Pulmonary HypertensionNCT05726669
Self-help Booklets for Depression in Adults With Pulmonary Hypertension.
A study testing Self-help materials for depression in people with Pulmonary Hypertension and Depression, run by Cardiff University at 1 site in United Kingdom.
Trial summary
The investigators have developed self-help booklets specifically for adults with PH who are experiencing difficulties with depression. The self-help booklets are based on a type of psychological treatment called Cognitive Behavioural Therapy or CBT for short. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Depression
- What is being tested?
- Self-help materials for depression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jun 2023to 12 Mar 2024
- 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
- Diagnosis of pulmonary hypertension
- Over the age of 18 years
- Able to complete questionnaires without help from others
- Can understand English
- They will read all study documents in detail and ask the researcher any questions they have. Based on this, they could provide informed consent to take part if they are eligible.
- Feels like they have difficulties with depression, low mood or negative thoughts.
- Not currently experiencing thoughts of self-harm or suicide. This means that they have not had thoughts of self-harm or suicide within the last month.
Who cannot join
- Current thoughts of self-harm or suicide.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiff University - however recruitment is done electronically
Cardiff, CF10 3AT
About this study
Official title: Randomised Controlled Trial of Self-help Cognitive Behavioural Therapy for Depression in Adults With Pulmonary Hypertension.
The investigators have developed self-help booklets specifically for adults with PH who are experiencing difficulties with depression. The self-help booklets are based on a type of psychological treatment called Cognitive Behavioural Therapy or CBT for short.
- CBT looks at the way people think and what they do, and how this affects their mood.
- It involves making changes to thoughts and behaviours.
- CBT can help people develop more helpful ways of coping with depression.
- CBT is one of the most effective therapies for depression, this means it works well.
Read more
There are four booklets that participants will work though weekly in their own time and at home. The aim of this study is to test whether the self-help booklets are helpful in reducing depression in people with pulmonary hypertension.
Those taking part will be asked to complete a series of questions asking about themselves including whether they are experiencing any difficulties such as depression and anxiety.
They will then be allocated at random to one of two groups. Group one will receive the self-help booklets, called the intervention group. Group two, or the wait list group, will receive the intervention at a later date if it is found to be helpful. Having two groups is very important as it will allow us to see whether benefits associated with taking part in the project was because of the self-help booklets or something else.
Participants in group one will also be contacted partway through the intervention to ask about their experiences of taking part.
Both groups will be asked to complete a series of questionnaires four weeks later and then again in one month. Participants in group one will be contacted again to find out more about their experiences of the project.
Read the detailed description
Previous research has demonstrated high rates of depression in people with pulmonary hypertension (PH). The psychological interventions that support people with depression are not made specific to people with PH and may not be relevant for them, and there is limited evidence examining psychological treatments for depression in people with PH. The aim of this study is to develop and test a self-help psychological intervention for depression based on cognitive behavioural therapy (CBT), which has been developed specifically for individuals with PH. When participants have agreed to take part, they will be allocated at random into an intervention or wait-list group. The self-help materials will be provided online (for people outside of the UK) or posted in paper form (for those living in the UK) and will take four weeks to complete at home. Both groups will complete questionnaires at the same time points (before starting the study, after four weeks and after eight weeks (pre-, post-intervention and one-month follow up). In addition, the intervention group will be contacted after two weeks of their participation and asked about their experiences of the intervention and participation in the study - measuring acceptability of the intervention. The intervention group will also be asked to complete a feedback questionnaire after completing the intervention to further examine acceptability. Analysis will be conducted by the researcher to examine whether the self-help intervention reduced depression in individuals with PH, compared to those with PH who did not receive the intervention. The potential benefit of the study includes a new intervention for depression in people with PH. When the study is completed, if the intervention is found to be helpful and safe, then the people who took part in the study and did not receive the intervention will be offered the intervention.
