Depressive Disorder, Treatment-ResistantNCT04428099
Healthy Lifestyle Promotion as Adjunctive Teletherapy for Treatment-resistant Major Depression
A study testing Lifestyle change promotion program, Mindfullness based cognitive program and Written Information in people with Depressive Disorder, Treatment-Resistant, run by University of the Balearic Islands at 1 site in Spain.
Trial summary
The main objective of the study will be to evaluate the effectiveness of an adjuvant lifestyle-based intervention for treatment-resistant patients with major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Treatment-Resistant
- What is being tested?
- Lifestyle change promotion program, Mindfullness based cognitive program and Written Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jan 2020to 12 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18 or older.
- Diagnosis of Major Depressive Disorder as stated by the DSM-5.
- Two previous treatment failures (non-response to an adequate dose of potentially effective medication for an adequate length of time or treatment intolerance or refusal) in the current episode.
- At least one month of treatment with a psychiatrist and/or psychologist in the current episode.
- Physical and cognitive aptitudes to understand and give written informed consent.
Who cannot join
- Comorbidity with other medical conditions which would affect the Central Nervous System (CNS).
- Other severe psychiatric disorders (except for anxiety disorders or personality disorders)
- Other non-controlled severe medical diseases, infectious or degenerative which would interfere with affective symptomatology or the adherence to the hygienic-dietary recommendations.
- Patients with delusions or hallucinations which are congruent or non-congruent with mood.
- Patients with an important risk for suicide
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat Illes Balears
Palma de Mallorca, Balearic Islands, 07122
Mauro García-Toro, PhD, 971 259966, mauro.garcia@uib.es
About this study
Official title: Effectiveness of a Healthy Lifestyle Promotion Program as Adjunctive Teletherapy for Treatment-resistant Major Depression During Covid 19 Pandemic: A Randomized Clinical Trial Protocol
The main objective of the study will be to evaluate the effectiveness of an adjuvant lifestyle-based intervention for treatment-resistant patients with major depressive disorder. Patients will be allocated to one of these three groups: 1)Treatment prescribed by their mental health team plus written lifestyle change suggestions 2)Treatment prescribed by their mental health team plus written lifestyle change suggestions plus 8-week Mindfulness-based cognitive therapy (MBCT) program 3) Treatment prescribed by their mental health team plus written lifestyle change suggestions plus 8-week lifestyle change promotion program. We will collect patient data using the questionnaires administered at baseline, immediately after the intervention, and at six and 12-month follow-up. The primary outcome will be depression severity and secondary outcomes will include health-related quality of life.
Read the detailed description
Depression is a very prevalent, incapacitating illness. The treatment available (psychotherapy and drug therapy) do not always manage to achieve complete remission of the symptoms or prevent its relapses or recurrences. For that reason, it is still necessary to investigate new adjuvant therapeutic antidepressant alternatives, especially if they can add efficacy to the treatment without reducing tolerance and safety. In the last few years, data have been growing about the usefulness of having patients who are depressed make specific changes in their lifestyles.
The main objective of the study will be to evaluate the effectiveness and efficiency of an adjuvant lifestyle-based intervention for treatment-resistant patients with major depressive disorder. Patients will be allocated to one of these three groups: 1)Treatment prescribed by their mental health team plus written lifestyle change suggestions 2)Treatment prescribed by their mental health team plus written lifestyle change suggestions plus 8-week MBCT program 3) Treatment prescribed by their mental health team plus written lifestyle change suggestions plus 8-week lifestyle change promotion program. Two control groups were designed: placebo-control (written lifestyle change suggestion) and active-control (MBCT). We selected this adjuvant therapy because MBCT has shown positive results as an adjunctive treatment for resistant depression in previous studies and it could be administered in a similar format as our intervention (8-weeks lifestyle change promotion program). We hypothesize that the lifestyle change promotion program at 12 months of follow-up will be more effective because patients will have better adherence to this intervention than to MBCT.
This study will be carried out during the COVID-19 pandemic, therefore the administration of the intervention will be administered by teletherapy. Different ways and technologies will be used to contact participants remotely: telephone calls, text messages, WhatsApp groups, and teleconferences.
We will collect patient data using the questionnaires administered at baseline, immediately after the intervention, and at six and 12-month follow-up. The primary outcome will be measured using the Beck Depression Inventory-II (BDI-II). Secondary outcomes will include Clinical Global Impressions (CGI) Scale, to quantify and track patient progress and treatment response over time and Health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire (EQ-5D).
- Conditions
- Depressive Disorder, Treatment-Resistant
- Being tested
- Lifestyle change promotion program, Mindfullness based cognitive program, Written Information
- Keywords
- heallthy Lifestyle, Minfullness based cognitive therapy, Teletherapy
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle change promotion programBehavioural
The intervention consists of 8 group sessions centered on healthy physical activity, healthy diet, social life, Good Sleep Hygiene, healthy sun exposure, nature contact, how to stop ruminating, review and maintenance tips.
Mindfullness based cognitive programBehavioural
The intervention consists of 8 group sessions with a mindfulness-based cognitive program
Written InformationBehavioural
Written information about lifestyle change suggestions
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Lifestyle change promotion program Receives: Behavioral: Lifestyle change promotion program; Behavioral: Written Information |
| Control 1 | Active comparator | MBCT program Receives: Behavioral: Mindfullness based cognitive program; Behavioral: Written Information |
| Control 2 | Placebo comparator | Usual care Receives: Behavioral: Written Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression severity
Beck Depression Inventory-II (BDI-II)
Measured: 12 month
Secondary outcomes (1)
Health-related quality of life
Questionnaire (EQ-5D)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start13 Jan 2020
- Primary completion12 Jan 2022 (estimated)
- Study completion12 Jul 2022 (estimated)
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 Depressive Disorder, Treatment-ResistantStudies of the same condition, open and under way.
- 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
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428099
- Sponsor's protocol ID
- RMD01
- Status last verified
- Jun 2020
- First submitted
- 9 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Navarro C, Yanez AM, Garcia A, Segui A, Gazquez F, Marino JA, Ibarra O, Serrano-Ripoll MJ, Gomez-Juanes R, Bennasar-Veny M, Salva J, Olivan B, Roca M, Gili M, Garcia-Toro M. Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol. Medicine (Baltimore). 2020 Nov 6;99(45):e22958. doi: 10.1097/MD.0000000000022958.
PubMed 33157937
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Healthy Lifestyle Promotion Program as Adjunctive Teletherapy for Treatment-resistant Major Depression During Covid 19 Pandemic: A Randomized Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT04428099
- Acronym / sponsor ID
- RMD01
- Conditions
- Depressive Disorder, Treatment-Resistant
- Keywords
- heallthy Lifestyle, Minfullness based cognitive therapy, Teletherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 12 Jan 2022 (estimated)
- Study completion
- 12 Jul 2022 (estimated)
- First posted
- 11 Jun 2020 (actual)
- 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.
The main objective of the study will be to evaluate the effectiveness of an adjuvant lifestyle-based intervention for treatment-resistant patients with major depressive disorder. Patients will be allocated to one of these three groups: 1)Treatment prescribed by their mental health team plus written lifestyle change suggestions 2)Treatment prescribed by their mental health team plus written lifestyle change suggestions plus 8-week Mindfulness-based cognitive therapy (MBCT) program 3) Treatment prescribed by their mental health team plus written lifestyle change suggestions plus 8-week lifestyle change promotion program. We will collect patient data using the questionnaires administered at baseline, immediately after the intervention, and at six and 12-month follow-up. The primary outcome will be depression severity and secondary outcomes will include health-related quality of life.
Detailed description
Depression is a very prevalent, incapacitating illness. The treatment available (psychotherapy and drug therapy) do not always manage to achieve complete remission of the symptoms or prevent its relapses or recurrences. For that reason, it is still necessary to investigate new adjuvant therapeutic antidepressant alternatives, especially if they can add efficacy to the treatment without reducing tolerance and safety. In the last few years, data have been growing about the usefulness of having patients who are depressed make specific changes in their lifestyles.
The main objective of the study will be to evaluate the effectiveness and efficiency of an adjuvant lifestyle-based intervention for treatment-resistant patients with major depressive disorder. Patients will be allocated to one of these three groups: 1)Treatment prescribed by their mental health team plus written lifestyle change suggestions 2)Treatment prescribed by their mental health team plus written lifestyle change suggestions plus 8-week MBCT program 3) Treatment prescribed by their mental health team plus written lifestyle change suggestions plus 8-week lifestyle change promotion program. Two control groups were designed: placebo-control (written lifestyle change suggestion) and active-control (MBCT). We selected this adjuvant therapy because MBCT has shown positive results as an adjunctive treatment for resistant depression in previous studies and it could be administered in a similar format as our intervention (8-weeks lifestyle change promotion program). We hypothesize that the lifestyle change promotion program at 12 months of follow-up will be more effective because patients will have better adherence to this intervention than to MBCT.
This study will be carried out during the COVID-19 pandemic, therefore the administration of the intervention will be administered by teletherapy. Different ways and technologies will be used to contact participants remotely: telephone calls, text messages, WhatsApp groups, and teleconferences.
We will collect patient data using the questionnaires administered at baseline, immediately after the intervention, and at six and 12-month follow-up. The primary outcome will be measured using the Beck Depression Inventory-II (BDI-II). Secondary outcomes will include Clinical Global Impressions (CGI) Scale, to quantify and track patient progress and treatment response over time and Health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire (EQ-5D).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Lifestyle change promotion program, Behavioral: Written InformationLifestyle change promotion program |
| Control 1 | Active comparator | Behavioral: Mindfullness based cognitive program, Behavioral: Written InformationMBCT program |
| Control 2 | Placebo comparator | Behavioral: Written InformationUsual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals aged 18 or older.
- Diagnosis of Major Depressive Disorder as stated by the DSM-5.
- Two previous treatment failures (non-response to an adequate dose of potentially effective medication for an adequate length of time or treatment intolerance or refusal) in the current episode.
- At least one month of treatment with a psychiatrist and/or psychologist in the current episode.
- Physical and cognitive aptitudes to understand and give written informed consent.
Key exclusion criteria (5 listed)
- Comorbidity with other medical conditions which would affect the Central Nervous System (CNS).
- Other severe psychiatric disorders (except for anxiety disorders or personality disorders)
- Other non-controlled severe medical diseases, infectious or degenerative which would interfere with affective symptomatology or the adherence to the hygienic-dietary recommendations.
- Patients with delusions or hallucinations which are congruent or non-congruent with mood.
- Patients with an important risk for suicide
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 |
|---|---|---|
| Lifestyle change promotion programThe intervention consists of 8 group sessions centered on healthy physical activity, healthy diet, social life, Good Sleep Hygiene, healthy sun exposure, nature contact, how to stop ruminating, review and maintenance tips. | Behavioural | Intervention |
| Mindfullness based cognitive programThe intervention consists of 8 group sessions with a mindfulness-based cognitive program | Behavioural | Control 1 |
| Written InformationWritten information about lifestyle change suggestions | Behavioural | Control 1, Control 2, Intervention |
Primary outcome
Depression severity
Time frame: 12 month
Beck Depression Inventory-II (BDI-II)
1 secondary outcome
Health-related quality of life
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 33157937Navarro C, Yanez AM, Garcia A, Segui A, Gazquez F, Marino JA, Ibarra O, Serrano-Ripoll MJ, Gomez-Juanes R, Bennasar-Veny M, Salva J, Olivan B, Roca M, Gili M, Garcia-Toro M. Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol. Medicine (Baltimore). 2020 Nov 6;99(45):e22958. doi: 10.1097/MD.0000000000022958.
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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 Lifestyle change promotion program, Mindfullness based cognitive program and Written Information in people with Depressive Disorder, Treatment-Resistant, run by University of the Balearic Islands at 1 site in Spain.
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: status not confirmed, as of the sponsor's last update on 11 Jun 2020. 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 Spain. 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 Mauro García-Toro, PhD (+34 971 259966, mauro.garcia@uib.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression severity (time frame: 12 month). 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 NCT04428099, 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 11 Jun 2020.