Condition category
Mental and Behavioural Disorders
Date applied
20/12/2006
Date assigned
07/06/2007
Last edited
04/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Arunraj Kaimal

ORCID ID

Contact details

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

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. Beck’s 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

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

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

Publication citations

Additional files

Editorial Notes

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