None listed
Conditions
Brief summary
Depression is common in people with Alzheimer’s disease (AD) and their carers and is a frequent cause of distress and reduced quality of life (QoL). Pharmacological treatment is modestly effective in treating major depression, although this is largely ineffective in those with milder depression (subsyndromal depression - SSD) and in people with dementia ,and is 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 reducing the severity of depressive symptoms in AD, the effect of CBM in improving mood in carers of people with AD, and the effect of CBM on QOL of people with AD and their carers. People with AD and their carers (dyads) will be randomly assigned to an active or control CBM intervention in a 2 x 2 double-blind, parallel design. The intervention will be conducted over 6 months. For AD participants and carers, change in severity of depressive symptoms, and change in QoL, after 12 weeks, will be outcomes of primary interest. For AD participants and carers, change in severity of depressive symptoms after completion of treatment at 26 weeks, and incidence of major depression at 6 months, will be secondary outcomes of interest. Burden of care as reported by carers at 12 and 26 weeks will also be a secondary outcome 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 parti
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 the CBM sessions will take place during office hours as follows: Week 1 – daily, Week 2 - 3 times, Weeks 3 to 12 – fortnightly, Weeks 13 to 26 – monthly (total of 16 sessions over 6 months). 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 outcome measures.
Sponsors
WA Centre for Health and Ageing
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
The inclusion criteria will be: For AD participants * Diagnosis of major neurocognitive disorder due to probable AD according to DSM-5 criteria * Mini-mental State Examination (MMSE) score of greater than or equal to 15 * Cornell Scale for Depression in Dementia (CSDD) score greater than or equal to 4 * Availability of a carer willing to participate in the trial * Fluent in written and spoken English For Carers, we will include those who: * Are aged greater than or equal to 18 years * Are fluent in written and spoken English * Are free of diseases likely to undermine ongoing participation in the study for 24 months (e.g., metastatic cancer) * Do not consume alcohol in excess of 14 standard drinks per week * Show no evidence of cognitive impairment (MMSE greater than or equal to 24/30) * Do not meet DSM-5 criteria for major depression * Show no evidence of active suicidal intent * Show no evidence of visual impairment that might compromise ability to read or use the computer * Are registered with a general practitioner
Exclusion criteria
We will exclude individuals who: * Meet National Institute of Mental Health criteria for depression in AD * Have medical conditions that are likely to compromise their ability to complete the required activities of the study e.g. severe sensory impairment or life expectancy of < 2 years from time of enrolment * Consume alcohol in excess of 14 standard drinks per week * Have no health practitioner who can provide ongoing clinical care * Decline or are unable to provide informed consent
Outcome results
None listed