Condition category
Mental and Behavioural Disorders
Date applied
07/04/2016
Date assigned
28/04/2016
Last edited
03/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Multiple sclerosis (MS) is one of the most common diseases of the central nervous system (brain and spinal cord). Healthy nerves are coated in a fatty casing (myelin sheath) which helps messages to travel quickly and smoothly along nerves. When a person is suffering from MS, the immune system, which normally helps to protect against infection, attacks the myelin sheath, stripping it from the nerves (demyelination). This demyelination means that messages cannot travel along the nerves effectively, causing a range of disturbances including loss of vision, problems with balance and coordination and weakness in the arms or legs. Depression is very common in people with MS and has been reported to be particularly bad at the time of diagnosis or the early stages of the disease. Cognitive behavioural therapy (BCT) is a type of taking therapy which works by changing the way a person thinks and behaves. There is currently little to no research looking at the effectiveness of CBT in the treatment of depression in the first two years following diagnosis. The aim of this study is to evaluate the effectiveness of an eight week course of tailored CBT for people with MS suffering from depression.

Who can participate?
Adults with MS who are suffering from depression.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in an eight week face to face course of CBT based therapy. His involves weekly sessions lasting for two hours (1.5 hours for the first session), and help to improve quality of life, sleep difficulties, MS illness acceptance, active coping skills, social support and resilience. Those in the second group receive treatment as usual for the duration of the study. At the start of the study and then again after 8 ad 20 weeks, participants in both groups complete a range of questionnaires in order to assess their depressive symptoms and quality of life.

What are the possible benefits and risks of participating?
Participants may benefit from improvement in their depressive symptoms. There are no notable risks involved with taking part in the study.

Where is the study run from?
Royal Melbourne Hospital (Australia)

When is the study starting and how long is it expected to run for?
October 2011 to December 2016

Who is funding the study?
University of Melbourne (Australia)

Who is the main contact?
Dr Litza Kiropoulos

Trial website

Contact information

Type

Public

Primary contact

Dr Litza Kiropoulos

ORCID ID

Contact details

Melbourne School of Psychological Sciences
University of Melbourne
Victoria
Melbourne
3010
Australia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A pilot randomised controlled trial of a tailored cognitive behavioural therapy based intervention for depression in those newly diagnosed with multiple sclerosis

Acronym

Study hypothesis

Primary aim:
To assess the efficacy of a tailored 8-week individualised CBT intervention in the treatment of depressive symptoms in individuals who are within 2 years of a multiple sclerosis diagnosis.

Secondary aim:
To examine improvements in levels of anxiety, fatigue, pain, sleep quality, quality of life, coping, MS illness acceptance and resilience at post and 20 week follow up time points and to evaluate satisfaction and adherence to the tailored intervention.

Ethics approval

Melbourne Health Human Research Ethics Committee 11/10/2011, ref: 2011.112

Study design

Single-centre pilot parallel group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Depression in multiple sclerosis

Intervention

Participants are randomly assigned using a computer generated random numbers table using an allocation ratio of 1: 1 to 1 of the 2 treatment groups.

Intervention group: The tailored intervention is an 8-week face to face cognitive behavioural based intervention aimed at decreasing the level of depression (primary outcome), anxiety, fatigue and pain impact and to contribute to improvements in levels of quality of life, sleep difficulties, MS illness acceptance, active coping skills, social support and resilience (secondary outcomes) in those newly diagnosed with MS. All sessions (apart from the first session which is 1.5 hours) are 1 hour in duration.

Control group: Those allocated to the treatment as usual (TAU) do not obtain any psychological treatment for depression or anxiety for the duration of their involvement in the trial (20 weeks). Individuals receive usual medical care from their neurologist which may include up to 3 visits for medication review during the course of involvement in the current trial.

Participants in both groups are followed up at 8 and 20 weeks.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Level of depression measured with the Beck Depression Inventory-2 at baseline, 8 and 20 weeks.

Secondary outcome measures

1. Level of anxiety measured with the State Trait Anxiety Inventory at baseline, 8 and 20 weeks
2. Level of fatigue impact with the 5-item Modified Fatigue Impact Scale at baseline, 8 and 20 weeks
3. Level of pain impact on mood and behaviour measured with the Pain Effects Scale (PES) at baseline, 8 and 20 weeks
4. Multiple Sclerosis related quality of life measured with the Multiple Sclerosis Quality of Life at baseline, 8 and 20 weeks
5. Sleep quality was measured with the Pittsburgh Sleep Quality Index at baseline, 8 and 20 weeks
6. Coping was measured with the Ways of Coping questionnaire at baseline, 8 and 20 weeks
7. Acceptance of MS illness was measured with the Acceptance of Chronic Health Conditions Scale at baseline, 8 and 20 weeks
8. Level of social support was measured with the Perceived Social Support Scale at baseline, 8 and 20 weeks
9. Level of resilience was measured with the Resilience Scale for Adults at baseline, 8 and 20 weeks
20. Level of therapeutic alliance was measured with the Helping Alliance Questionnaire-Version 2 at 8 weeks
11. Acceptance of the CBT based intervention was measured with a 5-item measure developed by the first author at 8 weeks
12. Patient satisfaction with the CBT intervention was measured with an 18-item Patient Satisfaction Questionnaire designed by the first author at 8 weeks

Overall trial start date

01/10/2011

Overall trial end date

01/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Having a definite diagnosis of MS from a neurologist
2. Scoring at least 10 on the Beck Depression Inventory-2 (BDI-2)
3. Not currently undertaking other psychological treatment for depressive and anxiety symptoms for the length of participation in the current trial
4. Speak English fluently
5. No current or lifetime diagnosis of psychosis
6. No current substance dependency
7. No gross cognitive impairment
8. No changes to medications prior and during involvement in the trial

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. No definite diagnosis of MS by a neurologist
2. Currently undertaking other psychological treatment for depressive and anxiety symptoms
3. Not able to speak English fluently
4. Current or lifetime diagnosis of psychosis
5. Current substance dependency
6. Gross cognitive impairment
7. Changes to medications prior or during involvement in the trial

Recruitment start date

01/10/2013

Recruitment end date

01/10/2014

Locations

Countries of recruitment

Australia

Trial participating centre

Royal Melbourne Hospital
300 Grattan Street
Melbourne
3050
Australia

Sponsor information

Organisation

University of Melbourne

Sponsor details

Melbourne School of Psychological Sciences
Melbourne
3010
Australia

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Melbourne

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Australia

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes