| Light Therapy (LT) | Experimental | LT will be initiated at 30-minutes in the morning at home, first thing upon awakening, using a light box with an ultraviolet shield that emits 10,000-lux of white fluorescent light. After the first week, an M.D. light therapy consultant will recommend individually-tailored, clinical adjustments to the duration and timing of light use to maximize response and reduce any reported side effects. For each of the 6-weeks of LT, LT participants will complete a Light Therapy Side Effects Questionnaire to assess side effects attributed to LT. Participants will keep daily LT compliance diaries to record the timing and duration of LT. After the 6-weeks of monitoring, participants may choose to continue using the light box through April. We will offer LT participants who wish to use light therapy in the next fall/winter season access to our light boxes if they agree to followup with a physician or other qualified professional for monitoring and side effects management. Receives: Device: Light Therapy (LT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression recurrence status on the Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD; Williams et al., 1992)
The SIGH-SAD (Williams et al., 1992), the most commonly used clinical assessment device for detecting changes in SAD symptoms in light therapy research, includes the 21-item Structured Interview Guide for the Hamilton Rating Scale for Depression (HAM-D) and a supplementary 8-item subscale to assess atypical depressive symptoms associated with SAD. The primary outcome measure is SIGH-SAD recurrence status at the next winter followup. A trained rater, blind to the treatment condition, will administer the SIGH-SAD at pre-treatment, treatment weeks 1-5, post-treatment, summer followup, next winter followup, and second winter followup. A second blinded rater will rate audiotapes of the SIGH-SADs to assess inter-rater reliability.
Measured: next winter followup (January or February of the next winter, approximately a year after study treatment)
Secondary outcomes (2)
Beck Depression Inventory-Second Edition (BDI-II; Beck et al., 1996)
The BDI-II (Beck et al., 1996) is a 21-item measure of depressive symptom severity. The BDI-II has demonstrated good test-retest reliability and convergent validity (Beck et al., 1996). This study will use the BDI-II as a continuous measure of depressive symptom severity. Studies have also used the BDI-II to estimate remission rates subsequent to treatment (Gortner et al., 1996). Therefore, dichomotous remission status on the BDI-II will also be assessed. The BDI-II will be administered at baseline, mid-treatment (week 3) and post-treatment (week 6), summer followup, next winter followup, and the second winter followup.
Measured: baseline, mid-treatment (week 3), post-treatment (week 6), summer followup (August), next winter followup (January or February or the next winter), and the second winter followup (January or February two winters later)
Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD)
In addition to the primary outcome of SIGH-SAD depression recurrence status, other secondary measures based on the SIGH-SAD will include continuous SIGH-SAD scores and SIGH-SAD remission status.
Measured: baseline, weekly during treatment (weeks 1-5), post-treatment (week 6), summer followup (August), next winter followup (January or February of the next winter), second winter followup (January or February two winters later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startJul 2008
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Seasonal Affective Disorder (SAD)Studies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kelly Rohan, University of Vermont
- Investigators
- Kelly J Rohan, Ph.D., Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714050
- Sponsor's protocol ID
- R01MH078982
- Other IDs
- R01MH078982
- Status last verified
- May 2023
- First submitted
- 17 Oct 2012
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Rohan KJ, Terman JM, Iyiewuare P, Perez J, Camuso JA, Postolache TT, DeSarno MJ, Vacek PM. Prospectively assessed summer mood status in major depression, recurrent with seasonal pattern: Evidence for SAD's construct validity. J Affect Disord. 2024 Mar 15;349:32-38. doi: 10.1016/j.jad.2023.12.070. Epub 2023 Dec 30.
PubMed 38160889Rohan KJ, Burt KB, Norton RJ, Perez J, Iyiewuare P, Terman JM. Change in Seasonal Beliefs Mediates the Durability Advantage of Cognitive-Behavioral Therapy Over Light Therapy for Winter Depression. Behav Ther. 2023 Jul;54(4):682-695. doi: 10.1016/j.beth.2022.11.002. Epub 2022 Dec 7.
PubMed 37330257Terman JM, Rohan KJ, Stickle TR, Wernhoff A. Personality Pathology in Winter Depression: Prevalence and Treatment Trajectories in Cognitive-Behavioral Therapy and Light Therapy. Behav Ther. 2023 Mar;54(2):361-374. doi: 10.1016/j.beth.2022.10.002. Epub 2022 Nov 2.
PubMed 36858765Rohan KJ, Burt KB, Camuso J, Perez J, Meyerhoff J. Applying experimental therapeutics to examine cognitive and chronological vulnerabilities as mediators of acute outcomes in cognitive-behavioral therapy and light therapy for winter depression. J Consult Clin Psychol. 2020 Aug;88(8):786-797. doi: 10.1037/ccp0000499.
PubMed 32700956Rohan KJ, Meyerhoff J, Ho SY, Evans M, Postolache TT, Vacek PM. Outcomes One and Two Winters Following Cognitive-Behavioral Therapy or Light Therapy for Seasonal Affective Disorder. Am J Psychiatry. 2016 Mar 1;173(3):244-51. doi: 10.1176/appi.ajp.2015.15060773. Epub 2015 Nov 5.
PubMed 26539881Rohan KJ, Mahon JN, Evans M, Ho SY, Meyerhoff J, Postolache TT, Vacek PM. Randomized Trial of Cognitive-Behavioral Therapy Versus Light Therapy for Seasonal Affective Disorder: Acute Outcomes. Am J Psychiatry. 2015 Sep 1;172(9):862-9. doi: 10.1176/appi.ajp.2015.14101293. Epub 2015 Apr 10.
PubMed 25859764Rohan KJ, Evans M, Mahon JN, Sitnikov L, Ho SY, Nillni YI, Postolache TT, Vacek PM. Cognitive-behavioral therapy vs. light therapy for preventing winter depression recurrence: study protocol for a randomized controlled trial. Trials. 2013 Mar 21;14:82. doi: 10.1186/1745-6215-14-82.
PubMed 23514124
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-behavioral Therapy vs. Light Therapy for Preventing Seasonal Affective Disorder Recurrence
- ClinicalTrials.gov ID
- NCT01714050
- Acronym / sponsor ID
- R01MH078982
- Conditions
- Seasonal Affective Disorder (SAD), Winter Depression, Major Depressive Disorder, Recurrent, With Seasonal Pattern
- Keywords
- seasonal affective disorder, winter depression, cognitive-behavioral therapy, light therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2008
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 25 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Major depression is a highly prevalent, chronic, and debilitating mental health problem with significant social cost that poses a tremendous economic burden. Winter seasonal affective disorder (SAD) is a subtype of recurrent major depression involving substantial depressive symptoms that adversely affect the family and workplace for about 5 months of each year during most years, beginning in young adulthood. This clinical trial is relevant to this public health challenge in seeking to develop and test a time-limited (i.e., acute treatment completed in a discrete period vs. daily treatment every fall/winter indefinitely), palatable cognitive-behavioral treatment with effects that endure beyond the cessation of acute treatment to prevent the annual recurrence of depression in SAD.
Aim (1) To compare the long-term efficacy of cognitive-behavioral therapy (CBT) and light therapy on depression recurrence status, symptom severity, and remission status during the next winter season (i.e., the next wholly new winter season after the initial winter of treatment completion), which we argue to be the most important time point for evaluating clinical outcomes following SAD intervention.
Hypothesis: CBT will be associated with a smaller proportion of depression recurrences, less severe symptoms, and a higher proportion of remissions than light therapy in the next winter. The study is designed to detect a clinically important difference between CBT and light therapy in depressive episode recurrences during the next winter, the primary endpoint, in an intent-to-treat analysis.
Aim (2) To compare the efficacy of CBT and light therapy on symptom severity and remission status at post-treatment (treatment endpoint).
Hypothesis: CBT and light therapy will not differ significantly on post-treatment outcomes.
Detailed description
Seasonal affective disorder (SAD) is a subtype of recurrent depression involving major depressive episodes during the fall and/or winter months that remit in the spring. SAD affects an estimated 5% of the U. S. population, over 14.5 million Americans. The central public health challenge in the management of SAD is prevention of winter depression recurrence. The established and best available treatment, light therapy, remits acute symptoms in 53% of SAD cases. However, long-term compliance with clinical practice guidelines recommending daily use of a light box from onset of first symptom through spontaneous springtime remission during every fall/winter season is poor. Time-limited alternative treatments with durable effects are needed to prevent the annual recurrence of these disabling symptoms. Our preliminary studies suggest that a novel, SAD-tailored cognitive-behavioral therapy (CBT) may be as efficacious as light therapy alone for acute SAD treatment and that CBT may have superior outcomes to light therapy during the next winter. During the next wholly new winter season following the initial winter of study treatment, the proportion of depression recurrences was significantly smaller in participants randomized to CBT (5.8%) or to CBT combined with light therapy (5.2%) than in participants randomized to light therapy alone (39.2%). As the next step in this programmatic line of intervention studies, the primary aim of the proposed project is to further test the efficacy of our CBT for SAD intervention against light therapy in a larger, more definitive randomized head-to-head comparison on next winter outcomes in an intent-to-treat (ITT) analysis using all randomized participants. This project is seeking to test for a clinically meaningful difference between CBT and light therapy on depression recurrence in the next winter (the primary outcome), thereby having the potential to impact clinical practice. The proposed work will go beyond our pilot studies in four ways: (1) This study will augment the generalizability of our prior pilot study data by relaxing the inclusion/exclusion criteria to allow for comorbid diagnoses and stable antidepressant medication use and by demonstrating the feasibility of training experienced community therapists to facilitate the CBT groups. (2) We will prospectively track recurrences and potential intervening variables that could affect outcome (e.g., new treatments, summer remission status) in the interim between treatment endpoint and the following winter. (3) This study includes a second annual winter followup to obtain preliminary data on the comparative effects of CBT vs. LT two winters after the initial winter of study treatment. (4) We will examine how potential modifiers influence the effects of CBT vs. LT, including demographic variables; baseline characteristics (e.g., depression severity, comorbidity, baseline medication status); and complete or incomplete summer remission status in the interim. If successful, this work will develop a novel treatment with important public health implications for winter depression prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy (CBT) | Experimental | Behavioral: Cognitive-Behavioral Therapy (CBT)The CBT is a SAD-tailored version of Beck et al.'s (1979) cognitive therapy for depression called "Coping with the Seasons" (Rohan, 2008). The rationale addresses environmental changes, thoughts, and behaviors in SAD onset and maintenance. It seeks to change behaviors and thoughts to improve coping with winter. Behaviors that promote enjoyment in the winter are increased. Negative thoughts that interfere with self-esteem and negative thoughts about winter are identified and addressed. A relapse-prevention component addresses early identification of negative anticipatory thoughts about winter and SAD-related behavior changes, using the CBT skills learned to cope with subsequent winter seasons, and development of a personalized relapse-prevention plan. The CBT sessions are administered twice a week over 6 weeks (total of 12 sessions) with 4-8 participants per group. The CBT is led by one of three licensed Ph.D.-level psychologists working on the project. |
| Light Therapy (LT) | Experimental | Device: Light Therapy (LT)LT will be initiated at 30-minutes in the morning at home, first thing upon awakening, using a light box with an ultraviolet shield that emits 10,000-lux of white fluorescent light. After the first week, an M.D. light therapy consultant will recommend individually-tailored, clinical adjustments to the duration and timing of light use to maximize response and reduce any reported side effects. For each of the 6-weeks of LT, LT participants will complete a Light Therapy Side Effects Questionnaire to assess side effects attributed to LT. Participants will keep daily LT compliance diaries to record the timing and duration of LT. After the 6-weeks of monitoring, participants may choose to continue using the light box through April. We will offer LT participants who wish to use light therapy in the next fall/winter season access to our light boxes if they agree to followup with a physician or other qualified professional for monitoring and side effects management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 or older
- meet DSM-IV criteria for Major Depression, Recurrent, with Seasonal Pattern
- meet Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD) criteria for a current SAD episode
Key exclusion criteria (5 listed)
- past light therapy or cognitive-behavioral therapy for SAD
- presence of a comorbid Axis I disorder that requires immediate treatment
- acute and serious suicidal intent
- positive laboratory findings for hypothyroidism
- plans for major vacations or absences from the study area through March
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 |
|---|---|---|
| Cognitive-Behavioral Therapy (CBT) | Behavioural | Cognitive-Behavioral Therapy (CBT) |
| Light Therapy (LT)SunRay (SunBox Company, Gaithersburg, MD) | Device | Light Therapy (LT) |
Primary outcome
Depression recurrence status on the Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD; Williams et al., 1992)
Time frame: next winter followup (January or February of the next winter, approximately a year after study treatment)
The SIGH-SAD (Williams et al., 1992), the most commonly used clinical assessment device for detecting changes in SAD symptoms in light therapy research, includes the 21-item Structured Interview Guide for the Hamilton Rating Scale for Depression (HAM-D) and a supplementary 8-item subscale to assess atypical depressive symptoms associated with SAD. The primary outcome measure is SIGH-SAD recurrence status at the next winter followup. A trained rater, blind to the treatment condition, will administer the SIGH-SAD at pre-treatment, treatment weeks 1-5, post-treatment, summer followup, next winter followup, and second winter followup. A second blinded rater will rate audiotapes of the SIGH-SADs to assess inter-rater reliability.
