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MAPLES Pilot Study for Low Mood in ABI (MAPLES)

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ClinicalTrials.gov Identifier: NCT03874650
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Tom Manly, University of Cambridge

Brief Summary:

Low mood and depression are common following acquired brain injury (ABI). We 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.


Condition or disease Intervention/treatment Phase
Acquired Brain Injury Depression Behavioral: Activity Planning Group Behavioral: Activity Engagement Group Behavioral: Waitlist Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Mood, Activity Participation, and Leisure Engagement Satisfaction (MAPLES): A Pilot Feasibility Study for Low Mood in Acquired Brain Injury
Actual Study Start Date : March 8, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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

Behavioral: Activity Planning Group
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.

Experimental: 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.
Behavioral: Activity Engagement Group
Participants in this group will attend 8 1-hour sessions of various social activities such as board games and puzzles.

Placebo Comparator: 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..
Behavioral: Waitlist Group
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.




Primary Outcome Measures :
  1. Behavioural Activation for Depression Scale (BADS; Kanter et al., 2007) [ Time Frame: Baseline, 1 week post-intervention, 1 month post-intervention ]
    Changes in activity level related to depression


Secondary Outcome Measures :
  1. Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983) [ Time Frame: Baseline, 1 week post-intervention, 1 month post-intervention ]
    Levels of depression and anxiety in clinical settings

  2. Behavioural Inhibition/Behavioural Activation Scales (BIS/BAS; Carver & White 1994) [ Time Frame: Baseline, 1 week post-intervention, 1 month post-intervention ]
    Individual disposition toward avoiding and engaging in activities

  3. Intolerance of Uncertainty-Short Form (IUS-SF; Carleton, Norton, & Asmundson) [ Time Frame: Baseline, 1 week post-intervention, 1 month post-intervention ]
    The degree to which an individual is bothered by uncertainty

  4. Impact of Events Scale-Revised (IES-R, Weiss, 2007) [ Time Frame: Baseline, 1 week post-intervention, 1 month post-intervention ]
    Acute and routine life stress

  5. Brain Injury Rehabilitation Trust Motivation Questionnaire-Self (BMQ-S) [ Time Frame: Baseline, 1 week post-intervention, 1 month post-intervention ]
    Difficulties with overall motivation after brain injury

  6. Modified Outcome Measure - Participation Objective, Participation Subjective (MOM-POPS, Brown et al., 2004) [ Time Frame: Baseline, 1 week post-intervention, 1 month post-intervention ]
    Desired and actual participation in home and community activities

  7. Sense of Control Scale (SCS; Lachman & Weaver, 1998a, 1998b) [ Time Frame: Baseline, 1 week post-intervention, 1 month post-intervention ]
    Perceived ability to exert control over one's life

  8. Motivation for Traumatic Brain Injury Rehabilitation Questionnaire (MOT-Q; Chervinsky et al., 1998) [ Time Frame: Baseline, 1 week post-intervention, 1 month post-intervention ]
    Level of motivation toward rehabilitation-related activities

  9. Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000) [ Time Frame: Baseline only ]
    Participant expectations of treatment outcome and perceived credibility of treatment

  10. Snaith Hamilton Pleasure Scale (SHAPS; Snaith et al., 1995) [ Time Frame: Baseline, 1 week post-intervention, 1 month post-intervention ]
    Level of ability to experience pleasure in day-to-day activities



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 client of Cambridgeshire Community Services
  4. Are a minimum of 3 months post-acquired brain injury
  5. 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 within Cambridgeshire Community Services 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. Are currently undergoing or will undergo a psychological intervention for low mood/depression (e.g., CBT) during the timeframe of the trial
  4. Unstable psychotropic medication (i.e., have recently started/recently changed medications)
  5. 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874650


Contacts
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Contact: Andrea Kusec, MSc +44 (0)1223 769720 andrea.kusec@mrc-cbu.cam.ac.uk
Contact: Tom Manly, PhD +44 (0)1223 767666 tom.manly@mrc-cbu.cam.ac.uk

Locations
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United Kingdom
Cambridgeshire Community Services Recruiting
Cambridge, Cambs, United Kingdom, CB4 1PX
Contact: Andrew Bateman    01353652169    andrew.bateman@nhs.net   
Sponsors and Collaborators
University of Cambridge
Investigators
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Principal Investigator: Tom Manly, PhD University of Cambridge
  Study Documents (Full-Text)

Documents provided by Tom Manly, University of Cambridge:

Publications:
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.
Kanter JW, Mulick PS, Busch AM, et al. The Behavioural Activation for Depression Scale (BADS): Psychometric properties and factor structure. J Psychopathol Behav 29(3), 191-202, 2007.
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.

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Responsible Party: Tom Manly, Programme Leader, University of Cambridge
ClinicalTrials.gov Identifier: NCT03874650     History of Changes
Other Study ID Numbers: 2026112018
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Only anonymised participant data from the study will be made accessible to other researchers upon publication of the study results. All data from all measures, including the questionnaires and qualitative interviews, will be made available once the study is completed. As we intend to publish the study as an open access article, all anonymised data will be available potentially indefinitely.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tom Manly, University of Cambridge:
acquired brain injury
traumatic brain injury
depression
rehabilitation
executive function

Additional relevant MeSH terms:
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Wounds and Injuries
Depression
Brain Injuries
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System