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Hypnosis in Working Memory Rehabilitation

Primary Purpose

Cognitive Rehabilitation, Brain Injuries, Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Hypnotic suggestion
Mindfulness
Sponsored by
Sunnaas Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Rehabilitation focused on measuring Aquired brain injury, Rehabilitation, Randomized controlled trial (RCT), Clinical Hypnosis, Self-efficacy

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sunnaas Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Hypnotic suggestion

Mindfulness

No treatment

Arm Description

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.

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 passive control group receives no intervention

Outcomes

Primary Outcome Measures

Change in WM on neuropsychological tests
Measured by the WM Index WAIS IV
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.

Secondary Outcome Measures

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 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 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 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.
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.

Full Information

First Posted
March 9, 2022
Last Updated
November 7, 2022
Sponsor
Sunnaas Rehabilitation Hospital
Collaborators
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT05287542
Brief Title
Hypnosis in Working Memory Rehabilitation
Official Title
Releasing Residual Cognitive Capacity After Acquired Brain Injury: A Randomized Controlled Trial Using Hypnotic Suggestion in Rehabilitation of Working Memory
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnaas Rehabilitation Hospital
Collaborators
University of Oslo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Rehabilitation, Brain Injuries, Cognitive Impairment, Working Memory
Keywords
Aquired brain injury, Rehabilitation, Randomized controlled trial (RCT), Clinical Hypnosis, Self-efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypnotic suggestion
Arm Type
Experimental
Arm Description
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.
Arm Title
Mindfulness
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
The passive control group receives no intervention
Intervention Type
Other
Intervention Name(s)
Hypnotic suggestion
Intervention Description
The intervention group will receive four weekly 60 min. sessions with hypnosis treatment including induction followed by hypnotic suggestion.
Intervention Type
Other
Intervention Name(s)
Mindfulness
Intervention Description
The active control group will receive four weekly 60 min. sessions of induction and mindfulness-based instructions.
Primary Outcome Measure Information:
Title
Change in WM on neuropsychological tests
Description
Measured by the WM Index WAIS IV
Time Frame
Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)
Title
Change in WM-related symptoms in everyday life
Description
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.
Time Frame
Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)
Secondary Outcome Measure Information:
Title
Change in cognitive composite score as seen on neuropsychological tests
Description
Measured by Trail Making A+B, D-KEFS CWIT 1-4, CVLT-II, WAIS IV Digit Symbol
Time Frame
Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)
Title
Change in TBI related challenges in everyday life
Description
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.
Time Frame
Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)
Title
Change in self reported mental health
Description
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.
Time Frame
Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)
Title
Change in quality of life
Description
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.
Time Frame
Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)
Title
Changes in community integration
Description
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.
Time Frame
Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)
Other Pre-specified Outcome Measures:
Title
Changes in ABI related self-efficacy
Description
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.
Time Frame
Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)
Title
Changes in WM self-efficacy
Description
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.
Time Frame
Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marianne Løvstad, Profesor
Phone
+4793452003
Email
Marianne.Lovstad@sunnaas.no
First Name & Middle Initial & Last Name or Official Title & Degree
Line Sophie Eide, Cand.psyc
Phone
+4797950051
Email
Line.Eide@sunnaas.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Løvstad, Profesor
Organizational Affiliation
Sunnaas Rehabilitation Hospital and University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnaas Rehabilitation Hospital
City
Nesoddtangen
State/Province
Viken
ZIP/Postal Code
1453
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Catrine Martinsen, PhD
Email
anne.catrine.traegde.martinsen@sunnaas.no

12. IPD Sharing Statement

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Hypnosis in Working Memory Rehabilitation

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