DepressionRECOVERYNCT03917550
RECOVERY: A Transdiagnostic Intervention for Anxiety and Depression
A study testing Recovery (Transdiagnostic & self) and Transdiagnostic in people with Depression and Dysthymic Disorder, run by West University of Timisoara at 1 site in Romania.
Trial summary
To investigate the efficacy and acceptability of a guided internet delivered transdiagnostic intervention, targeting mild to moderate clinical symptoms of anxiety and depression and emphasizing the changes taking place at the level of the structures of the self. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Dysthymic Disorder, Panic Disorder
- What is being tested?
- Recovery (Transdiagnostic & self) and Transdiagnostic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteRomania
- Study dates
- 18 Mar 2019to 27 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be fluent in Romanian,
- be at least 18 years of age,
- have at least a clinical diagnosis of major depressive disorder/dysthymia, and/or generalized anxiety disorder, and/or social anxiety disorder, panic anxiety disorder and/or Agoraphobia, specific phobia or any combination of these conditions on Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders 5 (SCID-I 5)
Who cannot join
- suicidal plans,
- changes in the dosage if psychotropic medication during the last month (if present),
- have bipolar disorder or psychosis (according to medication status),
- have an alcohol/substance abuse and/or dependence disorder,
- currently take part in other psychological treatment,
- obvious obstacle to participation (i.e., no current Internet access, long travel plans during the treatment period etc.)
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
West University of Timisoara
Timișoara, Timiș County, 300223
Bogdan Tudor Tulbure, PhD, 0040745753061, btulbure@gmail.com
About this study
Official title: RECOVERY: An Internet-delivered Transdiagnostic Cognitive Behavior Therapy in Romania
To investigate the efficacy and acceptability of a guided internet delivered transdiagnostic intervention, targeting mild to moderate clinical symptoms of anxiety and depression and emphasizing the changes taking place at the level of the structures of the self.
Read the detailed description
The effectiveness of a Transdiagnostic Cognitive-Behavioral Treatment will be compared with an improved version of it, in which new intervention techniques were added, pointing out the importance of improving some self-concept dimensions in reducing symptoms of anxiety and depression. In order to prove this, the study design will include two active intervention groups; a standard transdiagnostic intervention protocol will be delivered to one group and an improved version of the same transdiagnostic protocol will be delivered to the other group. The new added techniques targets some self-concepts, namely self-compassion, unconditional self-acceptance and self-esteem. The main goal of the study is to concurrently test effectiveness of these two transdiagnostic approaches in reducing symptoms of anxiety and depression and improving the above-mentioned self-concepts. This non-inferiority trial has the power to detect an effect size larger than Cohen's d = .40 (including 20% attrition at post-test and 6 month follow-up)
- Conditions
- Depression, Dysthymic Disorder, Panic Disorder, Social Phobia, Generalized Anxiety Disorder, Specific Phobia
- Being tested
- Recovery (Transdiagnostic & self), Transdiagnostic
- Keywords
- Transdiagnostic, Cognitive behavioural therapy (CBT), Depression, Anxiety
- Medical subject headings
- Depression, Dysthymic Disorder, Panic Disorder, Phobia, Social, Generalized Anxiety Disorder, Phobia, Specific, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery (Transdiagnostic & self)Behavioural
This transdiagnostic program is based on the general Cognitive Behavioral Therapy (CBT) principles and targets core higher order factors such as negative affectivity and emotion dysregulation, using common intervention techniques applicable across disorders. The program was designed to directly address the aversive emotional experiences often reported by clients, hoping to reverse participants' maladaptive thinking style and dysfunctional behaviors. In addition, specific intervention designed to improve self-compassion, unconditional self-acceptance, self-esteem and self concept clarity were added.
