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
Conditionsdepressive symptoms
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.
Investigators
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
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