Military Family(EFFRT)NCT05726539
The Military Spouse Resiliency Group (MSRG) Peer Support Program: Equipping Families For Resiliency With Tools
A study testing Group-based peer support in people with Military Family, run by University of Texas at Austin at 1 site in United States.
Trial summary
This study will adapt and test an established peer support program for military spouses that offers them significant weekly group-based support on an array of topics that affect their lives. The curriculum will be able to be used in-person through group meetings or virtually by using a web-based meeting platform. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Military Family
- What is being tested?
- Group-based peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to 15 Dec 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be married to or in a committed relationship with a service member stationed at Fort Hood;
- Participants must have a reasonable expectation of remaining at Fort Hood for at least 4 months.
- Participants must be willing to attend up to 10 sessions of a military spouse peer support group in person at Fort Hood.
Who cannot join
- Spouses who are separated or divorced from a service member are not eligible to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Austin
Austin, Texas, 78701
Elisa Borah, PhD, 512-639-8989, elisa.borah@austin.utexas.edu
About this study
Official title: The Military Spouse Resiliency Group (MSRG) Peer Support Program: Equipping Families For Resiliency With Tools (EFFRT)
This study will adapt and test an established peer support program for military spouses that offers them significant weekly group-based support on an array of topics that affect their lives. The curriculum will be able to be used in-person through group meetings or virtually by using a web-based meeting platform. The near-term impact of this study is that scientific knowledge will be developed about how well a curriculum-based, weekly, in-person support group for military spouses is effective in improving spouses' quality of life, mental health, social support and knowledge of health conditions impacting service members.
This study will assess whether offering military spouses support for coping with their mental health and social support needs to achieve a greater quality of life, a greater sense of social support and knowledge about and access to resources to address a range of issues they may be facing throughout their spouses' military careers. By educating them about the health conditions their service members may experience and how to support their recovery and access to treatment, service members will also benefit by having more familial support for seeking treatment. Educating family members about the injuries that SMs face will help to maintain stronger family relationships and reduce family relationship stress.
Read the detailed description
This study will examine the impact of structured, evidence-based peer support group adapted to address the specific concerns of military spouses designed to increase social support, reduce depression and increase knowledge of SM health needs. Research Plan: This study will address Specific Aim 1:To adapt an existing veteran spouse peer support curriculum for active-duty spouses based on data collected from focus groups and interviews with military spouses, and Specific Aim 2: Conduct a randomized controlled trial (N = 150) to evaluate how military spouses' participation in a peer support group influences their mental health, quality of life and social support outcomes as well as improves their knowledge about psychological health problems faced by SMs and their confidence in supporting SM access to treatment. Hypothesis 1: Military spouses and significant others who participate in the Military Spouse Resiliency Group (M-SRG) program will show improved quality of life, sense of social support, self-care practices and depression symptoms.Hypothesis 2: After completing M-SRG participants will possess greater knowledge of common SM psychological health problems and greater confidence in how to support SMs' access to care.Impact: The near-term impact of this study and its products are that scientific knowledge will be developed about how well a curriculum-based, weekly, in-person support group for military spouses is effective in improving spouses' quality of life, mental health, social support and knowledge of health conditions impacting service members. The long-term impact of this study will be to offer ongoing, necessary health and social support to spouses through peer support groups. Equipping spouses with skills to address the mental health and healthcare needs of SMs will provide spouses necessary supports for their unique experiences as part of military life.
- Conditions
- Military Family
- Being tested
- Group-based peer support
- Keywords
- military spouse, peer support, quality of life, social support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based peer supportBehavioural
Receipt of semi-structured curriculum based group peer support that addresses common concerns of military spouses
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | participants receive group-based peer support Receives: Behavioral: Group-based peer support |
| Waitlist | No intervention | participants wait to receive peer support until pre and post assessments are complete with their matched intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Enjoyment and Satisfaction Questionnaire (Short Form) (Q-LES-Q-SF)
The Quality of Life Enjoyment and Satisfaction Questionnaire measures satisfaction and enjoyment in different areas of daily functioning.
