Behavioral activation program for reducing depressive symptoms among the bereaved of cancer patients

JRCT ID: jRCT1030210427

Registered date:16/11/2021

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: depressive symptoms
• Date of first enrollment: 24/12/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Behavioral activation program (50 minutes interview plus 10 minutes homework x 7 sessions) for the bereaved of cancer patients is conducted by face-to-face or online.

Outcome(s)

• Primary Outcome: Depression (Patient Health Questionnaire:PHQ-9)

Secondary Outcome

1. Depression (Beck Depression Inventory)
2. Anxiety (Generalized Anxiety Disorder)
3. Behavioral Activation (Behavioral Activation for Depression Scale-Short Form)
4. Coping Strategies (Coping Strategies after Bereavement Short Form)
5. Valuing (Valuing Questionnaire)
6. Reward (Reward Probability Index)
7. Program Completion Rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Bereaved whose family had died of cancer , aged 20 years or older, and 3 years or more after bereavement at the time of enrollment
2. Bereaved with depression (PHQ-9 of 10 or higher )
3. Bereaved who can comply with total 7 sessions program
4. Bereaved who are able to speak Japanese
5. Bereaved who are able to provide written informed consent
(in case when participant in an online program added to the inclusion criteria)
6. Bereaved whose internet environment is capable of identifying appropriate use of online service (Wi-Fi internet access is protected by password , protective software of personal computer is up-to-date ect.)
7. Bereaved who are able to keep promise of appropriate use of online service (prohibition on video recording and secondary use of program tool ect.)

Exclude criteria

1.Bereaved with severe physical or psychological symptoms (cognitive dysfunction, impaired consciousness, severe depression with psychotic symptoms, imminent suicidal ideation, and history of suicide attempt)
2. Bereaved who have received psychological intervention, such as behavioral activation, by mental health professionals before enrollment
3.Those who are deemed to have difficulty in participating this program by the researcher due to other reasons.

Related Information

• Primary Sponsor: Asai Mariko
• Source(s) of Monetary Support: Ministry of Education,Ministry of Health, Labour and Welfare