Skip to content

Study on effectiveness of behavioral activation therapy program for depression in advanced cancer patients

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1030210687
Enrollment
38
Registered
2022-03-22
Start date
2022-06-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depressive symptoms

Interventions

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

Sponsors

Hirayama Takatoshi
Lead Sponsor
Suzuki Shin-ichi
Collaborator

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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)

Contacts

Public ContactTakatoshi Hirayama

National Cancer Center

thirayam@ncc.go.jp+81-3-3542-2411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026