DepressionNCT06456775
Tele-SSM: A Telephone Technology Innovation in the Intervention on Supported Self-management for Depression in Vietnam
A study testing Tele-SSM in people with Depression, run by Institute for Social Development Studies, Vietnam at 1 site in Vietnam.
Trial summary
Tele-SSM is a pre-post mixed-method study to investigate the feasibility, acceptability and the preliminary efficacy of the support self-management skills intervention for depression delivered from distance. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depression
- What is being tested?
- Tele-SSM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteVietnam
- Study dates
- 2 Feb 2021to 30 Aug 2023
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged from 18-64 years
- Have a score of PHQ-9 (26) greater than 5.
Who cannot join
- Any participants with severe mental health problems i.e. schizophrenia, bipolar disorder, recent suicide attempts and/or with suicide plans were excluded (current suicide ideation, but without recent suicide attempts and/or with suicide plans were not excluded).
Trial locations and contacts
1 site in 1 country.
About this study
Tele-SSM is a pre-post mixed-method study to investigate the feasibility, acceptability and the preliminary efficacy of the support self-management skills intervention for depression delivered from distance.
The specific objectives of this research include:
- Transform the SSM intervention for depression from face-to-face delivery to delivery from distance.
- Develop an software for intervention management
- Examine knowledge, attitudes and practices of people with depression toward depression
- Examine the feasibility, acceptability and preliminary efficacy of the intervention
- Investigate the cost analysis of Tele-SSM intervention
Read the detailed description
Introduction
In the context of limited interventions for depression in Vietnam and the strong potential for tele-health to improve accessibility to mental health care in low-middle income countries, the principal investigators conducted a pre-post mixed-method study of a supported self-management for depression delivered from distance (Tele-SSM) to evaluate the preliminary efficacy, feasibility and acceptability of this approach on depression and other mental health outcomes for adults with depression symptoms in Vietnam and to explore knowledge, attitudes and practices of people with depression towards depression.
Method
This is pre-post mixed method study. The princial investigators use both quantitative and quanlitative methodology to evaluate the preliminary efficacy, feasibility and acceptability of Tele-SSM intervention on depression and other mental health outcomes for adults with depression symptoms in Vietnam and to explore knowledge, attitudes and practices of people with depression towards depression.
Recruitment
Participants ages 18-64 years ared recruited online through social media from May 2022 and May 2023. Interested participants completed the PHQ-9 on Kobotoolbox. Potential participants who satisfy the eligibility criteria of the study provided contact information. A research assistant with a psychology background conducted a video call with each potential participant to confirm their eligibility, provide information about the study and the intervention. Informed consent was obtained from all individual participants included in the study.
All procedures performed in studies involving human participants are in accordance with the ethical standards of the institutional ethical committee and was approved by the Institutional Review Board at ISDS (IRB00011703) on 05th May 2021 in Hanoi.
Sample size considerations
Findings from meta-analytic studies examining the effect of CBT interventions indicate the effect size for CBT on depressive symptoms to be 0.53 (Cuijpers et al., 2013) and on health-related quality of life to be 0.63 (Hofmann et al., 2017). Sample size calculations indicated that a sample size of 52 participants was sufficient to detect a conservative anticipated effect size of 0.40, with a statistical power of 80% and a two-sided alpha level of 0.05. The target sample size was increased to 72, assuming an anticipated attrition rate of 20%. In reality, the principal investigators recruited 75 patients, with 58 patients completing the intervention.
Data management
- Participants completed pre- and post-questionnaires online using Kobotoolbox. The in-depth interviews are audio-recorded. Audio recordings are transcribed. Participant records are managed by a secured website.
Data Analysis Plan
- Qualitative analysis methods: The IDIs are audio-recorded, transcribed and analyzed thematically to identify significant themes, patterns, and potential correlational relationships. The analysis is conducted with Excel software.
- Quantitative analysis method: The principal investigators calculate descriptive statistics for all variables (means, ranges, standard deviations, percent data missing, and frequencies for categorical variables). For continuous variables, the principal investigators conduct statiscial tests to test for differences before and after intervention. For the acceptability, frequencies for questions on satisfaction were calculated from endline data.
