None listed
Conditions
Brief summary
Neuropsychiatric symptoms like depression are common in people with Alzheimer's disease (AD), as are a frequent cause of distress and reduced quality of life. Pharmacological treatments are only modestly effective in treating these symptoms but are largely ineffective for depression people with AD, and are frequently associated with unacceptable side effects. It is therefore essential that we are able to identify safe and easily accessible therapies for these debilitating symptoms. Cognitive bias modification (CBM) is a simple, novel and safe intervention that targets attentional and interpretative biases associated with anxiety and depression. CBM has been shown to be effective in reducing depressive symptoms in younger adults but studies in people with cognitive impairment and their carers are lacking. Our preliminary research has indicated that CBM is well tolerated by people with AD and could be easily accessed at home, making it a potentially invaluable intervention for depression in this population. The aims of this study are to determine the effect of CBM in preventing clinically significant depressive symptoms from occurring in patients with AD. This study will also investigate the impact of CBM on quality of life and cognitive decline, as well as investigating factors that may predict the development of depression in AD. People with AD will be randomly assigned to an active or control CBM intervention group in a double-blind parallel design. The intervention will be conducted over 24 months. Incidence of clinically significant depressive symptoms will be compared between groups across the duration of the trial, and will be the primary outcome of interest. Changes in quality of life, carer burden, and cognitive ability will also be compared between groups across the duration of the trial, and will serve as secondary outcomes of interest. The capacity of demographic, lifestyle, and neurophysiological factors to predict depressive symptom change in AD will also be assessed across participants, and will serve as secondary outcomes of interest. Dementia is a common condition and is frequently associated with a diverse range of neuropsychiatric symptoms, including depression and anxiety. Our current understanding of the cause and management of these symptoms is far from optimal. The proposed study trials a simple and safe treatment that could be easily implemented into everyday clinical practice. This study will provide high quality evidence for the efficacy of CBM in improving the quality of lives of people with AD.
Interventions
Cognitive bias modification (CBM) is a novel, simple, and safe computer-based intervention that requires behavioural responses from participants (i.e., pressing one of two buttons). CBM specifically targets attentional and interpretative biases associated with anxiety, dysphoria, and depression. CBM operates through implicit learning systems.
In this trial two forms of CBM will comprise the intervention, CBM-A (attentional modification) and CBM-I (interpretive modification).During CBM-A partici
Cognitive bias modification (CBM) is a novel, simple, and safe computer-based intervention that requires behavioural responses from participants (i.e., pressing one of two buttons). CBM specifically targets attentional and interpretative biases associated with anxiety, dysphoria, and depression. CBM operates through implicit learning systems. In this trial two forms of CBM will comprise the intervention, CBM-A (attentional modification) and CBM-I (interpretive modification).During CBM-A participants will be repeatedly exposed to pairs of emotional faces. Each face pair includes one face displaying a negative emotion, and one face portraying a non-negative emotion. The presentation of each face pair lasts 500 ms. After each face pair has been presented, a probe is presented in the same spatial position where one of the faces was located. Participants are asked to indicate the shape of each probe by pressing a square or a circle on a response box. The time taken for participants to discriminate the identity of the probe is recorded. In the active CBM-A condition, designed to reduce attention to negative information, and expected to result in subsequent reduction in symptoms of depression, probes always appear in the position of non-negative faces. During CBM-I, participants will be repeatedly exposed to single ambiguous words (e.g. 'cane') for 1000 ms on the computer screen, followed by a pair of words. In each word pair, one word will be semantically related to either a negative or benign meaning (e.g. 'hit' or 'furniture') of the cue word, and one semantically unrelated word (e.g. 'cloud'). Participants will be asked to indicate whether the semantically related word appeared on the left or right side of the computer screen by pressing the left or right button on a response box. The time taken for participants to discriminate the location of the semantically related word is recorded. In the active CBM-I condition, designed to reduce negative interpretation of ambiguous information, and expected to result in subsequent reduction in symptoms of depression, the semantically related word will always present a benign meaning. In this trial, each CBM session will last approximately 30 minutes: 15 minutes each for CBM-A and CBM-I, Over the course of the trial 35 CBM sessions will take place during office hours as follows: Week 1 - daily (5 sessions), Week 2 - 3 sessions, Weeks 3 to 4 - Twice a week (4 sessions), Week 5 to 25 months - Monthly (23 sessions). The CBM sessions will be delivered on a local PC station at the study centre, under supervision of a trained research officer. The first session will also comprise initial baseline assessment of primary and secondary outcomes. Adherence to the trial will be monitored via registration of participant attendance at each session.
Sponsors
WA Centre for Health and Ageing
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The inclusion criteria will be; * Diagnosis of major neurocognitive disorder due to probable Alzheimer's disease according to DSM-5 criteria * Mini-Mental State Examination (MMSE) score of greater than or equal to 15 * Neuropsychiatric Inventory (NPI) depression domain score of 1 (i.e. no depression) * Availability of a close and reliable informant * Fluent in written and spoken English
Exclusion criteria
We will exclude individuals who; * Have a medical condition that is likely to compromise their ability to complete the required activities of the study (e.g. severe sensory impairment) * Consume alcohol in excess of 28 standard drinks per week * Have no health practitioner who can provide ongoing clinical care * Have a contra-indication to MRI (MRI sub-group only) * Decline or are unable to provide informed consent.
Outcome results
None listed