Measured: Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Short Form) (Q-LES-Q-SF) from baseline, 2-weeks, 3 months
Patient Health Questionnaire-9
The Patient Health Questionnaire-9 measures symptoms of depression.
Measured: Change in Patient Health Questionnaire-9 from baseline, 2-weeks, and 3-months
Military Spouse Self-Care Inventory (MSSCI)
The Military Spouse Self-Care Inventory assesses five domains of self-care that military spouses regularly practice.
Measured: Change in Military Spouse Self-Care Inventory from baseline, 2-weeks, and 3-months
Interpersonal Support Evaluation List-12 (ISEL-12)
The Interpersonal Support Evaluation List-12 is used to measure perceived social support. It has been widely used (Donoho et al., 2017) as a short-form measure of the traditional ISEL, which measures perceived social support (Cohen et al., 1985).
Measured: Change in Interpersonal Support Evaluation List-12 from baseline, 2-weeks, and 3-months
Psychological Health Knowledge Assessment
Investigator-developed assessment of common psychological health concerns and available treatments commonly affecting service members
Measured: Change in Psychological Health Knowledge Assessment from baseline, 2-weeks, and 3-months
General Anxiety Disorder-7 (GAD-7)
General Anxiety Disorder-7 is a valid and reliable instrument to measure generalized anxiety (Spitzer et al., 2006). Minimum is 0 and maximum is 21 and higher scores indicate more severe anxiety.
Measured: Change in General Anxiety Disorder-7 from baseline, 2-weeks, and 3-months
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 start5 Feb 2024 (estimated)
- Primary completion5 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Military FamilyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa Borah, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726539
- Sponsor's protocol ID
- STUDY00003159
- Acronym
- (EFFRT)
- Status last verified
- Nov 2023
- First submitted
- 2 Jan 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barlow JH, Turner AP, Wright CC. A randomized controlled study of the Arthritis Self-Management Programme in the UK. Health Educ Res. 2000 Dec;15(6):665-80. doi: 10.1093/her/15.6.665.
PubMed 11142075Campbell SB, Renshaw KD. PTSD symptoms, disclosure, and relationship distress: explorations of mediation and associations over time. J Anxiety Disord. 2013 Jun;27(5):494-502. doi: 10.1016/j.janxdis.2013.06.007. Epub 2013 Jul 9.
PubMed 23917126Donoho CJ, LeardMann C, O'Malley CA, Walter KH, Riviere LA, Curry JF, Adler AB. Depression among military spouses: Demographic, military, and service member psychological health risk factors. Depress Anxiety. 2018 Dec;35(12):1137-1144. doi: 10.1002/da.22820. Epub 2018 Aug 13.
PubMed 30103266Eaton KM, Hoge CW, Messer SC, Whitt AA, Cabrera OA, McGurk D, Cox A, Castro CA. Prevalence of mental health problems, treatment need, and barriers to care among primary care-seeking spouses of military service members involved in Iraq and Afghanistan deployments. Mil Med. 2008 Nov;173(11):1051-6. doi: 10.7205/milmed.173.11.1051.
PubMed 19055177Griffiths C, Motlib J, Azad A, Ramsay J, Eldridge S, Feder G, Khanam R, Munni R, Garrett M, Turner A, Barlow J. Randomised controlled trial of a lay-led self-management programme for Bangladeshi patients with chronic disease. Br J Gen Pract. 2005 Nov;55(520):831-7.
PubMed 16281998Humphreys K, Wing S, McCarty D, Chappel J, Gallant L, Haberle B, Horvath AT, Kaskutas LA, Kirk T, Kivlahan D, Laudet A, McCrady BS, McLellan AT, Morgenstern J, Townsend M, Weiss R. Self-help organizations for alcohol and drug problems: toward evidence-based practice and policy. J Subst Abuse Treat. 2004 Apr;26(3):151-8; discussion 159-65. doi: 10.1016/S0740-5472(03)00212-5.
