MAPLES Pilot Study for Low Mood in ABI

Study Overview
=================
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.

Official Title
-----------------
Mood, Activity Participation, and Leisure Engagement Satisfaction (MAPLES): A Pilot Feasibility Study for Low Mood in Acquired Brain Injury

Conditions
-----------------
Acquired Brain Injury, Depression

Intervention / Treatment
-----------------
* Behavioral: Activity Planning Group
* Behavioral: Activity Engagement Group
* Behavioral: Waitlist Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a diagnosis of an acquired brain injury (e.g., traumatic brain injury, stroke) Speak and comprehend English Are a minimum of 3 months post-acquired brain injury Are identified as having low mood. Low mood will be identified by either: A score of at least 7 on the depression subscale of the Hospital Anxiety and Depression Scale, indicating clinically significant levels of depression, or 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: Are incapable of attending to and/or understanding the intervention materials (i.e., severe cognitive disability) Have a diagnosis of dementia or other neurodegenerative disorder Unstable psychotropic medication (i.e., have recently started/recently changed medications) 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Activity Planning Group<br>Those in the Activity Planning group receive training and practice in identifying realistic and safe activities in everyday life that may be enjoyable or rewarding to complete. They gain practice in scheduling activities and identifying and overcoming barriers to completion, such as memory problems, avoidance, sticking to habitual patterns and physical and transport issues. The intervention will consist of weekly 1 hour group sessions over 8 weeks, as below: Introduction to Group Therapy Identifying Enjoyable Activities The Automatic Pilot and Planning Pleasurable Activities Goal Review and Balancing Enjoyable and Routine Activities Identifying Solutions to Goal Attainment Increasing Mastery and Managing Fatigue Active Approaches to Engagement Relapse Prevention | Behavioral: Activity Planning Group<br>* Participants in this group will receive 8 1-hour sessions of Behavioural Activation combined with select Goal Management Training strategies over the course of 8 weeks.<br>|
| Experimental: Activity Engagement Group<br>Individuals randomised to this arm will meet weekly for 8 weeks for 1 hour and engage in various potentially rewarding and meaningful social activities such as board games, crafting, and puzzles. Participants in this group will not receive specific training on activity scheduling or overcoming barriers to activity participation. Rather the aim is that participants gain experience of positive reinforcement from the activities and that this explicitly or implicitly challenges potentially negative predictions about such situations and encourages generalised increases in positive activity beyond the group setting. The group will cover activities such as board games, t-shirt making, puzzles, painting, pub quizzes, figurine painting, origami/paper-craft, and clay sculptures. | Behavioral: Activity Engagement Group<br>* Participants in this group will attend 8 1-hour sessions of various social activities such as board games and puzzles.<br>|
| Placebo Comparator: Waitlist Group<br>In consenting to the study, individuals understand that access to groups cannot always be immediate. In the design we take advantage of this by completing the outcome measures before and after an 8-week period in participants randomized to this condition. We do not ask participants in any condition to discontinue any clinical services that they currently receive, hence the waitlist forms a treatment as usual control arm against which to judge and effects of the two groups. At the end of the waitlist the participants will be invited to take part in the Activity Planning or Activity Engagement Group depending upon their initial randomisation.. | Behavioral: Waitlist Group<br>* Participants in this group will continue on their care as usual before being re-randomised into either the Activity Planning Group or Activity Engagement Group after 8 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioural Activation for Depression Scale (BADS; Kanter et al., 2007) | This measure assesses changes in activity level related to depression. It consists of four subscales, Activation (engaging in meaningful activities) and Avoidance/Rumination (avoiding meaningful activities), Work/School impairment, and Social Impairment. To score the BADS, items from all scales other than the Activation scale are reverse-coded and then all items are summed. To score the subscales, no