- Cost analysis method: The principal investigators analyze all costs incurred from activities of Tele-SSM intervention for all participants in the study.
- Conditions
- Depression
- Being tested
- Tele-SSM
- Keywords
- depression, supported self-management, task-shifting approach, mobile health, mental health, Vietnam
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-SSMBehavioural
Tele-SSM an individual-level psychosocial intervention based on cognitive behavior therapy principles and non-violent communication. The intervention consists of the following 10 sessions delivered through 10 weekly coaching calls delivered by Zoom (audio only).
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | All participants in the study received a supported self-management intervention for depression delivered from distance. Receives: Behavioral: Tele-SSM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Measured by PHQ-9 questionnaire
Measured: Pre intervention and up to 12 weeks
Acceptability
Measured by questionnaire and in-depth interviews
Measured: Up to 12 weeks after pre-intervention survey
Feasiblity
Measured by questionnaire and in-depth interviews
Measured: Up to 12 weeks after pre-intervention survey
Cost
Measured by financial reports
Measured: Through study completion, an average 6 months
Secondary outcomes (6)
Anxiety
Measure by DASS-21 questionnaire
Measured: Pre intervention and up to 12 weeks
Stress
Measured by DASS-21 questionnaire
Measured: Pre intervention and up to 12 weeks
Self-esteem
Measured by Rosenberg self - Esteem scale
Measured: Pre intervention and up to 12 weeks
Social support
Measured by Multidimensional Scale of Perceived Social Support (MSPSS)
Measured: Pre intervention and up to 12 weeks
Health related quality of life
Measured by SF-12 and EQ-5D-5L questionnaire
Measured: Pre intervention and up to 12 weeks
Knowledge, attitude and practices of people with depression
Measured by in-depth interviews
Measured: Pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start2 Feb 2021
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group: Clinical trials with a single arm
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Social Development Studies, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- National Foundation for Science & Technology Development, Vietnam
- Responsible party
- Principal investigator, Tran Kieu Nhu, Institute for Social Development Studies, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456775
- Sponsor's protocol ID
- NCUD.05-2019.29
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data of this study are available on request from the principal investigator after the outcomes of the study are published. .
Publications
Konig H, Konig HH, Konnopka A. The excess costs of depression: a systematic review and meta-analysis. Epidemiol Psychiatr Sci. 2019 Apr 5;29:e30. doi: 10.1017/S2045796019000180.
PubMed 30947759Christensen MK, Lim CCW, Saha S, Plana-Ripoll O, Cannon D, Presley F, Weye N, Momen NC, Whiteford HA, Iburg KM, McGrath JJ. The cost of mental disorders: a systematic review. Epidemiol Psychiatr Sci. 2020 Aug 18;29:e161. doi: 10.1017/S204579602000075X.
PubMed 32807256Cuijpers P, Noma H, Karyotaki E, Cipriani A, Furukawa TA. Effectiveness and Acceptability of Cognitive Behavior Therapy Delivery Formats in Adults With Depression: A Network Meta-analysis. JAMA Psychiatry. 2019 Jul 1;76(7):700-707. doi: 10.1001/jamapsychiatry.2019.0268.
PubMed 30994877Cuijpers P, Karyotaki E, Reijnders M, Purgato M, Barbui C. Psychotherapies for depression in low- and middle-income countries: a meta-analysis. World Psychiatry. 2018 Feb;17(1):90-101. doi: 10.1002/wps.20493.
PubMed 29352530Bilsker D, Goldner EM, Anderson E. Supported self-management: a simple, effective way to improve depression care. Can J Psychiatry. 2012 Apr;57(4):203-9. doi: 10.1177/070674371205700402.
PubMed 22480584Linde K, Sigterman K, Kriston L, Rucker G, Jamil S, Meissner K, Schneider A. Effectiveness of psychological treatments for depressive disorders in primary care: systematic review and meta-analysis. Ann Fam Med. 2015 Jan-Feb;13(1):56-68. doi: 10.1370/afm.1719.
PubMed 25583894Pasarelu CR, Andersson G, Bergman Nordgren L, Dobrean A. Internet-delivered transdiagnostic and tailored cognitive behavioral therapy for anxiety and depression: a systematic review and meta-analysis of randomized controlled trials. Cogn Behav Ther. 2017 Jan;46(1):1-28. doi: 10.1080/16506073.2016.1231219. Epub 2016 Oct 7.
