Skip to main content
Clinical Trials/JPRN-jRCT1030210687
JPRN-jRCT1030210687
Recruiting
Phase 2

Study on effectiveness of behavioral activation therapy program for depression in advanced cancer patients: a pilot-multicenter randomized controlled trial - pilot BA-RCT

Hirayama Takatoshi0 sites38 target enrollmentMarch 22, 2022

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
depressive symptoms
Sponsor
Hirayama Takatoshi
Enrollment
38
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 22, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Hirayama Takatoshi

Eligibility Criteria

Inclusion Criteria

  • 1\. Physical condition: Those who meet the following (a) to (c).
  • (a) Cancer patients who have been diagnosed or have been notified of recurrence for more than 1 month and whose clinical stages are stage III or IV and whose attending physician has determined that they cannot aim for radical cure.
  • (b) Expected prognosis is expected to be about 1 year or more
  • (c) Those who can participate in all sessions of the program
  • 2\. Patients with depression: 16 points or more in Beck Depression Inventory\-II (BDI\-II)
  • 3\. Age: 20\-64 years old, 65 years old and over with MMSE\-J 24 points or more
  • 4\. PS (Performance status): ECOG performance status score is 0 or 1
  • 5\. Patients who can speak Japanese
  • 6\. Patients who have consented to participate in the study and wish to continue intervention

Exclusion Criteria

  • 1\. Patients with severe physical or psychological symptoms (cognitive dysfunction, impaired consciousness, severe depression with psychotic symptoms, imminent suicidal ideation, and history of suicide attempt)
  • 2\. Patients who have received psychological intervention, such as behavioral activation, by mental health professionals before enrollment
  • 3\. Patients taking or planning to use any psychotropic drug during the program
  • 4\. Patients with substance dependence based on the diagnostic criteria of DSM\-5
  • 5\. Patients who are deemed to have difficulty in participating this program by the attending physician or the researcher due to other reasons.

Outcomes

Primary Outcomes

Not specified

Similar Trials