Clinical Trials

Examining the efficacy of an Online Cognitive Behaviour Therapy (CBT) – based self-management Program for Adults with Neurological Disorders

Type of Study/Intervention

Interventional

Recruitment Status

Recruiting

Form of MS

Relapsing remitting MS, secondary progressive MS, primary progressive MS

Brief summary

The purpose of the proposed project is to examine the acceptability and efficacy of a low-intensity CBT-based self-management program, the Wellbeing Neuro Course to support the emotional wellbeing of adults with neurological disorders. The Course contains a 6-lesson 10-week internet delivered program. Participants will have brief weekly contact with a psychologist as they work through the Course.

A two-group CONSORT-R Compliant randomised controlled trial (RCT) design will be employed, where participants are randomised to one of two groups:

1. Treatment Group (n = 100)
2. Waitlist Control Group (n = 100)

Participants in the Active Treatment Group will receive full access to the Wellbeing Neuro Course. Participants are asked to complete standardised questionnaires at 4 main time points: Pre-treatment, mid-treatment, post-treatment, and 3-month follow-up. The Waitlist Control Group will receive the same treatment after the Active Treatment Group has completed the 10-week Course.

Inclusion criteria

Inclusion criteria include: (a) Diagnosis of Multiple Sclerosis, Epilepsy, Parkinson’s Disease, Stroke, Traumatic Brain Injury or Acquired Brain Injury by a GP or specialist (b) reporting that the neurological disorder affects their cognitive and emotional health, (c) 18+ years of age, (d) Living in Australia, (e) provide informed consent.

Exclusion criteria

Exclusion criteria include: (a) inability to use a computer, (b) very severe depressive symptoms indicative of >25 on the PhQ-9; (c) significant suicidal ideation (i.e., indicated by a score > 2 to Question 9 on the PHQ-9); (d) acutely suicidal or recent history of attempted suicide or self-harm, (e) Not being under medical management for their neurological disorder, (f) serious cognitive impairment (<21 on the Telephone Interview of Cognitive Status; TICS) indicative of dementia.

Anticipated start date

Already started

Recruitment contacts

Dr Milena Gandy
Phone: 0298504152
Email: [email protected]

Region

ACT, NSW, NT, QLD, SA, TAS, WA, VIC

Further details

Information on the course can be viewed here.

Further details can be viewed on the ANZCTR website: ACTRN12620000165987

Ethics approval

Yes

Last updated

02/03/2020

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