items are reverse-coded. For the total scale, higher scores represent increased activation, while for the Social Impairment subscale, higher scores represent increased social impairment. The minimum possible score on the BADS is 0, while the maximum possible is 150. | Baseline, 1 week post-intervention, 1 month post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983) | This measure assesses levels of depression (subscale 1) and anxiety (subscale 2) in clinical settings. Each subscale is scored independently. On each subscale, each item is summed with no reverse-coded items. Greater scores on either subscale represent greater depression or anxiety. The minimum possible score on each subscale is 0, while the maximum possible score on each subscale is 21. Higher scores indicate greater depression and anxiety. | Baseline, 1 week post-intervention, 1 month post-intervention | 
| Behavioural Inhibition/Behavioural Activation Scales (BIS/BAS; Carver & White 1994) | This measures assesses individual disposition toward avoiding and engaging in activities. The BIS/BAS has three behavioural activation (BA) subscales, and only one subscale assesses behavioural inhibition (BI). The BA subscales are Drive, Fun Seeking, and Reward Responsiveness. All items except for two are reverse coded. Four items are filler questions and are not used for the subscale scores. Once the appropriate questions are reverse coded, each subscale is summed to get the respective subscale scores. The minimum score on BA Drive is 4, maximum 16. Higher scores indicate greater drive to engage. The minimum score on the BA Fun Seeking subscale is 4, maximum 16. Higher scores indicate greater fun seeking. The minimum score on the BA Reward Responsiveness subscale is 5, maximum 20. Higher scores indicate greater reward responsiveness.The minimum score on the BI subscale is 7, maximum 28. Greater scores indicate greater behavioural inhibition. | Baseline, 1 week post-intervention, 1 month post-intervention | 
| Intolerance of Uncertainty Scale-Short Form (IUS-SF; Carleton, Norton, & Asmundson) | This measure assesses the degree to which an individual is bothered by uncertainty. The IUS-SF has two subscales, Prospective Anxiety (concerns about the future), and Inhibitory (concerns prevent one from doing things). The items on the subscale are summed. No items are reverse-coded. A total score can be produced from combining two subscales. The minimum score on the Prospective Anxiety subscale is 5, maximum 25. Greater scores indicate greater prospective anxiety. The minimum score on the Inhibitory Anxiety subscale is 7, maximum 35. Greater scores indicate greater inhibitory anxiety. | Baseline, 1 week post-intervention, 1 month post-intervention | 
| Impact of Events Scale-Revised (IES-R, Weiss, 2007) | This measure assesses acute and routine life stress. The IES-R has three subscales, Avoidance (not thinking of stressful events), Intrusion (whether memories of stressful events occur) and Hyperarousal (The degree to which stressful events cause somatic symptoms). No items are reverse-coded. Although each subscale can produce a score, typically the total score is summed to determine the level of impact a stressful event has had on an individual. The items on the subscale are summed, ranging from 0 to 88. Scores 24 or higher indicate cause for clinical concern, 33 represents a probably diagnosis of post-traumatic stress disorder, and 37 is high enough to suppress immune function (i.e., severe clinical concern). | Baseline, 1 week post-intervention, 1 month post-intervention | 
| Brain Injury Rehabilitation Trust Motivation Questionnaire-Self (BMQ-S) | This measure assesses difficulties with overall motivation after brain injury. The scale has no subscales, and has 15 reverse-scored items. Once the appropriate questions are reverse scored, all items are summed to generate a total score. The minimum possible score is 34, maximum 136. Greater scores indicate greater difficulties with motivation. | Baseline, 1 week post-intervention, 1 month post-intervention | 
| Modified Outcome Measure - Participation Objective, Participation Subjective (MOM-POPS, Brown et al., 2004) | This is a modified measure of desired and actual participation in home and community activities. The scale contains 3 items, asking participants to rate their involvement in, frequency of, and importance of household, occupational, and social activities. Participants are then asked to check off which activities they have engaged in the past week, such as cleaning the house, made social arrangements, attended religious services, etc. Each item is scored individually, hence there is no score total. The first 3 items represent desired participation in daily activities, and the final item represents actual participation. | Baseline, 1 week post-intervention, 1 month post-intervention | 
