Social IsolationCONNECTNCT05120765
The CONNECT Program: Testing a Telephone-Based Mental Health Intervention for Older Adults
A study testing The CONNECT Program in people with Social Isolation and Loneliness, run by University of Manitoba at 1 site in Canada.
Trial summary
This study will test a telephone-based group intervention called "The CONNECT Program" which is designed for adults aged 65+ who are currently experiencing social isolation or loneliness, and symptoms of anxiety or depression. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Isolation, Loneliness, Depression
- What is being tested?
- The CONNECT Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jan 2022to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years of age or older, currently living in Manitoba, self-reporting symptoms of social isolation and/or loneliness, and self-reporting symptoms of depression and/or anxiety.
Who cannot join
- Under 65 years of age, living outside of Manitoba, being unable to provide consent independently, deafness not corrected by hearing aids (hearing is needed as this is a telephone program), an absence of self-reported symptoms of anxiety or depression, an absence of symptoms of loneliness or social isolation, self-reporting suicidal ideation or suicidal behaviours that are current, substance use or substance dependence within the past six months, bipolar I or II, psychotic disorders, and major neurocognitive disorders. Another exclusion criteria would be an individual who does not have access to a telephone, or is not comfortable using the telephone for the purpose of The CONNECT Program or The research components (i.e., the questionnaires).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Controlled Trial of The CONNECT Program: Testing a Telephone-Based Mental Health Intervention in a Clinical Sample of Socially Isolated Older Adults
This study will test a telephone-based group intervention called "The CONNECT Program" which is designed for adults aged 65+ who are currently experiencing social isolation or loneliness, and symptoms of anxiety or depression. A pilot randomized controlled trial (RCT) will be conducted to evaluate The CONNECT Program using a clinical sample of adults 65+. The goals of this research include, (a) testing the feasibility of conducting a large-scale RCT using a clinical sample of adults 65+; (b) understanding the experiences of this clinical sample of adults 65+ in The CONNECT Program; and (c) investigating the preliminary effectiveness of this program with this sample. Participants (N=16) will be randomly assigned to either the waitlist or intervention group. Both groups will receive the intervention and share their experiences in The CONNECT Program. The waitlist group will receive the intervention after the waiting period. All participants will complete questionnaires before receiving the intervention, after receiving the intervention, and each week during the intervention. This study will provide us with insight regarding what this clinical sample of participants think of The CONNECT Program, how we can improve the program in the future in order to meet the needs of this group, what changes to the study design are needed in order to execute a large-scale randomized controlled trial in the future, and if this program shows preliminary effectiveness in this sample.
Read the detailed description
The population of adults aged 65+ in Canada is increasing (Statistics Canada, 2019). Some of the most common mental health and psychosocial problems experienced by adults aged 65+ include anxiety, depression, social isolation, and loneliness. The current research will test a telephone-based group intervention called "CONNECT" which is designed for adults aged 65+ who are currently experiencing social isolation or loneliness, and symptoms of anxiety or depression. CONNECT stands for: "Creating Opportunities to build social Networks, learn New skills to manage challenging emotions Enhance mindful awareness and acceptance of emotions, and increase self-Compassion, through Telephone-based group programming". A pilot randomized controlled trial will be conducted to evaluate The CONNECT Program using a clinical sample of adults 65+ recruited from Winnipeg and Brandon.
We will use a randomized design to pilot this intervention and assess the feasibility of implementing and testing this intervention with a clinical sample of adults 65+. Participants will be randomized 1:1 to one of two conditions (1 = intervention, 2 = waitlist). The quantitative data we collect will inform us about changes in self-reported symptoms on the primary and secondary outcome measures and it will reveal information about treatment satisfaction and how participants experienced each session. Additionally, the questionnaire that will be administered after each session and the post-CONNECT questionnaire will include open-ended questions where participants can expand on their answers about treatment satisfaction and their experiences in the program.
