Treatment of Depressive Symptoms in Breast Cancer Patients: Comparison of Cognitive Therapy and Bright Light Therapy
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ClinicalTrials.gov Identifier: NCT01637103 |
Recruitment Status
:
Completed
First Posted
: July 10, 2012
Last Update Posted
: May 10, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Treatment of Depressive Symptoms in Cancer Patients | Behavioral: Cognitive therapy of depression Behavioral: Bright light therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Depressive Symptoms in Breast Cancer Patients: Comparison of Cognitive Therapy and Bright Light Therapy |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | February 2015 |
Actual Study Completion Date : | February 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: Cognitive therapy of depression |
Behavioral: Cognitive therapy of depression
Cognitive therapy will involve eight individual weekly sessions of 50 minutes with a Ph.D. student in psychology.
|
Experimental: Bright light therapy |
Behavioral: Bright light therapy
Bright light therapy will consist of a 30-min daily morning exposition to a 10 000-lux BLT lamp during 8 weeks.
|
No Intervention: Waiting list |
- Changes in depressive symptoms [ Time Frame: Pre-treatment (at recruitment; about 2 weeks before starting the experimental condition of 8 weeks), post-treatment (immediately after the experimental condition of 8 weeks), 3-month follow-up and 6-month follow-up ]
- Changes in subjective and objective parameters of sleep [ Time Frame: Pre-treatment (at recruitment; about 2 weeks before starting the experimental condition of 8 weeks), post-treatment (immediately after the experimental condition of 8 weeks), 3-month follow-up and 6-month follow-up ]
- Changes in fatigue [ Time Frame: Pre-treatment (at recruitment; about 2 weeks before starting the experimental condition of 8 weeks), post-treatment (immediately after the experimental condition of 8 weeks), 3-month follow-up and 6-month follow-up ]
- Changes in anxiety [ Time Frame: Pre-treatment (at recruitment; about 2 weeks before starting the experimental condition of 8 weeks), post-treatment (immediately after the experimental condition of 8 weeks), 3-month follow-up and 6-month follow-up ]
- Changes in quality of life [ Time Frame: Pre-treatment (at recruitment; about 2 weeks before starting the experimental condition of 8 weeks), post-treatment (immediately after the experimental condition of 8 weeks), 3-month follow-up and 6-month follow-up ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- having received a diagnosis for a stage I-III cancer within the past 18 months;
- having a score of 7 or higher on the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D)84 or of 14 or higher on the Beck Depression Inventory-II (BDI-II);
Exclusion Criteria:
- have received bright light therapy in the past month or having previously received cognitive therapy for depression;
- having severe cognitive impairments (e.g., diagnosis of Parkinson's disease, dementia, or Mini-Mental State Examination [MMSE] score < 27);
- meeting DSM-IV criteria for a major depressive episode of severe intensity, or another severe psychiatric disorder (e.g., psychotic, bipolar, or substance use disorder);
- presenting suicidal ideations with a risk of acting out, or having attempted suicide in the past five years;
- having started a new psychotropic medication or having modified the dosage or frequency of use during the past two weeks;
- currently taking a photosensitive medication (e.g., lithium, L-tryptophan);
- having evidence of an ocular pathology from an optometrist exam or a medical condition contraindicating the use of bright light therapy (e.g., severe cataracts, glaucoma, diabetes).

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): NCT01637103
Canada, Quebec | |
L'Hôtel-Dieu de Québec | |
Québec, Quebec, Canada, G1R 2J6 |
Study Director: | Josée Savard, Ph.D. | Laval University Cancer Research Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Josée Savard, Professeure titulaire/Chercheuse, Centre Hospitalier Universitaire de Québec, CHU de Québec |
ClinicalTrials.gov Identifier: | NCT01637103 History of Changes |
Other Study ID Numbers: |
H10-12-123 |
First Posted: | July 10, 2012 Key Record Dates |
Last Update Posted: | May 10, 2016 |
Last Verified: | May 2016 |
Keywords provided by Josée Savard, Centre Hospitalier Universitaire de Québec, CHU de Québec:
Cancer Depression Anxiety Fatigue |
Sleep Quality of life Cognitive therapy Bright light therapy |
Additional relevant MeSH terms:
Depression Behavioral Symptoms |