An interventional study of Transcranial Light Therapy in Generalized Anxiety Disorder, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-08-05.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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Among 11 studies in Generalized Anxiety Disorder by Massachusetts General Hospital — none open to participants now, 1 under way, none of them phase 3. Generalized Anxiety Disorder · Massachusetts General Hospital.
Among the 11 studies in Generalized Anxiety Disorder by Massachusetts General Hospital, this one is the 9th largest by enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2018, is one of 6 with no phase, and was the 10th registered.
518 studies on the registry are indexed under Generalized Anxiety Disorder; 125 are open to participants now.
Browse Generalized Anxiety Disorder studies →None of the 11 studies in Generalized Anxiety Disorder by Massachusetts General Hospital is open now. The open studies under Generalized Anxiety Disorder, anywhere →
Of the 86 Generalized Anxiety Disorder studies recruiting now, 32 (37%) set no upper age limit and 52 (60%) stop at 75 or younger; 15 take children under 18; 16 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 17 is below the median of 83 across 440 interventional studies indexed under Generalized Anxiety Disorder.
Median enrollment 70 across the 10 interventional studies. Of the 10 that completed or were terminated, 5 (50%) have results posted.
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Massachusetts General Hospital is the lead sponsor of 2,589 studies on the registry; 447 are open to participants now.
Of its 223 completed or terminated interventional studies of FDA-regulated products, 168 (75%) have results posted.
1 of the studies in Generalized Anxiety Disorder by Massachusetts General Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01075672Massachusetts General HospitalOutcomes of Cognitive Behavioral Therapy (CBT) Interventions Provided by Unlicensed Professionals | 2027-01 |
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Among the 11 studies in Generalized Anxiety Disorder by Massachusetts General Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Transcranial Light Therapy involves non-invasive and invisible beams of light that increase energy metabolism in the brain. Transcranial light therapy has been found to promote brain metabolism which may help people with anxiety. The research team proposes a novel approach to treating anxiety by using transcranial light therapy.
The purpose of this study is to see if using Transcranial Light Therapy (TLT), also called near- infrared light, helps improve symptoms of generalized anxiety disorder (GAD). Subjects will be randomized at a 1:2 ratio into 2 groups: pulse light (TLT) and sham. The sham group will be randomized after 8 weeks at a 1:1 ratio in to TLT and sham.
The study involves 1 screening visit which may last up to 3 hours, 16 weekly study visits, and one follow-up visit. There are 2 in-office treatment visits, during which a clinician applies transcranial light therapy to the participant's head for about 30 minutes. The other study visits involve assessments with a study clinician. The participants will administer the treatment once daily at home during the 16-week treatment period.
If a participant qualifies for the study, the study team assigns the participant by chance to receive either active transcranial light therapy or sham transcranial light therapy treatment. During sham transcranial light therapy visits, the transcranial light therapy device will not produce near infrared waves (e.g., light energy that cannot penetrate the skin and cranium). Participants have more than an equal chance of being assigned to the active transcranial light therapy or the sham transcranial light therapy over the course of the study. Neither the participant, nor the clinician, nor any research staff other than the study statistician will know which study group the participant belongs.
Participants are randomized a second time after 8-weeks in the study. If the participant were in the sham group the first 8-weeks, that participant may receive the active transcranial light therapy treatment after re-randomization. If the participant were already in the active transcranial light therapy group during the first 8-weeks the participant continues receiving the active treatment. All in all, participants have a 2 in 3 chance of receiving the active transcranial light therapy treatment at some point during the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Transcranial light therapy penetrates the skin and brain using light energy and the light energy may activate under-stimulated brain regions.
Device: Transcranial Light Therapy
Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
Also known as: Low Level Laser-Light Therapy, Photobiomodulation
Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A)
This instrument is completed by the clinician based on his/her assessment of the patient's anxiety symptoms, using a structured interview, specific instructions, and defined anchor points. Answers to the questions are rated on a scale of 0-4, with higher scores indicating more severe pathology. Scores range between 0 to 56; \<17 indicates mild severity, 18-24 mild-to-moderate severity, and 25-30 moderate to severe.
Time frame: 8 weeks - Sequential-parallel comparison design
Clinical Global Impressions - Severity and Improvement (CGI-S, CGI-I)
These two instruments are scored 1-7 by the clinician based on assessment of the subject's overall clinical status. They measure, based on history and scores on other instruments: (a) symptom severity (CGI-S) and (b) clinical improvement (CGI-I).
Time frame: 8 weeks - Sequential-parallel comparison design
Plan to share: Yes — Personally unidentifiable information will be sent to Dr. Anastasia Ivanova, a privately contracted biostatistician form Chapel Hill North Carolina, for consultation on analyses. All information sent to Dr. Ivanova uses acrostics in place of personally identifiable information.
No publications or documents are linked to this record.
Ran from Sep 2018 to primary completion in May 2019, 7 months.
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This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Generalized Anxiety Disorder →
Massachusetts General Hospital →