Within one week before the first CONNECT session, all participants will complete the baseline questionnaire and will then be randomized to one of two groups (1 = intervention, 2 = waitlist). One week after the baseline questionnaire is complete, participants in the intervention group will receive six weeks of CONNECT group therapy, and participants in the waitlist group will begin the waiting period. Within one week of the last CONNECT session, all participants will complete the post-CONNECT questionnaire. Participants receiving the intervention will also complete the Group Session Rating Scale (GSRS) after each session in order to monitor the participant progress from session to session and to evaluate the group-therapy alliance. Due to the exploratory nature of this pilot RCT, participants in the waitlist group will complete the baseline questionnaire again, they will receive the intervention and complete the GSRS each week, and they will complete post-CONNECT questionnaire one week after the last session. We plan to collect this data because we want to capture the experiences of the waitlist participants both when they are waiting for the intervention and when they receive the intervention. The purpose of including a waitlist group is to help determine if the current study procedures are acceptable. This will allow us to better understand potential issues such as participant dropout, and it will help us identify changes that should be made for a future RCT.
- Conditions
- Social Isolation, Loneliness, Depression, Anxiety
- Being tested
- The CONNECT Program
- Keywords
- Mental health problems, Adults 65+, Loneliness, Social Isolation, Intervention, Telephone therapy, Group therapy, Aging, Older adults, Clinical, Acceptance and Commitment Therapy, Self-compassion, Mindfulness
- Medical subject headings
- Social Isolation, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The CONNECT ProgramBehavioural
The CONNECT Program is a 6-week, group-based, telephone-based, mental health intervention for socially isolated older adults. This group-therapy intervention is based on principles of Acceptance and Commitment Therapy (ACT). The group sessions take place once a week and they last 90 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention to be administered is "The CONNECT Program". This is a 6-week, group-based, telephone-based, mental health intervention for socially isolated older adults. This group-therapy intervention is based on principles of Acceptance and Commitment Therapy (ACT). Receives: Behavioral: The CONNECT Program |
| Waitlist | No intervention | Waitlist intervention requires participants to wait 6 weeks. This waitlist group will receive the intervention after this 6 week waiting period, due to the exploratory nature of this Pilot Randomized Controlled Trial (RCT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Satisfaction and Feedback
Measured using Group Session Rating Scale (Duncan \& Miller, 2007), and open-ended questions in the post-CONNECT questionnaire. Reference: Duncan, B., \& Miller, S. (2007). The Group Session Rating Scale. Jensen Beach, FL: Author.
Measured: Immediately after session 1, immediately after session 2, immediately after session 3, immediately after session 4, immediately after session 5, immediately after session 6, immediately after the intervention ends
Acceptance and Action Questionnaire II (AAQ-II) (Bond et al., 2011).
Measures psychological flexibility
Measured: 1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
PROMIS (Patient-Reported Outcomes Measurement Information System) Depression Short Form 4a (Cella et al., 2010; Cella et al., 2019)
Measures symptoms of depression
Measured: 1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
The PROMIS Anxiety Short Form 4a (Cella et al., 2010; Cella et al., 2019)
Measures symptoms of anxiety
Measured: 1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
Secondary outcomes (5)
Three Item Loneliness Scale (Hughes et al., 2004)
Measures feelings of loneliness
Measured: 1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
PROMIS Social Isolation 8a (Cella et al., 2010)
Measures feelings of social isolation
Measured: 1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
PROMIS Emotional Support 8a (Cella et al., 2010)
Measures emotional support
Measured: 1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
The Brief Measure of Mental Health Literacy Scale (Mackenzie & Reynolds, in preparation)
Measures mental health literacy (one's knowledge of mental health problems and services available for these mental health problems).
Measured: 1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
Demographic Information
Gender identification, age, highest level of education completed, occupational status, marital status, living arrangement, location of residence, and racial and ethnic background.
Measured: 1 week before the intervention begins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start25 Jan 2022
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Why it stopped: Change in study design was implemented and the study design no longer follows a pilot randomized controlled trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Social IsolationStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inga Christianson, University of Manitoba
- Investigators
- Inga A Christianson, BA, Principal investigator, The University of ManitobaKristin Reynolds, Ph.D., Principal investigator, The University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120765
- Sponsor's protocol ID
- HE2021-0124
- Acronym
- CONNECT
- Status last verified
- Aug 2022
- First submitted
- 17 Oct 2021
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share this data.
Publications
Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.
PubMed 22035996Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
PubMed 20685078Cella D, Choi SW, Condon DM, Schalet B, Hays RD, Rothrock NE, Yount S, Cook KF, Gershon RC, Amtmann D, DeWalt DA, Pilkonis PA, Stone AA, Weinfurt K, Reeve BB. PROMIS(R) Adult Health Profiles: Efficient Short-Form Measures of Seven Health Domains. Value Health. 2019 May;22(5):537-544. doi: 10.1016/j.jval.2019.02.004.
