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N/A N=392 Randomized Single-blind Treatment

Intervention Study of Depression in Breast Cancer Patients

Breast Cancer · Depression · Anxiety

Bottom Line

View on ClinicalTrials.gov: NCT01256008 ↗
Enrolled (actual)
392
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Hamilton Depression Rating Scale (HAMD-17) — 11.52; 13.31; 11.01; 10.23 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
CBT (Behavioral); Clinical Management (Behavioral)
Age
Adult, Older Adult · 20+ yrs
Sex
Female
Sponsor
Wenzhou Medical University
Primary completion
Dec 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Hamilton Depression Rating Scale (HAMD-17)		 11.52; 13.31; 11.01; 10.23; 11.72; 10.28 —
PRIMARY
Hamilton Anxiety Scale (HAMA-14)		 12.11; 13.38; 11.37; 10.89; 11.34; 10.63 —
SECONDARY
Visual Analogue Scale (VAS)		 3.23; 3.60; 3.31; 2.39; 2.48; 2.71 —
SECONDARY
Athens Insomnia Scale(AIS)		 6.95; 8.49; 7.14; 6.06; 5.37; 6.19 —
SECONDARY
Functional Assessment of Cancer Treatment (FACT-B)		 78.09; 76.78; 79.49; 80.41; 86.67; 80.07 —

Summary

The purpose of this study is to evaluate the efficacy of cognitive-behavioral therapy on depression and anxiety in breast cancer patients.

Eligibility Criteria

Inclusion Criteria

  • Age: 20-65 years;
  • Pathologically diagnosed breast cancer patients, with the diagnosis from at least 2 comprehensive clinical attending physicians, in line with clinical diagnosis of breast cancer;
  • A week after breast cancer surgery;
  • With complaints and symptoms of depression or anxiety
  • HAMD-17 ≥ 8 points or / and HAMA ≥ 8 points;
  • Have some reading comprehension skills (could complete the self-rating scale independently or with others' help);
  • Informed consent

Exclusion Criteria

  • Previous diagnosis of mental disorder or Bipolar Disorder; alcohol and drug abusing history;
  • Use antidepressants, antipsychotics or accept any form of psychological treatment, or participation in other clinical trials in the last month
  • Patients with cardiovascular disease, liver and kidney dysfunction and other serious diseases;
  • Hearing, visual or understanding impairment;
  • Severe depression, suicidal tendencies;
  • Can not or will not comply with clinical treatment programs based on the physicians' judgment

Exit criteria:

  • Persons with poor compliance during the trial period;
  • Persons whose depression increased during the trial period, has serious suicidal tendencies and requires urgent intervention;
  • Persons who are believed have other circumstances and should be suspended by Physicians
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01256008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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