Condition category
Mental and Behavioural Disorders
Date applied
09/02/2013
Date assigned
04/03/2013
Last edited
29/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Depression is considered the second leading cause of disability caused by illness affecting about 121 million people around the world. Cognitive behaviour therapy (CBT) is an evidence-based treatment for depression. However, only approximately 5 out of 10 of patients respond and only a third remain recovered at follow-up. Initial studies show that meta-cognitive therapy (MCT) might optimize effectiveness. The present study intents to compare 128 depressed Danish outpatients randomly assigned to up to 24 weekly sessions of either CBT or MCT. The approach of the data-analysis consists of a mixed-model analysis of variance and analysis of co-variance to assess relative treatment effects. The results of the trial will have significant impact on enhancing treatment methods for depression.

Who can participate?
Participants are patients referred from their general practitioner (GP) to get psychological treatment at the CEKTOS center for their depression who want treatment within 2 weeks and are willing to participate in a trial.

What does the study involve?
After screening and diagnosis the participants are randomly allocated to receive either treatment as usual - CBT or MCT.
Patients who are suitable for the trial receive either up to 24 sessions of CBT or MCT.

What are the possible benefits and risks of participating?
No known risks or side effects from either CBT or MCT.

Where is the study run from?
It takes place at CEKTOS Center for Kognitiv Terapi og Supervision in Næstved. Supervision is given at Manchester University where the manager of the trial is a PhD student.

When is the study starting and how long is it expected to run for?
The trial started in 2010 and is expected to run for at least 4 years.

Who is funding the study?
It is a privately funded study sponsored by CEKTOS- Center for Kognitiv Terapi og Supervision.

Who is the main contact?
Pia Callesen
pcallesen@gmail.com
Pia.callesen@cektos.dk

Trial website

http://www.cektos.dk/cektos/index.php?option=com_content&view=article&id=130&Itemid=157

Contact information

Type

Scientific

Primary contact

Ms Pia Callesen

ORCID ID

Contact details

Riddergade 7
1
Næstved
4700
Denmark
+4522684281
Pia.callesen@cektos.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Meta-cognitive Therapy (MCT) versus Cognitive Behaviour Therapy (CBT) for Depression: A randomised clinical trial

Acronym

MetaDep

Study hypothesis

The null hypothesis is that MCT is just as effective as CBT.

Ethics approval

Danish Ethical Committee, 13 December 2010

Study design

Randomised parallel between-groups design. Groups are stratified for gender and level of depression.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depression

Intervention

Cognitive behaviour therapy versus metacognitive behaviour therapy.

The two therapists in the trial give both treatment. Patients are referred according to therapist availability. They are offered up to 24 sessions of 50-60 mins. once a week. Treatment is terminated when they score below depressive threshold on the BDI-II in two consecutive sessions. Patients symptoms are evaluated before, mid, post and at 6 months follow-up.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Depressive symptoms (Hamilton Depression Inventory administered by blind assessor)
2. Depressive symptoms on self report questionnaire (Beck Depression Inventory – BDI-II

Measured before, mid, post and at 6 months follow-up.

Secondary outcome measures

1. Anxiety related symptoms (Beck Anxiety Inventory - BAI)
2. Co-morbidity (SCID I)
3. Patients’ expectancies about treatment outcome
4. Meta-cognitive scales (Meta-cognitive Questionnaire - MCQ-30, negative and positive beliefs about rumination scales (NBRS PBRS), Rumination Response Scale (RRS)
5. CBT specific scales (Dysfunctional Attitude Scale DAS and Young’s Schema Inventory - short version)
6. Patient-therapist alliance (Havarth Aliance Inventory HAI)
7. Objective measure (Concentration and attention subtests from the WAIS)

Measured before, mid, post and at 6 months follow-up.

Overall trial start date

01/11/2010

Overall trial end date

01/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients (male and female, aged 18-68 years) who have a main or primary diagnosis of major depressive disorder (MDD) according to Structured Clinical Interview for DSM-IV Disorders (SCID) I.
2. Patients who only attend therapy in this trial and have not received other psychological treatments for the current episode.
3. Patients in combined medical treatment as long as they are stable or willing to remain stable on their medication for the period of the trial.
4. Patients who sign informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

128

Participant exclusion criteria

1. Patients suffering from psychosis or bipolar disorder as screened by SCID I
2. Patients suffering from substance and alcohol-abuse as screened by SCID I
3. Patients suffering from borderline personality disorder as screened by SCID II
4. Patients with organic brain syndrome or mental retardation
5. Female patients who are pregnant or lactating
6. Participants who had not responded favorably to an earlier adequate trial of either CBT or MCT

Recruitment start date

01/11/2010

Recruitment end date

01/11/2015

Locations

Countries of recruitment

Denmark

Trial participating centre

Riddergade 7, 1
Næstved
4700
Denmark

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

c/o Adrian Wells
Ph.D
Professor of Clinical and Experimental Psychopathology
School of Psychological Sciences
Division of Clinical Psychology
Rawnsley Building
MRI
Manchester
M13 9WL
United Kingdom
+44 161 276 5399
adrian.wells@manchester.ac.uk

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

Funders

Funder type

Other

Funder name

Investigator initiated and funded (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

29/11/2016: The overall trial end date has been updated from 01/11/2015 to 01/06/2017.