Evaluating the effectiveness of a psychoeducational intervention for caregivers of individuals with acquired brain injury

Efficacy of a psychoeducative intervention program versus treatment as usual to prevent or reduce the burden associated with caring for a person with acquired brain injury: a two arm, evaluator blind, multicentre, randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16513116

Enrollment

200

Registered

2023-12-12

Start date

2019-01-01

Completion date

Unknown

Last updated

2024-09-30

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

Conditions

The burden associated with acquired brain injury caregiving Not Applicable

Interventions

Randomization: The randomization process will be conducted in each research site using block randomization, with block sizes ranging from 1 to 4. The "Randomizer v. 0.4.0" module of Jamovi will be use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Caregivers: 1. Aged 18 years old and over 2. Be caring for a person with acquired brain injury (ABI) (traumatic brain injury, stroke, anoxia, brain tumour or encephalitis) 3. Be an informal (unpaid) caregiver 4. Spend a minimum of 4 hours/week caring for the care-receiver Participants with ABI: 1. Aged 16 years old and over 2. Residents in the community 3. Receiving appropriate outpatient rehabilitation 4. Being stable clinically 5. Time since the ABI is more than 3 months

Exclusion criteria

Exclusion criteria: Caregivers: Those who did not have the time to attend the weekly sessions of intervention or had received a standardized intervention comparable to the one administered in the trial within the past year Participants with ABI: 1. Having been cared for in a respite care unit during the last 30 days 2. Living in professionally supervised housing

Design outcomes

Primary

Measure	Time frame
Caregiver burden measured using the Zarit Burden Interview at baseline and 4 and 8 months	—

Secondary

Measure	Time frame
The following secondary outcome measures are assessed at baseline and 4 and 8 months: 1. Caregiver's mental health measured using the General Health Questionnaire, 28 items (GHQ-28) 2. Caregiver anxiety measured using the State-Trait Anxiety Inventory (STAI) 3. Caregiver depression measured using the Center for Epidemiologic Studies Depression Scale (CES-D)	—

Countries

Spain

Contacts

Public ContactAna Isabel Domínguez

aidominguez.aitamenni@hospitalarias.es+34 944 43 49 27

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026