Hypnosis in Working Memory Rehabilitation

Sponsor
Sunnaas Rehabilitation Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05287542
Collaborator
University of Oslo (Other)
90
1
3
24.6
3.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Hypnotic suggestion
  • Other: Mindfulness
N/A

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

  1. 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

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled TrialRandomized Controlled Trial
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Releasing Residual Cognitive Capacity After Acquired Brain Injury: A Randomized Controlled Trial Using Hypnotic Suggestion in Rehabilitation of Working Memory
Anticipated Study Start Date :
Mar 15, 2022
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

Active Comparator: 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.

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

No Intervention: No treatment

The passive control group receives no intervention

Outcome Measures

Primary Outcome Measures

  1. Change in WM on neuropsychological tests [Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)]

    Measured by the WM Index WAIS IV

  2. Change in WM-related symptoms in everyday life [Change from Baseline (T1) to immediately after the intervention period (T2) and 8 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.

Secondary Outcome Measures

  1. 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)]

    Measured by Trail Making A+B, D-KEFS CWIT 1-4, CVLT-II, WAIS IV Digit Symbol

  2. 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)]

    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.

  3. Change in self reported mental health [Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)]

    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.

  4. Change in quality of life [Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)]

    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.

  5. Changes in community integration [Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)]

    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.

Other Outcome Measures

  1. Changes in ABI related self-efficacy [Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)]

    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.

  2. Changes in WM self-efficacy [Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 67 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sunnaas Rehabilitation Hospital Nesoddtangen Viken Norway 1453

Sponsors and Collaborators

  • Sunnaas Rehabilitation Hospital
  • University of Oslo

Investigators

  • Principal Investigator: Marianne Løvstad, Profesor, Sunnaas Rehabilitation Hospital and University of Oslo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sunnaas Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT05287542
Other Study ID Numbers:
  • Hypnoseprosjektet
First Posted:
Mar 18, 2022
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sunnaas Rehabilitation Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2022