Major DepressionNCT05575960
Interpersonal Psychotherapy for Adolescents and Young Adults
A study testing Interpersonal Psychotherapy for Adolescents (IPT-A) in people with Major Depression, run by Linnaeus University at 1 site in Sweden.
Trial summary
The purpose of the project is to study the effectiveness of Interpersonal Psychotherapy (IPT) for adolescents with depression. Specific aims are to analyze the effects, change mechanisms, predictors, and implementation of IPT for youth. In this four-year project we will include 60 patients with depression. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Interpersonal Psychotherapy for Adolescents (IPT-A)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 3 Oct 2022to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Major depressive disorder according to the DSM-V
- Age 15 to 17,5 years.
- Good-enough knowledge in Swedish to be able to read instructions in questionnaires and who do not require an interpreter.
Who cannot join
- Ongoing psychosis
- Drug or alcohol addiction
- Bipolar disorder
- Suspected mental retardation
- Acute suicidality or severe depression requiring hospitalization
- Patients who have started antidepressant medication within the last six weeks will need to wait until medication effects have stabilized.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Liselott Lindegren contact
Sweden1 site, 1 recruiting
- Recruiting
Norrköping Child and Adolescent Psychiatric Services (BUP Norrköping)
Norrköping
Liselott Lindegren, MSc, +46706027590
About this study
The purpose of the project is to study the effectiveness of Interpersonal Psychotherapy (IPT) for adolescents with depression. Specific aims are to analyze the effects, change mechanisms, predictors, and implementation of IPT for youth. In this four-year project we will include 60 patients with depression. Outcome will be studied using a quasi-experimental multiple-baseline design. Change mechanisms will be studied in the form of mentalizing, emotion regulation, social support, and working alliance session-by-session, and with post-treatment qualitative interviews about the participants' experiences of change. Predictors of effectiveness of IPT for adolescents will be explored by measuring severity of symptoms, anxiety symptoms, presence and severity of parent-child conflicts, quality of interpersonal relationships, experiences of bullying, and school functioning. The implementation process of IPT for youth will be studied through interviews with adolescents, parents, therapists, co-workers, and local managers.
The study is conducted within child and adolescent psychiatric services in Norrköping using a practice-oriented research strategy which emphasizes close collaboration with clinicians. The project is a collaboration between researchers at Linnaeus University and Linköping University, and clinicians at BUP Norrköping.
Read the detailed description
Aim: To analyze the effects and the usefulness of IPT for adolescents with depression .
Site Norrköping Child and Adolescent Psychiatric Services BUP Norrköping receives approximately 820 new patient every year, and about 285 of these are diagnosed with depression. Seven therapists are working with IPT for adolescents. (Depression data)
Patients Inclusion and exclusion criteria will be evaluated using the Mini-International Neuropsychiatric Interview.
Therapists The requirement of therapists is to have IPT training of at least level B. All therapists will be employed within the Child and Adolescent Psychiatric Services, and work under the regulations of the Health Care Act.
Sample Size It is estimated that recruiting and treating 15-20 patients a year will be feasible. In four years, 60 adolescents with depression will be recruited.
Statistical Power Power was calculated by running Monte Carlo simulation analyses. The difference between treatment and baseline was assumed to be similar to the difference between treatment and waiting lists in between-group randomized trials, which is usually above d = 0.80. Power was evaluated for the same statistical method that will be used in outcome analysis. Assuming an effect size of d = 0.80 and a sample size of 60, statistical power for the difference between the treatment and baseline slopes was 84%.
Measurement Instruments For outcome measures, longer scales are used before starting and at the end of treatment, and shorter measures are filled out prior to each session. The process measures are used each session, and match roughly the theoretically identified IPT change mechanisms (Lipsitz \& Markowitz, 2013).
Outcome Measures: Depression (i) Montgomery Åsberg Depression Rating Scale is a widely used measurement instrument for depressive symptoms. It has been validated for use with adolescents. The observer version of MADRS will be administered before waiting list, at treatment start, and at termination, using the structured interview SIGMA.
