Treatment of Depressive Symptoms in Breast Cancer Patients: Comparison of Cognitive Therapy and Bright Light Therapy
Primary Purpose
Treatment of Depressive Symptoms in Cancer Patients
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive therapy of depression
Bright light therapy
Sponsored by

About this trial
This is an interventional treatment trial for Treatment of Depressive Symptoms in Cancer Patients focused on measuring Cancer, Depression, Anxiety, Fatigue, Sleep, Quality of life, Cognitive therapy, Bright light therapy
Eligibility Criteria
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).
Sites / Locations
- L'Hôtel-Dieu de Québec
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Cognitive therapy of depression
Bright light therapy
Waiting list
Arm Description
Outcomes
Primary Outcome Measures
Changes in depressive symptoms
Secondary Outcome Measures
Changes in subjective and objective parameters of sleep
Changes in fatigue
Changes in anxiety
Changes in quality of life
Full Information
NCT ID
NCT01637103
First Posted
April 18, 2012
Last Updated
May 9, 2016
Sponsor
CHU de Quebec-Universite Laval
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT01637103
Brief Title
Treatment of Depressive Symptoms in Breast Cancer Patients: Comparison of Cognitive Therapy and Bright Light Therapy
Official Title
Treatment of Depressive Symptoms in Breast Cancer Patients: Comparison of Cognitive Therapy and Bright Light Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHU de Quebec-Universite Laval
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Depressive symptoms are highly frequent among cancer patients. These symptoms significantly impair quality of life (e.g., hopelessness, greater risk of suicidal behaviours) and may even affect patients' prognosis (e.g., through decreased adherence to cancer treatments). Cognitive therapy (CT) is an established treatment for depression in the general population, but its efficacy has not yet been investigated in non-metastatic cancer patients. Furthermore, because the accessibility to CT is very limited in routine cancer care and because many patients are reluctant to use pharmacological treatment, they often turn to alternative treatments such as bright light therapy (BLT), but empirical data on its efficacy are needed before its use can be recommended. Goal 1: To assess at post-treatment, as compared to a waiting-list control condition, the effect of bright light therapy (BLT) and cognitive therapy (CT): (1a) in reducing depressive symptoms; and (1b) in improving subjective and objective sleep parameters, in reducing fatigue and anxiety and in increasing patients' functioning and quality of life. Goal 2: To compare at post-treatment and at 3- and 6-month follow-ups the effect of BLT and CT : (2a) in reducing depressive symptoms; and (2b) in improving subjective and objective parameters of sleep, in reducing fatigue and anxiety and in increasing patients' functioning and quality of life. It is hypothesized that, As compared to control patients after their waiting period, both BLT and CT groups will have significantly greater improvement of all symptoms at post-treatment. However, as compared to BLT patients, CT patients will show greater improvements of all symptoms at post-treatment and at 3- and 6-month follow-ups. This study will provide empirical data on the efficacy of two approaches for treating depressive symptoms in cancer patients in order to better inform the scientific community, health care providers, and patients on the most effective depression treatments to implement in cancer care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Depressive Symptoms in Cancer Patients
Keywords
Cancer, Depression, Anxiety, Fatigue, Sleep, Quality of life, Cognitive therapy, Bright light therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive therapy of depression
Arm Type
Experimental
Arm Title
Bright light therapy
Arm Type
Experimental
Arm Title
Waiting list
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive therapy of depression
Intervention Description
Cognitive therapy will involve eight individual weekly sessions of 50 minutes with a Ph.D. student in psychology.
Intervention Type
Behavioral
Intervention Name(s)
Bright light therapy
Intervention Description
Bright light therapy will consist of a 30-min daily morning exposition to a 10 000-lux BLT lamp during 8 weeks.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josée Savard, Ph.D.
Organizational Affiliation
Laval University Cancer Research Center
Official's Role
Study Director
Facility Information:
Facility Name
L'Hôtel-Dieu de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
31264101
Citation
Desautels C, Savard J, Ivers H. Moderators of Cognitive Therapy and Bright Light Therapy Effects on Depressive Symptoms in Patients with Breast Cancer. Int J Behav Med. 2019 Aug;26(4):380-390. doi: 10.1007/s12529-019-09802-6.
Results Reference
derived
PubMed Identifier
29172605
Citation
Desautels C, Savard J, Ivers H, Savard MH, Caplette-Gingras A. Treatment of depressive symptoms in patients with breast cancer: A randomized controlled trial comparing cognitive therapy and bright light therapy. Health Psychol. 2018 Jan;37(1):1-13. doi: 10.1037/hea0000539. Epub 2017 Nov 27.
Results Reference
derived
Learn more about this trial
Treatment of Depressive Symptoms in Breast Cancer Patients: Comparison of Cognitive Therapy and Bright Light Therapy
We'll reach out to this number within 24 hrs