Problem adaptation therapy for depression in dementia (PATHFINDER)

Problem adaptation therapy for individuals with mild to moderate dementia and depression: the PATHFINDER trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11185706

Enrollment

334

Registered

2018-05-31

Start date

2019-09-01

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression in Alzheimers disease Nervous System Diseases Alzheimer disease

Interventions

This is a 6-centre, single-blind, parallel, 2-arm randomised controlled feasibility trial to assess the clinical and cost-effectiveness of adapted PATH for depression in mild and moderate dementia wit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of probable AD or mixed AD and vascular dementia using NIA-AA criteria 2. Mild to moderate dementia severity, defined by an SMMSE score >10 3. Clinically significant depression, defined by score of 8+ on the Cornell Scale for Depression in Dementia 4. Aged >50 years 5. Sufficiently fluent in English to engage with the PATH intervention 6. Identified family carer who spends >1 hour per day on at least 3 days per week with participant and agrees to act as co-therapist for intervention

Exclusion criteria

Exclusion criteria: 1. Diagnosis of rarer dementias, including dementia with Lewy bodies, Parkinson’s disease dementia and frontotemporal dementia 2. Initiation of prescription or change in dose of antidepressant or other psychotropic medication in previous 4 weeks or plan to change treatment during the next 12 weeks 3. Those currently engaged in formal psychological therapy 4. Those requiring treatment for a severe psychiatric disorder such as schizophrenia or bipolar disorder 5. Are severely depressed and expressing suicidal ideation with active plans/suicidal behaviours and intent, as other forms of treatment and support would be indicated

Design outcomes

Primary

Measure	Time frame
The change in Cornell Scale for Depression in Dementia (CSDD) (26) score between baseline and 6 months post-randomisation. This is a 19-item scale on which each item is rated 0 (absent), 1 (mild or intermittent) or 2 (severe) and a total score of 8 or more suggests significant depressive symptoms. The CSDD differs from rating scales for assessing depressed mood in people without dementia through inclusion of a combination of observed and informant-based questions rather than simply analysing differences in the phenomenology of depression in dementia. Taking up to 30 minutes to complete (20 minutes with the carer and 10 minutes with the patient), the scale covers 5 main areas of symptoms and signs of depression: (1) Mood-Related Signs (anxiety, sadness, lack of reactivity to pleasant events and irritability), (2) Behavioural Disturbance (agitation, retardation, multiple physical complaints, loss of interest in usual activities in last month), (3) Physical Signs (appetite loss, weight loss, lack of energy in last month), (4) Cyclic Functions (diurnal variation in mood, difficulty falling asleep, multiple awakenings during sleep, early morning awakening), (5) Ideational Disturbance (suicidal thoughts or attempts, poor self-esteem, pessimism, mood-congruent delusions). The CSDD was the primary outcome measure in HTA-SADD and we will use the same regimen of initial and refresher training, together with regular group exercises to assess reliability of research workers that we developed for HTA-SADD.	—

Measure

Time frame

The change in Cornell Scale for Depression in Dementia (CSDD) (26) score between baseline and 6 months post-randomisation. This is a 19-item scale on which each item is rated 0 (absent), 1 (mild or intermittent) or 2 (severe) and a total score of 8 or more suggests significant depressive symptoms. The CSDD differs from rating scales for assessing depressed mood in people without dementia through inclusion of a combination of observed and informant-based questions rather than simply analysing differences in the phenomenology of depression in dementia. Taking up to 30 minutes to complete (20 minutes with the carer and 10 minutes with the patient), the scale covers 5 main areas of symptoms and signs of depression: (1) Mood-Related Signs (anxiety, sadness, lack of reactivity to pleasant events and irritability), (2) Behavioural Disturbance (agitation, retardation, multiple physical complaints, loss of interest in usual activities in last month), (3) Physical Signs (appetite loss, weight loss, lack of energy in last month), (4) Cyclic Functions (diurnal variation in mood, difficulty falling asleep, multiple awakenings during sleep, early morning awakening), (5) Ideational Disturbance (suicidal thoughts or attempts, poor self-esteem, pessimism, mood-congruent delusions). The CSDD was the primary outcome measure in HTA-SADD and we will use the same regimen of initial and refresher training, together with regular group exercises to assess reliability of research workers that we developed for HTA-SADD.

