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

Study on effectiveness of behavioral activation therapy program for depression in advanced cancer patients (pilot BA-RCT)

Hirayama Takatoshi

National Cancer Center

5-1-1 Tsukiji, Chuo-ku, Tokyo

thirayam@ncc.go.jp

Hirayama Takatoshi

National Cancer Center

5-1-1 Tsukiji, Chuo-ku, Tokyo

+81-3-3542-2411

thirayam@ncc.go.jp

Recruiting

Mar. 22, 2022

Interventional

randomized controlled trial

single blind

no treatment control/standard of care control

crossover assignment

treatment purpose

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

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.

Both

depressive symptoms

Behavioral activation program (50 minutes interview plus 10 minutes homework x 7 sessions) for the advanced cancer patients is conducted by face-to-face

behavioral activation

Depression(Beck Depression Inventory-II: BDI-II)

Generalized Anxiety Disorder-7(GAD-7)
Functional Assessment of Cancer Therapy-General(FACT-G)
Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale(FACIT-SP-12)
Behavioral Activation for Depression Scale-Short Form(BADS-SF)
Valuing Questionnaire(VQ)
Numerical rating scale(NRS)
Integrated Palliative care Outcome Scale(IPOS)

+81-3-3542-2511

Jan. 17, 2022

No

none