Behavioural Activation for Low Mood in Multiple Sclerosis

NCT03935529 | Completed

• 1 other identifier: 181001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Secondary-progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change in depression: Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983

  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.

  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

Secondary Outcomes (3)

• Changes to fatigue: Modified Fatigue Impact Scale; Vickrey et al., 1995

  Baseline, Week 6, Week 12

• Changes to quality of life: Health Status Questionnaire Short form version 2. SF-12v2; Ware, Kosinski, & Keller, 1996

  Baseline, Week 6, Week 12

• Changes in behaviour associated with depression: The Behavioural Activation for Depression Scale Short Form

  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

Other Outcomes (2)

• Changes in depression during baseline phase: The Patient Health Questionnaire 2; Kroenke, Spitzer, & Williams, 2003

  Day 1, day 3, day 5, day 7, day 9, day 11, day 13, day 15

• Changes to valued living: The Engaged Living Scale; Trompetter et al., 2013

  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

Study Arms (1)

Behavioural Acitivation

EXPERIMENTAL

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

Interventions

Behavioural Activation BEHAVIORAL

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.

Behavioural Acitivation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Lincoln: lead
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (1)

Nottingham University Hospitals - Queens Medical Centre

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Depression; Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nima Moghaddam, PhD

  University of Lincoln

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multiple Single Case Experimental Design

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: May 2, 2019
• Study Start: March 4, 2019
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: June 11, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)