PubMed 15063905Kees M, Rosenblum K. Evaluation of a psychological health and resilience intervention for military spouses: A pilot study. Psychol Serv. 2015 Aug;12(3):222-30. doi: 10.1037/ser0000035.
PubMed 26213791Kennedy A, Reeves D, Bower P, Lee V, Middleton E, Richardson G, Gardner C, Gately C, Rogers A. The effectiveness and cost effectiveness of a national lay-led self care support programme for patients with long-term conditions: a pragmatic randomised controlled trial. J Epidemiol Community Health. 2007 Mar;61(3):254-61. doi: 10.1136/jech.2006.053538.
PubMed 17325405Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Lester P, Peterson K, Reeves J, Knauss L, Glover D, Mogil C, Duan N, Saltzman W, Pynoos R, Wilt K, Beardslee W. The long war and parental combat deployment: effects on military children and at-home spouses. J Am Acad Child Adolesc Psychiatry. 2010 Apr;49(4):310-20.
PubMed 20410724Long JA, Jahnle EC, Richardson DM, Loewenstein G, Volpp KG. Peer mentoring and financial incentives to improve glucose control in African American veterans: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):416-24. doi: 10.7326/0003-4819-156-6-201203200-00004.
PubMed 22431674Mailey EL, Mershon C, Joyce J, Irwin BC. "Everything else comes first": a mixed-methods analysis of barriers to health behaviors among military spouses. BMC Public Health. 2018 Aug 15;18(1):1013. doi: 10.1186/s12889-018-5938-z.
PubMed 30111307Pfeiffer PN, Heisler M, Piette JD, Rogers MA, Valenstein M. Efficacy of peer support interventions for depression: a meta-analysis. Gen Hosp Psychiatry. 2011 Jan-Feb;33(1):29-36. doi: 10.1016/j.genhosppsych.2010.10.002. Epub 2010 Nov 13.
PubMed 21353125Pflieger JC, LeardMann CA, McMaster HS, Donoho CJ, Riviere LA; Millennium Cohort Family Study Team. The Impact of Military and Nonmilitary Experiences on Marriage: Examining the Military Spouse's Perspective. J Trauma Stress. 2018 Oct;31(5):719-729. doi: 10.1002/jts.22321. Epub 2018 Oct 19.
PubMed 30338551Schulz U, Pischke CR, Weidner G, Daubenmier J, Elliot-Eller M, Scherwitz L, Bullinger M, Ornish D. Social support group attendance is related to blood pressure, health behaviours, and quality of life in the Multicenter Lifestyle Demonstration Project. Psychol Health Med. 2008 Aug;13(4):423-37. doi: 10.1080/13548500701660442.
PubMed 18825581
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Military Spouse Resiliency Group (MSRG) Peer Support Program: Equipping Families For Resiliency With Tools (EFFRT)
- ClinicalTrials.gov ID
- NCT05726539
- Acronym / sponsor ID
- (EFFRT) / STUDY00003159
- Conditions
- Military Family
- Keywords
- military spouse, peer support, quality of life, social support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 5 Feb 2024 (estimated)
- Primary completion
- 5 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- 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.
This study will adapt and test an established peer support program for military spouses that offers them significant weekly group-based support on an array of topics that affect their lives. The curriculum will be able to be used in-person through group meetings or virtually by using a web-based meeting platform. The near-term impact of this study is that scientific knowledge will be developed about how well a curriculum-based, weekly, in-person support group for military spouses is effective in improving spouses' quality of life, mental health, social support and knowledge of health conditions impacting service members.
This study will assess whether offering military spouses support for coping with their mental health and social support needs to achieve a greater quality of life, a greater sense of social support and knowledge about and access to resources to address a range of issues they may be facing throughout their spouses' military careers. By educating them about the health conditions their service members may experience and how to support their recovery and access to treatment, service members will also benefit by having more familial support for seeking treatment. Educating family members about the injuries that SMs face will help to maintain stronger family relationships and reduce family relationship stress.
