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Cognitive-behavioral Therapy vs. Light Therapy for Preventing SAD Recurrence

Primary Purpose

Seasonal Affective Disorder (SAD), Winter Depression, Major Depressive Disorder, Recurrent, With Seasonal Pattern

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy (CBT)
Light Therapy (LT)
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Seasonal Affective Disorder (SAD) focused on measuring seasonal affective disorder, winter depression, cognitive-behavioral therapy, light therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Vermont, Psychology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cognitive-Behavioral Therapy (CBT)

Light Therapy (LT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 17, 2012
Last Updated
May 8, 2023
Sponsor
University of Vermont
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01714050
Brief Title
Cognitive-behavioral Therapy vs. Light Therapy for Preventing SAD Recurrence
Official Title
Cognitive-behavioral Therapy vs. Light Therapy for Preventing Seasonal Affective Disorder Recurrence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Affective Disorder (SAD), Winter Depression, Major Depressive Disorder, Recurrent, With Seasonal Pattern
Keywords
seasonal affective disorder, winter depression, cognitive-behavioral therapy, light therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-Behavioral Therapy (CBT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Light Therapy (LT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy (CBT)
Intervention Type
Device
Intervention Name(s)
Light Therapy (LT)
Intervention Description
SunRay (SunBox Company, Gaithersburg, MD)
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
next winter followup (January or February of the next winter, approximately a year after study treatment)
Secondary Outcome Measure Information:
Title
Beck Depression Inventory-Second Edition (BDI-II; Beck et al., 1996)
Description
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.
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)
Title
Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD)
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly J Rohan, Ph.D.
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont, Psychology Department
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405-0134
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32700956
Citation
Rohan 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.
Results Reference
derived
PubMed Identifier
26539881
Citation
Rohan 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.
Results Reference
derived
PubMed Identifier
25859764
Citation
Rohan 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.
Results Reference
derived
PubMed Identifier
23514124
Citation
Rohan 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.
Results Reference
derived

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Cognitive-behavioral Therapy vs. Light Therapy for Preventing SAD Recurrence

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