- Conditions
- Pulmonary Hypertension, Depression
- Being tested
- Self-help materials for depression
- Medical subject headings
- Hypertension, Pulmonary, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help materials for depressionOther
Self-help materials for depression based on cognitive behavioural therapy have been created and tailored to those with PH by researchers involved in this project, using the evidence base and theory plus clinical experience. The Medical Research Council Frameworks for complex interventions (Craig et al., 2008; Skivington et al., 2021) have been followed as well as the quality appraisal tool for self-help interventions in depression (Cape, 2015). The self-help materials will be shared for feedback with a readership panel of people with PH and caregivers who are members of Pulmonary Hypertension Association UK (a charity for people with PH) prior to being given to participants. The self-help materials will be provided online or posted in paper form to the intervention group and will take four weeks for the person to complete at home (one booklet per week).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Self-help intervention based on cognitive behavioural therapy for depression in pulmonary hypertension. There will be four booklets which will take four weeks for participants to work through in their own time at home. Receives: Other: Self-help materials for depression |
| Wait list control group | No intervention | The wait list control group will not receive the self-help intervention, and will be compared to the intervention group on the outcome measures. The wait-list control group will receive the intervention after study completion if it is found to be helpful (June 2024). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
The Patient Health Questionnaire (PHQ-8) (Kroenke et al., 2009) will be used to measure depression as the primary outcome. The minimum score is 0 and the maximum score is 24. A higher score indicates a worse outcome.
Measured: Pre-, post intervention and one month follow up. This means before starting the study, after 4 weeks and after 8 weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.
Secondary outcomes (5)
Anxiety
The Generalised Anxiety Disorder (GAD-7) (Spitzer et al., 2006) will be used to measure anxiety. The minimum score is 0 and the maximum score is 21. A higher score indicates a worse outcome.
Measured: Pre-, post intervention and one month follow up. This means before starting the study, after 4 weeks and after 8 weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.
Health-related quality of life
The emPHasis-10 (Yorke et al., 2014) will be used to measure health-related quality of life. The minimum score is 0 and maximum score is 50. A higher score indicates a worse outcome.
Measured: Pre-, post intervention and one month follow up. This means before starting the study, after 4 weeks and after 8 weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.
Fatigue
The Fatigue Severity Scale (FSS) (Learmouth et al., 2013) will be used to measure fatigue. The minimum score is 9 and the maximum score is 63. A higher score indicates a worse outcome.
Measured: Pre-, post intervention and one month follow up. This means before starting the study, after 4 weeks and after 8 weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.
Pain Self Efficacy
The Pain Self-Efficacy Questionnaire (Nicholas, 2007) will measure pain. The minimum score is 0 and the maximum score is 60. A higher score indicates a better outcome.
Measured: Pre-, post intervention and one month follow up. This means before starting the study, after four weeks and after eight weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.
Cognition and behaviours
To examine whether cognitions and behaviours have an impact on change in depression, the Cognitive Behavioural Processes Questionnaire (CBP-Q) will be used. The minimum score is 0 and the maximum score is 120. A higher score indicates a worse outcome.
Measured: Pre-, post intervention and one month follow up.This means before starting the study, after 4 weeks and after 8 weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start8 Jun 2023
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies 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
- Model description
- A randomised controlled trial (RCT) design will be used, with participants randomised on a 1:1 basis to either a CBT informed self-help intervention to help manage depression in pulmonary hypertension or a controlled wait list condition.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff University
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham Trent University
- Responsible party
- Principal investigator, Abbie Stark, Cardiff University
- Investigators
- Abbie Stark, Psychology, Principal investigator, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726669
- Sponsor's protocol ID
- PHDEP2023
- Status last verified
- Aug 2024
- First submitted
- 3 Feb 2023
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study investigators aim to publish the final report in a peer reviewed international journal and also make the anonymised data available in Cardiff University's data repository. The investigators would also like to share the findings in conferences. The data in anonymised format would be available to other researchers upon reasonable request. When the study is complete, electronic files will be stored for a minimum of 15 years by Cardiff University after the end of the project or after publication of any findings based upon the data (whichever is later). The end of project is defined as completion of project closure report or publishing of final articles. This follows Cardiff University's research records retention policy.
Publications
Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
PubMed 18752852Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Yorke J, Corris P, Gaine S, Gibbs JS, Kiely DG, Harries C, Pollock V, Armstrong I. emPHasis-10: development of a health-related quality of life measure in pulmonary hypertension. Eur Respir J. 2014 Apr;43(4):1106-13. doi: 10.1183/09031936.00127113. Epub 2013 Nov 14.
PubMed 24232702Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
PubMed 34593508Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.
PubMed 16446108Learmonth YC, Dlugonski D, Pilutti LA, Sandroff BM, Klaren R, Motl RW. Psychometric properties of the Fatigue Severity Scale and the Modified Fatigue Impact Scale. J Neurol Sci. 2013 Aug 15;331(1-2):102-7. doi: 10.1016/j.jns.2013.05.023. Epub 2013 Jun 20.
PubMed 23791482Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
PubMed 18824488
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Self-help Cognitive Behavioural Therapy for Depression in Adults With Pulmonary Hypertension.
- ClinicalTrials.gov ID
- NCT05726669
- Acronym / sponsor ID
- PHDEP2023
- Conditions
- Pulmonary Hypertension, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Cardiff UniversityUniversity, hospital or other
- Collaborators
- Nottingham Trent University
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 14 Feb 2023 (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 investigators have developed self-help booklets specifically for adults with PH who are experiencing difficulties with depression. The self-help booklets are based on a type of psychological treatment called Cognitive Behavioural Therapy or CBT for short.
- CBT looks at the way people think and what they do, and how this affects their mood.
- It involves making changes to thoughts and behaviours.
- CBT can help people develop more helpful ways of coping with depression.
- CBT is one of the most effective therapies for depression, this means it works well.
There are four booklets that participants will work though weekly in their own time and at home. The aim of this study is to test whether the self-help booklets are helpful in reducing depression in people with pulmonary hypertension.
Those taking part will be asked to complete a series of questions asking about themselves including whether they are experiencing any difficulties such as depression and anxiety.
They will then be allocated at random to one of two groups. Group one will receive the self-help booklets, called the intervention group. Group two, or the wait list group, will receive the intervention at a later date if it is found to be helpful. Having two groups is very important as it will allow us to see whether benefits associated with taking part in the project was because of the self-help booklets or something else.
Participants in group one will also be contacted partway through the intervention to ask about their experiences of taking part.
Both groups will be asked to complete a series of questionnaires four weeks later and then again in one month. Participants in group one will be contacted again to find out more about their experiences of the project.
Detailed description
Previous research has demonstrated high rates of depression in people with pulmonary hypertension (PH). The psychological interventions that support people with depression are not made specific to people with PH and may not be relevant for them, and there is limited evidence examining psychological treatments for depression in people with PH. The aim of this study is to develop and test a self-help psychological intervention for depression based on cognitive behavioural therapy (CBT), which has been developed specifically for individuals with PH. When participants have agreed to take part, they will be allocated at random into an intervention or wait-list group. The self-help materials will be provided online (for people outside of the UK) or posted in paper form (for those living in the UK) and will take four weeks to complete at home. Both groups will complete questionnaires at the same time points (before starting the study, after four weeks and after eight weeks (pre-, post-intervention and one-month follow up). In addition, the intervention group will be contacted after two weeks of their participation and asked about their experiences of the intervention and participation in the study - measuring acceptability of the intervention. The intervention group will also be asked to complete a feedback questionnaire after completing the intervention to further examine acceptability. Analysis will be conducted by the researcher to examine whether the self-help intervention reduced depression in individuals with PH, compared to those with PH who did not receive the intervention. The potential benefit of the study includes a new intervention for depression in people with PH. When the study is completed, if the intervention is found to be helpful and safe, then the people who took part in the study and did not receive the intervention will be offered the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomised controlled trial (RCT) design will be used, with participants randomised on a 1:1 basis to either a CBT informed self-help intervention to help manage depression in pulmonary hypertension or a controlled wait list condition.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Self-help materials for depressionSelf-help intervention based on cognitive behavioural therapy for depression in pulmonary hypertension. There will be four booklets which will take four weeks for participants to work through in their own time at home. |
| Wait list control group | No intervention | –The wait list control group will not receive the self-help intervention, and will be compared to the intervention group on the outcome measures. The wait-list control group will receive the intervention after study completion if it is found to be helpful (June 2024). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of pulmonary hypertension
- Over the age of 18 years
- Able to complete questionnaires without help from others
- Can understand English
- They will read all study documents in detail and ask the researcher any questions they have. Based on this, they could provide informed consent to take part if they are eligible.
