Mood, Activity Participation, and Leisure Engagement Satisfaction (MAPLES): A randomised controlled feasibility study for low mood in acquired brain injury
Acquired brain injury (ABI) affects approximately 79.3 million individuals annually and is linked with elevated rates of depression and low mood. Existing methods for treating depression in ABI have shown mixed efficacy. Behavioural Activation (BA) is a potentially promising intervention. Its premise is that individuals with low mood avoid planning and engaging in activities due to low expectations of a positive outcome. Consequently, their exposure to positive reinforcement is reduced,
... is reduced, exacerbating low mood. BA aims to break this cycle by encouraging activity planning and engagement. It is unknown whether cognitive demands of traditional BA may undermine efficacy in ABI. Here we assess the feasibility and acceptability of two groups designed to increase activity engagement. In the Activity Planning Group (traditional BA) the importance of meaningful and positive activity will be discussed and participants encouraged to plan/engage in activities in everyday life. The Activity Engagement Group (experiential BA) instead focuses on engagement in positive experiences (crafts, games, discussion) within the group. The primary aims are to evaluate the feasibility and acceptability of the two groups in ABI. A secondary aim is to explore relative efficacy of the groups compared to an equivalent period of waitlist controls. Method: This study outlines a parallel-arm feasibility pilot trial for individuals with low mood and ABI that compares a traditional vs experiential BA group vs. waitlist controls. Adults (>18 years) will be recruited from local ABI services and randomised to condition. Feasibility and acceptability will be assessed via recruitment, retention, attendance, and participant feedback. Groups will be compared (pre-and post-intervention and 1 month follow-up) by assessing self-reported activity engagement. Secondary outcomes include self-report measures of depression, anxiety, post-traumatic distress related to the ABI, motivation, participation, and sense of control over one's life. 4 Ethics and Dissemination: The trial has been approved by the Health Research Authority of the NHS in the UK (East of England -Cambridge Central, REF: 18/EE/0305). Results will inform future research on interventions for mood in ABI and be disseminated broadly via peer-reviewed journals, conference presentations, and social media. Background Acquired brain injury (ABI) refers to damage to the brain from a blow to the head (traumatic brain injury; TBI), from an interruption to the brain's blood supply (stroke) or oxygen supply (anoxia), or as a result of pressure from a growing tumour . On a global scale, each year TBI's affect an estimated 10 million people , and strokes a further 13.7 million  . Anoxic brain damage due to cardiac arrest affects roughly 50 people per 100,000 annually , brain tumours a further 7 per 100,000 , and encephalitis approximately 5 per 100,000 per year . In the United Kingdom (UK) alone, the cost of TBI and stroke is £15 billion and £8.9 billion per year, respectively [7, 8] . Taken together, ABI is a leading cause of long-term disability worldwide  and presents a considerable public health challenge. ABIs can have far-reaching negative effects on an individual's physical, cognitive, behavioural, emotional, and social status [2,10]. The purpose of rehabilitation is to enable those with an ABI to successfully reintegrate into the community by developing essential skills necessary for a patient's goals  . However, positive long-term outcome of rehabilitation can be significantly reduced by depression [12, 13] . Of those with ABI with depression, roughly 66% do not fully recover from their depressive symptoms  . Individuals with an ABI and depression are more likely to experience greater difficulties in many aspects of day-to-day function [8, 9], including poorer quality of life, impaired overall cognitive function, reduced physical activity and engagement in activities of daily living, and a higher mortality rate     . Alarmingly, individuals with an ABI are at least 5 3 times as likely to die by suicide relative to the general population  . Clearly, there is an urgent need to develop effective interventions for depression in ABI populations. Though existing therapies for depression such as Cognitive Behavioural Therapy (CBT) have a strong evidence base in the general population, they place heavy demands on skills often compromised in ABI, such as comprehension, memory, and mental flexibility, which may help account for the mixed outcomes for CBT in ABI . A promising alternative with lower demands and established efficacy in the non-ABI population is Behavioural Activation (BA). Individuals with depression have difficulties anticipating and imagining positive future activities, and tend not to plan or engage in them [21-23] for reasons that include reduced motivation, fatigue, or fear of negative consequences. This