TransdiagnosticBehavioural
This transdiagnostic program is based on the general Cognitive Behavioral Therapy (CBT) principles and targets core higher order factors such as negative affectivity and emotion dysregulation, using common intervention techniques applicable across disorders. The program was designed to directly address the aversive emotional experiences often reported by clients, hoping to reverse participants' maladaptive thinking style and dysfunctional behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Recovery (Transdiagnostic & self) | Experimental | A longitudinal study conducted before has shown that self-compassion, unconditional self-acceptance, self-esteem and self concept clarity could be considered risk factors for the severity of the clinical symptoms in anxiety and depression. This is the main reason why this arm consists of the Transdiagnostic intervention program for emotional disorders plus a number of intervention techniques targeting the self-concepts mentioned before. The intervention, based on the Cognitive Behavioral Therapy (CBT) principles, is designed to encourage participants to confront and experience uncomfortable emotions, and use adaptive coping mechanisms. Moreover, additional intervention techniques targeting self-concepts will be used to improve participants' self. Receives: Behavioral: Recovery (Transdiagnostic & self) |
| Transdiagnostic | Active comparator | This arm represents the Transdiagnostic intervention program for emotional disorders. The intervention, based on the Cognitive Behavioral Therapy (CBT) principles, is designed to encourage participants to confront and experience uncomfortable emotions, and use adaptive coping mechanisms. Receives: Behavioral: Transdiagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire 9 (PHQ9)
The Patient Health Questionnaire 9 (PHQ9) was designed to measure participant's level of depression. The scale is unidimensional and the total score ranges from 0 to 27. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.
Measured: Absolute values (average score) of PHQ9 at 10 weeks (post-intervention)
Generalized Anxiety Disorder 7 (GAD7)
Generalized Anxiety Disorder 7 (GAD7) was designed to measure participant's level of generalized anxiety or worry. The scale is unidimensional and the total score ranges from 0 to 21. Low scores are associated with low levels of worry, while high scores are associated with high levels of worry.
Measured: Absolute values (average score) of GAD7 at 10 weeks (post-intervention)
Social Phobia Inventory (SPIN)
The SPIN was designed to measure participant's level of social phobia. The scale is unidimensional and the total score ranges from 0 to 68. Low scores are associated with low levels of social phobia, while high scores are associated with high levels of social phobia.
Measured: Absolute values (average score) of SPIN at 10 weeks (post-intervention)
Panic Disorder Severity Scale-Self Report (PDSS-SR)
The PDSS-SR was designed to measure participant's level of panic. The scale is unidimensional and the total score rages from 0 to 28. Low scores are associated with low levels of panic, while high scores are associated with high levels of panic.
Measured: Absolute values (average score) of PDSS-SR at 10 weeks (post-intervention)
Secondary outcomes (13)
Work and Social Adjustment Scale (WSAS)
Work and Social Adjustment Scale (WSAS) was designed to measure symptom interference. The scale is unidimensional and the total score ranges from 0 to 40. Low scores are associated with higher levels of functioning (less interference of clinical symptoms) while high scores are associated with lower levels of functioning (or high interference of clinical symptoms).
Measured: Absolute values (average score) of WSAS at 10 weeks (post-intervention)
Beck Depression Inventory-II (BDI-II)
The Beck Depression Inventory-II (BDI-II) was designed to measure participant's level of depression. The scale is unidimensional and the total score ranges from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.
Measured: Absolute values (average score) of BDI-II at 10 weeks (post-intervention)
Penn State Worry Questionnaire (PSWQ)
The PSWQ was designed to measure participant's level of generalized anxiety or worry. The scale is unidimensional and the total score ranges from 16 to 80. Low scores are associated with low levels of worry, while high scores are associated with high levels of worry.
Measured: Absolute values (average score) of PSWQ at 10 weeks (post-intervention)
Anxiety Sensitivity Index 16 (ASI16)
The ASI was designed to measure participant's level of anxiety sensitivity. The scale is unidimensional and the total score rages from 0 to 64. Low scores are associated with low levels of anxiety sensitivity, while high scores are associated with high levels of anxiety sensitivity.
Measured: Absolute values (average score) of ASI at 10 weeks (post-intervention)
Self-Concept Clarity Scale (SCCS)
SCCS was designed to measure participant's level of their Self-Concept Clarity. The scale is unidimensional and the total score rages from 12 to 60. Low scores are associated with low levels of Self-Clarity, while high scores are associated with high levels of Self-Clarity.
