Predicting and Understanding Neurocognitive Mechanisms of Relapse Prevention: a randomized controlled trial of preventive cognitive therapy in remitted Major Depressive Disorder using fMRI and pupillometry

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Patients and healthy controls:
- between 18 en 60 years of age, Patients:
- MDD diagnosis lifetime according to DSM criteria as assessed with the
Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)
- current remission (>2 months; according to criteria defined in DSM IV))
- >2 major depressive episodes in past 5 years
- recency of last episode: <2 years
- currently not using any anti-depressant medication (>4 weeks)

Exclusion Criteria

Patients:
- current major depressive episode
- current use of antidepressant medication, Patients and healthy controls:
- neurological problems (incl. epilepsy, dementia, neuromuscular illness)
- drug abuse, alcohol dependency, or at this moment a psychiatric disorder
found out during the screening
- use of psychotropic medication other than infrequent use of benzodiazepine
(not in 48 hours prior to research, < 3 times per week )
- any other current DSM-IV Axis-I diagnosis, as objectified with the SCID-I
- MR-contraindications:
*any risk of having metal particles in the eye
*(suspected) pregnancy
*claustrophobia
* implants incompatible with the MRI-scanner (such as pacemaker, heart
valves, vascular clips, eye-implants, copper containing intra-uterine devices,
or non-removable piercings, ear prosthesis or other metal implants in the body)
*the refusal to be informed of structural brain abnormalities that could be
detected during the fMRI experiment
- the refusal to sign the informed consent
- history of contusion cerebri with >15 minutes loss of consciousness
- visual impairments other than correctable by glasses or lenses

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measures are the preventive cognitive therapy-induced changes<br /><br>in attentional biases, prefrontal control, and the pupil dilation response,<br /><br>measured with cognitive paradigms, functional MRI and pupillometry,<br /><br>respectively. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures include changes in mood, affect, (depressive)<br /><br>cognitions and long term course of the depressive disorder (relapse: yes/no at<br /><br>18-month follow-up). </p><br>