PubMed 27712544Chau LW, Murphy J, Nguyen VC, Lou H, Khanh H, Thu T, Minas H, O'Neil J. Lay social workers implementing a task-sharing approach to managing depression in Vietnam. Int J Ment Health Syst. 2021 May 29;15(1):52. doi: 10.1186/s13033-021-00478-8.
PubMed 34051848Connolly SM, Vanchu-Orosco M, Warner J, Seidi PA, Edwards J, Boath E, Irgens AC. Mental health interventions by lay counsellors: a systematic review and meta-analysis. Bull World Health Organ. 2021 Aug 1;99(8):572-582. doi: 10.2471/BLT.20.269050. Epub 2021 Apr 29.
PubMed 34354312Murphy JK, Xie H, Nguyen VC, Chau LW, Oanh PT, Nhu TK, O'Neil J, Goldsmith CH, Van Hoi N, Ma Y, Lou H, Jones W, Minas H. Is supported self-management for depression effective for adults in community-based settings in Vietnam?: a modified stepped-wedge cluster randomized controlled trial. Int J Ment Health Syst. 2020 Feb 12;14:8. doi: 10.1186/s13033-020-00342-1. eCollection 2020.
PubMed 32071614Richards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012 Jun;32(4):329-42. doi: 10.1016/j.cpr.2012.02.004. Epub 2012 Feb 28.
PubMed 22466510Murphy J, Goldsmith CH, Jones W, Oanh PT, Nguyen VC. The effectiveness of a Supported Self-management task-shifting intervention for adult depression in Vietnam communities: study protocol for a randomized controlled trial. Trials. 2017 May 5;18(1):209. doi: 10.1186/s13063-017-1924-5.
PubMed 28476148Tran NK, Ngo TT, Nguyen TK, Murphy JK, Dang HM. Feasibility, acceptability, and preliminary efficacy of a telehealth supported self-management intervention for adults with depression symptoms in Vietnam: a mixed-method pre-post study. Pilot Feasibility Stud. 2025 Dec 10;12(1):8. doi: 10.1186/s40814-025-01750-1.
PubMed 41372992Tran NK, Nguyen QT, Nguyen TK, Hoang MV, Kane S, Dang HM. Knowledge, attitudes, and practices toward depression among people living with depression in Vietnam: the cultural dynamics in the era of globalization. BMC Psychol. 2025 Aug 29;13(1):983. doi: 10.1186/s40359-025-03281-z.
PubMed 40883799
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-SSM: A Telephone Technology Innovation in the Intervention on Supported Self-management for Depression in Vietnam
- ClinicalTrials.gov ID
- NCT06456775
- Acronym / sponsor ID
- NCUD.05-2019.29
- Conditions
- Depression
- Keywords
- depression, supported self-management, task-shifting approach, mobile health, mental health, Vietnam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Institute for Social Development Studies, VietnamUniversity, hospital or other
- Collaborators
- National Foundation for Science & Technology Development, Vietnam
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 13 Jun 2024 (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.
Tele-SSM is a pre-post mixed-method study to investigate the feasibility, acceptability and the preliminary efficacy of the support self-management skills intervention for depression delivered from distance.
The specific objectives of this research include:
- Transform the SSM intervention for depression from face-to-face delivery to delivery from distance.
- Develop an software for intervention management
- Examine knowledge, attitudes and practices of people with depression toward depression
- Examine the feasibility, acceptability and preliminary efficacy of the intervention
- Investigate the cost analysis of Tele-SSM intervention
Detailed description
Introduction
In the context of limited interventions for depression in Vietnam and the strong potential for tele-health to improve accessibility to mental health care in low-middle income countries, the principal investigators conducted a pre-post mixed-method study of a supported self-management for depression delivered from distance (Tele-SSM) to evaluate the preliminary efficacy, feasibility and acceptability of this approach on depression and other mental health outcomes for adults with depression symptoms in Vietnam and to explore knowledge, attitudes and practices of people with depression towards depression.
