The effectiveness of Brain Injury Family Intervention (BIFI) in improving psychological well-being of Traumatic Brain Injury (TBI) caregivers at two government hospitals in Malaysia

A randomized controlled trial on the effectiveness of Brain Injury Family Intervention (BIFI) in improving psychological well-being of Traumatic Brain Injury (TBI) caregivers at two government hospitals in Malaysia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180809040746N1

Enrollment

100

Registered

2018-09-01

Start date

2639-11-22

Completion date

Unknown

Last updated

2018-09-11

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

Conditions

Condition 1: Traumatic brain Injury (TBI) caregivers. Condition 2: Traumatic Brain Injury caregivers. Condition 3: Traumatic Brain Injury caregivers. Condition 4: Traumatic Brain Injury caregivers. Diffuse traumatic brain injury Open wound of head Focal traumatic brain injury Crushing injury of head

Interventions

Intervention 1: Intervention group: The participants will be involved in BIFI program and also treatment as usual (TAU). It will be scheduled for 5 sessions in 5 weeks. Each session will take for abou

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: TBI caregivers must be Malaysian or Permanent Resident of Malaysia. TBI caregivers with any type of races/ethnicity (Malay, Chinese, Indian and others) Participants could be parents, spouses, siblings, sons/daughters or relatives. The participants must be able to read or write in Bahasa Malaysia or English. The caregivers must have been caring for TBI patients for > 3 month post injury. Time spend for caring activities is at least 2 hours per day.

Exclusion criteria

Exclusion criteria: The exclusion criteria include paid caregiver or formal caregiver. The injury which is not due to TBI will be excluded.

Design outcomes

Primary

Measure	Time frame
Emotional distress. Timepoint: Baseline, immediately after intervention program, 3 months and 6 months follow-up. Method of measurement: Beck Depression Inventory, Positive and Negative Affect Schedule.	—

Secondary

Measure	Time frame
TBI caregiver's burden level. Timepoint: Baseline, immediately after intervention program, 3 months and 6 months follow-up. Method of measurement: Caregiver Strain Index.;TBI caregiver's needs. Timepoint: Baseline, immediately after intervention program, 3 months and 6 months follow-up. Method of measurement: Family Needs Questionnaire.;TBI caregiver's life satisfaction. Timepoint: Baseline, immediately after intervention program, 3 months and 6 months follow-up. Method of measurement: Satisfaction With Life Scale.	—

Measure

Time frame

TBI caregiver's burden level. Timepoint: Baseline, immediately after intervention program, 3 months and 6 months follow-up. Method of measurement: Caregiver Strain Index.;TBI caregiver's needs. Timepoint: Baseline, immediately after intervention program, 3 months and 6 months follow-up. Method of measurement: Family Needs Questionnaire.;TBI caregiver's life satisfaction. Timepoint: Baseline, immediately after intervention program, 3 months and 6 months follow-up. Method of measurement: Satisfaction With Life Scale.

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Countries

Malaysia

Contacts

Public ContactSiti Aminah Omar

Universiti Teknologi MARA

city_min@yahoo.com+60 3-6126 7206

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026