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Clinical effectiveness of non-confrontational feedback during cognitive rehabilitation: an intervention for improving self-awareness of deficits for people with acquired brain injury

Clinical effectiveness of non-confrontational feedback during cognitive rehabilitation: an intervention for improving self-awareness of deficits for people with acquired brain injury - Non-confrontational feedback after ABI

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52910
Enrollment
40
Registered
2018-03-07
Start date
2018-08-30
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

niet-aangeboren hersenletsel ABI brain damage

Interventions

All patients receive rehabilitation aimed at improving cognitive functioning. Patients will be randomized over 2 conditions: 1) *Non-confrontational feedback*: this group receives from the start of
- Performance of specific cognitive tasks during the intervention sessions and in real-life settings and/or virtual reality settings
- Structured multimodal (verbal, visual and audiovisual) feedback according to the socalled 'Socratic method' consisting of (as much as possible) positive reinformcement and non-confrontational disc

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: For patients, inclusion criteria are: - 18 years or older - indication for (outpatient or inpatient) cognitive rehabilitation -diagnosed with ABI (e.g. stroke, traumatic brain injury, hypoxia after cardiac arrest, postoperative brain tumor) - impaired self-awareness of deficits, based on clinical judgment and score on Patient Competency Rating Scale and/or Self-Regulation Skills Interview.For each patient a significant other participates in the study, for filling out a questionnaire on the patient. Significant others can participate in case they are 18 years or older.

Exclusion criteria

Exclusion criteria: Patient are excluded in case of: - no informed consent. - neurodegenerative disease - insufficient command of the Dutch language - aphasia. - visual impairments (that hinder test assessment) - patient is still in PTA (GOAT>74). - premorbid psychiatric conditions / substance abuse for which hospital admission was needed Significant others cannot participate in case they are not able to fill out the PCRS due to insufficent command of the Dutch language, or in case of no informed consentinvull

Design outcomes

Primary

MeasureTime frame
The primary aim of the intervention is to improve self-awareness of deficits. The main study parameter is change between T0 (baseline) and T6 (12 months after T0) in terms of self-awareness of deficits (SRSI). The reason for adding additional post-measurements (T1, T2, T3, T4, T5) is twofold. First, adding additional post-measurements increases statistical power (see for example Vickers,2003). Second, adding additional post-measurements makes it possible to look at differences between the control group and experimental group in the course of recovery/response to treatment (e.g. does the experimental group reach a certain level of self-awareness of deficits more quickly than the control group).

Secondary

MeasureTime frame
Secundairy goals are: - on the short term improve self-awareness of deficits, motivation for rehabiliation treatment and participation in rehabilitation treatment. Study parameters are changes between T0 (baseline) and T2 (6 weeks after the start of cognitive rehabilitation) in terms of self-awareness of deficits (PCRS, SRSI), motivation for treatment (from the perspective of the patient (MOT-Q) and from the perspective of the therapist (VAS-scale)), and participation in rehabilitation treatment from the perspective of the therapist (PRPS). - on the long term improve quality of life, social participation and mood. Study parameters are changes between T3 (3 months after T0) and T6 (12 months after T0) in terms self-awareness of deficits (PCRS), quality of life (SS-QOL-12), social participation (USER-P), mood (HADS-D). - finally it will be evaluated whether the new intervention is usable from the perspective of rehabiliation professionals als well as patients (in terms of among other things patient satisfaction, burden/worklaod for the patient, length and content of sessions, patient compliance).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)