Cognitive RehabilitationNCT05287542
Hypnosis in Working Memory Rehabilitation
A study testing Hypnotic suggestion and Mindfulness in people with Cognitive Rehabilitation and Brain Injuries, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Cognitive Rehabilitation, Brain Injuries, Cognitive Impairment
- What is being tested?
- Hypnotic suggestion and Mindfulness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteNorway
- Study dates
- 15 Dec 2022to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with severe mental illness
- Patients progressive neurologic disease
- Patients with ongoing ICD-10 diagnosis of substance dependence
- Patients that lack Norwegian language skills
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The potential impact of applying hypnosis in cognitive rehabilitation is substantial. Deficits in WM is one of the most common challenges after ABI and plays a critical role in post-injury outcome. Still, state-of-the-art approaches within WM rehabilitation have not been able to produce significant effects that transfer to real- life functioning for the affected patients. Building on the strong results of hypnosis on WM in ABI from a Danish single trial, we will aim at replication and expansion of the study in a Norwegian context. The initial study will be expanded in terms of number of participants, injury-characteristics will be included, outcome measures of relevance to real-life functioning, and underlying mechanisms of change will be explored. Self-efficacy is generalizable by nature (self-efficacy gained from mastery experiences in one situation generalizes to others), thus WM rehabilitation effects are expected to generalize and transfer to other domains in daily life.
This randomized controlled trial (RCT) aims to evaluate the effectiveness of hypnosis in WM rehabilitation in ABI patients. Ninety patients will be recruited from Sunnaas Rehabilitation Hospital. Inclusion criteria are non-progressive ABI, minimum 12 months post- injury, ongoing WM deficits and age between 18 and 67 years. Patients will be randomized to either a) an intervention group receiving four weekly 60 min. sessions with induction and hypnosis, b) an active control group receiving four weekly 60 min. sessions of induction and mindfulness, or c) a passive control group without intervention. The targeted procedure consists of suggestions about enhancing WM functions through the instantiation of preinjury WM ability in the present using age regression and visualizations of brain plasticity. The non- targeted suggestions contain no explicit mentioning of ABI or WM-related abilities. Each participant will be assessed at baseline, immediately after intervention and six months after baseline. Primary outcome is WM as measured by neuropsychological tests as well as self- and informant reported WM capacity. Secondary outcomes include self-rated ABI related symptoms, self-efficacy, mental health, and global outcome. A process evaluation will be carried out to evaluate treatment experience,
Rehabilitation of impaired WM after ABI has hitherto yielded limited clinical effects, and clinical trials of new interventions are thus warranted. Long-standing empirical evidence demonstrates that hypnosis is an effective therapeutic technique in a wide range of conditions, including in altering cognitive functions and improving WM in healthy adults, supported by imaging data. Recent exploratory research has suggested remarkable efficacy of hypnosis in improving WM in patients with ABI. However, these findings need replication in studies applying scientifically rigorous designs. If successful, our ambition is to provide recommendations and materials to implement hypnotic suggestion as an adjunct treatment following ABI in Norwegian rehabilitation clinics. Study findings may inform future studies exploring the use of clinical hypnosis in other areas of rehabilitation, such as mild TBI, and in other neurological conditions where WM deficit is prominent.
- Being tested
- Hypnotic suggestion, Mindfulness
- Keywords
- Aquired brain injury, Rehabilitation, Randomized controlled trial (RCT), Clinical Hypnosis, Self-efficacy
- Medical subject headings
- Brain Injuries, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnotic suggestionOther
The intervention group will receive four weekly 60 min. sessions with hypnosis treatment including induction followed by hypnotic suggestion.
MindfulnessOther
The active control group will receive four weekly 60 min. sessions of induction and mindfulness-based instructions.
| Study group | Role | What they receive |
|---|---|---|
| Hypnotic suggestion | Experimental | During the first phase of the study, two groups will receive identical hypnotic inductions followed by targeted suggestion for one group and non-targeted suggestion for the other. The targeted procedure consists of suggestions about enhancing WM functions through the instantiation of preinjury WM ability in the present using age regression and visualizations of brain plasticity. Receives: Other: Hypnotic suggestion |
| Mindfulness | Active comparator | The targeted procedure consists of suggestions about enhancing WM functions through the instantiation of preinjury WM ability in the present using age regression and visualizations of brain plasticity. Receives: Other: Mindfulness |
| No treatment | No intervention | The passive control group receives no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WM on neuropsychological tests
Measured by the WM Index WAIS IV
Measured: Change from Baseline (T1) to immediately after the intervention period (T2) and 6 months after Baseline (T3)
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.
Measured: Change from Baseline (T1) to immediately after the intervention period (T2) and 6 months after Baseline (T3)
Secondary outcomes (5)
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
Measured: Change from Baseline (T1) to immediately after the intervention period (T2) and 6 months after Baseline (T3)
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.
Measured: Change from Baseline (T1) to immediately after the intervention period (T2) and 6 months after Baseline (T3)
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.
Measured: Change from Baseline (T1) to immediately after the intervention period (T2) and 6 months after Baseline (T3)
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.
Measured: Change from Baseline (T1) to immediately after the intervention period (T2) and 6 months after Baseline (T3)
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.
Measured: Change from Baseline (T1) to immediately after the intervention period (T2) and 6 months after Baseline (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start15 Dec 2022
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnaas Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
- Investigators
- Marianne Løvstad, Profesor, Principal investigator, Sunnaas Rehabilitation Hospital and University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287542
- Sponsor's protocol ID
- Hypnoseprosjektet
- Status last verified
- Nov 2022
- First submitted
- 9 Mar 2022
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eide LS, Rike PO, Reme SE, Snekkevik H, Rossner S, Rosen G, Lindelov JK, Lovstad M. Using hypnotic suggestion in the rehabilitation of working memory capacity after acquired brain injury: study protocol for a randomized controlled trial. Trials. 2024 Jan 2;25(1):11. doi: 10.1186/s13063-023-07867-z.
PubMed 38167204
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Releasing Residual Cognitive Capacity After Acquired Brain Injury: A Randomized Controlled Trial Using Hypnotic Suggestion in Rehabilitation of Working Memory
- ClinicalTrials.gov ID
- NCT05287542
- Acronym / sponsor ID
- Hypnoseprosjektet
- Keywords
- Aquired brain injury, Rehabilitation, Randomized controlled trial (RCT), Clinical Hypnosis, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sunnaas Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The potential impact of applying hypnosis in cognitive rehabilitation is substantial. Deficits in WM is one of the most common challenges after ABI and plays a critical role in post-injury outcome. Still, state-of-the-art approaches within WM rehabilitation have not been able to produce significant effects that transfer to real- life functioning for the affected patients. Building on the strong results of hypnosis on WM in ABI from a Danish single trial, we will aim at replication and expansion of the study in a Norwegian context. The initial study will be expanded in terms of number of participants, injury-characteristics will be included, outcome measures of relevance to real-life functioning, and underlying mechanisms of change will be explored. Self-efficacy is generalizable by nature (self-efficacy gained from mastery experiences in one situation generalizes to others), thus WM rehabilitation effects are expected to generalize and transfer to other domains in daily life.
This randomized controlled trial (RCT) aims to evaluate the effectiveness of hypnosis in WM rehabilitation in ABI patients. Ninety patients will be recruited from Sunnaas Rehabilitation Hospital. Inclusion criteria are non-progressive ABI, minimum 12 months post- injury, ongoing WM deficits and age between 18 and 67 years. Patients will be randomized to either a) an intervention group receiving four weekly 60 min. sessions with induction and hypnosis, b) an active control group receiving four weekly 60 min. sessions of induction and mindfulness, or c) a passive control group without intervention. The targeted procedure consists of suggestions about enhancing WM functions through the instantiation of preinjury WM ability in the present using age regression and visualizations of brain plasticity. The non- targeted suggestions contain no explicit mentioning of ABI or WM-related abilities. Each participant will be assessed at baseline, immediately after intervention and six months after baseline. Primary outcome is WM as measured by neuropsychological tests as well as self- and informant reported WM capacity. Secondary outcomes include self-rated ABI related symptoms, self-efficacy, mental health, and global outcome. A process evaluation will be carried out to evaluate treatment experience,
Rehabilitation of impaired WM after ABI has hitherto yielded limited clinical effects, and clinical trials of new interventions are thus warranted. Long-standing empirical evidence demonstrates that hypnosis is an effective therapeutic technique in a wide range of conditions, including in altering cognitive functions and improving WM in healthy adults, supported by imaging data. Recent exploratory research has suggested remarkable efficacy of hypnosis in improving WM in patients with ABI. However, these findings need replication in studies applying scientifically rigorous designs. If successful, our ambition is to provide recommendations and materials to implement hypnotic suggestion as an adjunct treatment following ABI in Norwegian rehabilitation clinics. Study findings may inform future studies exploring the use of clinical hypnosis in other areas of rehabilitation, such as mild TBI, and in other neurological conditions where WM deficit is prominent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Hypnotic suggestion | Experimental | Other: Hypnotic suggestionDuring the first phase of the study, two groups will receive identical hypnotic inductions followed by targeted suggestion for one group and non-targeted suggestion for the other. The targeted procedure consists of suggestions about enhancing WM functions through the instantiation of preinjury WM ability in the present using age regression and visualizations of brain plasticity. |
| Mindfulness | Active comparator | Other: MindfulnessThe targeted procedure consists of suggestions about enhancing WM functions through the instantiation of preinjury WM ability in the present using age regression and visualizations of brain plasticity. |
| No treatment | No intervention | –The passive control group receives no intervention |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Patients with severe mental illness
- Patients progressive neurologic disease
- Patients with ongoing ICD-10 diagnosis of substance dependence
- Patients that lack Norwegian language skills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnotic suggestionThe intervention group will receive four weekly 60 min. sessions with hypnosis treatment including induction followed by hypnotic suggestion. | Other | Hypnotic suggestion |
| MindfulnessThe active control group will receive four weekly 60 min. sessions of induction and mindfulness-based instructions. | Other | Mindfulness |
Primary outcome
Change in WM on neuropsychological tests
Time frame: Change from Baseline (T1) to immediately after the intervention period (T2) and 6 months after Baseline (T3)
Measured by the WM Index WAIS IV
Change in WM-related symptoms in everyday life
Time frame: Change from Baseline (T1) to immediately after the intervention period (T2) and 6 months after Baseline (T3)
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.
5 secondary outcomes
Change in cognitive composite score as seen on neuropsychological tests
Time frame: Change from Baseline (T1) to immediately after the intervention period (T2) and 6 months after Baseline (T3)
Change in TBI related challenges in everyday life
Time frame: Change from Baseline (T1) to immediately after the intervention period (T2) and 6 months after Baseline (T3)
Change in self reported mental health
Time frame: Change from Baseline (T1) to immediately after the intervention period (T2) and 6 months after Baseline (T3)
Change in quality of life
Time frame: Change from Baseline (T1) to immediately after the intervention period (T2) and 6 months after Baseline (T3)
Changes in community integration
Time frame: Change from Baseline (T1) to immediately after the intervention period (T2) and 6 months after Baseline (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Derived from this study: PubMed 38167204Eide LS, Rike PO, Reme SE, Snekkevik H, Rossner S, Rosen G, Lindelov JK, Lovstad M. Using hypnotic suggestion in the rehabilitation of working memory capacity after acquired brain injury: study protocol for a randomized controlled trial. Trials. 2024 Jan 2;25(1):11. doi: 10.1186/s13063-023-07867-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Løvstad, Profesor principal investigator
Sunnaas Rehabilitation Hospital and University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotic suggestion and Mindfulness in people with Cognitive Rehabilitation and Brain Injuries, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in WM on neuropsychological tests (time frame: Change from Baseline (T1) to immediately after the intervention period (T2) and 6 months after Baseline (T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05287542, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.