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Augmenting Internet-Based Cognitive Behavioral Therapy for Major Depressive Disorder With Low-Level Light Therapy (CBT/LLLT)

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ClinicalTrials.gov Identifier: NCT02898233
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Christopher G. Beevers, University of Texas at Austin

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Depression Other: Deprexis Device: Active low-level light therapy Device: Sham low-level light therapy Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Augmenting Internet-Based Cognitive Behavioral Therapy for Major Depressive Disorder With Low-Level Light Therapy
Study Start Date : February 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : February 2020

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Deprexis and active LLLT
Participants will have access to Deprexis and will receive active low-level light therapy (4 days X 8 minutes of active LLLT)
 Other: Deprexis
Deprexis is an experimental internet-based treatment program for depression created by Gaia (Hamburg, Germany).

Device: Active low-level light therapy
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.
Other Name: LLLT
Sham Comparator: Deprexis and sham LLLT
Participants will have access to Deprexis and will receive sham low-level light therapy (4 days X 5 seconds of active LLLT and 55 seconds of sham LLLT)
 Other: Deprexis
Deprexis is an experimental internet-based treatment program for depression created by Gaia (Hamburg, Germany).

Device: Sham low-level light therapy
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 Name: LLLT-sham
Deprexis only
Participants will have access to Deprexis but will not receive real or sham LLLT
 Other: Deprexis
Deprexis is an experimental internet-based treatment program for depression created by Gaia (Hamburg, Germany).


Outcome Measures
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Primary Outcome Measures :
  1. Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) [ Time Frame: Week 0 to Week 12, one time per week ]
    Change in QIDS-SR score from Week 0 to Week 12


Secondary Outcome Measures :
  1. Deprexis usage [ Time Frame: through study completion; an average of 540 minutes of usage over 12 weeks ]
    total minutes that participants use Deprexis over 12 weeks

  2. Inventory of Depression and Anxiety Symptoms (IDAS) [ Time Frame: Week 0, Week 12 ]
  3. Tridimensional Personality Questionnaire (TPQ) [ Time Frame: Week 0, Week 12 ]
  4. Massachusetts General Hospital Antidepressant Treatment Questionnaire (ATRQ) [ Time Frame: Week 0, Week 12 ]
  5. Sheehan Disability Scale (SDS) [ Time Frame: Week 0, Week 12 ]
  6. Perseverative Thinking Questionnaire (PTQ) [ Time Frame: Week 0, Week 12 ]
  7. Questionnaire about daily activities and mood [ Time Frame: once per day throughout course of study; daily beginning Week 0 until Week 12 ]
    Brief questionnaire about what the participant did and how the participant felt during the day

  8. Colombia Suicide Severity Rating Scale [ Time Frame: through study completion, once during phone screening, thereafter up to once per week, an average of 2 times total ]
    C-SSRS will be completed at baseline, and up to once per week throughout the study if a participant ever has an increase in suicidal ideation, average of 2 times total


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ability to speak, read, and understand English fluently
  • owns a smartphone and able to receive emails on their phone and access REDCap on a web browser on their phone
  • current depressive episode as determined by the Center for Epidemiological Studies - Depression Screening (CES-D) and Mini International Neuropsychiatric Interview (MINI)

Exclusion Criteria:

  • serious medical complications, including conditions that change electrical functioning in the brain (e.g., cancer, diabetes, epilepsy, head trauma, history of brain surgery, neurocognitive impairment, stroke, transient ischemic attack)
  • comorbid psychiatric disorders, excluding anxiety disorders, as determined by Mini International Neuropsychiatric Interview (MINI)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898233


Contacts
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Contact: Rochelle A Stewart, B.A. 5122324750 mdl@utexas.edu
Contact: Jocelyn Labrada, B.A. mdl@utexas.edu

Locations
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United States, Texas
The University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Rochelle A Stewart, B.A.    512-232-4750    mdl@utexas.edu   
Contact: Jocelyn Labrada, B.A.       mdl@utexas.edu   
Principal Investigator: Christopher G Beevers, Ph.D.         
Principal Investigator: Francisco Gonzalez-Lima, Ph.D.         
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Christopher G Beevers, Ph.D. Psychology Department, University of Texas at Austin
Principal Investigator: Francisco Gonzalez-Lima, Ph.D. Psychology Department, University of Texas at Austin
More Information
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Publications:

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Responsible Party: Christopher G. Beevers, Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT02898233     History of Changes
Other Study ID Numbers: 2015-09-0100
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Christopher G. Beevers, University of Texas at Austin:
depression
internet-based
treatment
 low-level light therapy
LLLT
deprexis
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders