Major Depressive DisorderNCT02747134
Combining Emotion Regulation and Mindfulness Skills for Preventing Depression Relapse
A study testing Emotion Regulation and Mindfulness skills in people with Major Depressive Disorder, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
In the present study researchers aim to investigate the effectiveness of an intervention combining emotion regulation and mindfulness skills in a single 10-week program. A total of 75 individuals with major depressive disorder (MDD) diagnosis in complete or partial remission participated in this randomized controlled… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Emotion Regulation and Mindfulness skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Sep 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 75 years
- having a former MDD diagnosis in complete or partial remission at the time of the study as indicated by the major depressive section of the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) and scores below 17 on the Hamilton Depression Rating Scale (HSRD)
- having the last major depressive episode between 18 and 2 months prior to the study
- having at least two previous depressive episodes
- patients could continue pharmacological treatment on condition that it remained stable for at least the last two months before entering the study.
Who cannot join
- DSM-IV-TR criteria for current MDD or any other affective disorder
- DSM-IV-TR criteria for alcohol or drug dependence, schizophrenia or psychotic disorders
- DSM-IV-TR criteria for personality disorders; severe physical conditions such as organic brain syndrome or neurological disease; mental retardation or cognitive impairments
- having received any psychotherapy including cognitive-behavioral therapy in the past
- changes in the pharmacological treatment during the study.
About this study
In the present study researchers aim to investigate the effectiveness of an intervention combining emotion regulation and mindfulness skills in a single 10-week program. A total of 75 individuals with major depressive disorder (MDD) diagnosis in complete or partial remission participated in this randomized controlled trial (RCT) comparing an intervention including emotion regulation and mindfulness skills (ER+M) with a psychoeducative program. After treatment, participants were followed for a 1-year period. Researchers results indicate that ER+M was not more effective than the treatment used with the control group in preventing depression relapse. Participants allocated to the ER+M group showed a significant decrease on global psychiatric symptoms, whereas those in the control group did not. Further studies are needed in order to better determine the combined effects of mindfulness and behavioral activation.
- Conditions
- Major Depressive Disorder
- Being tested
- Emotion Regulation and Mindfulness skills
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Regulation and Mindfulness skillsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Emotion Regulation and Mindfulness skills | Experimental | A 10 week intervention including emotion regulation and mindfulness skills from dialectical behavioral therapy (DBT) was delivered. Receives: Behavioral: Emotion Regulation and Mindfulness skills |
| Psychoeducation | Active comparator | Psychoeducation consisted of 5 session in which basic information about depressive symptoms and how to prevent depression relapse was given. Receives: Behavioral: Emotion Regulation and Mindfulness skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startSep 2008
- Primary completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747134
- Sponsor's protocol ID
- EC/07/178/2678
- Status last verified
- Apr 2016
- First submitted
- 19 Apr 2016
- Last updated
- 21 Apr 2016
- Results posted
- No
Publications
Elices M, Soler J, Feliu-Soler A, Carmona C, Tiana T, Pascual JC, Garcia-Palacios A, Alvarez E. Combining emotion regulation and mindfulness skills for preventing depression relapse: a randomized-controlled study. Borderline Personal Disord Emot Dysregul. 2017 Jul 5;4:13. doi: 10.1186/s40479-017-0064-6. eCollection 2017.
PubMed 28690851
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Emotion Regulation and Mindfulness Skills for Preventing Depression Relapse
- ClinicalTrials.gov ID
- NCT02747134
- Acronym / sponsor ID
- EC/07/178/2678
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2011 (actual)
- First posted
- 21 Apr 2016 (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.
In the present study researchers aim to investigate the effectiveness of an intervention combining emotion regulation and mindfulness skills in a single 10-week program. A total of 75 individuals with major depressive disorder (MDD) diagnosis in complete or partial remission participated in this randomized controlled trial (RCT) comparing an intervention including emotion regulation and mindfulness skills (ER+M) with a psychoeducative program. After treatment, participants were followed for a 1-year period. Researchers results indicate that ER+M was not more effective than the treatment used with the control group in preventing depression relapse. Participants allocated to the ER+M group showed a significant decrease on global psychiatric symptoms, whereas those in the control group did not. Further studies are needed in order to better determine the combined effects of mindfulness and behavioral activation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotion Regulation and Mindfulness skills | Experimental | Behavioral: Emotion Regulation and Mindfulness skillsA 10 week intervention including emotion regulation and mindfulness skills from dialectical behavioral therapy (DBT) was delivered. |
| Psychoeducation | Active comparator | Behavioral: Emotion Regulation and Mindfulness skillsPsychoeducation consisted of 5 session in which basic information about depressive symptoms and how to prevent depression relapse was given. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age between 18 and 75 years
- having a former MDD diagnosis in complete or partial remission at the time of the study as indicated by the major depressive section of the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) and scores below 17 on the Hamilton Depression Rating Scale (HSRD)
- having the last major depressive episode between 18 and 2 months prior to the study
- having at least two previous depressive episodes
- patients could continue pharmacological treatment on condition that it remained stable for at least the last two months before entering the study.
Key exclusion criteria (5 listed)
- DSM-IV-TR criteria for current MDD or any other affective disorder
- DSM-IV-TR criteria for alcohol or drug dependence, schizophrenia or psychotic disorders
- DSM-IV-TR criteria for personality disorders; severe physical conditions such as organic brain syndrome or neurological disease; mental retardation or cognitive impairments
- having received any psychotherapy including cognitive-behavioral therapy in the past
- changes in the pharmacological treatment during the study.
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 |
|---|---|---|
| Emotion Regulation and Mindfulness skills | Behavioural | Emotion Regulation and Mindfulness skills, Psychoeducation |
Primary outcome
Hamilton Depression Rating Scale
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Derived from this study: PubMed 28690851Elices M, Soler J, Feliu-Soler A, Carmona C, Tiana T, Pascual JC, Garcia-Palacios A, Alvarez E. Combining emotion regulation and mindfulness skills for preventing depression relapse: a randomized-controlled study. Borderline Personal Disord Emot Dysregul. 2017 Jul 5;4:13. doi: 10.1186/s40479-017-0064-6. eCollection 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion Regulation and Mindfulness skills in people with Major Depressive Disorder, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02747134, which also lists 1 linked publication.
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 21 Apr 2016.