Trial Outcomes & Findings for Cognitive Behavioural Therapy Software for the Treatment of Depression in People With Multiple Sclerosis (NCT NCT00678496)

Results Overview

Beck Depression Inventory II-21 Item (BDI-II) - a self-report measure of severity of symptoms of depression. This is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63 (severe depression). The study reports change from baseline at 21 weeks.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

21 weeks

Results posted on

2021-03-17

Participant Flow

We reached our recruitment target on 30 July 2009 (in 281 days; 2.6 participants/month) after adding a second centre (The Walton Centre National Health Service (NHS) Foundation Trust, Liverpool).

Participants were invited to take part via clinic mailouts. Responders were excluded if their Beck Depression Inventory score was too high, too low, if they were under the care of a psychiatrist, or were not resident within the boundaries of participating primary care trusts (UK NHS commissioning bodies 2001-2013), or if they refused consent.

Participant milestones

Participant milestones
Measure	Computerised CBT Using 'Beating the Blues'® (Ultrasis Ltd) CBT software (n=12). Beating the Blues® consists of eight computer-interactive sessions, of approximately 50 minutes each in duration, designed to be taken weekly.	Treatment as Usual Treatment as usual (n=12). The research protocol did not manualise or restrict treatment as usual, but a client service receipt inventory was used at baseline, 8 weeks and 21 weeks to identify concomitant medication and service use in both arms.
Overall Study STARTED	12	12
Overall Study Completed 8 Weeks Follow-up	9	12
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CBT Software n=12 Participants CBT using 'Beating the Blues'® software (Ultrasis Ltd). Beating the Blues® consists of eight computer-interactive sessions, of approximately 50 minutes each in duration, designed to be taken weekly. Each session consists of a mix of cognitive and behavioural strategies, which the user customises to their individual problems.	Treatment as Usual n=12 Participants Treatment as usual. The research protocol did not manualise or restrict treatment as usual, but a client service receipt inventory was used at baseline, 8 weeks and 21 weeks to identify concomitant medication and service use in both arms.	Total n=24 Participants Total of all reporting groups
Age, Continuous	48 years STANDARD_DEVIATION 7.7 • n=12 Participants	42 years STANDARD_DEVIATION 7.0 • n=12 Participants	45 years STANDARD_DEVIATION 7.9 • n=24 Participants
Sex: Female, Male Female	11 Participants n=12 Participants	7 Participants n=12 Participants	18 Participants n=24 Participants
Sex: Female, Male Male	1 Participants n=12 Participants	5 Participants n=12 Participants	6 Participants n=24 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Expanded Disability Status Scale (EDSS) score	4.8 units on a scale STANDARD_DEVIATION 1.7 • n=12 Participants	3.6 units on a scale STANDARD_DEVIATION 1.8 • n=12 Participants	4.2 units on a scale STANDARD_DEVIATION 1.8 • n=24 Participants
BDI total score (0 weeks)	21 units on a scale STANDARD_DEVIATION 4.0 • n=12 Participants	23 units on a scale STANDARD_DEVIATION 5.2 • n=12 Participants	22 units on a scale STANDARD_DEVIATION 4.7 • n=24 Participants

PRIMARY outcome

Timeframe: 21 weeks

Population: There may be different numbers of patients analysed at 8 weeks and 21 weeks, as patients may have dropped out, or there may have been missing information at 8 weeks meaning that the score could not be calculated, but the patient was still followed up at 21 weeks.

Beck Depression Inventory II-21 Item (BDI-II) - a self-report measure of severity of symptoms of depression. This is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63 (severe depression). The study reports change from baseline at 21 weeks.

Outcome measures

Outcome measures
Measure	CCBT n=10 Participants Ultrasis - Beating the Blues® is a computer-interactive programme for the treatment of anxiety and depression. It is based on cognitive behavioural therapy (CBT), which helps patients to identify and change unhelpful ways of thinking and to learn more effective ways of solving problems.	Treatment as Usual n=12 Participants The research protocol did not manualise or restrict treatment as usual. A client service receipt inventory was used at baseline, 8 weeks and 21 weeks to identify concomitant medication and service use in both arms.
Change in Self-reported Symptoms of Depression, as Measured by Total BDI-II Score 8 weeks	-5.33 units on a scale Standard Deviation 4.7	-1.17 units on a scale Standard Deviation 8.1
Change in Self-reported Symptoms of Depression, as Measured by Total BDI-II Score 21 weeks	-2.00 units on a scale Standard Deviation 5.1	0.25 units on a scale Standard Deviation 8.8

SECONDARY outcome

Timeframe: Eight weeks or on completion of CCBT (whichever is later), and three months thereafter.

Population: There may be different numbers of patients analysed at 8 weeks and 21 weeks, as patients may have dropped out, or there may have been missing information at 8 weeks meaning that the score could not be calculated, but the patient was still followed up at 21 weeks.

The Multiple Sclerosis Impact Scale (MSIS-29) is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates greater impact of disease on daily function (worse health). This study measured the change from baseline at 8 weeks and 21 weeks.

Outcome measures

Outcome measures
Measure	CCBT n=9 Participants Ultrasis - Beating the Blues® is a computer-interactive programme for the treatment of anxiety and depression. It is based on cognitive behavioural therapy (CBT), which helps patients to identify and change unhelpful ways of thinking and to learn more effective ways of solving problems.	Treatment as Usual n=11 Participants The research protocol did not manualise or restrict treatment as usual. A client service receipt inventory was used at baseline, 8 weeks and 21 weeks to identify concomitant medication and service use in both arms.
Change in Disease-specific Quality of Life, Measured on the Multiple Sclerosis Impact Scale-29 Item (MSIS-29) Psychological - 8 weeks	-5.88 units on a scale Standard Deviation 9.5	0.18 units on a scale Standard Deviation 5.1
Change in Disease-specific Quality of Life, Measured on the Multiple Sclerosis Impact Scale-29 Item (MSIS-29) Psychological - 21 weeks	-4.33 units on a scale Standard Deviation 8.0	-2.60 units on a scale Standard Deviation 5.6
Change in Disease-specific Quality of Life, Measured on the Multiple Sclerosis Impact Scale-29 Item (MSIS-29) Physical - 8 weeks	-7.00 units on a scale Standard Deviation 12.9	-1.82 units on a scale Standard Deviation 7.8
Change in Disease-specific Quality of Life, Measured on the Multiple Sclerosis Impact Scale-29 Item (MSIS-29) Physical - 21 weeks	-7.89 units on a scale Standard Deviation 12.3	-2.20 units on a scale Standard Deviation 11.0

Adverse Events

CCBT Using 'Beating the Blues'® (Ultrasis Ltd)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CCBT Using 'Beating the Blues'® (Ultrasis Ltd) n=8 participants at risk CBT software (n=12). Beating the Blues® consists of eight computer-interactive sessions, of approximately 50 minutes each in duration, designed to be taken weekly.	Treatment as Usual n=10 participants at risk Treatment as usual (n=12). The research protocol did not manualise or restrict treatment as usual, but a client service receipt inventory was used at baseline, 8 weeks and 21 weeks to identify concomitant medication and service use in both arms.
Musculoskeletal and connective tissue disorders Broken arm	12.5% 1/8 • Number of events 1	0.00% 0/10

Other adverse events

Adverse event data not reported

Additional Information

Daniel Hind, Assistant Director, Sheffield CTRU

University of Sheffield

Phone: +441142220707

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place