2 secondary outcomes
Beck Depression Inventory-Second Edition (BDI-II; Beck et al., 1996)
Time frame: baseline, mid-treatment (week 3), post-treatment (week 6), summer followup (August), next winter followup (January or February or the next winter), and the second winter followup (January or February two winters later)
Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD)
Time frame: baseline, weekly during treatment (weeks 1-5), post-treatment (week 6), summer followup (August), next winter followup (January or February of the next winter), second winter followup (January or February two winters later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Derived from this study: PubMed 38160889Rohan KJ, Terman JM, Iyiewuare P, Perez J, Camuso JA, Postolache TT, DeSarno MJ, Vacek PM. Prospectively assessed summer mood status in major depression, recurrent with seasonal pattern: Evidence for SAD's construct validity. J Affect Disord. 2024 Mar 15;349:32-38. doi: 10.1016/j.jad.2023.12.070. Epub 2023 Dec 30.
- Derived from this study: PubMed 37330257Rohan KJ, Burt KB, Norton RJ, Perez J, Iyiewuare P, Terman JM. Change in Seasonal Beliefs Mediates the Durability Advantage of Cognitive-Behavioral Therapy Over Light Therapy for Winter Depression. Behav Ther. 2023 Jul;54(4):682-695. doi: 10.1016/j.beth.2022.11.002. Epub 2022 Dec 7.
- Derived from this study: PubMed 36858765Terman JM, Rohan KJ, Stickle TR, Wernhoff A. Personality Pathology in Winter Depression: Prevalence and Treatment Trajectories in Cognitive-Behavioral Therapy and Light Therapy. Behav Ther. 2023 Mar;54(2):361-374. doi: 10.1016/j.beth.2022.10.002. Epub 2022 Nov 2.
- Derived from this study: PubMed 32700956Rohan KJ, Burt KB, Camuso J, Perez J, Meyerhoff J. Applying experimental therapeutics to examine cognitive and chronological vulnerabilities as mediators of acute outcomes in cognitive-behavioral therapy and light therapy for winter depression. J Consult Clin Psychol. 2020 Aug;88(8):786-797. doi: 10.1037/ccp0000499.
- Derived from this study: PubMed 26539881Rohan KJ, Meyerhoff J, Ho SY, Evans M, Postolache TT, Vacek PM. Outcomes One and Two Winters Following Cognitive-Behavioral Therapy or Light Therapy for Seasonal Affective Disorder. Am J Psychiatry. 2016 Mar 1;173(3):244-51. doi: 10.1176/appi.ajp.2015.15060773. Epub 2015 Nov 5.
- Derived from this study: PubMed 25859764Rohan KJ, Mahon JN, Evans M, Ho SY, Meyerhoff J, Postolache TT, Vacek PM. Randomized Trial of Cognitive-Behavioral Therapy Versus Light Therapy for Seasonal Affective Disorder: Acute Outcomes. Am J Psychiatry. 2015 Sep 1;172(9):862-9. doi: 10.1176/appi.ajp.2015.14101293. Epub 2015 Apr 10.
- Derived from this study: PubMed 23514124Rohan KJ, Evans M, Mahon JN, Sitnikov L, Ho SY, Nillni YI, Postolache TT, Vacek PM. Cognitive-behavioral therapy vs. light therapy for preventing winter depression recurrence: study protocol for a randomized controlled trial. Trials. 2013 Mar 21;14:82. doi: 10.1186/1745-6215-14-82.
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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, Ph.D. principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy (CBT) and Light Therapy (LT) in people with Seasonal Affective Disorder (SAD) and Winter Depression, run by University of Vermont 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 3 inclusion and 5 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 9 May 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depression recurrence status on the Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD; Williams et al., 1992) (time frame: next winter followup (January or February of the next winter, approximately a year after study treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01714050, which also lists 7 linked publications.
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 9 May 2023.