- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01637103
Treatment of Depressive Symptoms in Breast Cancer Patients: Comparison of Cognitive Therapy and Bright Light Therapy
May 9, 2016 updated by: Josée Savard, CHU de Quebec-Universite Laval
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Québec, Quebec, Canada, G1R 2J6
- L'Hôtel-Dieu de Québec
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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 Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Josée Savard, Ph.D., Laval University Cancer Research Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (ACTUAL)
February 1, 2015
Study Completion (ACTUAL)
February 1, 2015
Study Registration Dates
First Submitted
April 18, 2012
First Submitted That Met QC Criteria
July 6, 2012
First Posted (ESTIMATE)
July 10, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
May 10, 2016
Last Update Submitted That Met QC Criteria
May 9, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H10-12-123
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Treatment of Depressive Symptoms in Cancer Patients
-
BayerCompletedTreatment of Venous Thromboembolism in Cancer Patients | Prophylaxis of Recurrent Venous Thromboembolism in Cancer PatientsUnited States
-
Fayoum UniversityUnknownCompare Serum Level of Klotho in Patients on Oral Antidiabetic TreatmentEgypt
-
Yonsei UniversityWithdrawnPatients in the Treatment of Subjects With All-comer Who Are to Undergo PCI
-
BayerJanssen Research & Development, LLCCompletedCancer | Venous Thromboembolism | Treatment of Venous Thromboembolism in Cancer PatientsGermany
-
University of AarhusOdense University Hospital; Ferring Pharmaceuticals; Herlev Hospital; The Fertility... and other collaboratorsTerminatedPatients for In Vitro Fertilization(IVF)TreatmentDenmark
-
Heidelberg UniversityWithdrawnDistress in Caregivers of Cancer Patients
-
BayerJanssen Research & Development, LLCCompletedTreatment of Venous Thromboembolism in Cancer PatientsSweden
-
BayerJanssen Research & Development, LLCCompletedTreatment of Venous Thromboembolism in Cancer PatientsUnited Kingdom
-
Anemia Working Group RomaniaDr Carol Davila Teaching Hospital of Nephrology; Romanian Renal RegistryWithdrawnBio-Equivalency of 2 Treatment Schedules in HD PatientsRomania
-
Copenhagen Trial Unit, Center for Clinical Intervention...The Info Trial Group; Charlotte Behnke; Pia Caspersen; Dorte Fischer; Rolf I. Hansen and other collaboratorsCompletedAmbulatory Patients in the Dep. of Medical Gastroenterology | Ambulatory Patients in the Dep. of Gynecology | Ambulatory Patients in the Dep. of Orthopedic Surgery | Ambulatory Patients in the Dep. of UrologyDenmark
Clinical Trials on Cognitive therapy of depression
-
University of ZurichUnknownUnipolar DepressionSwitzerland
-
University Hospital TuebingenCompletedMajor Depressive DisorderGermany
-
University of California, BerkeleyVanderbilt UniversityCompletedDepressive Disorder, MajorUnited States
-
Oregon Health and Science UniversityCompletedPregnancy Related | Infant Development | Prenatal Stress | Functional Neuroimaging | Maternal Psychological DistressUnited States
-
Oregon Health and Science UniversityTerminatedPostpartum Depression | Prenatal Stress | Maternal Psychological DistressUnited States
-
The University of Hong KongChinese University of Hong KongRecruitingDepression, Unipolar | EveningnessHong Kong
-
University of BarcelonaUniversity of Minho; University of Bern; University of Hertfordshire; Hospital... and other collaboratorsCompletedMajor Depressive Disorder | Dysthymic DisorderSpain
-
Kaiser PermanenteUniversity of California, BerkeleyCompleted
-
The University of Hong KongChinese University of Hong Kong; University of OxfordCompletedDepression | InsomniaHong Kong
-
Karolinska InstitutetRegion StockholmCompletedMajor Depressive DisorderSweden