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Behavioural Activation for Low Mood in Multiple Sclerosis (BALMS)

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ClinicalTrials.gov Identifier: NCT03935529
Recruitment Status : Completed
First Posted : May 2, 2019
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
Nottingham University Hospitals NHS Trust
Information provided by (Responsible Party):
University of Lincoln

Brief Summary:

Title: Behavioural Activation for Low mood in Multiple Sclerosis The study will be sponsored by the University of Lincoln, indemnity will be provided by U M Association Limited.

Depression is highly prevalent among people with Multiple Sclerosis (MS). More specifically, as the disease progresses, people are more likely to develop depression and there is limited evidence of suitable interventions in this group. There are few studies that investigate the most appropriate duration, delivery modality, or individual adaptations for therapy for people with secondary progressive Multiple Sclerosis. This is problematic because continued reduction in physical and cognitive ability, combined with greater incidence of depression, may make accessing and engaging in therapies difficult.

Behavioural activation is a technique used as a component of psychotherapy. Behavioural activation aims to reduce behaviours that maintain or exacerbate depression by promoting counteracting behaviours, using strategies such as activity monitoring and scheduling.

However, there is no research looking in-depth at the underlying processes. Therefore, this research aims to explore the feasibility and efficacy of behavioural activation by:

  • Adapting an existing behavioural activation manual into five sessions, suitable for people with secondary progressive MS.
  • Examining if behavioural activation is followed by phases of change that are considered to predict later therapeutic outcome and to determine whether behavioural activation accounts for changes observed.

Up to ten participants from Nottingham University Hospitals will be recruited. Participants will be briefed on the research aims and consent will be obtained before commencing the intervention. The project will follow a multiple baseline single-case experimental design. Participants will complete weekly outcome measures that aim to observe low mood, quality of life, and adherence to behavioural activation and alignment with individual's values. Following five to six contact sessions, participants will take part in a follow-up interview. Participants will then be debriefed.


Condition or disease Intervention/treatment Phase
Depression Secondary-progressive Multiple Sclerosis Behavioral: Behavioural Activation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Multiple Single Case Experimental Design
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Behavioural Activation for Low Mood in Multiple Sclerosis
Actual Study Start Date : March 4, 2019
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Behavioural Acitivation
Behavioural Activation. Originally a component of cognitive behavioural therapy, Behavioural Activation is a structured psychotherapeutic approach which aims to (a) increase engagement in activities associated with pleasure or mastery, (b) decrease engagement in activities that maintain depression, and (c) problem solve barriers limiting access to reward or maintain aversive control. Behavioural Activation involves the use of activities to improve life situations or depressed mood.
Behavioral: Behavioural Activation

Participants will receive five sessions of Behavioural Activation. Behavioural Activation uses strategies such as activity scheduling, mastery and pleasure ratings, and graded task assignments to change a participant's perception of specific situations.

Behavioural Activation is based on the behavioural model of depression (Lewinsohn & Shaffer, 1971). Specifically, that depression is a result of reduced positive reinforcement, particularly in social relationships. Behavioural Activation aims to reduce depressive symptoms by implementing a schedule of positive reinforcement by altering a participant's behaviour and/or their environment. As, in certain environmental contexts, behaviours that reduce depression will continue to occur through reinforcement and those that increase depression will decrease over time (Roane, Fisher, & Carr, 2016).

Behavioural Activation has been shown to be an effective intervention for the reduction of depressed mood.





Primary Outcome Measures :
  1. Change in depression: Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983 [ Time Frame: Screening, Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12 ]
    Measures changes to anxiety and depression over the last one week. The questionnaire is comprised of two scales (anxiety and depression). Each scale has 7 questions, asking participants to rate between 0-3. The questions for each scale are totalled to produce an overall score between 0-21. Higher scores indicate increased severity of anxiety or depression.


Secondary Outcome Measures :
  1. Changes to fatigue: Modified Fatigue Impact Scale; Vickrey et al., 1995 [ Time Frame: Baseline, Week 6, Week 12 ]
    Measures changes to fatigue. The modified fatigue impact scale is a modified form of the Fatigue Impact Scale (Fisk et al, 1994b) based on items derived from interviews with Multiple Sclerosis patients concerning how fatigue impacts their lives. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. Assess the effects of fatigue on quality of life in patients with chronic diseases. Total number of questions 5, asking participants to reflect over the last 4 weeks. The modified fatigue impact scale total score consists of the sum of the raw scores on these 5 items, and thus, can range from 0-20. Higher scores indicate a greater impact of fatigue on a patient's activities.

  2. Changes to quality of life: Health Status Questionnaire Short form version 2. SF-12v2; Ware, Kosinski, & Keller, 1996 [ Time Frame: Baseline, Week 6, Week 12 ]
    Measures changes to quality of life. Addresses health concepts from the patient's perspective over 8 domains. The survey uses norm-based scoring

  3. Changes in behaviour associated with depression: The Behavioural Activation for Depression Scale Short Form [ Time Frame: Day 1, day 3, day 5, day 7, day 9, day 11, day 13, day 15, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12 ]
    Measures changes in behaviours that underlie depression. Track weekly changes in behaviours that underlie depression and that are specifically targeted for change by Behavioural Activation. Asks 9 questions using a 0-6 scale, comprised of 3 subscales. To score, 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. This process allows high scores on the total scale and the subscales to be represented by the scale and subscale names. In other words, for the total scale, higher scores represent increased activation, while for the Social Impairment subscale, higher scores represent increased social impairment.


Other Outcome Measures:
  1. Changes in depression during baseline phase: The Patient Health Questionnaire 2; Kroenke, Spitzer, & Williams, 2003 [ Time Frame: Day 1, day 3, day 5, day 7, day 9, day 11, day 13, day 15 ]
    Measures changes to depression. The Patient Health Questionnaire 2 (PHQ2; Kroenke, Spitzer, & Williams, 2003) a two-item questionnaire will be administered every-other-day, during the baseline phase (up to 4 weeks), to establish a baseline for the primary outcome variable of interest (depression). As no higher frequency measure exists questions will be adapted to ask 'over the last two days.' To overcome the impact of adapting the measure, outcome measures such as the Hospital Anxiety and Depression Scale, will be used on a weekly basis.

  2. Changes to valued living: The Engaged Living Scale; Trompetter et al., 2013 [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12 ]
    Measures alignment to values. The scale will be used to identify alignment to values, this will allow us to understand the impact of values-based action. The scale is comprised of 16 items using a 5-point Likert scale. The scale has 2 subscales, Valued Living (10 items) and Life Fulfillment (6 items). Higher scores indicate participants are more aligned to their values.



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:

  • Clinical diagnosis of Secondary Progressive Multiple Sclerosis
  • Must speak English
  • Must have capacity to give consent
  • Must have a telephone
  • Must have access to the internet
  • Must be able to use a computer
  • Must score ≥ 8 on the Hospital Anxiety and Depression Scale - depression subscale

Exclusion Criteria:

• Receiving psychological therapy for a pre-existing mood problem.


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): NCT03935529


Locations
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United Kingdom
Nottingham University Hospitals - Queens Medical Centre
Nottingham, United Kingdom
Sponsors and Collaborators
University of Lincoln
Nottingham University Hospitals NHS Trust
Investigators
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Principal Investigator: Nima Moghaddam, PhD University of Lincoln
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Responsible Party: University of Lincoln
ClinicalTrials.gov Identifier: NCT03935529    
Other Study ID Numbers: 181001
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases