Clinical trial NCT03874650: MAPLES Pilot Study for Low Mood in ABI
Official title: Mood, Activity Participation, and Leisure Engagement Satisfaction (MAPLES): A Pilot Feasibility Study for Low Mood in Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Brain Injury
Depression
Keywords: acquired brain injury
traumatic brain injury
depression
rehabilitation
executive function
Lead sponsor: University of Cambridge
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Have a diagnosis of an acquired brain injury (e.g., traumatic brain injury, stroke)
2. Speak and comprehend English
3. Are a minimum of 3 months post-acquired brain injury
4. Are identified as having low mood. Low mood will be identified by either:

   1. A score of at least 7 on the depression subscale of the Hospital Anxiety and Depression Scale, indicating clinically significant levels of depression, or
   2. Clinicians have identified that a client has low mood (i.e., through their own administration of the HADS within the past 3 months, through clinical interview determining that the client has low mood or would benefit emotionally from increased activity level)

Exclusion Criteria:

1. Are incapable of attending to and/or understanding the intervention materials (i.e., severe cognitive disability)
2. Have a diagnosis of dementia or other neurodegenerative disorder
3. Unstable psychotropic medication (i.e., have recently started/recently changed medications)
4. Are actively suicidal (i.e., have attempted suicide in the past 3 months, currently self-harm, and/or have a concrete plan to attempt suicide in the future, as identified by recurring clinician)

Primary outcomes:
measure: Behavioural Activation for Depression Scale (BADS; Kanter et al., 2007)
timeFrame: Baseline, 1 week post-intervention, 1 month post-intervention
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)
timeFrame: Baseline, 1 week post-intervention, 1 month post-intervention
measure: Behavioural Inhibition/Behavioural Activation Scales (BIS/BAS; Carver & White 1994)
timeFrame: Baseline, 1 week post-intervention, 1 month post-intervention
measure: Intolerance of Uncertainty Scale-Short Form (IUS-SF; Carleton, Norton, & Asmundson)
timeFrame: Baseline, 1 week post-intervention, 1 month post-intervention
measure: Impact of Events Scale-Revised (IES-R, Weiss, 2007)
timeFrame: Baseline, 1 week post-intervention, 1 month post-intervention
measure: Brain Injury Rehabilitation Trust Motivation Questionnaire-Self (BMQ-S)
timeFrame: Baseline, 1 week post-intervention, 1 month post-intervention
measure: Modified Outcome Measure - Participation Objective, Participation Subjective (MOM-POPS, Brown et al., 2004)
timeFrame: Baseline, 1 week post-intervention, 1 month post-intervention
measure: Sense of Control Scale (SCS; Lachman & Weaver, 1998a, 1998b)
timeFrame: Baseline, 1 week post-intervention, 1 month post-intervention
measure: Motivation for Traumatic Brain Injury Rehabilitation Questionnaire (MOT-Q; Chervinsky et al., 1998)
timeFrame: Baseline, 1 week post-intervention, 1 month post-intervention
measure: Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)
timeFrame: Baseline only
measure: Snaith Hamilton Pleasure Scale (SHAPS; Snaith et al., 1995)
timeFrame: Baseline, 1 week post-intervention, 1 month post-intervention
measure: Fatigue Severity Scale (FSS; Krupp et al., 1989)
timeFrame: Baseline, 1 week post-intervention, 1 month post-intervention
measure: Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006)
timeFrame: Baseline, 1 week post-intervention, 1 month post-intervention
measure: Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001)
timeFrame: Baseline, 1 week post-intervention, 1 month post-intervention
measure: Verbal and Spatial Reasoning Test (VESPAR; Langdon & Warrington, 1995)
timeFrame: Baseline only
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridgeshire Community Services
state: Cambs
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Trust
Study officials:
affiliation: University of Cambridge
name: Tom Manly, PhD
role: PRINCIPAL_INVESTIGATOR
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