Spinal Cord InjuriesNCT03390140
ReInventing Yourself After SCI: an Intervention to Improve Outcomes After Spinal Cord Injury
A study testing ReInventing Yourself after SCI structured group CBT, ReInventing Yourself after SCI study-specific workbook and ReInventing Yourself after SCI YouTube videos in people with Spinal Cord Injuries, run by Craig Hospital at 3 sites in United States.
Trial summary
The primary goal of this study is to conduct a multi-site RCT to evaluate the replicability and efficacy of the ReInventing Yourself after SCI intervention in improving health and function outcomes for persons with spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- ReInventing Yourself after SCI structured group CBT, ReInventing Yourself after SCI study-specific workbook and ReInventing Yourself after SCI YouTube videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Jul 2018to 1 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of spinal cord injury/disorder (SCI/D) at any neurological level
- At least 4 weeks post-discharge from initial inpatient rehabilitation
- English speaking in order to complete study measures and participate in group interactions
- Access to the internet and a laptop/desktop computer/smartphone with webcam and the ability and willingness to download Zoom software to join a video conference
- Able to provide informed consent to participate.
Who cannot join
- Diagnosed with MS, Lupus, ALS, or Spina Bifida
- History of moderate or severe traumatic brain injury
- Current participation in another RCT
- Unable to verbally communicate
- Unable to attend group sessions
- Active participation in another formal clinical group or psychological therapy
- Currently experiencing moderately severe or greater levels of depressive symptoms which would require more intense treatment than is provided in this intervention, as evidenced by a score of 15 or higher on the PHQ-9
- Has any medical or psychological condition that, in the judgment of the investigators, precludes successful participation in the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109
Craig Hospital
Englewood, Colorado, 80113
Kessler Foundation
West Orange, New Jersey, 07052
About this study
Official title: ReInventing Yourself After SCI: A Multi-site Randomized Controlled Trial of an Intervention to Improve Outcomes After Spinal Cord Injury
The primary goal of this study is to conduct a multi-site RCT to evaluate the replicability and efficacy of the ReInventing Yourself after SCI intervention in improving health and function outcomes for persons with spinal cord injury (SCI). A total of 252 participants will be randomized to one of three research arms: 1) Group treatment plus workbook (Group), 2) individual self-study through YouTube video plus workbook (Indiv), and 3) no treatment, no workbook (Control). Participants randomized to the Group arm will attend 6 virtual weekly group sessions led by a pair of group facilitators and will utilize the study workbook. Indiv arm participants will receive the workbook and will be instructed to independently access YouTube videos of the group session content. Control arm participants will not receive any intervention during the 6 week period. Participants in all three arms will be assessed at identical time points throughout the study: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks, and 46 weeks.
It is hypothesized that individuals in the Group intervention arm will show greater improvements after the six week intervention in SCI-specific and general self-efficacy, emotional well-being, increased societal participation, less depressive and anxiety symptomatology, and improved resilience than participants in the Indiv and Control arms.
Read the detailed description
The purpose of this study is to conduct a multi-site randomized controlled trial (RCT) to evaluate the replicability and efficacy of a structured six-week, manualized, group therapy intervention, ReInventing Yourself after SCI that delivers positive psychology concepts within a cognitive behavioral therapy (CBT)-based model. The goals of this RCT are to increase SCI-specific and general self-efficacy, enhance emotional well-being, and improve participation in society for people with SCI living in the community. Craig Hospital is the lead site for this study, collaborating with the University of Michigan, Ann Arbor, and Kessler Institute for Rehabilitation in New Jersey.
The intervention is delivered through six sessions, each lasting approximately 2 hours. Eight skills are presented over the course of the intervention to address reframing a person's method of looking at events, building confidence by focusing on personal strengths, developing methods of recognizing and appreciating the good in one's life and expressing gratitude for positive attributes. These skills are presented in a specific sequence through a workbook so that participants can gain mastery of introductory concepts before undertaking those that are both more difficult and complex.
The RCT will have three research arms: 1) Group treatment plus workbook (Group), 2) individual self-study through YouTube video plus workbook (Indiv), and 3) no group or individual sessions, no workbook (Control). It is hypothesized that presenting the positive psychotherapy topics in an interactive structured CBT group format while restructuring maladaptive thought processes and providing experiential opportunities to reinforce behavioral change will result in increased self-efficacy, enhanced well-being and improved societal participation. Three specific hypotheses will be tested:
Hypothesis 1 (Primary): Individuals in the Group arm will show greater improvements after the six week intervention in SCI-specific and general self-efficacy, emotional well-being, increased societal participation, less depressive and anxiety symptomatology, and improved resilience than participants in the Indiv and Control arms.
