Augmenting Internet-Based Cognitive Behavioral Therapy for Major Depressive Disorder With Low-Level Light Therapy
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to better understand how low-level light therapy (LLLT) can be
      used to augment the antidepressant effects of Deprexis, an internet-based treatment program
      for depression, for participants with current major depressive disorder. The researchers will
      administer active and placebo LLLT to the right forehead of participants who show an
      improvement of at least 10% in depressive symptoms from baseline after two weeks of Deprexis
      treatment.

      Hypothesis: Participants who receive active LLLT will show a greater reduction of depressive
      symptoms than participants who receive placebo LLLT.
    

Detailed description: 
      1. Online screening Following a digital informed consent, all participants will complete a
           brief online screening questionnaire to determine the severity level of their
           depression, using the Center for Epidemiological Studies - Depression Scale (CES-D).
           Initial consent and screening procedures will be conducted online via Research
           Electronic Data Capture (REDCap), a secure, on-line assessment tool designed to collect
           self-report questionnaire data for research studies. Participants with a CES-D score of
           16 or higher will be eligible to continue with the study. At this initial screening,
           eligible participants will also provide contact information (name, email address, and
           phone number) for a follow-up phone screening.

        2. Phone screening Following the online screening, eligible participants will complete a
           phone screening, the Mini International Neuropsychiatric Interview (MINI), conducted by
           researchers in the Mood Disorders Laboratory. The phone screening will be audio recorded
           for quality control purposes. Participants will be eligible to continue on in the study
           if they meet criteria for current Major Depression without any comorbid disorders,
           excluding anxiety disorders. Next, participants will complete the Colombia-Suicide
           Severity Rating Scale (C-SSRS) to assess for suicidality. Any participant who endorses
           suicidal intent, with or without plan, (i.e., items 4 or 5) within the last six months,
           will be deemed ineligible. Researchers will provide resources to any participant
           endorsing suicidal ideation, and will contact authorities if necessary. At the end of
           the phone screening, eligible participants will be scheduled to come into the Mood
           Disorders Laboratory for their initial study meeting within a week.

        3. Initial meeting

           Participants deemed eligible by the online and phone screenings will come into the Mood
           Disorders Laboratory within a week of their phone screening. The initial meeting will
           last approximately one hour. The initial meeting will have several objectives:

           First, participants will provide informed consent. Research personnel will provide
           participants with detailed oral and written description of all study procedures in order
           to ensure understanding of all components of the study. Participants will provide
           informed consent for completing the Deprexis program, pre-treatment questionnaires,
           daily questionnaires, weekly questionnaires, and post-treatment questionnaires. All
           questionnaires will be accessed online via REDCap.

           Next, participants will complete several pre-treatment questionnaires. Also, researchers
           will introduce the Deprexis program, and participants will receive an access code that
           will allow them immediate access to the Deprexis site. Information about the Deprexis
           program is detailed below.

           Participants will also complete an eye tracking/pupil dilation task during the meeting.
           Pupil dilation response to emotional stimuli has been shown to be related to depression.
           In this pupil dilation task, participants will passively view emotional and neutral
           stimuli (images). More details about the task are below.

        4. Pre-treatment questionnaires Participants eligible to take part in the Deprexis program
           will complete several pre-treatment questionnaires at the initial meeting.

        5. Deprexis All Deprexis treatment will be provided via the Deprexis website:
           http://deprexis.com/. Participants will have access to this website for twelve weeks.
           They can access this website as often as they would like. The Deprexis program is
           self-guided, so participants determine how often they access the material (see below for
           a description of the Deprexis treatment).

           While participants are engaged in the Deprexis treatment program, they will complete the
           Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) each week, starting
           with the pre-treatment meeting. This will be automated within the REDCap system and will
           serve as our primary outcome measure to determine the efficacy of Deprexis in improving
           depressive symptoms.

           Researchers will monitor the progression of the Deprexis treatment and the QIDS-SR
           scores for each participant. Participants will be contacted via phone or email as needed
           to encourage them to continue participating. Participants whose QIDS-SR scores improve
           by at least 10% from baseline in the first two weeks of Deprexis treatment will be
           contacted via phone and email to schedule four weekly LLLT sessions in the lab.
           Participants whose QIDS-SR scores do not improve by 10% from baseline in the first two
           weeks within the first six weeks of treatment will not be eligible for LLLT, but will
           continue to have access to the Deprexis program.

