Treatment of Depressive Symptoms in Breast Cancer Patients: Comparison of Cognitive Therapy and Bright Light Therapy

Study Description

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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.

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 Measures :

1. 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 ]
2. 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 ]
3. 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 ]
4. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

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Locations

Canada, Quebec
L'Hôtel-Dieu de Québec
Québec, Quebec, Canada, G1R 2J6

Sponsors and Collaborators

CHU de Quebec-Universite Laval

Canadian Institutes of Health Research (CIHR)

Investigators

Study Director:	Josée Savard, Ph.D.	Laval University Cancer Research Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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
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