Hypnosis in Working Memory Rehabilitation

NCT05287542 | Unknown

• 1 other identifier: Hypnoseprosjektet
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Rehabilitation; Brain Injuries; Cognitive Impairment; Working Memory

Keywords

Aquired brain injury; Rehabilitation; Randomized controlled trial (RCT); Clinical Hypnosis; Self-efficacy

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

• Change in cognitive composite score as seen on neuropsychological tests

  Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)

• Change in TBI related challenges in everyday life

  Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)

• Change in self reported mental health

  Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)

• Change in quality of life

  Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)

• Changes in community integration

  Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)

Other Outcomes (2)

• Changes in ABI related self-efficacy

  Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)

• Changes in WM self-efficacy

  Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)

Study Arms (3)

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.

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.

Other: Mindfulness

No treatment

NO INTERVENTION

The passive control group receives no intervention

Interventions

Hypnotic suggestion OTHER

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

Hypnotic suggestion

Mindfulness OTHER

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

Mindfulness

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with severe mental illness
• Patients progressive neurologic disease
• Patients with ongoing ICD-10 diagnosis of substance dependence
• Patients that lack Norwegian language skills

Sponsors & Collaborators

• Sunnaas Rehabilitation Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

Sunnaas Rehabilitation Hospital

Nesoddtangen, Akershus, 1453, Norway

RECRUITING

Related Publications (1)

• 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.

  PMID: 38167204 DERIVED

MeSH Terms

Conditions

Brain Injuries; Cognitive Dysfunction

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Marianne Løvstad, Profesor

  Sunnaas Rehabilitation Hospital and University of Oslo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Løvstad, Profesor

CONTACT

+4793452003; Marianne.Lovstad@sunnaas.no

Line Sophie Eide, Cand.psyc

CONTACT

+4797950051; Line.Eide@sunnaas.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: It is not possible to blind participants or therapists to group allocation during the intervention. Independent Outcome Assessor(s) will be blinded to group allocation. Participants will be provided with new IDs in final database, blinding researchers to which group is the interventions group, active control group or passive control group during analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 18, 2022
• Study Start: August 15, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

NO (1)