Psychotherapy in mild cognitive impairment
| ISRCTN | ISRCTN42983681 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42983681 |
| Protocol serial number | 1234 |
| Sponsor | Manchester Mental Health and Social Care Trust (UK) |
| Funder | Wythenshawe Hospital (the academic division of old age psychiatry, Education Research Centre) (UK) |
- 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
Scientific
SPR in old age psychiatry
Academic Department of Psychiatry
Second floor
Education Research Centre
Wythenshawe Hospital
Manchester
M23 9LT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Psychotherapy in mild cognitive impairment |
| Study acronym | PICT-MCI |
| Study objectives | 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(s) | Being reviewed by South Manchester Research Ethics Committee as of 20/12/2006 – approval pending |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Clinical outcomes in routine evaluation |
| Key secondary outcome measure(s) |
1. Geriatric Depression Scale [GDS] |
| Completion date | 01/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 01/02/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Wythenshawe Hospital
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/04/2016: No publications found, verifying study status with principal investigator
