Treatment of Depressive Symptoms in Cancer Patients: Comparison of Light Therapy and Cognitive Therapy
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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 Cancer Patients: Comparison of Light Therapy and Cognitive Therapy |
- 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 ]
- 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: | July 2014 |
| Estimated Primary Completion Date: | December 2013 (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 |
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| Contact: Caroline Desautels | 418-525-4444 ext 20619 | caroline.desautels.1@ulaval.ca |
| Canada, Quebec | |
| L'Hôtel-Dieu de Québec | Recruiting |
| Québec, Quebec, Canada, G1R 2J6 | |
| Contact: Caroline Desautels 418-525-4444 ext 20619 caroline.desautels.1@ulaval.ca | |
| Principal Investigator: Josée Savard, Ph.D. | |
| 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: | July 6, 2012 |
| 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:
|
Depression Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013