Hypothesis 2 (Secondary): Individuals in the Group arm will maintain greater improvements through 46 weeks post-intervention in SCI-specific self-efficacy than participants in the Indiv and Control arms.
Hypothesis 3 (Secondary): Individuals in the Group arm will show greater improvements after six weeks of treatment and through 46 weeks post-intervention in general self-efficacy, life satisfaction, community participation, resilience, and less depressive and anxiety symptomatology than participants in the Indiv and Control groups.
The Moorong Self-Efficacy Scale (MSES) will serve as the primary outcome measure for this study. Secondary outcome measures include the General Self-Efficacy Scale, Diener Satisfaction with Life Scale, and measures of participation, resilience, anxiety and depression.
Each collaborating site will enroll 84 individuals to be randomized into one of the three study arms in waves of 21 people per wave (up to 6 waves per site). Training of site facilitators will take place at Craig Hospital.
- Conditions
- Spinal Cord Injuries
- Being tested
- ReInventing Yourself after SCI structured group CBT, ReInventing Yourself after SCI study-specific workbook, ReInventing Yourself after SCI YouTube videos
- Keywords
- Spinal Cord Injuries, Group Intervention, Self Efficacy
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReInventing Yourself after SCI structured group CBTBehavioural
ReInventing Yourself after SCI intervention integrates positive psychotherapy concepts into structured group cognitive behavioral therapy (CBT) to develop optimistic self-efficacy beliefs, thereby strengthening resilience to emotional distress, enhancing a sense of well-being and promoting a more active lifestyle. The intervention consists of six weekly two-hour facilitator-led sessions that include didactic presentations of eight core skills and related experiential exercises with extensive group discussion.
ReInventing Yourself after SCI study-specific workbookBehavioural
A study-specific workbook that incorporates positive psychotherapy concepts to develop optimistic self-efficacy beliefs, thereby strengthening resilience to emotional distress, enhancing a sense of well-being and promoting a more active lifestyle.
ReInventing Yourself after SCI YouTube videosBehavioural
YouTube videos containing the content of the ReInventing Yourself after SCI structured group CBT sessions
| Study group | Role | What they receive |
|---|---|---|
| Group | Experimental | ReInventing Yourself after SCI structured group CBT and ReInventing Yourself after SCI study-specific workbook Receives: Behavioral: ReInventing Yourself after SCI structured group CBT; Behavioral: ReInventing Yourself after SCI study-specific workbook |
| Indiv | Active comparator | ReInventing Yourself after SCI study-specific workbook and ReInventing Yourself after SCI YouTube videos Receives: Behavioral: ReInventing Yourself after SCI study-specific workbook; Behavioral: ReInventing Yourself after SCI YouTube videos |
| Control | No intervention | No group sessions, no YouTube videos, no workbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moorong Self-Efficacy Scale (MSES) - assessing change over time
The MSES is a 16 item self-report measure of self-efficacy related to everyday life activities, designed specifically for persons with SCI. Individuals use a 7-point Likert scale ranging from 1 (very uncertain) to 7 (very certain) to rate their ability to perform 16 everyday tasks, with higher scores representing greater perceived self-efficacy. A Total Score, ranging from 16 to 112 is calculated by summing all item responses
Measured: The MSES will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
Secondary outcomes (6)
Generalized Self-Efficacy Scale (GSES)- assessing change over time
The GSES is a questionnaire designed to assess a person's ability to cope with a variety of difficult demands in life, with ten items scored using a Likert rating scale, ranging from 1 (not at all true) to 4 (exactly true).
Measured: The GSES will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
Diener Satisfaction with Life Scale (SWLS)- assessing change over time
The SWLS will be used to measure global life satisfaction. This is a five item measure on which respondents rate their life satisfaction using a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). A Total Score is calculated by summing each of the items, and has a range of 5 to 35, with higher scores representing greater perceived QoL.
Measured: The SWLS will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
Participation Assessment with Recombined Tools - Objective (PART-O)- assessing change over time
The PART-O is a 24-item assessment of participation and has demonstrated good psychometric properties in measuring participation for people living with disabilities. An Averaged Total Score is computed by taking the mean of 17 items, with scores ranging from 0 (never participate in these types of activities) to 5 (almost always participate in these types of activities), with higher scores representing greater participation. This assessment will be utilized to measure overall participation.
