Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-01-02 @ 11:09 AM
Study NCT ID:
NCT03874650
Status:
COMPLETED
Last Update Posted:
2021-05-04
First Post:
2019-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MAPLES Pilot Study for Low Mood in ABI
Sponsor:
University of Cambridge
Organization:
Study Overview
Official Title:
Mood, Activity Participation, and Leisure Engagement Satisfaction (MAPLES): A Pilot Feasibility Study for Low Mood in Acquired Brain Injury
Status:
COMPLETED
Status Verified Date:
2021-05
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:
MAPLES
Brief Summary:
Low mood and depression are common following acquired brain injury (ABI). There is a lack evidence on effective treatments in ABI. Behavioural Activation (BA) is a potentially valuable option. People with low mood can have problems imagining, planning and engaging in positive activities, or avoid activities due to fear of negative consequences. This can reduce positive reinforcement, further lowering mood. BA aims to reverse this cycle by encouraging individuals to engage in enjoyable activities. Despite its simplicity, it has been as effective as "talking therapies" and mood medication in non-ABI populations. Its simplicity may be particularly helpful in ABI where cognitive problems can form additional barriers to activity engagement.
This study will examine two ways to increase activity levels and improve mood. The first (Activity Engagement Group) is a social group run once a week for 8 weeks in which ABI participants will be encouraged to engage in games, crafts and discussion. The aim is that members gain direct positive reinforcement and may challenge fears such that activity levels could be maintained and mood enhanced after the group ends.
The second approach (Activity Planning Group), again an 8-week group, is to help participants identify, plan and schedule positive activities. The group will include discussion on identifying and overcoming problems in planning activities. Again, the hope is that training skills in planning and scheduling will generalise beyond the group.
The primary purpose is to examine the practicality, feasibility, and acceptability of the two approaches in ABI. A secondary purpose is to evaluate whether either group leads to improvements in activity levels and mood compared to a waitlist group. Individuals will be randomised to the Activity Engagement, Activity Planning Group or the 8-week Waitlist group. All will complete measures of activity levels and mood. At the end of the groups, these measures will be repeated. Waitlist participants will then be re-randomised to either the Activity Engagement Group or the Activity Planning Group.
Recruitment rates, drop out rates, and exit interviews will be used to assess feasibility and how meaningful or valuable participants found the groups. Comparison of measures will provide some indication of whether the groups are associated with improvements compared to those waitlisted. To establish whether any benefits last, all participants will repeat the measures 1 month after the groups end.
This study will examine two ways to increase activity levels and improve mood. The first (Activity Engagement Group) is a social group run once a week for 8 weeks in which ABI participants will be encouraged to engage in games, crafts and discussion. The aim is that members gain direct positive reinforcement and may challenge fears such that activity levels could be maintained and mood enhanced after the group ends.
The second approach (Activity Planning Group), again an 8-week group, is to help participants identify, plan and schedule positive activities. The group will include discussion on identifying and overcoming problems in planning activities. Again, the hope is that training skills in planning and scheduling will generalise beyond the group.
The primary purpose is to examine the practicality, feasibility, and acceptability of the two approaches in ABI. A secondary purpose is to evaluate whether either group leads to improvements in activity levels and mood compared to a waitlist group. Individuals will be randomised to the Activity Engagement, Activity Planning Group or the 8-week Waitlist group. All will complete measures of activity levels and mood. At the end of the groups, these measures will be repeated. Waitlist participants will then be re-randomised to either the Activity Engagement Group or the Activity Planning Group.
Recruitment rates, drop out rates, and exit interviews will be used to assess feasibility and how meaningful or valuable participants found the groups. Comparison of measures will provide some indication of whether the groups are associated with improvements compared to those waitlisted. To establish whether any benefits last, all participants will repeat the measures 1 month after the groups end.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: