Hypnosis in Working Memory Rehabilitation

NCT ID: NCT05287542

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2024-04-01

Brief 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 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.

Conditions

Cognitive Rehabilitation; Brain Injuries; Cognitive Impairment; Working Memory

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hypnotic suggestion

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.

Group Type: EXPERIMENTAL

Hypnotic suggestion

Intervention Type: OTHER

The intervention group will receive four weekly 60 min. sessions with hypnosis treatment including induction followed by hypnotic suggestion.

Mindfulness

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.

Group Type: ACTIVE_COMPARATOR

Mindfulness

Intervention Type: OTHER

The active control group will receive four weekly 60 min. sessions of induction and mindfulness-based instructions.

No treatment

The passive control group receives no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hypnotic suggestion

The intervention group will receive four weekly 60 min. sessions with hypnosis treatment including induction followed by hypnotic suggestion.

Intervention Type: OTHER

Mindfulness

The active control group will receive four weekly 60 min. sessions of induction and mindfulness-based instructions.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Sunnaas Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marianne Løvstad, Profesor

Role: PRINCIPAL_INVESTIGATOR

Sunnaas Rehabilitation Hospital and University of Oslo

Locations

Sunnaas Rehabilitation Hospital

Nesoddtangen, Akershus, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Marianne Løvstad, Profesor

Role: CONTACT

Marianne.Lovstad@sunnaas.no

+4793452003

Line Sophie Eide, Cand.psyc

Role: CONTACT

Line.Eide@sunnaas.no

+4797950051

Facility Contacts

Anne Catrine Martinsen, PhD

Role: primary

anne.catrine.traegde.martinsen@sunnaas.no

References

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.

Reference Type: DERIVED

PMID: 38167204 (View on PubMed)

Other Identifiers

Hypnoseprosjektet

Identifier Type: -

Identifier Source: org_study_id