Measured: The PART-O will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
Patient Health Questionnaire - 9 (PHQ-9)- assessing change over time
The PHQ-9 is a 9 item scale that will be used to assess depression. Respondents rate the frequency at which specific problems have been bothersome during the past two weeks, using a four point scale ranging from 0 (not at all) to 3 (nearly every day). A Total Score is calculated by summing all items, with higher scores indicating an increasing severity of depression.
Measured: The PHQ-9 will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
General Anxiety Disorder 7-item (GAD-7)- assessing change over time
The GAD-7 is a brief 7 item measure that will be used to assess the severity of general anxiety. Using a four point Likert scale ranging from 0 (not at all sure) to 3 (nearly every day), respondents rate how often they have been bothered by specific symptoms during the past two weeks. A Total Severity Score, ranging from 0 to 21, is calculated by summing all items.
Measured: The GAD-7 will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
The Connor-Davidson Resilience Scale (CD-RISC 10) short form- assessing change over time
The CD-RISC 10 will be used to measure resilience. The measure consists of 10 items using a 5-point Likert scale ranging from 0 (not true at all) to 4 (true nearly all of the time). The scale measures how the participant felt over the past month. The questionnaire produces an overall resilience score that ranges from 0-40, with higher scores representing greater resilience.
Measured: The CD-RISC 10 will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start22 Jul 2018
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Kessler Foundation
- Responsible party
- Sponsor
- Investigators
- Susan Charlifue, PhD, Principal investigator, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390140
- Sponsor's protocol ID
- 90DPHF0002-01-00
- Status last verified
- Jun 2022
- First submitted
- 27 Dec 2017
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReInventing Yourself After SCI: A Multi-site Randomized Controlled Trial of an Intervention to Improve Outcomes After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03390140
- Acronym / sponsor ID
- 90DPHF0002-01-00
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injuries, Group Intervention, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Collaborators
- University of Michigan, Kessler Foundation
- Study start
- 22 Jul 2018 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 4 Jan 2018 (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 primary goal of this study is to conduct a multi-site RCT to evaluate the replicability and efficacy of the ReInventing Yourself after SCI intervention in improving health and function outcomes for persons with spinal cord injury (SCI). A total of 252 participants will be randomized to one of three research arms: 1) Group treatment plus workbook (Group), 2) individual self-study through YouTube video plus workbook (Indiv), and 3) no treatment, no workbook (Control). Participants randomized to the Group arm will attend 6 virtual weekly group sessions led by a pair of group facilitators and will utilize the study workbook. Indiv arm participants will receive the workbook and will be instructed to independently access YouTube videos of the group session content. Control arm participants will not receive any intervention during the 6 week period. Participants in all three arms will be assessed at identical time points throughout the study: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks, and 46 weeks.
It is hypothesized that individuals in the Group intervention arm will show greater improvements after the six week intervention in SCI-specific and general self-efficacy, emotional well-being, increased societal participation, less depressive and anxiety symptomatology, and improved resilience than participants in the Indiv and Control arms.
Detailed description
The purpose of this study is to conduct a multi-site randomized controlled trial (RCT) to evaluate the replicability and efficacy of a structured six-week, manualized, group therapy intervention, ReInventing Yourself after SCI that delivers positive psychology concepts within a cognitive behavioral therapy (CBT)-based model. The goals of this RCT are to increase SCI-specific and general self-efficacy, enhance emotional well-being, and improve participation in society for people with SCI living in the community. Craig Hospital is the lead site for this study, collaborating with the University of Michigan, Ann Arbor, and Kessler Institute for Rehabilitation in New Jersey.
The intervention is delivered through six sessions, each lasting approximately 2 hours. Eight skills are presented over the course of the intervention to address reframing a person's method of looking at events, building confidence by focusing on personal strengths, developing methods of recognizing and appreciating the good in one's life and expressing gratitude for positive attributes. These skills are presented in a specific sequence through a workbook so that participants can gain mastery of introductory concepts before undertaking those that are both more difficult and complex.
The RCT will have three research arms: 1) Group treatment plus workbook (Group), 2) individual self-study through YouTube video plus workbook (Indiv), and 3) no group or individual sessions, no workbook (Control). It is hypothesized that presenting the positive psychotherapy topics in an interactive structured CBT group format while restructuring maladaptive thought processes and providing experiential opportunities to reinforce behavioral change will result in increased self-efficacy, enhanced well-being and improved societal participation. Three specific hypotheses will be tested:
Hypothesis 1 (Primary): Individuals in the Group arm will show greater improvements after the six week intervention in SCI-specific and general self-efficacy, emotional well-being, increased societal participation, less depressive and anxiety symptomatology, and improved resilience than participants in the Indiv and Control arms.
