ISRCTN ISRCTN42983681
DOI https://doi.org/10.1186/ISRCTN42983681
Secondary identifying numbers 1234
Submission date
20/12/2006
Registration date
07/06/2007
Last edited
04/04/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Arunraj Kaimal
Scientific

SPR in old age psychiatry
Academic Department of Psychiatry
Second floor
Education Research Centre
Wythenshawe Hospital
Manchester
M23 9LT
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePsychotherapy in mild cognitive impairment
Study acronymPICT-MCI
Study objectives1. 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(s)Being reviewed by South Manchester Research Ethics Committee as of 20/12/2006 – approval pending
Health condition(s) or problem(s) studiedMild cognitive impairment
InterventionBaseline 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 typeOther
Primary outcome measureClinical outcomes in routine evaluation
Secondary outcome measures1. Geriatric Depression Scale [GDS]
2. Beck’s Anxiety Inventory
3. Marital Intimacy Scale in Dementia
4. MMSE
5. QUAL-AD
6. RSQ and RQ-Attachment
Overall study start date01/02/2007
Completion date01/02/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40 couples
Key inclusion criteriaPsychotherapy:
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
Key exclusion criteriaPsychotherapy:
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
Date of first enrolment01/02/2007
Date of final enrolment01/02/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Wythenshawe Hospital
Manchester
M23 9LT
United Kingdom

Sponsor information

Manchester Mental Health and Social Care Trust (UK)
Hospital/treatment centre

Manchester mental health and social care trust
Second floor
Education Research Centre
Wythenshawe Hospital
Wythenshawe
Manchester
M23 9LT
England
United Kingdom

Website http://www.mhsc.nhs.uk/

Funders

Funder type

Government

Wythenshawe Hospital (the academic division of old age psychiatry, Education Research Centre) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

04/04/2016: No publications found, verifying study status with principal investigator