Measured: Absolute values (average score) of SCCS at 10 weeks (post-intervention)
New General Self-Efficacy Scale (NGSE)
NGSE was designed to measure participant's level of Self-Efficacy. The scale is unidimensional and the total score rages from 8 to 40. Low scores are associated with low levels of Self-Efficacy, while high scores are associated with high levels of Self-Efficacy.
Measured: Absolute values (average score) of NGSE at 10 weeks (post-intervention)
Unconditional Self-Acceptance Questionnaire (USAQ)
USAQ was designed to measure participant's level of unconditional Self-Acceptance. The scale is unidimensional and the total score rages from 20 to 140. Low scores are associated with low levels of unconditional Self-Acceptance, while high scores are associated with high levels of unconditional Self-Acceptance.
Measured: Absolute values (average score) of USAQ at 10 weeks (post-intervention)
Overall Anxiety Severity and Impairment Scale (OASIS)
The OASIS was designed to measure participant's level of overall anxiety level. The scale is unidimensional and the total score rages from 0 to 20. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety.
Measured: Absolute values (average score) of OASIS at 10 weeks (post-intervention)
Overall Depression Severity and Impairment Scale (ODSIS)
The ODSIS was designed to measure participant's level of overall depression level. The scale is unidimensional and the total score rages from 0 to 20. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.
Measured: Absolute values (average score) of ODSIS at 10 weeks (post-intervention)
Rosenberg Self-Esteem Scale (RSES)
Rosenberg Self-Esteem Scale was designed to measure participant's level of Self-Esteem. The scale is unidimensional and the total score rages from 10 to 40. Low scores are associated with low levels of Self-Esteem, while high scores are associated with high levels of Self-Esteem.
Measured: Absolute values (average score) of RSES at 10 weeks (post-intervention)
Self-Compassion Scale (SCS)
SCS was designed to measure participant's level of their Self-Compassion. The scale is multidimensional and the total score rages from 26 to 130. Low scores are associated with low levels of Self-Compassion, while high scores are associated with high levels of Self-Compassion.
Measured: Absolute values (average score) of SCS at 10 weeks (post-intervention)
Minnesota Multiphasic Personality Inventory 2 Neagtive Treatment Indicator Scale (MMPI2TRT)
MMPI2TRT was designed to measure participants negative attitudes toward doctors/mental health professionals and unwilling to discuss personal problems. The scale is unidimensional and the total score rages from 0 to 26. Low scores are associated positive attitudes towards doctors and willingness to discuss problems while high scores are associated with negative attitudes toward doctors and unwilling to discuss personal problems.
Measured: Absolute values (average score) of MMPI2TRT at 10 weeks (post-intervention)
Personality Clinical Form - Neagtive TReaTment Indicator Scale (PCFTRT)
PCFTRT is a new subscale designed to assess participants negative attitudes toward mental health professionals and unwilling to discuss personal problems. The subscale is unidimensional and the total score rages from 0 to 24. Low scores are associated positive attitudes towards doctors and willingness to discuss problems while high scores are associated with negative attitudes toward doctors and unwilling to discuss personal problems.
Measured: Absolute values (average score) of PCFTRT at 10 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start18 Mar 2019
- Primary completion30 Aug 2019 (estimated)
- Study completion27 Mar 2020 (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 DepressionStudies 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
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West University of Timisoara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreea Isbasoiu, PhD student, Study director, West University of Timisoara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917550
- Sponsor's protocol ID
- WUT - RECOVERY
- Acronym
- RECOVERY
- Status last verified
- Apr 2019
- First submitted
- 14 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be process only at the group level. No individual data will be shared to third parties.
Publications
Isbasoiu AB, Tulbure BT, Rusu A, Sava FA. Can We Boost Treatment Adherence to an Online Transdiagnostic Intervention by Adding Self-Enhancement Strategies? Results From a Randomized Controlled Non-inferiority Trial. Front Psychol. 2021 Dec 2;12:752249. doi: 10.3389/fpsyg.2021.752249. eCollection 2021.
PubMed 34925157
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECOVERY: An Internet-delivered Transdiagnostic Cognitive Behavior Therapy in Romania
- ClinicalTrials.gov ID
- NCT03917550
- Acronym / sponsor ID
- RECOVERY / WUT - RECOVERY
- Conditions
- Depression, Dysthymic Disorder, Panic Disorder, Social Phobia, Generalized Anxiety Disorder, Specific Phobia
- Keywords
- Transdiagnostic, Cognitive behavioural therapy (CBT), Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- West University of TimisoaraUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 27 Mar 2020 (estimated)
- First posted
- 17 Apr 2019 (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.
