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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fonds de recherche Société et culture Québec (FQRSC)
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT01637103
First received: April 18, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention
Treatment of Depressive Symptoms in Cancer Patients
Behavioral: Cognitive therapy of depression
Behavioral: Bright light therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Depressive Symptoms in Breast Cancer Patients: Comparison of Light Therapy and Cognitive Therapy

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637103

Locations
Canada, Quebec
L'Hôtel-Dieu de Québec
Québec, Quebec, Canada, G1R 2J6
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
Fonds de recherche Société et culture Québec (FQRSC)
Investigators
Study Director: Josée Savard, Ph.D. Laval University Cancer Research Center
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier: NCT01637103     History of Changes
Other Study ID Numbers: H10-12-123
Study First Received: April 18, 2012
Last Updated: August 5, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by 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:
Breast Neoplasms
Depression
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 26, 2014