           Participants will be scheduled for their initial meeting within 1 week of their phone
           screening. After the initial meeting, participants will have immediate access to the
           Deprexis program. During the 12 weeks that participants have access to the Deprexis
           program, participants will complete the QIDS-SR weekly and may come into the
           Gonzalez-Lima Lab for LLLT treatment once weekly for four weeks. The maximum amount of
           time spent in this study for each participant would therefore be 13 weeks.

        6. Daily REDCap questionnaires REDCap will automatically send an email to prompt users to
           answer questions at several times each day during the course of their enrollment in this
           study. Participants will respond to questions about their mood, stress level, sleep
           patterns, social interactions, and recent activity. Several times each week,
           participants will also indicate which, if any, of the Deprexis CBT techniques they have
           recently used.

        7. LLLT Eligible participants will come into the Gonzalez-Lima Lab in Seay 3.304 at their
           scheduled appointment times. Written informed consent to receive active or placebo LLLT
           for four sessions will be collected of all lab participants before the first LLLT
           session. Each session will last approximately twenty minutes. Participants will receive
           either active or placebo LLLT for eight minutes (procedure described below). Each
           participant will receive either active LLLT only for all four sessions or sham LLLT only
           for all four sessions, but not a combination of active and placebo LLLT. Participants
           will return to the lab at one-week intervals for four weeks. Following each session,
           participants will be asked if they experienced any perceived side effects (physical or
           psychological) from the LLLT treatment. In the unlikely event that a participant
           experiences adverse effects, appropriate measures will be taken to eliminate these
           effects, and participants will be dismissed from the study if necessary.

        8. Post-treatment questionnaires Following completion of the Deprexis treatment,
           participants will complete several more questionnaires.

        9. Location Researchers in the Mood Disorders Laboratory, located in the Liberal Arts
           Building at The University of Texas at Austin, will administer and assess the
           participation of each subject in the Deprexis program. Participants will complete the
           Deprexis treatment online at a location of their choice. Participants who have shown an
           improvement in depressive symptoms of at least 10% from baseline in the first two weeks
           of Deprexis treatment will be scheduled to come into the lab for LLLT treatment.

      LLLT treatment will be administered in the Gonzalez-Lima Lab, located in Seay 3.304 at The
      University of Texas at Austin. Participants will come to the lab for four sessions, held
      approximately one week apart, each of which will last approximately twenty minutes.

      Because Deprexis treatment lasts twelve weeks and LLLT lasts four weeks, participants will
      continue to complete the Deprexis treatment online in the weeks during and after their LLLT
      sessions. Participants who do not show a 10% improvement in depressive symptoms from baseline
      in the first two weeks of the Deprexis program will not be eligible to receive LLLT, but will
      still have access to the Deprexis treatment for the full twelve weeks.
    

Intervention name(s): Deprexis; Active low-level light therapy; Sham low-level light therapy
Intervention type(s): Other; Device; Device
Intervention description(s): Deprexis is an experimental internet-based treatment program for depression created by Gaia (Hamburg, Germany).; Administration of LLLT consists of applying light of a specific wavelength (1064 nanometers) that intersects with the absorption spectrum of cytochrome oxidase, using a laser diode, the high density laser (HD laser; Cell Gen Therapeutics, LLC). Active LLLT includes 4 days, once per week for 4 weeks, during which LLLT is applied to two alternating positions on the participant's right forehead for 8 minutes total.; Administration of LLLT consists of applying light of a specific wavelength (1064 nanometers) that intersects with the absorption spectrum of cytochrome oxidase, using a laser diode, the high density laser (HD laser; Cell Gen Therapeutics, LLC). Sham LLLT includes 4 days, once per week for 4 weeks, during which sham LLLT (5 seconds active, 55 seconds sham) is applied to two alternating positions on the participant's right forehead for 8 minutes total.
Other intervention name(s): LLLT; LLLT-sham
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: depression; internet-based; treatment; low-level light therapy; LLLT; deprexis