To investigate the efficacy and acceptability of a guided internet delivered transdiagnostic intervention, targeting mild to moderate clinical symptoms of anxiety and depression and emphasizing the changes taking place at the level of the structures of the self.
Detailed description
The effectiveness of a Transdiagnostic Cognitive-Behavioral Treatment will be compared with an improved version of it, in which new intervention techniques were added, pointing out the importance of improving some self-concept dimensions in reducing symptoms of anxiety and depression. In order to prove this, the study design will include two active intervention groups; a standard transdiagnostic intervention protocol will be delivered to one group and an improved version of the same transdiagnostic protocol will be delivered to the other group. The new added techniques targets some self-concepts, namely self-compassion, unconditional self-acceptance and self-esteem. The main goal of the study is to concurrently test effectiveness of these two transdiagnostic approaches in reducing symptoms of anxiety and depression and improving the above-mentioned self-concepts. This non-inferiority trial has the power to detect an effect size larger than Cohen's d = .40 (including 20% attrition at post-test and 6 month follow-up)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recovery (Transdiagnostic & self) | Experimental | Behavioral: Recovery (Transdiagnostic & self)A longitudinal study conducted before has shown that self-compassion, unconditional self-acceptance, self-esteem and self concept clarity could be considered risk factors for the severity of the clinical symptoms in anxiety and depression. This is the main reason why this arm consists of the Transdiagnostic intervention program for emotional disorders plus a number of intervention techniques targeting the self-concepts mentioned before. The intervention, based on the Cognitive Behavioral Therapy (CBT) principles, is designed to encourage participants to confront and experience uncomfortable emotions, and use adaptive coping mechanisms. Moreover, additional intervention techniques targeting self-concepts will be used to improve participants' self. |
| Transdiagnostic | Active comparator | Behavioral: TransdiagnosticThis arm represents the Transdiagnostic intervention program for emotional disorders. The intervention, based on the Cognitive Behavioral Therapy (CBT) principles, is designed to encourage participants to confront and experience uncomfortable emotions, and use adaptive coping mechanisms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- be fluent in Romanian,
- be at least 18 years of age,
- have at least a clinical diagnosis of major depressive disorder/dysthymia, and/or generalized anxiety disorder, and/or social anxiety disorder, panic anxiety disorder and/or Agoraphobia, specific phobia or any combination of these conditions on Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders 5 (SCID-I 5)
Key exclusion criteria (6 listed)
- suicidal plans,
- changes in the dosage if psychotropic medication during the last month (if present),
- have bipolar disorder or psychosis (according to medication status),
- have an alcohol/substance abuse and/or dependence disorder,
- currently take part in other psychological treatment,
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 |
|---|---|---|
| Recovery (Transdiagnostic & self)This transdiagnostic program is based on the general Cognitive Behavioral Therapy (CBT) principles and targets core higher order factors such as negative affectivity and emotion dysregulation, using common intervention techniques applicable across disorders. The program was designed to directly address the aversive emotional experiences often reported by clients, hoping to reverse participants' maladaptive thinking style and dysfunctional behaviors. In addition, specific intervention designed to improve self-compassion, unconditional self-acceptance, self-esteem and self concept clarity were added. | Behavioural | Recovery (Transdiagnostic & self) |
| TransdiagnosticThis transdiagnostic program is based on the general Cognitive Behavioral Therapy (CBT) principles and targets core higher order factors such as negative affectivity and emotion dysregulation, using common intervention techniques applicable across disorders. The program was designed to directly address the aversive emotional experiences often reported by clients, hoping to reverse participants' maladaptive thinking style and dysfunctional behaviors. | Behavioural | Transdiagnostic |
Primary outcome
Patient Health Questionnaire 9 (PHQ9)
Time frame: Absolute values (average score) of PHQ9 at 10 weeks (post-intervention)
The Patient Health Questionnaire 9 (PHQ9) was designed to measure participant's level of depression. The scale is unidimensional and the total score ranges from 0 to 27. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.
