Mood, Activity Participation, and Leisure Engagement Satisfaction (MAPLES): A Pilot Feasibility Study for Low Mood in Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Behavioural Activation for Depression Scale (BADS; Kanter et al., 2007)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Given that this is a psychological assessment, it is not possible to mask the participant, care provider, or investigator. Hence, only the outcomes assessor will be masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Waitlist Group
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..
干预措施: Waitlist Group (Behavioral)
Activity Planning Group
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
干预措施: Activity Planning Group (Behavioral)
Activity Engagement Group
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.
干预措施: Activity Engagement Group (Behavioral)
结局指标
主要结局
Behavioural Activation for Depression Scale (BADS; Kanter et al., 2007)
时间窗: Baseline, 1 week post-intervention, 1 month post-intervention
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.
次要结局
- Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)(Baseline, 1 week post-intervention, 1 month post-intervention)
- Behavioural Inhibition/Behavioural Activation Scales (BIS/BAS; Carver & White 1994)(Baseline, 1 week post-intervention, 1 month post-intervention)
- Intolerance of Uncertainty Scale-Short Form (IUS-SF; Carleton, Norton, & Asmundson)(Baseline, 1 week post-intervention, 1 month post-intervention)
- Impact of Events Scale-Revised (IES-R, Weiss, 2007)(Baseline, 1 week post-intervention, 1 month post-intervention)
- Brain Injury Rehabilitation Trust Motivation Questionnaire-Self (BMQ-S)(Baseline, 1 week post-intervention, 1 month post-intervention)
- Modified Outcome Measure - Participation Objective, Participation Subjective (MOM-POPS, Brown et al., 2004)(Baseline, 1 week post-intervention, 1 month post-intervention)
- Sense of Control Scale (SCS; Lachman & Weaver, 1998a, 1998b)(Baseline, 1 week post-intervention, 1 month post-intervention)
- Motivation for Traumatic Brain Injury Rehabilitation Questionnaire (MOT-Q; Chervinsky et al., 1998)(Baseline, 1 week post-intervention, 1 month post-intervention)
- Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)(Baseline only)
- Snaith Hamilton Pleasure Scale (SHAPS; Snaith et al., 1995)(Baseline, 1 week post-intervention, 1 month post-intervention)
- Fatigue Severity Scale (FSS; Krupp et al., 1989)(Baseline, 1 week post-intervention, 1 month post-intervention)
- Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006)(Baseline, 1 week post-intervention, 1 month post-intervention)
- Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001)(Baseline, 1 week post-intervention, 1 month post-intervention)
- Verbal and Spatial Reasoning Test (VESPAR; Langdon & Warrington, 1995)(Baseline only)
研究者
Tom Manly
Programme Leader
University of Cambridge