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Secondary

Measure	Time frame
1. Change in CSDD score between baseline and 3 and 12 months post-randomisation. 2. Change in disease-specific health-related quality of life (HRQL) measured with the DEMQOL and DEMQOL-proxy and generic quality of life with the EQ-5D. DEMQOL (28 items) and DEMQOL-Proxy (31 items) are interviewer-administered measures which obtain self and informant reports of the HRQL of people with dementia; items cover the feelings, memory, and everyday life of the person with dementia in the last week and Likert-scale responses (a lot/quite a bit/a little/not at all) are used with higher overall total scores reflecting better HRQL. The EQ-5D is a 5-item self-report measure of health-related quality of life used to calculate utility scores for use in economic evaluations. Each of the 5 items is rated on a 5-point scale from no problem to extreme problems. Measured at baseline, 6 and 12 months. 3. Functional abilities with the Bristol Activities of Daily Living Scale, a 20-item scale completed with the carer and covering everyday daily living activities (food preparation, eating, drink preparation, drinking, dressing, personal hygiene, cleaning teeth, bathing/showering, toileting, transfers, mobility, orientation to time, orientation to place, communication, use of telephone, housework/gardening, shopping, finances, games/hobbies and transport) that has excellent psychometric properties across the mild to moderate dementia severity range. Measured at baseline, 6 and 12 months. 4. General cognitive function with the SMMSE, a more objective and valid version of the traditional MMSE, that takes between 5 and 10 minutes to administer to a patient. Measured at baseline, 6 and 12 months. 5. Anxiety, measured with the Rating Anxiety in Dementia scale, a 20-item scale assessing worry about physical health, cognitive performance, family problems, false beliefs, items considered trivial by others, level of frightfulness, noise sensitivity, sleep disturbance, irritability, trembling, motor te	—

Measure

Time frame

1. Change in CSDD score between baseline and 3 and 12 months post-randomisation. 2. Change in disease-specific health-related quality of life (HRQL) measured with the DEMQOL and DEMQOL-proxy and generic quality of life with the EQ-5D. DEMQOL (28 items) and DEMQOL-Proxy (31 items) are interviewer-administered measures which obtain self and informant reports of the HRQL of people with dementia; items cover the feelings, memory, and everyday life of the person with dementia in the last week and Likert-scale responses (a lot/quite a bit/a little/not at all) are used with higher overall total scores reflecting better HRQL. The EQ-5D is a 5-item self-report measure of health-related quality of life used to calculate utility scores for use in economic evaluations. Each of the 5 items is rated on a 5-point scale from no problem to extreme problems. Measured at baseline, 6 and 12 months. 3. Functional abilities with the Bristol Activities of Daily Living Scale, a 20-item scale completed with the carer and covering everyday daily living activities (food preparation, eating, drink preparation, drinking, dressing, personal hygiene, cleaning teeth, bathing/showering, toileting, transfers, mobility, orientation to time, orientation to place, communication, use of telephone, housework/gardening, shopping, finances, games/hobbies and transport) that has excellent psychometric properties across the mild to moderate dementia severity range. Measured at baseline, 6 and 12 months. 4. General cognitive function with the SMMSE, a more objective and valid version of the traditional MMSE, that takes between 5 and 10 minutes to administer to a patient. Measured at baseline, 6 and 12 months. 5. Anxiety, measured with the Rating Anxiety in Dementia scale, a 20-item scale assessing worry about physical health, cognitive performance, family problems, false beliefs, items considered trivial by others, level of frightfulness, noise sensitivity, sleep disturbance, irritability, trembling, motor te

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026