Method
This is pre-post mixed method study. The princial investigators use both quantitative and quanlitative methodology to evaluate the preliminary efficacy, feasibility and acceptability of Tele-SSM intervention on depression and other mental health outcomes for adults with depression symptoms in Vietnam and to explore knowledge, attitudes and practices of people with depression towards depression.
Recruitment
Participants ages 18-64 years ared recruited online through social media from May 2022 and May 2023. Interested participants completed the PHQ-9 on Kobotoolbox. Potential participants who satisfy the eligibility criteria of the study provided contact information. A research assistant with a psychology background conducted a video call with each potential participant to confirm their eligibility, provide information about the study and the intervention. Informed consent was obtained from all individual participants included in the study.
All procedures performed in studies involving human participants are in accordance with the ethical standards of the institutional ethical committee and was approved by the Institutional Review Board at ISDS (IRB00011703) on 05th May 2021 in Hanoi.
Sample size considerations
Findings from meta-analytic studies examining the effect of CBT interventions indicate the effect size for CBT on depressive symptoms to be 0.53 (Cuijpers et al., 2013) and on health-related quality of life to be 0.63 (Hofmann et al., 2017). Sample size calculations indicated that a sample size of 52 participants was sufficient to detect a conservative anticipated effect size of 0.40, with a statistical power of 80% and a two-sided alpha level of 0.05. The target sample size was increased to 72, assuming an anticipated attrition rate of 20%. In reality, the principal investigators recruited 75 patients, with 58 patients completing the intervention.
Data management
- Participants completed pre- and post-questionnaires online using Kobotoolbox. The in-depth interviews are audio-recorded. Audio recordings are transcribed. Participant records are managed by a secured website.
Data Analysis Plan
- Qualitative analysis methods: The IDIs are audio-recorded, transcribed and analyzed thematically to identify significant themes, patterns, and potential correlational relationships. The analysis is conducted with Excel software.
- Quantitative analysis method: The principal investigators calculate descriptive statistics for all variables (means, ranges, standard deviations, percent data missing, and frequencies for categorical variables). For continuous variables, the principal investigators conduct statiscial tests to test for differences before and after intervention. For the acceptability, frequencies for questions on satisfaction were calculated from endline data.
- Cost analysis method: The principal investigators analyze all costs incurred from activities of Tele-SSM intervention for all participants in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group: Clinical trials with a single arm
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Behavioral: Tele-SSMAll participants in the study received a supported self-management intervention for depression delivered from distance. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults aged from 18-64 years
- Have a score of PHQ-9 (26) greater than 5.
Key exclusion criteria (1 listed)
- Any participants with severe mental health problems i.e. schizophrenia, bipolar disorder, recent suicide attempts and/or with suicide plans were excluded (current suicide ideation, but without recent suicide attempts and/or with suicide plans were not excluded).
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 |
|---|---|---|
| Tele-SSMTele-SSM an individual-level psychosocial intervention based on cognitive behavior therapy principles and non-violent communication. The intervention consists of the following 10 sessions delivered through 10 weekly coaching calls delivered by Zoom (audio only). | Behavioural | Single arm |
Primary outcome
Depression
Time frame: Pre intervention and up to 12 weeks
Measured by PHQ-9 questionnaire
Acceptability
Time frame: Up to 12 weeks after pre-intervention survey
Measured by questionnaire and in-depth interviews
Feasiblity
Time frame: Up to 12 weeks after pre-intervention survey
Measured by questionnaire and in-depth interviews
Cost
Time frame: Through study completion, an average 6 months
Measured by financial reports
6 secondary outcomes
Anxiety
Time frame: Pre intervention and up to 12 weeks
Stress
Time frame: Pre intervention and up to 12 weeks
Self-esteem
Time frame: Pre intervention and up to 12 weeks
Social support
Time frame: Pre intervention and up to 12 weeks
Health related quality of life
Time frame: Pre intervention and up to 12 weeks
Knowledge, attitude and practices of people with depression
Time frame: Pre-intervention
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 13 Jun 2024.
- Background: PubMed 30947759Konig H, Konig HH, Konnopka A. The excess costs of depression: a systematic review and meta-analysis. Epidemiol Psychiatr Sci. 2019 Apr 5;29:e30. doi: 10.1017/S2045796019000180.
- Background: PubMed 32807256Christensen MK, Lim CCW, Saha S, Plana-Ripoll O, Cannon D, Presley F, Weye N, Momen NC, Whiteford HA, Iburg KM, McGrath JJ. The cost of mental disorders: a systematic review. Epidemiol Psychiatr Sci. 2020 Aug 18;29:e161. doi: 10.1017/S204579602000075X.
- Background: PubMed 30994877Cuijpers P, Noma H, Karyotaki E, Cipriani A, Furukawa TA. Effectiveness and Acceptability of Cognitive Behavior Therapy Delivery Formats in Adults With Depression: A Network Meta-analysis. JAMA Psychiatry. 2019 Jul 1;76(7):700-707. doi: 10.1001/jamapsychiatry.2019.0268.
- Background: PubMed 29352530Cuijpers P, Karyotaki E, Reijnders M, Purgato M, Barbui C. Psychotherapies for depression in low- and middle-income countries: a meta-analysis. World Psychiatry. 2018 Feb;17(1):90-101. doi: 10.1002/wps.20493.
- Background: PubMed 22480584Bilsker D, Goldner EM, Anderson E. Supported self-management: a simple, effective way to improve depression care. Can J Psychiatry. 2012 Apr;57(4):203-9. doi: 10.1177/070674371205700402.
- Background: PubMed 25583894Linde K, Sigterman K, Kriston L, Rucker G, Jamil S, Meissner K, Schneider A. Effectiveness of psychological treatments for depressive disorders in primary care: systematic review and meta-analysis. Ann Fam Med. 2015 Jan-Feb;13(1):56-68. doi: 10.1370/afm.1719.
- Background: PubMed 27712544Pasarelu CR, Andersson G, Bergman Nordgren L, Dobrean A. Internet-delivered transdiagnostic and tailored cognitive behavioral therapy for anxiety and depression: a systematic review and meta-analysis of randomized controlled trials. Cogn Behav Ther. 2017 Jan;46(1):1-28. doi: 10.1080/16506073.2016.1231219. Epub 2016 Oct 7.
- Background: PubMed 34051848Chau LW, Murphy J, Nguyen VC, Lou H, Khanh H, Thu T, Minas H, O'Neil J. Lay social workers implementing a task-sharing approach to managing depression in Vietnam. Int J Ment Health Syst. 2021 May 29;15(1):52. doi: 10.1186/s13033-021-00478-8.
- Background: PubMed 34354312Connolly SM, Vanchu-Orosco M, Warner J, Seidi PA, Edwards J, Boath E, Irgens AC. Mental health interventions by lay counsellors: a systematic review and meta-analysis. Bull World Health Organ. 2021 Aug 1;99(8):572-582. doi: 10.2471/BLT.20.269050. Epub 2021 Apr 29.
- Background: PubMed 32071614Murphy JK, Xie H, Nguyen VC, Chau LW, Oanh PT, Nhu TK, O'Neil J, Goldsmith CH, Van Hoi N, Ma Y, Lou H, Jones W, Minas H. Is supported self-management for depression effective for adults in community-based settings in Vietnam?: a modified stepped-wedge cluster randomized controlled trial. Int J Ment Health Syst. 2020 Feb 12;14:8. doi: 10.1186/s13033-020-00342-1. eCollection 2020.
- Background: PubMed 22466510Richards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012 Jun;32(4):329-42. doi: 10.1016/j.cpr.2012.02.004. Epub 2012 Feb 28.
- Background: PubMed 28476148Murphy J, Goldsmith CH, Jones W, Oanh PT, Nguyen VC. The effectiveness of a Supported Self-management task-shifting intervention for adult depression in Vietnam communities: study protocol for a randomized controlled trial. Trials. 2017 May 5;18(1):209. doi: 10.1186/s13063-017-1924-5.
- Individual participant dataSharing planned: Yes. The data of this study are available on request from the principal investigator after the outcomes of the study are published. .
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-SSM in people with Depression, run by Institute for Social Development Studies, Vietnam at 1 site in Vietnam.
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 2 inclusion and 1 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 13 Jun 2024. 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 Vietnam. 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?
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?
Depression (time frame: Pre intervention and up to 12 weeks). 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 NCT06456775, which also lists 14 linked publications.
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 13 Jun 2024.