limits their exposure to opportunities for positive reinforcement which can exacerbate low mood . In BA, rather than waiting until their mood improves spontaneously, individuals are encouraged to plan and engage in meaningful and valued activities and overcome barriers to their occurrence. Despite its simplicity, BA's effectiveness in the non-ABI population  is on par with medication and CBT [26,27]. Since BA has relatively low cognitive demands compared with, say, CBT, it may be particularly well suited to individuals with ABI. Furthermore, a core component of BA is problem solving barriers related to activity engagement, which is well suited to addressing the considerable cognitive, physical, motivational and societal challenges that are common in ABI. Reduced activity engagement is an important factor contributing to the elevated rates of depression and low mood in ABI [28-32] and thus interventions aimed at improving activity engagement are well-suited toward this population. Promising work examining BA in the specific context of stroke is already underway [33, 34] . In a reanalysis of randomised controlled trial data, Bombardier and colleagues  concluded that environmental rewards from daily activities correlated with decreased depression, 2. Any details on parts of the brain affected and how indicated (e.g, frontotemporal damage, CT scan) 3. Any details on length of stay in acute care 4. Date of initial assessment within CCS and rehabilitation services received 5. Severity of injury and how indicated (e.g., Glasgow Coma Scale scores, Loss of Consciousness, Post-traumatic Amnesia, Stroke Severity Scale) 6. Any health-related comorbidities (e.g., diabetes, alcohol dependence) 7. Any available data on the Dysexecutive Questionnaire [52,53] and the European Brain Injury Questionnaire , both self and informant coefficient (0.90)  The Motivation for Traumatic Brain Injury Rehabilitation Questionnaire (MOT-Q ) is a 31-item scale designed to measure motivation for rehabilitation activities in ABI. It consists of four subscales: Lack of Denial ("I have always had the problems I am having now" [reverse scored]), Interest in Rehabilitation ("Rehabilitation is very useful"), Lack of Anger ("Rehabilitation therapists can't help me with my problems" [reverse scored]) and Reliance on Professional Help ("I rely on doctors to help me with my problems"). It uses a 5 point Likert scale rated from -2 to +2 (Strongly Disagree to Strongly Agree). Total scores range from -62 to +62, with higher scores indicating greater motivation for rehabilitation. Chervinsky and colleagues  reported the MOT-Q total score had a Cronbach's alpha of 0.91, and a Cronbach's alpha of 0.86, 0.86, 0.83, and 0.73 for the subscales Lack of Denial, Interest in Rehabilitation, Lack of Anger, and Reliance on Professional Help, respectively. The MOT-Q has additionally been found to have good test-retest reliability . The Modified Outcome Measure -Participation Objective, Participation Subjective (MOM-POPS; ) is a shortened version of the original POPS scale. The POPS was originally designed to be a measure of community integration in individuals post-TBI, with the scale aimed at producing a Participation Objective score and a Participation Subjective score. In the MOM-POPS, participants are asked to rate their participation in household, occupational, and social activities in the past week, based on 1) an estimate of the amount of household, occupational, and social activities engaged in within the past week (Participation Objective score); 2) whether they would like to be doing more, less, or the same of these activities (Participation Subjective score ) and 3) whether these activities are the most, very, moderate, a little, or not at all important to their satisfaction with life. Participants are then asked to circle from a list of options (e.g., cleaned the house, 25 volunteer work, made social arrangements) which activities they have engaged in within the past week, and have the option to list any additional activities they have engaged in. Although the difficulty of assessing the reliability and validity of a measure that provides both objective and subjective data has been discussed , the original POPS has shown acceptable internal consistency and good test-retest reliability and has good ecological validity. The Snaith-Hamilton Pleasure Scale (SHAPS; ) is a 14-item measure of hedonic capacity within the past few days. Items are rated either Strongly Disagree, Disagree, Agree, or Strongly Agree. If a participant responds to either Disagree category they receive a score of 1, and if either of the Agree categories they receive a score of 0. Hence, the scale total range is 0 to 14, with higher scores representing greater anhedonia. Example items include "I would enjoy a warm bath or a refreshing shower" and "I would be able to enjoy a beautiful landscape or view." The SHAPS has shown high internal consistency, convergent and discriminant validity, and test-retest reliability in clinical and non-clinical populations    .