Key exclusion criteria (1 listed)
- Current thoughts of self-harm or 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 |
|---|---|---|
| Self-help materials for depressionSelf-help materials for depression based on cognitive behavioural therapy have been created and tailored to those with PH by researchers involved in this project, using the evidence base and theory plus clinical experience. The Medical Research Council Frameworks for complex interventions (Craig et al., 2008; Skivington et al., 2021) have been followed as well as the quality appraisal tool for self-help interventions in depression (Cape, 2015). The self-help materials will be shared for feedback with a readership panel of people with PH and caregivers who are members of Pulmonary Hypertension Association UK (a charity for people with PH) prior to being given to participants. The self-help materials will be provided online or posted in paper form to the intervention group and will take four weeks for the person to complete at home (one booklet per week). | Other | Intervention group |
Primary outcome
Depression
Time frame: Pre-, post intervention and one month follow up. This means before starting the study, after 4 weeks and after 8 weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.
The Patient Health Questionnaire (PHQ-8) (Kroenke et al., 2009) will be used to measure depression as the primary outcome. The minimum score is 0 and the maximum score is 24. A higher score indicates a worse outcome.
5 secondary outcomes
Anxiety
Time frame: Pre-, post intervention and one month follow up. This means before starting the study, after 4 weeks and after 8 weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.
Health-related quality of life
Time frame: Pre-, post intervention and one month follow up. This means before starting the study, after 4 weeks and after 8 weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.
Fatigue
Time frame: Pre-, post intervention and one month follow up. This means before starting the study, after 4 weeks and after 8 weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.
Pain Self Efficacy
Time frame: Pre-, post intervention and one month follow up. This means before starting the study, after four weeks and after eight weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.
Cognition and behaviours
Time frame: Pre-, post intervention and one month follow up.This means before starting the study, after 4 weeks and after 8 weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.
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 20 Aug 2024.
- Results publication: PubMed 18752852Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
- Results publication: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Results publication: PubMed 24232702Yorke J, Corris P, Gaine S, Gibbs JS, Kiely DG, Harries C, Pollock V, Armstrong I. emPHasis-10: development of a health-related quality of life measure in pulmonary hypertension. Eur Respir J. 2014 Apr;43(4):1106-13. doi: 10.1183/09031936.00127113. Epub 2013 Nov 14.
- Results publication: PubMed 34593508Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
- Results publication: PubMed 16446108Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.
- Results publication: PubMed 23791482Learmonth YC, Dlugonski D, Pilutti LA, Sandroff BM, Klaren R, Motl RW. Psychometric properties of the Fatigue Severity Scale and the Modified Fatigue Impact Scale. J Neurol Sci. 2013 Aug 15;331(1-2):102-7. doi: 10.1016/j.jns.2013.05.023. Epub 2013 Jun 20.
- Results publication: PubMed 18824488Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
- Individual participant dataSharing planned: Yes. The study investigators aim to publish the final report in a peer reviewed international journal and also make the anonymised data available in Cardiff University's data repository. The investigators would also like to share the findings in conferences. The data in anonymised format would be available to other researchers upon reasonable request. When the study is complete, electronic files will be stored for a minimum of 15 years by Cardiff University after the end of the project or after publication of any findings based upon the data (whichever is later). The end of project is defined as completion of project closure report or publishing of final articles. This follows Cardiff University's research records retention policy.
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
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.
Abbie Stark, Psychology principal investigator
Cardiff University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-help materials for depression in people with Pulmonary Hypertension and Depression, run by Cardiff University at 1 site in United Kingdom.
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 7 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 20 Aug 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 United Kingdom. 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-, post intervention and one month follow up. This means before starting the study, after 4 weeks and after 8 weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.). 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 NCT05726669, which also lists 7 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 20 Aug 2024.