Generalized Anxiety Disorder 7 (GAD7)
Time frame: Absolute values (average score) of GAD7 at 10 weeks (post-intervention)
Generalized Anxiety Disorder 7 (GAD7) was designed to measure participant's level of generalized anxiety or worry. The scale is unidimensional and the total score ranges from 0 to 21. Low scores are associated with low levels of worry, while high scores are associated with high levels of worry.
Social Phobia Inventory (SPIN)
Time frame: Absolute values (average score) of SPIN at 10 weeks (post-intervention)
The SPIN was designed to measure participant's level of social phobia. The scale is unidimensional and the total score ranges from 0 to 68. Low scores are associated with low levels of social phobia, while high scores are associated with high levels of social phobia.
Panic Disorder Severity Scale-Self Report (PDSS-SR)
Time frame: Absolute values (average score) of PDSS-SR at 10 weeks (post-intervention)
The PDSS-SR was designed to measure participant's level of panic. The scale is unidimensional and the total score rages from 0 to 28. Low scores are associated with low levels of panic, while high scores are associated with high levels of panic.
13 secondary outcomes
Work and Social Adjustment Scale (WSAS)
Time frame: Absolute values (average score) of WSAS at 10 weeks (post-intervention)
Beck Depression Inventory-II (BDI-II)
Time frame: Absolute values (average score) of BDI-II at 10 weeks (post-intervention)
Penn State Worry Questionnaire (PSWQ)
Time frame: Absolute values (average score) of PSWQ at 10 weeks (post-intervention)
Anxiety Sensitivity Index 16 (ASI16)
Time frame: Absolute values (average score) of ASI at 10 weeks (post-intervention)
Self-Concept Clarity Scale (SCCS)
Time frame: Absolute values (average score) of SCCS at 10 weeks (post-intervention)
New General Self-Efficacy Scale (NGSE)
Time frame: Absolute values (average score) of NGSE at 10 weeks (post-intervention)
Unconditional Self-Acceptance Questionnaire (USAQ)
Time frame: Absolute values (average score) of USAQ at 10 weeks (post-intervention)
Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: Absolute values (average score) of OASIS at 10 weeks (post-intervention)
Overall Depression Severity and Impairment Scale (ODSIS)
Time frame: Absolute values (average score) of ODSIS at 10 weeks (post-intervention)
Rosenberg Self-Esteem Scale (RSES)
Time frame: Absolute values (average score) of RSES at 10 weeks (post-intervention)
Self-Compassion Scale (SCS)
Time frame: Absolute values (average score) of SCS at 10 weeks (post-intervention)
Minnesota Multiphasic Personality Inventory 2 Neagtive Treatment Indicator Scale (MMPI2TRT)
Time frame: Absolute values (average score) of MMPI2TRT at 10 weeks (post-intervention)
Personality Clinical Form - Neagtive TReaTment Indicator Scale (PCFTRT)
Time frame: Absolute values (average score) of PCFTRT at 10 weeks (post-intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Derived from this study: PubMed 34925157Isbasoiu AB, Tulbure BT, Rusu A, Sava FA. Can We Boost Treatment Adherence to an Online Transdiagnostic Intervention by Adding Self-Enhancement Strategies? Results From a Randomized Controlled Non-inferiority Trial. Front Psychol. 2021 Dec 2;12:752249. doi: 10.3389/fpsyg.2021.752249. eCollection 2021.
- Project official websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be process only at the group level. No individual data will be shared to third parties.
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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.
Andreea Isbasoiu, PhD student study director
West University of Timisoara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery (Transdiagnostic & self) and Transdiagnostic in people with Depression and Dysthymic Disorder, run by West University of Timisoara at 1 site in Romania.
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 3 inclusion and 6 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 17 Apr 2019. 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 Romania. 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. 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 Bogdan Tudor Tulbure, PhD (0040745753061, btulbure@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire 9 (PHQ9) (time frame: Absolute values (average score) of PHQ9 at 10 weeks (post-intervention)). The study lists 4 primary outcomes in all. 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 NCT03917550, 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 17 Apr 2019.