A psychosocial therapy to benefit people with Parkinson’s-related dementia (INVEST)

Not Applicable

Completed

• Conditions: Topic: Dementia; Subtopic: Parkinson's Disease; Disease: Parkinson's Disease; Nervous System Diseases; 1. Parkinson's disease dementia2. Dementia with Lewy bodies

• Registration Number: ISRCTN11455062
• Lead Sponsor: Manchester Mental Health & Social Care Trust

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28630086 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31161388 results (added 05/06/2019) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31320931/ (added 26/04/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-18
• Study Completion: 2017-10-31
• Last Update Posted: 8 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Caregiver inclusion criteria:
1. Caregiver of a person with PD-MCI, PDD or DLB: Must live with or be carer for someone who has a diagnosis of PDMCI, PDD or DLB
2. Must be well enough to deliver 20 – 30 minute sessions of iCST, two or three times per week

Patient inclusion criteria:
1. Must have received a diagnosis of probable PD-MCI, PDD or DLB. Diagnosis will be based on standard clinical diagnostic criteria (Emre et al, 2007; McKeith et al., 2005) determined by the referring clinician and verified by the lead applicant (IL).
2. Must be willing to participate in 20 – 30 minute sessions of iCST, two or three times per week
3. Must be well enough to participate in 20 – 30 minute sessions of iCST, two or three times per week
4. Must be stable on medication regime four weeks prior study entry

Exclusion Criteria

Caregiver exclusion criteria:
1. Not a caregiver for someone with PD-MCI, PDD or DLB
2. Cannot understand English or are non-literate
3. Severe physical illness
4. Diagnosis of dementia
5. The person being cared for meets the patient exclusion criteria

Patient exclusion criteria:
1. Unwilling to participate in 20 – 30 minute sessions of iCST, two or three times per week
2. Not well enough to participate in 20 – 30 minute sessions of iCST, two or three times per week
3. Caregiver contact less than 3 time per week
4. No caregiver (or caregiver not willing) to deliver therapy and complete study assessments
5. Lives in residential care
6. Cannot understand English or are non-literate
7. Severe physical illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified