Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1234
Study information
Scientific title
Psychotherapy in mild cognitive impairment
Acronym
PICT-MCI
Study hypothesis
1. The hypothesis is that, structured psychotherapeutic intervention, based on Psychodynamic Interpersonal Therapy principles, directed at sufferers of MCI and their partners/spouses will result in improved well being of sufferers [as assessed by measures of cognitive function, mood, psychological distress, interpersonal functioning and quality of life] and lowered psychological distress in their partners/ spouses, in comparison with controls.
2. The improved well being of sufferers of MCI, as a result of successful Psychodynamic Interpersonal Therapy would result in changes in task induced Blood Oxygenation Level Dependant (BOLD) signal of functional Magnetic Resonance Imaging (fMRI).
Ethics approval
Being reviewed by South Manchester Research Ethics Committee as of 20/12/2006 – approval pending
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Mild cognitive impairment
Intervention
Baseline fMRI measures will be obtained before a course of psychotherapy in patients in the experimental group receiving psychotherapy, and patients in the control group receiving standard care. After which patients are classified as responders or non-responders in both groups based on symptom improvement or other clinical outcome measures and they will be re-examined with the same imaging protocol. This technique allows for the assessment of psychotherapy related changes in brain activation and their specificity for successful outcome.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Clinical outcomes in routine evaluation
Secondary outcome measures
1. Geriatric Depression Scale [GDS]
2. Becks Anxiety Inventory
3. Marital Intimacy Scale in Dementia
4. MMSE
5. QUAL-AD
6. RSQ and RQ-Attachment
Overall trial start date
01/02/2007
Overall trial end date
01/02/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Psychotherapy:
1. Diagnosis of MCI according to the criteria suggested by the International Psychogeriatric Association expert conference on mild cognitive impairment
2. Living with a spouse or partner
3. Ability to create of a conversation in English aiming to develop a mutual feeling language based on psychodynamic interpersonal concepts
4. Mini Mental State Examination (MMSE) above 26
Imaging:
5. Fifteen patients with MCI from the intervention arm and 15 patients with MCI from the control arm as described in inclusion criteria above without any standard contraindications to MR imaging
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 couples
Participant exclusion criteria
Psychotherapy:
1. People not meeting the inclusion criteria
2. Patients/spouses suffering from serious physical conditions
Imaging:
1. Patients with standard contraindications to MR imaging, including patients with metal implants, or cardiac pacemakers
2. Patients with psychological distress (e.g. phobias) associated with MR imaging
Recruitment start date
01/02/2007
Recruitment end date
01/02/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wythenshawe Hospital
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
Manchester Mental Health and Social Care Trust (UK)
Sponsor details
Manchester mental health and social care trust
Second floor
Education Research Centre
Wythenshawe Hospital
Wythenshawe
Manchester
M23 9LT
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Wythenshawe Hospital (the academic division of old age psychiatry, Education Research Centre) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary