DepressionNCT02538835
The Effect of Group Treatment for Depression: A Study of Metacognitive Therapy, Mindfulness and Support Groups
A study testing Metacognitive therapy, Mindfulness based cognitive therapy, group and Support groups in people with Depression, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
This study evaluates the effect of metacognitive group therapy on depression compared to mindfulness groups and supportive groups. The participants, all with a history of depression and with current symptoms of depression, will be randomized to one of the three group interventions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Metacognitive therapy, Mindfulness based cognitive therapy, group and Support groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2018to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent to participate
- History of clinical depression
- Current depressive symptoms
- Verbal and cognitive abilities to complete the questionnaires during the study
- Stable medication - if any medication is ordinated
- Speaks fluently danish
Who cannot join
- If criteria for psychosis, bipolar disorder or personality disorder is matched
- known brain damage or mental retardation
- substance abuse
- women who are pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Southern Denmark
Odense, Southern Denmark, 5230
Mette E Andersen, PhD, 65504625 ext. +45, melandersen@health.sdu.dk
Tonny Andersen, PhD, 65502778 ext. +45, tandersen@health.sdu.dk
About this study
Official title: The Effect of Group Treatment for Depression: A Randomised Controlled Study of Metacognitive Therapy, Mindfulness and Support Groups
This study evaluates the effect of metacognitive group therapy on depression compared to mindfulness groups and supportive groups. The participants, all with a history of depression and with current symptoms of depression, will be randomized to one of the three group interventions.
Read the detailed description
Metacognitive therapy (MCT) show promising results in alleviating depressive symptoms and reducing relapse of depression. However studies of MCT as a group intervention is limited and higher quality studies of the effectiveness of MCT is warranted. The present study aim to produce more conclusive evidence on the effect of MCT comparing MCT in groups with both and active control group and mindfulness based cognitive therapy (MBCT), which together with pharmacotherapy is currently one of the preferred treatment choices. Currently pharmacotherapy, cognitive therapy and MBCT seem to help 40-58% of the patients efficiently. The current studies of MCT indicate that this intervention may help a higher proportion of the patients.
- Conditions
- Depression
- Being tested
- Metacognitive therapy, Mindfulness based cognitive therapy, group, Support groups
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive therapyBehavioural
Group format, 10-12 participants in each group. 8 weekly sessions of two hours each.
Mindfulness based cognitive therapy, groupBehavioural
Group format, 10-12 participants in each group. 8 weekly sessions of two hours each following the manual described by Williams, Zindel \& Segal.
Support groupsBehavioural
Group format, 10-12 participants in each group. The sessions will only be of supportive character and will not focus on changing or restructuring thoughts, scripts or thought patterns. The format will follow a manual but compared to the other intervention groups the format allow participants to suggests themes for discussions.
| Study group | Role | What they receive |
|---|---|---|
| Metacognitive Therapy | Experimental | Not described Receives: Behavioral: Metacognitive therapy |
| Mindfulness based cognitive therapy | Active comparator | Not described Receives: Behavioral: Mindfulness based cognitive therapy, group |
| Support groups | Placebo comparator | Not described Receives: Behavioral: Support groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on Hamilton depression scale
Measured: 8 weeks
Change from baseline on Hamilton depression scale
Measured: 32 weeks
Secondary outcomes (8)
Change from baseline on Becks depression inventory
Measured: 8 weeks
Change from baseline on Becks depression inventory
Measured: 32 weeks
Change from baseline on Becks Anxiety Inventory
Measured: 8 weeks
Change from baseline on Becks Anxiety Inventory
Measured: 32 weeks
Change from baseline on Ruminative Response Scale
Measured: 8 weeks
Change from baseline on Ruminative Response Scale
Measured: 32 weeks
Change from baseline on Metacognitive questionnaire
Measured: 8 weeks
Change from baseline on Metacognitive questionnaire
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startAug 2018
- Primary completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Kognitive Terapier og Supervision
- Responsible party
- Principal investigator, Tonny Elmose Andersen, phd., University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538835
- Sponsor's protocol ID
- 46332
- Status last verified
- Nov 2016
- First submitted
- 31 Aug 2015
- Last updated
- 15 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Group Treatment for Depression: A Randomised Controlled Study of Metacognitive Therapy, Mindfulness and Support Groups
- ClinicalTrials.gov ID
- NCT02538835
- Acronym / sponsor ID
- 46332
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Center for Kognitive Terapier og Supervision
- Study start
- Aug 2018
- Primary completion
- Jul 2020 (estimated)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effect of metacognitive group therapy on depression compared to mindfulness groups and supportive groups. The participants, all with a history of depression and with current symptoms of depression, will be randomized to one of the three group interventions.
Detailed description
Metacognitive therapy (MCT) show promising results in alleviating depressive symptoms and reducing relapse of depression. However studies of MCT as a group intervention is limited and higher quality studies of the effectiveness of MCT is warranted. The present study aim to produce more conclusive evidence on the effect of MCT comparing MCT in groups with both and active control group and mindfulness based cognitive therapy (MBCT), which together with pharmacotherapy is currently one of the preferred treatment choices. Currently pharmacotherapy, cognitive therapy and MBCT seem to help 40-58% of the patients efficiently. The current studies of MCT indicate that this intervention may help a higher proportion of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metacognitive Therapy | Experimental | Behavioral: Metacognitive therapy |
| Mindfulness based cognitive therapy | Active comparator | Behavioral: Mindfulness based cognitive therapy, group |
| Support groups | Placebo comparator | Behavioral: Support groups |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Consent to participate
- History of clinical depression
- Current depressive symptoms
- Verbal and cognitive abilities to complete the questionnaires during the study
- Stable medication - if any medication is ordinated
Key exclusion criteria (4 listed)
- If criteria for psychosis, bipolar disorder or personality disorder is matched
- known brain damage or mental retardation
- substance abuse
- women who are pregnant or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive therapyGroup format, 10-12 participants in each group. 8 weekly sessions of two hours each. | Behavioural | Metacognitive Therapy |
| Mindfulness based cognitive therapy, groupGroup format, 10-12 participants in each group. 8 weekly sessions of two hours each following the manual described by Williams, Zindel \& Segal. | Behavioural | Mindfulness based cognitive therapy |
| Support groupsGroup format, 10-12 participants in each group. The sessions will only be of supportive character and will not focus on changing or restructuring thoughts, scripts or thought patterns. The format will follow a manual but compared to the other intervention groups the format allow participants to suggests themes for discussions. | Behavioural | Support groups |
Primary outcome
Change from baseline on Hamilton depression scale
Time frame: 8 weeks
Change from baseline on Hamilton depression scale
Time frame: 32 weeks
8 secondary outcomes
Change from baseline on Becks depression inventory
Time frame: 8 weeks
Change from baseline on Becks depression inventory
Time frame: 32 weeks
Change from baseline on Becks Anxiety Inventory
Time frame: 8 weeks
Change from baseline on Becks Anxiety Inventory
Time frame: 32 weeks
Change from baseline on Ruminative Response Scale
Time frame: 8 weeks
Change from baseline on Ruminative Response Scale
Time frame: 32 weeks
Change from baseline on Metacognitive questionnaire
Time frame: 8 weeks
Change from baseline on Metacognitive questionnaire
Time frame: 32 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive therapy, Mindfulness based cognitive therapy, group and Support groups in people with Depression, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mette E Andersen, PhD (65504625 ext. +45, melandersen@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on Hamilton depression scale (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.