| Sense of Control Scale (SCS; Lachman & Weaver, 1998a, 1998b) | This measure assesses perceived ability to exert control over one's life. It consists of two subscales, Perceived Constraints (i.e., whether there are barriers to control) and Perceived Mastery (one's subjective belief about their competency in one's life). All items on the perceived constraints scale are reverse coded. Each subscale is summed and interpreted independently. The minimum possible score on the Perceived Constraints scale is 8, maximum 56. Greater scores indicate more constraints.The minimum possible score on the Perceived Mastery subscale is 4, maximum 28. Greater scores indicate greater mastery. | Baseline, 1 week post-intervention, 1 month post-intervention | 
| Motivation for Traumatic Brain Injury Rehabilitation Questionnaire (MOT-Q; Chervinsky et al., 1998) | This scale assesses level of motivation toward rehabilitation-related activities in traumatic brain injury. It consists of 4 subscales, Lack of Denial (good insight), Interest in Rehabilitation, Lack of Anger, and Reliance on Professional Help. The MOT-Q uses a 5-point Likert scale from -2 to +2. The scale contains 19 reverse coded items. Each subscale is totaled separately, and can be added together to produce a total score. Higher scores indicate greater motivation for rehabilitation. Total scores can range from -62 to +62. The Lack of Denial subscale ranges from -16 to +16, with higher scores indicating better insight. The Interest in Rehabilitation subscale ranges from -14 to +14, with greater scores indicating greater interest. The Lack of Anger scubscale ranges from -20 to +20, with higher scores indicating lower anger. The Reliance on Professional Help subscale ranges from -12 to +12, with higher scores indicating greater reliance. | Baseline, 1 week post-intervention, 1 month post-intervention | 
| Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000) | This scale assesses participant expectations of treatment outcome and perceived credibility of treatment. It consists of 6 items. The first 4 items reflect what one think about the intervention, and the last 2 items evaluate how one feels about the intervention. This measure has two factors, Credibility and Expectancy. The Credibility subscale ranges from 3 to 27. Two items on the Expectancy subscale are perecentage based (0 to 100%) and the third item is Likert based from 1 to 9. Typically, items are evaluated individually rather than produce a scale total | Baseline only | 
| Snaith Hamilton Pleasure Scale (SHAPS; Snaith et al., 1995) | This scale assesses level of ability to experience pleasure in day-to-day activities. It consists on 14 items, with 7 items reverse coded. Greater scores indicate greater ability to experience pleasure in daily activities. Once the appropriate items are reverse-coded, all items are summed. The minimum possible score is 14, maximum 56. | Baseline, 1 week post-intervention, 1 month post-intervention | 
| Fatigue Severity Scale (FSS; Krupp et al., 1989) | This scale assess overall levels of fatigues in patient populations within the past week. It consists of 7 Likert-rated items and one visual analogue scale for participants to rate overall fatigue. Greater scores indicate higher levels of fatigue. The minimum possible score is 7, maximum 49. | Baseline, 1 week post-intervention, 1 month post-intervention | 
| Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006) | This scale measures symptoms of generalized anxiety disorder such as excessive worry and irritability, over the past two weeks. It consists of 8 items, with greater scores indicating greater anxiety. The minimum possible score is 0, and the highest possible score is 24. | Baseline, 1 week post-intervention, 1 month post-intervention | 
| Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001) | This scale measures symptoms of depression such as poor appetite or difficulties concentrating, over the past two weeks. It consists of 8 items, with greater scores indicating greater anxiety. The minimum possible score is 0, and the highest possible score is 24. | Baseline, 1 week post-intervention, 1 month post-intervention | 
| Verbal and Spatial Reasoning Test (VESPAR; Langdon & Warrington, 1995) | This neuropsychological assessment measures fluid intelligence in neurological patients. It consists of 3 verbal and 3 spatial reasoning tasks, designed to calculate an individual's IQ. | Baseline only | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acquired brain injury, traumatic brain injury, depression, rehabilitation, executive function