Ignite Creation Date:
2024-05-06 @ 5:40 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05393492
Status:
RECRUITING
Last Update Posted:
2022-05-26
First Post:
2022-01-18
Brief Title:
Regulating Emotions and Behaviors After Brain Injury
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
Official Title:
Dialectical Behavior Therapy for Challenging Behaviors and Emotional Distress After Acquired Brain Injury a Pilot Study
Status:
RECRUITING
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GREMO-LCA
Brief Summary:
After acquired brain injury ABI persons can experience emotional and behavioral difficulties that can be painful both for the person and hisher family This clinical study aims at measuring the effectiveness of a third wave cognitive behavioral therapy called dialectical behavior therapy DBT DBT aims at teaching persons emotion regulation skills interpersonal effectiveness skills mindfulness and distress tolerance skills through group and individual sessions
The studys hypothesis is that DBT in an adapted format for persons with ABI can lead to
a better quality of life emotional and behavioral regulation and self-esteem
decrease in problematic behaviors
progress in life goals
increase post traumatic growth and spirituality
better family functioning and lesser burden for care givers
experiencing more emotions and more free will
45 persons with an ABI sustained more than 18 month back will follow a 3 phases follow-up with care as usual for 5 months followed by 5 months of DBT followed by 5 months of care as usual DBT monthly sessions
Self- and family-questionnaire will explore quality of life emotional regulation self-esteem stress anxiety cognitive difficulties family functioning and coping post traumatic growth and spirituality and will be compared across the 3 phases Results will be analyzed at a group level but also at an individual level each patient separately to test for decrease in unwanted behaviors and at a dyadic level the person and hisher spouse to test for the mutual effect of regulating emotions Persons memories will by analyzed at 3 time points by a linguistic analysis and experience of free will after ABI will be analyzed by transcribed narratives of participants
The studys hypothesis is that DBT in an adapted format for persons with ABI can lead to
a better quality of life emotional and behavioral regulation and self-esteem
decrease in problematic behaviors
progress in life goals
increase post traumatic growth and spirituality
better family functioning and lesser burden for care givers
experiencing more emotions and more free will
45 persons with an ABI sustained more than 18 month back will follow a 3 phases follow-up with care as usual for 5 months followed by 5 months of DBT followed by 5 months of care as usual DBT monthly sessions
Self- and family-questionnaire will explore quality of life emotional regulation self-esteem stress anxiety cognitive difficulties family functioning and coping post traumatic growth and spirituality and will be compared across the 3 phases Results will be analyzed at a group level but also at an individual level each patient separately to test for decrease in unwanted behaviors and at a dyadic level the person and hisher spouse to test for the mutual effect of regulating emotions Persons memories will by analyzed at 3 time points by a linguistic analysis and experience of free will after ABI will be analyzed by transcribed narratives of participants
Detailed Description:
The study will explore the impact of Dialectical Behavior Therapy DBT skills training on patients with ABI their families and on for their family system interactions
-Triple methodology
1 3 stages monocentric comparative open-label for part of the outcome measures and single-blinded only for linguistic markers with active control treatment
2 Prospective at the individual level and correlational at the dyad level client - family member single-case experimental study exploring emotional-behavioral interactions as a function of the use of DBT skills by the client over time
Further it will explore the experience of free will the property of the human will to determine itself freely in relation to emotions and meaning of lifespirituality after ABI and the modifications of this experience after DBT
3 qualitative study of semi-structured individual by Interpretative Phenomenological Analysis IPA
The objectives of this research are to show that a group training of DBT skills allows persons with ABI 1 to improve quality of life - main objective 2 to improve self-esteem and emotional regulation 3 to decrease depressive symptoms and problematic behaviors 4 to self-determine and achieve ones goals Goal Attainment Scaling for a life worth living 5 to improve coping and family functioning 7 to decrease caregiver burden 8 to interpret ones life with more expression of emotions non-judgment acceptance of the difficulty of life and motivation to change measured by linguistic analysis of emotionally charged memories
-Triple methodology
1 3 stages monocentric comparative open-label for part of the outcome measures and single-blinded only for linguistic markers with active control treatment
2 Prospective at the individual level and correlational at the dyad level client - family member single-case experimental study exploring emotional-behavioral interactions as a function of the use of DBT skills by the client over time
Further it will explore the experience of free will the property of the human will to determine itself freely in relation to emotions and meaning of lifespirituality after ABI and the modifications of this experience after DBT
3 qualitative study of semi-structured individual by Interpretative Phenomenological Analysis IPA
The objectives of this research are to show that a group training of DBT skills allows persons with ABI 1 to improve quality of life - main objective 2 to improve self-esteem and emotional regulation 3 to decrease depressive symptoms and problematic behaviors 4 to self-determine and achieve ones goals Goal Attainment Scaling for a life worth living 5 to improve coping and family functioning 7 to decrease caregiver burden 8 to interpret ones life with more expression of emotions non-judgment acceptance of the difficulty of life and motivation to change measured by linguistic analysis of emotionally charged memories
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None