Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05912036 |
| Other study ID # |
03C214 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2023 |
| Est. completion date |
May 31, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
Istituto Auxologico Italiano |
| Contact |
Giada Pietrabissa |
| Phone |
+393495324303 |
| Email |
giada.pietrabissa[@]unicatt.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: This study aims to evaluate the feasibility and efficacy of a novel
Computer-Assisted Cognitive Remediation Therapy (CA-CRT) program as adjunctive treatment to
standard care (TAU) in improving cognitive skills in adult inpatients with anorexia nervosa
(AN) Methods: A multicenter randomized controlled trial (RCT) will be conducted to compare
the experimental condition with controls receiving TAU only. A minimum sample of 54 subjects
with a diagnosis of AN will be recruited in each site. After the initial screening,
participants will be randomized to either the experimental group or the control condition.
The treatment will last 5 weeks and consists of 10 individual CRT sessions with 15 individual
CA-CRT sessions. The impact of the intervention on selected primary and secondary outcomes
will be tested at the end of the intervention.
Expected results: We expect subjects assigned to the CA-CRT group to develop more flexible
and holistic thinking styles, and achieving increased clinical outcomes.
Description:
For this reason, the present multicenter Randomized Control Trial (RCT) aims to implement a
new CA-CRT for AN (CA-CRT-AN) and to test its feasibility and efficacy as an adjunctive
intervention on selected neuropsychological (cognitive flexibility, verbal fluency,
visuospatial processing, and attention) and psychological measures (eating disorders,
health-related quality of life - HRQoL, and motivation to change) in populations of
inpatients with AN following a nutritional rehabilitation program compared to controls
following the treatment already used in the clinics (TAU).
Patients with AN will be invited to take part in the study at admission to each
rehabilitation center according to the above-mentioned inclusion/exclusion criteria, and
those eligible will be randomly assigned to either the experimental (CA-CRT) or control group
(TAU).
Before the randomization, they will be asked to sign the informed consent to participate in
the research and complete the psychodiagnostic (BAI, BDI II, OCI-R) and psychological (EDE-Q,
WHOQOL-BREF, URICA) measures under the supervision of a clinical psychologist independent of
the study. The selected neuropsychological measures will be also administered at baseline
Randomization will be stratified by center and performed using permuted block technique
within each site by a researcher independent of the study. Subjects will be assigned to one
of two conditions: both groups received usual hospital care, and the experimental group, in
addition, will receive the CA-CRT treatment.
At the end of the treatment (after 5 weeks), subjects in both conditions will be
re-administered with neuropsychological tests and psychological measures The total duration
of the research will be 6 months, considering a discontinuous enrollment related to the
admission to the clinics
