Group Based Treatment for Persons With Social Communication Difficulties

NCT ID: NCT03636399

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-06-16

Brief Summary

A large proportion of patients with ABI have cognitive deficits that affect the way they communicate. Cognitive difficulties with attention, memory, executive functions and so on affect social communication. Without successful social skills, a person may engage in conflicts, become isolated and be denied access to social and vocational opportunities. Internationally, several group interventions have been developed for treating social communication difficulties during the last years.

Group Interactive Structured Treatment (GIST) is a validated holistic multidisciplinary group treatment targeting social communication skills after traumatic brain injury. The main aim of the present study is to examine the efficacy of GIST for improving social communication in persons with acquired brain injury, including TBI, stroke, tumor ect. Secondary the study aims to compare the standard GIST protocol to an newly developed intensive GIST protocol. Efficacy will be assessed immediately after intervention, but also three and six months after the intervention. The project is in line with international research efforts aimed to establish more knowledge about group treatment for persons with social communication disorders after ABI.

Conditions

Brain Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard GIST

Standard Group Interactive Structured Treatment.

Group Type: EXPERIMENTAL

Standard GIST

Intervention Type: BEHAVIORAL

13 group modules will be administered to outpatients in 12 x 2,5-3 hours sessions. Manualized intervention; In every group session a new topic is presented, discussed and practiced in group exercises. Homework assignments between sessions.

Waitlist control/Intensive GIST

After a wait list control period of nine months the participants receive Intensive Group Interactive Structured Treatment.

Group Type: OTHER

Intensive GIST

Intervention Type: BEHAVIORAL

13 group modules will be administered to inpatients during 4 weeks in hospital. Participants is admitted to a hospital unit for cognitive rehabilitation treating patients in acute and/or cronic phase. The participants are given extended leave every weekend to work on homework Assignments between each treatment week.

Interventions

Standard GIST

13 group modules will be administered to outpatients in 12 x 2,5-3 hours sessions. Manualized intervention; In every group session a new topic is presented, discussed and practiced in group exercises. Homework assignments between sessions.

Intervention Type: BEHAVIORAL

Intensive GIST

13 group modules will be administered to inpatients during 4 weeks in hospital. Participants is admitted to a hospital unit for cognitive rehabilitation treating patients in acute and/or cronic phase. The participants are given extended leave every weekend to work on homework Assignments between each treatment week.

Intervention Type: BEHAVIORAL

Other Intervention Names

GIST; GIST

Eligibility Criteria

Inclusion Criteria

• traumatic brain injury (TBI), cerebrovascular accidents (stroke; CVA) patients with no concomitant diseases minimum 6 months post-injury
• The patient are experiencing social communication disorders
• The family member is experiencing the patients social communication disorders
• The patient is motivated and expresses a desire to change communication behavior
• One close family member is able to participate in the intervention process
• Adequate Norwegian language proficiency to participate in the group
• The patient experiences moderate to severe difficulties with minimum 3 aspects of communication assessed with La Trobe Questionnaire
• The patient have insight into their communication difficulties (minimum intellectual insight) assessed with Awareness Questionnaire

Exclusion Criteria

• Age <18 years
• Aphasia. Based on previous records.
• Major psychiatric disorder or reported ongoing alcohol or substance abuse
• Premorbid neurological disease or insult and/or comorbid neurological disease
• Impaired basic linguistic, mnemonic, motor, or perceptual function that can interfere with the ability to engage with the training or intelligence quotient (IQ) < 85

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 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

Silje Merethe Hansen

Co-Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melanie Kirmess, PHD

Role: PRINCIPAL_INVESTIGATOR

Sunnaas Sykehus

Locations

Sunnaas rehabilitation hospital

Nesoddtangen, , Norway

Countries

Norway

References

Hansen SM, Stubberud J, Hjertstedt M, Kirmess M. Intensive and standard group-based treatment for persons with social communication difficulties after an acquired brain injury: study protocol for a randomised controlled trial. BMJ Open. 2019 Sep 8;9(9):e029392. doi: 10.1136/bmjopen-2019-029392.

Reference Type: BACKGROUND

PMID: 31501112 (View on PubMed)

Ingebretsen SMH, Kirmess M, Smastuen MC, Hawley L, Newman J, Stubberud J. Rehabilitation of Social Communication Skills in Patients With Acquired Brain Injury With Intensive and Standard Group Interactive Structured Treatment: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2023 Jul;104(7):1016-1025. doi: 10.1016/j.apmr.2023.02.023. Epub 2023 Mar 24.

Reference Type: DERIVED

PMID: 36966953 (View on PubMed)

Other Identifiers

2017/1360

Identifier Type: -

Identifier Source: org_study_id