PubMed 31104731Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
PubMed 18504506
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of The CONNECT Program: Testing a Telephone-Based Mental Health Intervention in a Clinical Sample of Socially Isolated Older Adults
- ClinicalTrials.gov ID
- NCT05120765
- Acronym / sponsor ID
- CONNECT / HE2021-0124
- Conditions
- Social Isolation, Loneliness, Depression, Anxiety
- Keywords
- Mental health problems, Adults 65+, Loneliness, Social Isolation, Intervention, Telephone therapy, Group therapy, Aging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in study design was implemented and the study design no longer follows a pilot randomized controlled trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 15 Nov 2021 (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 test a telephone-based group intervention called "The CONNECT Program" which is designed for adults aged 65+ who are currently experiencing social isolation or loneliness, and symptoms of anxiety or depression. A pilot randomized controlled trial (RCT) will be conducted to evaluate The CONNECT Program using a clinical sample of adults 65+. The goals of this research include, (a) testing the feasibility of conducting a large-scale RCT using a clinical sample of adults 65+; (b) understanding the experiences of this clinical sample of adults 65+ in The CONNECT Program; and (c) investigating the preliminary effectiveness of this program with this sample. Participants (N=16) will be randomly assigned to either the waitlist or intervention group. Both groups will receive the intervention and share their experiences in The CONNECT Program. The waitlist group will receive the intervention after the waiting period. All participants will complete questionnaires before receiving the intervention, after receiving the intervention, and each week during the intervention. This study will provide us with insight regarding what this clinical sample of participants think of The CONNECT Program, how we can improve the program in the future in order to meet the needs of this group, what changes to the study design are needed in order to execute a large-scale randomized controlled trial in the future, and if this program shows preliminary effectiveness in this sample.
Detailed description
The population of adults aged 65+ in Canada is increasing (Statistics Canada, 2019). Some of the most common mental health and psychosocial problems experienced by adults aged 65+ include anxiety, depression, social isolation, and loneliness. The current research will test a telephone-based group intervention called "CONNECT" which is designed for adults aged 65+ who are currently experiencing social isolation or loneliness, and symptoms of anxiety or depression. CONNECT stands for: "Creating Opportunities to build social Networks, learn New skills to manage challenging emotions Enhance mindful awareness and acceptance of emotions, and increase self-Compassion, through Telephone-based group programming". A pilot randomized controlled trial will be conducted to evaluate The CONNECT Program using a clinical sample of adults 65+ recruited from Winnipeg and Brandon.
We will use a randomized design to pilot this intervention and assess the feasibility of implementing and testing this intervention with a clinical sample of adults 65+. Participants will be randomized 1:1 to one of two conditions (1 = intervention, 2 = waitlist). The quantitative data we collect will inform us about changes in self-reported symptoms on the primary and secondary outcome measures and it will reveal information about treatment satisfaction and how participants experienced each session. Additionally, the questionnaire that will be administered after each session and the post-CONNECT questionnaire will include open-ended questions where participants can expand on their answers about treatment satisfaction and their experiences in the program.
Within one week before the first CONNECT session, all participants will complete the baseline questionnaire and will then be randomized to one of two groups (1 = intervention, 2 = waitlist). One week after the baseline questionnaire is complete, participants in the intervention group will receive six weeks of CONNECT group therapy, and participants in the waitlist group will begin the waiting period. Within one week of the last CONNECT session, all participants will complete the post-CONNECT questionnaire. Participants receiving the intervention will also complete the Group Session Rating Scale (GSRS) after each session in order to monitor the participant progress from session to session and to evaluate the group-therapy alliance. Due to the exploratory nature of this pilot RCT, participants in the waitlist group will complete the baseline questionnaire again, they will receive the intervention and complete the GSRS each week, and they will complete post-CONNECT questionnaire one week after the last session. We plan to collect this data because we want to capture the experiences of the waitlist participants both when they are waiting for the intervention and when they receive the intervention. The purpose of including a waitlist group is to help determine if the current study procedures are acceptable. This will allow us to better understand potential issues such as participant dropout, and it will help us identify changes that should be made for a future RCT.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: The CONNECT ProgramIntervention to be administered is "The CONNECT Program". This is a 6-week, group-based, telephone-based, mental health intervention for socially isolated older adults. This group-therapy intervention is based on principles of Acceptance and Commitment Therapy (ACT). |
| Waitlist | No intervention | –Waitlist intervention requires participants to wait 6 weeks. This waitlist group will receive the intervention after this 6 week waiting period, due to the exploratory nature of this Pilot Randomized Controlled Trial (RCT). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 65 years of age or older, currently living in Manitoba, self-reporting symptoms of social isolation and/or loneliness, and self-reporting symptoms of depression and/or anxiety.
