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

NCT ID: NCT01637103

Last Updated: 2016-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-02-28

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.

Conditions

Treatment of Depressive Symptoms in Cancer Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive therapy of depression

Group Type: EXPERIMENTAL

Cognitive therapy of depression

Intervention Type: BEHAVIORAL

Cognitive therapy will involve eight individual weekly sessions of 50 minutes with a Ph.D. student in psychology.

Bright light therapy

Group Type: EXPERIMENTAL

Bright light therapy

Intervention Type: BEHAVIORAL

Bright light therapy will consist of a 30-min daily morning exposition to a 10 000-lux BLT lamp during 8 weeks.

Waiting list

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive therapy of depression

Cognitive therapy will involve eight individual weekly sessions of 50 minutes with a Ph.D. student in psychology.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: lead

Responsible Party

Josée Savard

Professeure titulaire/Chercheuse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josée Savard, Ph.D.

Role: STUDY_DIRECTOR

Laval University Cancer Research Center

Locations

L'Hôtel-Dieu de Québec

Québec, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 31264101 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29172605 (View on PubMed)

Other Identifiers

H10-12-123

Identifier Type: -

Identifier Source: org_study_id