Jane Fossey1, Georgina Charlesworth2, Jo-Ann Fowler3, Elena Frangou4, Theo John Pimm5, June Dent6, Joanne Ryder7, Amanda Robinson8, Robert Kahn9, Dag Aarsland10, James Pickett11, Clive Ballard12. 1. Fulbrook Centre, Oxford Health NHS Foundation Trust, Oxford, United Kingdom; University of Exeter Medical School, Exeter, United Kingdom. 2. Research and Development, North East London NHS Foundation Trust, Ilford, United Kingdom; Clinical, Educational and Health Psychology, University College London, London, United Kingdom. 3. Fulbrook Centre, Oxford Health NHS Foundation Trust, Oxford, United Kingdom. 4. Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom; MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London, United Kingdom. 5. Whiteleaf Centre, Oxford Health NHS Foundation Trust, Aylesbury, United Kingdom. 6. Warneford Hospital, Oxford Health NHS Foundation Trust, Oxford, United Kingdom; Oxford VR, Oxford Centre for Innovation, Oxford, United Kingdom. 7. Warneford Hospital, Oxford Health NHS Foundation Trust, Oxford, United Kingdom. 8. TalkingSpace Plus, Oxford Health NHS Foundation Trust, Oxford, United Kingdom. 9. Alzheimer's Society Research Network Volunteer, Warrington, United Kingdom. 10. Wolfson Centre for Age Related Diseases, Kings College London, United Kingdom. 11. Alzheimer's Society UK, London, United Kingdom. 12. University of Exeter Medical School, Exeter, United Kingdom. Electronic address: cb723@exeter.ac.uk.
Abstract
OBJECTIVES: To compare online cognitive-behavioral therapy (CBT) with and without telephone support respectively to online psychoeducation in a randomized controlled trial (RCT) in caregivers of people with dementia with mild anxiety or depression. DESIGN: Three-arm parallel-group RCT comparing online CBT with and without telephone support respectively to online psychoeducation. SETTING AND PARTICIPANTS: Online study with caregivers of people with dementia. MEASURES: The primary outcome measure was mental health measured by General Health Questionnaire-12 (GHQ-12) at 26 weeks. Secondary outcomes included the Hospital Anxiety and Depression Scale (HADS); the Relative Stress Scale (RSS) and the Short Sense of Competency Questionnaire. The primary analysis focused on people completing GHQ-12 at both baseline and 26 weeks, evaluated using analysis of covariance. RESULTS:638 people were randomized to the 3 treatment arms, of whom 208 were included in the analysis population. There were significant improvements in GHQ-12 in all treatment arms compared to baseline (P < .001 for all interventions), but neither CBT with nor without telephone support conferred any significant advantage compared to psychoeducation. For the secondary outcomes, there were no significant differences between CBT with telephone support and psychoeducation, but CBT without telephone support was less effective than psychoeducation with respect to HADS depression subscale [mean difference 1.86, 95% confidence interval (CI) 0.61, 3.11; P = .004] and caregiver stress (RSS mean difference 3.11, 95% CI 0.13, 6.09; P = .04). Good safety was achieved in all 3 treatment arms, with no deaths or serious adverse events. CONCLUSIONS AND IMPLICATIONS: Online CBT with telephone support and psychoeducation both achieved significant benefits over 26 weeks compared with baseline in mental health and mood, but there were no advantages for CBT compared with the psychoeducation intervention. CBT without telephone support was less effective with respect to mood outcomes than psychoeducation and should not be recommended based on current evidence.
RCT Entities:
OBJECTIVES: To compare online cognitive-behavioral therapy (CBT) with and without telephone support respectively to online psychoeducation in a randomized controlled trial (RCT) in caregivers of people with dementia with mild anxiety or depression. DESIGN: Three-arm parallel-group RCT comparing online CBT with and without telephone support respectively to online psychoeducation. SETTING AND PARTICIPANTS: Online study with caregivers of people with dementia. MEASURES: The primary outcome measure was mental health measured by General Health Questionnaire-12 (GHQ-12) at 26 weeks. Secondary outcomes included the Hospital Anxiety and Depression Scale (HADS); the Relative Stress Scale (RSS) and the Short Sense of Competency Questionnaire. The primary analysis focused on people completing GHQ-12 at both baseline and 26 weeks, evaluated using analysis of covariance. RESULTS: 638 people were randomized to the 3 treatment arms, of whom 208 were included in the analysis population. There were significant improvements in GHQ-12 in all treatment arms compared to baseline (P < .001 for all interventions), but neither CBT with nor without telephone support conferred any significant advantage compared to psychoeducation. For the secondary outcomes, there were no significant differences between CBT with telephone support and psychoeducation, but CBT without telephone support was less effective than psychoeducation with respect to HADS depression subscale [mean difference 1.86, 95% confidence interval (CI) 0.61, 3.11; P = .004] and caregiver stress (RSS mean difference 3.11, 95% CI 0.13, 6.09; P = .04). Good safety was achieved in all 3 treatment arms, with no deaths or serious adverse events. CONCLUSIONS AND IMPLICATIONS: Online CBT with telephone support and psychoeducation both achieved significant benefits over 26 weeks compared with baseline in mental health and mood, but there were no advantages for CBT compared with the psychoeducation intervention. CBT without telephone support was less effective with respect to mood outcomes than psychoeducation and should not be recommended based on current evidence.