'I can't forget to worry': cognitive behavioural therapy (CBT) for anxiety in people with dementia

Completed

• Conditions: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Dementia; Nervous System Diseases; Unspecified dementia

• Registration Number: ISRCTN46521766
• Lead Sponsor: orth East London Foundation Trust (NELFT) (UK)

Brief Summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23092336 2. 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25698766

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-21
• Study Completion: 2013-01-01
• Last Update Posted: 10 December 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Meet DSMIV criteria for dementia in mild to moderate range
2. Clinical Dementia Rating score of 0.5, 1 or 2
3. Clinical anxiety, as determined by a score of 11 or above on the RAID (Rating Anxiety in Dementia)
4. Living in the community
5. The presence of a carer, who is willing to participate in the therapy
6. An ability to understand and communicate in English
7. Willing to engage in therapy involving discussion of thoughts and feelings
8. Male or female

Exclusion Criteria

1. Co-morbid psychiatric disorder (e.g. psychosis) or challenging behaviour (e.g. severe agitation) likely to prevent engagement in therapy, not including anxiety or depression
2. Presence of a learning disability or severe physical illness, which could impact on participation, involving discussions of thoughts and feelings

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Rating Anxiety in Dementia (RAID). This rates signs and symptoms of anxiety using interviews with carers and people with dementia. There are 18 questions in various categories: worry, apprehension, vigilance, motor tension and autonomic hypersensitivity. A score of 11 or above indicates significant clinical anxiety. It has good inter-rater and test-retest reliability, is sensitive to change and correlates with quality of life.<br><br> Measured at baseline, 12 weeks and 6 months.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Cornell Scale for Depression in Dementia at 1, 12 and 24 weeks<br> 2. Hospital Anxiety and Depression Scale (HADS) at 1, 12 and 24 weeks<br> 3. Mini Mental State Examination (MMSE) at 1, 12 and 24 weeks<br> 4. Quality of Caregiver and Patient Relationship (QCPR) at 1, 12 and 24 weeks<br> 5. Quality of Life in Alzheimer's Disease (QOLAD) at 1, 12 and 24 weeks<br>