Detailed description
This study will examine the impact of structured, evidence-based peer support group adapted to address the specific concerns of military spouses designed to increase social support, reduce depression and increase knowledge of SM health needs. Research Plan: This study will address Specific Aim 1:To adapt an existing veteran spouse peer support curriculum for active-duty spouses based on data collected from focus groups and interviews with military spouses, and Specific Aim 2: Conduct a randomized controlled trial (N = 150) to evaluate how military spouses' participation in a peer support group influences their mental health, quality of life and social support outcomes as well as improves their knowledge about psychological health problems faced by SMs and their confidence in supporting SM access to treatment. Hypothesis 1: Military spouses and significant others who participate in the Military Spouse Resiliency Group (M-SRG) program will show improved quality of life, sense of social support, self-care practices and depression symptoms.Hypothesis 2: After completing M-SRG participants will possess greater knowledge of common SM psychological health problems and greater confidence in how to support SMs' access to care.Impact: The near-term impact of this study and its products are that scientific knowledge will be developed about how well a curriculum-based, weekly, in-person support group for military spouses is effective in improving spouses' quality of life, mental health, social support and knowledge of health conditions impacting service members. The long-term impact of this study will be to offer ongoing, necessary health and social support to spouses through peer support groups. Equipping spouses with skills to address the mental health and healthcare needs of SMs will provide spouses necessary supports for their unique experiences as part of military life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Group-based peer supportparticipants receive group-based peer support |
| Waitlist | No intervention | –participants wait to receive peer support until pre and post assessments are complete with their matched intervention group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be married to or in a committed relationship with a service member stationed at Fort Hood;
- Participants must have a reasonable expectation of remaining at Fort Hood for at least 4 months.
- Participants must be willing to attend up to 10 sessions of a military spouse peer support group in person at Fort Hood.
Key exclusion criteria (1 listed)
- Spouses who are separated or divorced from a service member are not eligible to participate.
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 |
|---|---|---|
| Group-based peer supportReceipt of semi-structured curriculum based group peer support that addresses common concerns of military spouses | Behavioural | Intervention |
Primary outcome
Quality of Life Enjoyment and Satisfaction Questionnaire (Short Form) (Q-LES-Q-SF)
Time frame: Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Short Form) (Q-LES-Q-SF) from baseline, 2-weeks, 3 months
The Quality of Life Enjoyment and Satisfaction Questionnaire measures satisfaction and enjoyment in different areas of daily functioning.
Patient Health Questionnaire-9
Time frame: Change in Patient Health Questionnaire-9 from baseline, 2-weeks, and 3-months
The Patient Health Questionnaire-9 measures symptoms of depression.
Military Spouse Self-Care Inventory (MSSCI)
Time frame: Change in Military Spouse Self-Care Inventory from baseline, 2-weeks, and 3-months
The Military Spouse Self-Care Inventory assesses five domains of self-care that military spouses regularly practice.
Interpersonal Support Evaluation List-12 (ISEL-12)
Time frame: Change in Interpersonal Support Evaluation List-12 from baseline, 2-weeks, and 3-months
The Interpersonal Support Evaluation List-12 is used to measure perceived social support. It has been widely used (Donoho et al., 2017) as a short-form measure of the traditional ISEL, which measures perceived social support (Cohen et al., 1985).
Psychological Health Knowledge Assessment
Time frame: Change in Psychological Health Knowledge Assessment from baseline, 2-weeks, and 3-months
Investigator-developed assessment of common psychological health concerns and available treatments commonly affecting service members
General Anxiety Disorder-7 (GAD-7)
Time frame: Change in General Anxiety Disorder-7 from baseline, 2-weeks, and 3-months
General Anxiety Disorder-7 is a valid and reliable instrument to measure generalized anxiety (Spitzer et al., 2006). Minimum is 0 and maximum is 21 and higher scores indicate more severe anxiety.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Background: PubMed 11142075Barlow JH, Turner AP, Wright CC. A randomized controlled study of the Arthritis Self-Management Programme in the UK. Health Educ Res. 2000 Dec;15(6):665-80. doi: 10.1093/her/15.6.665.
- Background: PubMed 23917126Campbell SB, Renshaw KD. PTSD symptoms, disclosure, and relationship distress: explorations of mediation and associations over time. J Anxiety Disord. 2013 Jun;27(5):494-502. doi: 10.1016/j.janxdis.2013.06.007. Epub 2013 Jul 9.
- Background: PubMed 30103266Donoho CJ, LeardMann C, O'Malley CA, Walter KH, Riviere LA, Curry JF, Adler AB. Depression among military spouses: Demographic, military, and service member psychological health risk factors. Depress Anxiety. 2018 Dec;35(12):1137-1144. doi: 10.1002/da.22820. Epub 2018 Aug 13.
- Background: PubMed 19055177Eaton KM, Hoge CW, Messer SC, Whitt AA, Cabrera OA, McGurk D, Cox A, Castro CA. Prevalence of mental health problems, treatment need, and barriers to care among primary care-seeking spouses of military service members involved in Iraq and Afghanistan deployments. Mil Med. 2008 Nov;173(11):1051-6. doi: 10.7205/milmed.173.11.1051.
- Background: PubMed 16281998Griffiths C, Motlib J, Azad A, Ramsay J, Eldridge S, Feder G, Khanam R, Munni R, Garrett M, Turner A, Barlow J. Randomised controlled trial of a lay-led self-management programme for Bangladeshi patients with chronic disease. Br J Gen Pract. 2005 Nov;55(520):831-7.
- Background: PubMed 15063905Humphreys K, Wing S, McCarty D, Chappel J, Gallant L, Haberle B, Horvath AT, Kaskutas LA, Kirk T, Kivlahan D, Laudet A, McCrady BS, McLellan AT, Morgenstern J, Townsend M, Weiss R. Self-help organizations for alcohol and drug problems: toward evidence-based practice and policy. J Subst Abuse Treat. 2004 Apr;26(3):151-8; discussion 159-65. doi: 10.1016/S0740-5472(03)00212-5.
- Background: PubMed 26213791Kees M, Rosenblum K. Evaluation of a psychological health and resilience intervention for military spouses: A pilot study. Psychol Serv. 2015 Aug;12(3):222-30. doi: 10.1037/ser0000035.
- Background: PubMed 17325405Kennedy A, Reeves D, Bower P, Lee V, Middleton E, Richardson G, Gardner C, Gately C, Rogers A. The effectiveness and cost effectiveness of a national lay-led self care support programme for patients with long-term conditions: a pragmatic randomised controlled trial. J Epidemiol Community Health. 2007 Mar;61(3):254-61. doi: 10.1136/jech.2006.053538.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 20410724Lester P, Peterson K, Reeves J, Knauss L, Glover D, Mogil C, Duan N, Saltzman W, Pynoos R, Wilt K, Beardslee W. The long war and parental combat deployment: effects on military children and at-home spouses. J Am Acad Child Adolesc Psychiatry. 2010 Apr;49(4):310-20.
- Background: PubMed 22431674Long JA, Jahnle EC, Richardson DM, Loewenstein G, Volpp KG. Peer mentoring and financial incentives to improve glucose control in African American veterans: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):416-24. doi: 10.7326/0003-4819-156-6-201203200-00004.
- Background: PubMed 30111307Mailey EL, Mershon C, Joyce J, Irwin BC. "Everything else comes first": a mixed-methods analysis of barriers to health behaviors among military spouses. BMC Public Health. 2018 Aug 15;18(1):1013. doi: 10.1186/s12889-018-5938-z.
- Individual participant dataSharing planned: No
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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.
Elisa Borah, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based peer support in people with Military Family, run by University of Texas at Austin at 1 site in United States.
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 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: status not confirmed, as of the sponsor's last update on 1 Dec 2023. 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 States. 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 Elisa V Borah, PhD (5126398989, elisa.borah@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Enjoyment and Satisfaction Questionnaire (Short Form) (Q-LES-Q-SF) (time frame: Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Short Form) (Q-LES-Q-SF) from baseline, 2-weeks, 3 months). The study lists 6 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 NCT05726539, which also lists 19 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 1 Dec 2023.