Key exclusion criteria (1 listed)
- Under 65 years of age, living outside of Manitoba, being unable to provide consent independently, deafness not corrected by hearing aids (hearing is needed as this is a telephone program), an absence of self-reported symptoms of anxiety or depression, an absence of symptoms of loneliness or social isolation, self-reporting suicidal ideation or suicidal behaviours that are current, substance use or substance dependence within the past six months, bipolar I or II, psychotic disorders, and major neurocognitive disorders. Another exclusion criteria would be an individual who does not have access to a telephone, or is not comfortable using the telephone for the purpose of The CONNECT Program or The research components (i.e., the questionnaires).
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 |
|---|---|---|
| The CONNECT ProgramThe CONNECT Program is a 6-week, group-based, telephone-based, mental health intervention for socially isolated older adults. This group-therapy intervention is based on principles of Acceptance and Commitment Therapy (ACT). The group sessions take place once a week and they last 90 minutes each. | Behavioural | Intervention |
Primary outcome
Treatment Satisfaction and Feedback
Time frame: Immediately after session 1, immediately after session 2, immediately after session 3, immediately after session 4, immediately after session 5, immediately after session 6, immediately after the intervention ends
Measured using Group Session Rating Scale (Duncan \& Miller, 2007), and open-ended questions in the post-CONNECT questionnaire. Reference: Duncan, B., \& Miller, S. (2007). The Group Session Rating Scale. Jensen Beach, FL: Author.
Acceptance and Action Questionnaire II (AAQ-II) (Bond et al., 2011).
Time frame: 1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
Measures psychological flexibility
PROMIS (Patient-Reported Outcomes Measurement Information System) Depression Short Form 4a (Cella et al., 2010; Cella et al., 2019)
Time frame: 1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
Measures symptoms of depression
The PROMIS Anxiety Short Form 4a (Cella et al., 2010; Cella et al., 2019)
Time frame: 1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
Measures symptoms of anxiety
5 secondary outcomes
Three Item Loneliness Scale (Hughes et al., 2004)
Time frame: 1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
PROMIS Social Isolation 8a (Cella et al., 2010)
Time frame: 1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
PROMIS Emotional Support 8a (Cella et al., 2010)
Time frame: 1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
The Brief Measure of Mental Health Literacy Scale (Mackenzie & Reynolds, in preparation)
Time frame: 1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
Demographic Information
Time frame: 1 week before the intervention begins
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Background: PubMed 22035996Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.
- Background: PubMed 20685078Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
- Background: PubMed 31104731Cella D, Choi SW, Condon DM, Schalet B, Hays RD, Rothrock NE, Yount S, Cook KF, Gershon RC, Amtmann D, DeWalt DA, Pilkonis PA, Stone AA, Weinfurt K, Reeve BB. PROMIS(R) Adult Health Profiles: Efficient Short-Form Measures of Seven Health Domains. Value Health. 2019 May;22(5):537-544. doi: 10.1016/j.jval.2019.02.004.
- Background: PubMed 18504506Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
- Statistics Canada. (2019). Population Projections: Canada, provinces, and territories, 2018 to 2068. Statistics Canada.Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share this data.
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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.
Inga A Christianson, BA principal investigator
The University of Manitoba
Kristin Reynolds, Ph.D. principal investigator
The University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The CONNECT Program in people with Social Isolation and Loneliness, run by University of Manitoba at 1 site in Canada.
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 1 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: withdrawn, as of the sponsor's last update on 26 Aug 2022. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Treatment Satisfaction and Feedback (time frame: Immediately after session 1, immediately after session 2, immediately after session 3, immediately after session 4, immediately after session 5, immediately after session 6, immediately after the intervention ends). 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 NCT05120765, which also lists 4 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 26 Aug 2022.