MAPLES Pilot Study for Low Mood in ABI

NCT03874650 | Completed

• 1 other identifier: 2026112018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Acquired Brain Injury; Depression

Keywords

acquired brain injury; traumatic brain injury; depression; rehabilitation; executive function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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

Study Arms (3)

Activity Planning Group

EXPERIMENTAL

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

Activity Engagement Group

EXPERIMENTAL

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

Waitlist Group

PLACEBO COMPARATOR

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

Interventions

Activity Planning Group BEHAVIORAL

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.

Activity Planning Group

Activity Engagement Group BEHAVIORAL

Participants in this group will attend 8 1-hour sessions of various social activities such as board games and puzzles.

Activity Engagement Group

Waitlist Group BEHAVIORAL

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.

Waitlist Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Cambridge: lead

Study Sites (2)

Cambridgeshire Community Services

Cambridge, Cambs, CB4 1PX, United Kingdom

Location

Cambridge University Hospitals NHS Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Related Publications (27)

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• Carver CS, White TL. Behavioural inhibition, behavioural activation, and affective responses to impending reward and punishment: The BIS/BAS scales. J Pers Soc Psychol, 67, 319-333, 1994.

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• Raes F, Hoes D, Van Gucht D, Kanter JW, Hermans D. The Dutch version of the Behavioral Activation for Depression Scale (BADS): psychometric properties and factor structure. J Behav Ther Exp Psychiatry. 2010 Sep;41(3):246-50. doi: 10.1016/j.jbtep.2010.02.001. Epub 2010 Feb 10.

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• Levine B, Robertson IH, Clare L, Carter G, Hong J, Wilson BA, Duncan J, Stuss DT. Rehabilitation of executive functioning: an experimental-clinical validation of goal management training. J Int Neuropsychol Soc. 2000 Mar;6(3):299-312. doi: 10.1017/s1355617700633052.

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• Mazzucchelli T, Kane R, Rees CS. Behavioural activation treatments for depression in adults: A meta-analysis and review. Clin Psychol-Sci Pr 16(4): 383-411, 2009.

  BACKGROUND

• McDonald S, Tate R, Togher L, Bornhofen C, Long E, Gertler P, Bowen R. Social skills treatment for people with severe, chronic acquired brain injuries: a multicenter trial. Arch Phys Med Rehabil. 2008 Sep;89(9):1648-59. doi: 10.1016/j.apmr.2008.02.029.

  PMID: 18760150 BACKGROUND

• Medley AR, Powell T. Motivational Interviewing to promote self-awareness and engagement in rehabilitation following acquired brain injury: A conceptual review. Neuropsychol Rehabil. 2010 Aug;20(4):481-508. doi: 10.1080/09602010903529610. Epub 2010 Feb 1.

  PMID: 20182952 BACKGROUND

• Oddy M, Cattran C, Wood R. The development of a measure of motivational changes following acquired brain injury. J Clin Exp Neuropsychol. 2008 Jul;30(5):568-75. doi: 10.1080/13803390701555598.

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• Richards DA, Ekers D, McMillan D, Taylor RS, Byford S, Warren FC, Barrett B, Farrand PA, Gilbody S, Kuyken W, O'Mahen H, Watkins ER, Wright KA, Hollon SD, Reed N, Rhodes S, Fletcher E, Finning K. Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial. Lancet. 2016 Aug 27;388(10047):871-80. doi: 10.1016/S0140-6736(16)31140-0. Epub 2016 Jul 23.

  PMID: 27461440 BACKGROUND

• Roozenbeek B, Maas AI, Menon DK. Changing patterns in the epidemiology of traumatic brain injury. Nat Rev Neurol. 2013 Apr;9(4):231-6. doi: 10.1038/nrneurol.2013.22. Epub 2013 Feb 26.

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• Teasell R, Bayona N, Marshall S, Cullen N, Bayley M, Chundamala J, Villamere J, Mackie D, Rees L, Hartridge C, Lippert C, Hilditch M, Welch-West P, Weiser M, Ferri C, McCabe P, McCormick A, Aubut JA, Comper P, Salter K, Van Reekum R, Collins D, Foley N, Nowak J, Jutai J, Speechley M, Hellings C, Tu L. A systematic review of the rehabilitation of moderate to severe acquired brain injuries. Brain Inj. 2007 Feb;21(2):107-12. doi: 10.1080/02699050701201524.

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• Kusec A, Murphy FC, Peers PV, Bennett R, Carmona E, Korbacz A, Lawrence C, Cameron E, Bateman A, Watson P, Allanson J, duToit P, Manly T. Mood, Activity Participation, and Leisure Engagement Satisfaction (MAPLES): results from a randomised controlled pilot feasibility trial for low mood in acquired brain injury. BMC Med. 2023 Nov 16;21(1):445. doi: 10.1186/s12916-023-03128-7.

  PMID: 37974189 DERIVED

• Kusec A, Murphy FC, Peers PV, Lawrence C, Cameron E, Morton C, Bateman A, Watson P, Manly T. Mood, Activity Participation, and Leisure Engagement Satisfaction (MAPLES): a randomised controlled pilot feasibility trial for low mood in acquired brain injury. Pilot Feasibility Stud. 2020 Sep 22;6:135. doi: 10.1186/s40814-020-00660-8. eCollection 2020.

  PMID: 32974044 DERIVED

MeSH Terms

Conditions

Brain Injuries; Depression; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavioral Symptoms; Behavior

Study Officials

• Tom Manly, PhD

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Programme Leader

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 14, 2019
• Study Start: May 20, 2019
• Primary Completion: April 27, 2021
• Study Completion: April 27, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The study protocol and statistical analysis plan will be made available upon registration of the trial, along with publication of the trial protocol. This is expected to occur before May 2019. Analytic code will be made available upon publication of the study results, approximately 1 year following the completion of the trial (February 2022).
• Access Criteria: The study protocol, statistical analysis plan, and analytic code will be available to any interested party.

Locations

GB (2)