Cognitive Impairment Clinical Trial
Official title:
Releasing Residual Cognitive Capacity After Acquired Brain Injury: A Randomized Controlled Trial Using Hypnotic Suggestion in Rehabilitation of Working Memory
Establishment of effective, efficient, and evidence-based interventions in rehabilitation of working memory (WM) deficits after acquired brain injury (ABI) is sorely needed. Despite robust evidence for the usefulness of clinical hypnosis in a wide range of clinical conditions, and improved understanding of mechanisms underlying it ́s effects, the potential of clinical hypnosis in cognitive rehabilitation is virtually unexplored. The current study seeks to replicate resent intriguing findings where large effects of hypnotic suggestion were seen on WM capacity following ABI, and further, explore underlying mechanisms of change.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | April 1, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 67 Years |
Eligibility | Inclusion Criteria: - A documented non-progressive ABI, minimum 12 months post- injury and ongoing WM deficits by self-report and/or neuropsychological assessment - The above mentioned patients have received multidisciplinary cognitive rehabilitation before participation Exclusion Criteria: - Patients with severe mental illness - Patients progressive neurologic disease - Patients with ongoing ICD-10 diagnosis of substance dependence - Patients that lack Norwegian language skills |
Country | Name | City | State |
---|---|---|---|
Norway | Sunnaas Rehabilitation Hospital | Nesoddtangen | Viken |
Lead Sponsor | Collaborator |
---|---|
Sunnaas Rehabilitation Hospital | University of Oslo |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in ABI related self-efficacy | The tool to measure Traumatic Brain Injury Self-Efficacy is rated on a scale from 0 (very uncertain) to 10 (Very certain). Higher total score on the questionnaire indicates higher TBI related self-efficacy. | Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3) | |
Other | Changes in WM self-efficacy | The Memory Self-Efficacy Questionnaire (MSEQ) is rated on a scale from 0 (never) to 12 (100% of the time). Higher total scales score indicates higher WM self-efficacy. | Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3) | |
Primary | Change in WM on neuropsychological tests | Measured by the WM Index WAIS IV | Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3) | |
Primary | Change in WM-related symptoms in everyday life | Assessed with the WM subscale from the Behavior Rating Inventory of Executive functioning Adult version (BRIEF-A) on a 3-point scale: Never a problem, sometimes a problem or often a problem. Higher scaled score indicates higher level of problems with WM. | Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3) | |
Secondary | Change in cognitive composite score as seen on neuropsychological tests | Measured by Trail Making A+B, D-KEFS CWIT 1-4, CVLT-II, WAIS IV Digit Symbol | Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3) | |
Secondary | Change in TBI related challenges in everyday life | Measured by the Patient Competency Rating Scale on a 5-point scale from 1 can't do it to 5: No problem to do it. Higher total scaled score represents better every day functioning. | Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3) | |
Secondary | Change in self reported mental health | Measured with the Hopkins Symptom Checklist (HSCL) on a scale from 1 (not at all) to 4 (a lot). Higher mean score reflects a higher level of emotional distress. | Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3) | |
Secondary | Change in quality of life | Assessed with Quality of Life After Brain Injury (QOLIBRI) on a satisfaction scale from 0 (not satisfied) to 5 (very satisfied). Higher satisfaction indicates higher quality of life. | Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3) | |
Secondary | Changes in community integration | Assesed with Participation Assessment with Recombines Tools-Objective (PART-O) on a 5-point scale: None, 1-4 hours, 5-9 hours, 10-19 hours, 20-34 hours, 35 hours or more. Higher mean scaled score indicates better community integration. | Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3) |
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