Augmenting Internet-Based Cognitive Behavioral Therapy for Major Depressive Disorder With Low-Level Light Therapy

NCT02898233 | Terminated

• 1 other identifier: 2015-09-0100
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

depression; internet-based; treatment; low-level light therapy; LLLT; deprexis

Outcome Measures

Primary Outcomes (1)

• Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)

  Change in QIDS-SR score from Week 0 to Week 12

  Week 0 to Week 12, one time per week

Secondary Outcomes (8)

• Deprexis usage

  through study completion; an average of 540 minutes of usage over 12 weeks

• Inventory of Depression and Anxiety Symptoms (IDAS)

  Week 0, Week 12

• Tridimensional Personality Questionnaire (TPQ)

  Week 0, Week 12

• Massachusetts General Hospital Antidepressant Treatment Questionnaire (ATRQ)

  Week 0, Week 12

• Sheehan Disability Scale (SDS)

  Week 0, Week 12

Study Arms (3)

Deprexis and active LLLT

ACTIVE COMPARATOR

Participants will have access to Deprexis and will receive active low-level light therapy (4 days X 8 minutes of active LLLT)

Other: Deprexis; Device: Active low-level light therapy

Deprexis and sham LLLT

SHAM COMPARATOR

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; Device: Sham low-level light therapy

Deprexis only

OTHER

Participants will have access to Deprexis but will not receive real or sham LLLT

Other: Deprexis

Interventions

Deprexis OTHER

Deprexis is an experimental internet-based treatment program for depression created by Gaia (Hamburg, Germany).

Deprexis and active LLLT; Deprexis and sham LLLT; Deprexis only

Active low-level light therapy DEVICE

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.

Also known as: LLLT

Deprexis and active LLLT

Sham low-level light therapy DEVICE

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.

Also known as: LLLT-sham

Deprexis and sham LLLT

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (3)

• Barrett DW, Gonzalez-Lima F. Transcranial infrared laser stimulation produces beneficial cognitive and emotional effects in humans. Neuroscience. 2013 Jan 29;230:13-23. doi: 10.1016/j.neuroscience.2012.11.016. Epub 2012 Nov 27.

  PMID: 23200785 BACKGROUND

• Meyer B, Berger T, Caspar F, Beevers CG, Andersson G, Weiss M. Effectiveness of a novel integrative online treatment for depression (Deprexis): randomized controlled trial. J Med Internet Res. 2009 May 11;11(2):e15. doi: 10.2196/jmir.1151.

  PMID: 19632969 BACKGROUND

• Schiffer F, Johnston AL, Ravichandran C, Polcari A, Teicher MH, Webb RH, Hamblin MR. Psychological benefits 2 and 4 weeks after a single treatment with near infrared light to the forehead: a pilot study of 10 patients with major depression and anxiety. Behav Brain Funct. 2009 Dec 8;5:46. doi: 10.1186/1744-9081-5-46.

  PMID: 19995444 BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 13, 2016
• Study Start: February 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: November 30, 2020
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

US (1)