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| [ Print-friendly version ] |
| Psychotherapy in Mild Cognitive Impairment |
| ISRCTN | ISRCTN42983681 |
| ClinicalTrials.gov identifier | |
| Public title | Psychotherapy in Mild Cognitive Impairment |
| Scientific title | |
| Acronym | PICT-MCI |
| Serial number at source | 1234 |
| 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 December 2006. |
| Study design | Randomised controlled trial. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Mild cognitive impairment |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/02/2007 |
| Anticipated end date | 01/02/2009 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 40 couples |
| Interventions | 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. |
| Primary outcome measure(s) | Clinical outcomes in routine evaluation |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Wythenshawe Hospital (the academic division of old age psychiatry, Education Research Centre) (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Arunraj Kaimal |
| Address |
SPR in old age psychiatry
Academic Department of Psychiatry Second floor Education Research Centre Wythenshawe Hospital |
| City/town | Manchester |
| Zip/Postcode | M23 9LT |
| Country | United Kingdom |
| Sponsor | Manchester Mental Health and Social Care Trust (UK) |
| Address |
Manchester mental health and social care trust
Second floor Education Research Centre Wythenshawe Hospital Wythenshawe |
| City/town | Manchester |
| Zip/Postcode | M23 9LT |
| Country | United Kingdom |
| Sponsor website: | http://www.mhsc.nhs.uk/ |
| Date applied | 20/12/2006 |
| Last edited | 12/06/2007 |
| Date ISRCTN assigned | 07/06/2007 |
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