Hypothesis 2 (Secondary): Individuals in the Group arm will maintain greater improvements through 46 weeks post-intervention in SCI-specific self-efficacy than participants in the Indiv and Control arms.
Hypothesis 3 (Secondary): Individuals in the Group arm will show greater improvements after six weeks of treatment and through 46 weeks post-intervention in general self-efficacy, life satisfaction, community participation, resilience, and less depressive and anxiety symptomatology than participants in the Indiv and Control groups.
The Moorong Self-Efficacy Scale (MSES) will serve as the primary outcome measure for this study. Secondary outcome measures include the General Self-Efficacy Scale, Diener Satisfaction with Life Scale, and measures of participation, resilience, anxiety and depression.
Each collaborating site will enroll 84 individuals to be randomized into one of the three study arms in waves of 21 people per wave (up to 6 waves per site). Training of site facilitators will take place at Craig Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group | Experimental | Behavioral: ReInventing Yourself after SCI structured group CBT, Behavioral: ReInventing Yourself after SCI study-specific workbookReInventing Yourself after SCI structured group CBT and ReInventing Yourself after SCI study-specific workbook |
| Indiv | Active comparator | Behavioral: ReInventing Yourself after SCI study-specific workbook, Behavioral: ReInventing Yourself after SCI YouTube videosReInventing Yourself after SCI study-specific workbook and ReInventing Yourself after SCI YouTube videos |
| Control | No intervention | –No group sessions, no YouTube videos, no workbook |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of spinal cord injury/disorder (SCI/D) at any neurological level
- At least 4 weeks post-discharge from initial inpatient rehabilitation
- English speaking in order to complete study measures and participate in group interactions
- Access to the internet and a laptop/desktop computer/smartphone with webcam and the ability and willingness to download Zoom software to join a video conference
- Able to provide informed consent to participate.
Key exclusion criteria (8 listed)
- Diagnosed with MS, Lupus, ALS, or Spina Bifida
- History of moderate or severe traumatic brain injury
- Current participation in another RCT
- Unable to verbally communicate
- Unable to attend group sessions
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 |
|---|---|---|
| ReInventing Yourself after SCI structured group CBTReInventing Yourself after SCI intervention integrates positive psychotherapy concepts into structured group cognitive behavioral therapy (CBT) to develop optimistic self-efficacy beliefs, thereby strengthening resilience to emotional distress, enhancing a sense of well-being and promoting a more active lifestyle. The intervention consists of six weekly two-hour facilitator-led sessions that include didactic presentations of eight core skills and related experiential exercises with extensive group discussion. | Behavioural | Group |
| ReInventing Yourself after SCI study-specific workbookA study-specific workbook that incorporates positive psychotherapy concepts to develop optimistic self-efficacy beliefs, thereby strengthening resilience to emotional distress, enhancing a sense of well-being and promoting a more active lifestyle. | Behavioural | Group, Indiv |
| ReInventing Yourself after SCI YouTube videosYouTube videos containing the content of the ReInventing Yourself after SCI structured group CBT sessions | Behavioural | Indiv |
Primary outcome
Moorong Self-Efficacy Scale (MSES) - assessing change over time
Time frame: The MSES will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
The MSES is a 16 item self-report measure of self-efficacy related to everyday life activities, designed specifically for persons with SCI. Individuals use a 7-point Likert scale ranging from 1 (very uncertain) to 7 (very certain) to rate their ability to perform 16 everyday tasks, with higher scores representing greater perceived self-efficacy. A Total Score, ranging from 16 to 112 is calculated by summing all item responses
6 secondary outcomes
Generalized Self-Efficacy Scale (GSES)- assessing change over time
Time frame: The GSES will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
Diener Satisfaction with Life Scale (SWLS)- assessing change over time
Time frame: The SWLS will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
Participation Assessment with Recombined Tools - Objective (PART-O)- assessing change over time
Time frame: The PART-O will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
Patient Health Questionnaire - 9 (PHQ-9)- assessing change over time
Time frame: The PHQ-9 will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
General Anxiety Disorder 7-item (GAD-7)- assessing change over time
Time frame: The GAD-7 will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
The Connor-Davidson Resilience Scale (CD-RISC 10) short form- assessing change over time
Time frame: The CD-RISC 10 will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
Susan Charlifue, PhD principal investigator
Craig Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReInventing Yourself after SCI structured group CBT, ReInventing Yourself after SCI study-specific workbook and ReInventing Yourself after SCI YouTube videos in people with Spinal Cord Injuries, run by Craig Hospital at 3 sites 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 5 inclusion and 8 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 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Moorong Self-Efficacy Scale (MSES) - assessing change over time (time frame: The MSES will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2022.