The COMET study: Metacognitive Therapy and Cognitive Behaviour Therapy for Depressio

Not Applicable

• Conditions: Major depressive disorder; Mental Health - Depression

• Registration Number: ACTRN12611000804987
• Lead Sponsor: Jennifer Jordan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Current major depressive disorder (DSM-IV)
Able to complete questionnaires and psychotherapy in the english language.

Exclusion Criteria

On no psychoactive drugs (e.g. antidepressants, mood stabilisers, anxiolytics or antipsychotic drugs), moderate or severe alcohol or drug dependence as a primary diagnosis, bipolar I disorder or schizophrenia, major physical illness or head injury which could interfere with the fMRI procedure, neuropsychological assessment or psychotherapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in depressive symptoms at end treatment measured by change in the Quick Inventory of Depressive Symptomatology (QIDS-C-16 item) (rated by an independent rater)[weeks 0 and 12];Speed of early change measured by reduction in Quick Inventory of Depressive Symptomatology scores (QIDS-C-16 item) (rated by an independent rater)[weeks 0 and 4];Early change measured by percent change in brain activation on fMRI in the dorso-lateral prefrontal cortex and amygdala regions[weeks 0 and 4]

Secondary Outcome Measures

Name	Time	Method
Time to achieve non-depressed status over the course of treatment measured by the Quick Inventory of Depressive Symptomatology- self report (QIDS- SR) (survival curve, QIDS-SR<6).[weekly self-report questionnaires for 12 weeks];Improvement in executive functioning, measured by the Rapid Visual Information Processing (CANTAB)[weeks 0, 4 and 12 weeks];Improved emotional processing, measured by the Recognition of posed facial expressions task[weeks 0, 4,and 12];Reduction in depressive rumination, measured by the Response Styles Questionnaire- rumination subscale[weeks 0, 4 and 12];Reduction in maladaptive metacognitions measured by the Metacognitions-30 scale[weeks 0, 4,and 12];Reduction in self-report depressive symptoms at end treatment rated by the Quick Inventory of Depressive Symptomatology- self report (QIDS- SR)[weeks 0, 4 and 12]