The Effect of Hypnotic Suggestion After Acquired Brain Injury or Concussion

NCT05142007 | Completed DMC

• 1 other identifier: 342096
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

A recent randomized clinical trial (RCT) demonstrated large effects of hypnotic suggestion on working memory following acquired brain injury. However, no studies have investigated long-term effects (\> 2 months) effects on return to work (RTW). Therefore the aim is in a RCT to study the effect of hypnotic suggestion on RTW in employed individuals with acquired brain injury or concussion, that were referred to an out-patient municipal vocational rehabilitation center in Denmark. Participants were randomized to a passive (treatment as usual), active comparison (a weekly treatment session of mindfullness-based stress reduction for four weeks) or intervention group (a weekly treatment session of targeted suggestion for four weeks). Intention-to-treat analysis of the hypnosis effect on return to work within six months follow-up will be performed. Results Participants (N=77) have accepted and participated in the study. Effect measures are to be analysed.

Conditions

Acquired Brain Injury; Concussion, Brain

Keywords

Brain Injuries; Brain Concussion; Hypnosis; Return To Work; Sick Leave; Randomized Controlled Trial [Publication Type]

Outcome Measures

Primary Outcomes (1)

• Return to work

  The probability of returning to work is based on registry-based data. Dichotomous outcome: 0 (no), 1 (yes).

  Within one year of follow-up

Secondary Outcomes (9)

• WAIS-IV Working Memory Index

  Six months follow-up

• Trail Making Test (executive component of working memory)

  Six months follow-up

• Go-nogo reaction time difference

  Six months follow-up

• Story recall - immediate recall

  Six months follow-up

• Working memory

  Six months follow-up

Study Arms (3)

Hypnosis

EXPERIMENTAL

The first treatment arm ("targeted suggestion") consist of suggestions about enhancing working memory functions through the instantiation of preinjury working memory ability in the present using age regression, visualizations of neuroplasticity in the present, and posthypnotic suggestions about continued improvement. The overarching theme of the suggestions is that thinking itself will become effortless and reliable, leading to reduced fatigue, better memory, and the absence of information overload.

Behavioral: Hypnosis

Mindfulness-based stress reduction

ACTIVE COMPARATOR

The second treatment arm ("non-targeted suggestion" or MBSR) contains no explicit mentioning of brain injury or working memory-related abilities and thus serves to isolate the 'targetedness' of suggestion as well as factoring out other influences from placebo, retest effects, etc.

Behavioral: Mindfulness-based stress reduction

Control group

NO INTERVENTION

The (passive) control group receives no contact over and beyond testing.

Interventions

Hypnosis BEHAVIORAL

A number of steps are taken to make the treatment arms identical in all other respects. The participants are unaware that there are two treatment arms to homogenize expectations. Each session is a manualized hypnosis script which is dictated by the hypnotist, including the hypnosis test. The only degrees of freedom for the hypnotist is in intonation and speed. Identical induction and termination is used in both arms and the scripts are of comparable durations.

Hypnosis

Mindfulness-based stress reduction BEHAVIORAL

A number of steps are taken to make the treatment arms identical in all other respects. The participants are unaware that there are two treatment arms to homogenize expectations. Each session is a manualized hypnosis script which is dictated by the hypnotist, including the hypnosis test. The only degrees of freedom for the hypnotist is in intonation and speed. Identical induction and termination is used in both arms and the scripts are of comparable durations.

Mindfulness-based stress reduction

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Documented concussion or acquired brain injury which is at least 6 months old at the first (potential) therapy session.
• Employment more than 50% of the time after finishing the latest education and employed at least 6 consecutive months immediately preceding the injury
• If the patient is currently fully employed, he/she must have substantial risk of decreasing vocational status.
• No substance abuse or issues currently in- or requiring- psychiatric treatment.

You may not qualify if:

• Progressive injuries are excluded, including dementias.

Sponsors & Collaborators

• Aalborg University: lead
• Defactum, Central Denmark Region: collaborator

Study Sites (1)

Aalborg University

Aalborg, 9100, Denmark

Location

Related Publications (7)

• Lindelov JK, Overgaard R, Overgaard M. Improving working memory performance in brain-injured patients using hypnotic suggestion. Brain. 2017 Apr 1;140(4):1100-1106. doi: 10.1093/brain/awx001.

  PMID: 28335012 BACKGROUND

• Milos R. Hypnotic exploration of amnesia after cerebral injuries. Int J Clin Exp Hypn. 1975 Apr;23(2):103-10. doi: 10.1080/00207147508415934. No abstract available.

  PMID: 1120625 BACKGROUND

• Sullivan DS, Johnson A, Bratkovitch J. Reduction of behavioral deficit in organic brain damage by use of hypnosis. J Clin Psychol. 1974 Jan;30(1):96-8. doi: 10.1002/1097-4679(197401)30:13.0.co;2-a. No abstract available.

  PMID: 4811938 BACKGROUND

• Kihlstrom JF, Glisky ML, McGovern S, Rapcsak SZ, Mennemeier MS. Hypnosis in the right hemisphere. Cortex. 2013 Feb;49(2):393-9. doi: 10.1016/j.cortex.2012.04.018. Epub 2012 May 15.

  PMID: 22705266 BACKGROUND

• Laidlaw TM. Hypnosis and attention deficits after closed head injury. Int J Clin Exp Hypn. 1993 Apr;41(2):97-111. doi: 10.1080/00207149308414541.

  PMID: 8468107 BACKGROUND

• Cedercreutz C, Lahteenmaki R, Tulikoura J. Hypnotic treatment of headache and vertigo in skull injured patients. Int J Clin Exp Hypn. 1976 Jul;24(3):195-201. doi: 10.1080/00207147608416201. No abstract available.

  PMID: 1262079 BACKGROUND

• Ma VY, Chan L, Carruthers KJ. Incidence, prevalence, costs, and impact on disability of common conditions requiring rehabilitation in the United States: stroke, spinal cord injury, traumatic brain injury, multiple sclerosis, osteoarthritis, rheumatoid arthritis, limb loss, and back pain. Arch Phys Med Rehabil. 2014 May;95(5):986-995.e1. doi: 10.1016/j.apmr.2013.10.032. Epub 2014 Jan 21.

  PMID: 24462839 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Brain Concussion

Interventions

Hypnosis; Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Injuries, Traumatic; Head Injuries, Closed; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy

Study Officials

• Jonas K Lindeløv

  Department for Communication and Psychology, Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: December 2, 2021
• Study Start: May 11, 2017
• Primary Completion: November 6, 2020
• Study Completion: October 29, 2021
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)