(ii) Patient Health Questionnaire - 9M is based on the DSM criteria for major depressive disorder, with nine items focusing on depressive symptoms and ask the individual to rate the duration for which they experienced each symptom. The 9M version is adjusted specifically to the diagnostic criteria for adolescent depression. Items are scored on a Likert scale of 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 27. The PHQ-9 has demonstrated high sensitivity (89.5%) and good specificity (78.8%) in detecting depression in adolescents in a care sample. The PHQ-9 will be administered before the start of each session.
Change Process Measures Rated by External Observers (i) Symptom-Specific Reflective Functioning is a measure of the capacity for understanding connections between psychiatric symptoms, mental states, and interpersonal relationships; in other words, mentalizing about psychiatric symptoms. This capacity has been postulated to be especially relevant for IPT, due to its focus on connecting symptoms with interpersonal relationships and emotions. External raters will rate SSRF from the first few minutes of each session, in which IPT therapists ask about symptoms and interpersonal relationships from the previous week.
Change Process Measures Rated by Therapists (i) Working Alliance Inventory - Short form Revised, therapist version is a 12-item measure of the quality of the working alliance, i.e., collaborative relationship, between therapist and patient. This measure is administered to therapists immediately after each session.
Change Process Measures Rated by Patients (i) Session Alliance Inventory is a six-item patient-report measure of the quality of the working alliance, i.e., collaborative relationship, between therapist and patient during the previous session. This measure is administered to both patients and therapists immediately after each session.
(ii) Brief Mentalized Affectivity Scale is a validated patient-report measure for assessing emotion regulation. The short version (12 items) will be filled out immediately before each session.
(iii) Social Support Questionnaire - 6 asks about the person's available network for social support, the availability and quality of support from the network. This will be filled out at treatment start, at mid-treatment, and at treatment termination.
Study 1: Test the Effectiveness of IPT using a Quasi-Experimental Multiple-Baseline Design.
A non-concurrent multiple baseline design will be used, that is, not all patients start treatment at the same time. The sequence will be an A1BA2 design, in which A means no treatment and B means treatment. A1 is the baseline and A2 is the follow-up period. The distinction between A1 and A2 is due to the fact that reversibility of effects in the follow-up phase are not expected. The fact that waiting times vary quasi-randomly according to availability in the therapists' calendars will be utilized, with a minimum waiting of three weeks to establish a slope for the baseline period. Data for Study 1 will be analyzed using a piecewise multilevel growth curve model, in which two separate slopes for change over time in the outcome measure - one for the baseline phase and one for the treatment phase - are compared. If treatment is effective, symptoms should improve at a faster rate during treatment than before treatment. Thus, the test is the average change rate during the treatment phase minus the average change rate during the baseline phase.
Study 2: Mechanisms of change in IPT-A for depression Longitudinal (session-by-session) observation study using data from the treatment phase (B). Specifically, the proposed change mechanisms (mentalization, emotion regulation, social support, and working alliance) are measured each session, and used to predict next-session outcome. In addition, post-treatment qualitative interviews with patients will be used to retrospectively study the participants' experiences of change and what contributed to this. For Study 3, disaggregated time-lagged panel models will be used, in which candidate mechanisms of change are used as predictors of change in the outcome measure from one session to the following session.
Study 3: Predictors of improvement in IPT-A for depression Longitudinal observation design using baseline data on patients to predict differential trajectories during the treatment- and follow-up phases to explore for which patients IPT-A is effective. Session-wise measurements will be used to enable tests of causal direction for the candidate mechanisms. Multilevel growth curve modeling using pre-treatment variables as predictors of the intercepts and slopes of the outcome measure will be used. The cross-level interaction between a pre-treatment variable and the slope of time is the test of interest. Based on previous research, severity of symptoms (depression/eating disorder), comorbid anxiety disorder, the presence and severity of parent-child conflicts, quality of interpersonal relationships, experiences of bullying, and school functioning will be explored as potential predictors of IPT effectiveness.
- Conditions
- Major Depression
- Being tested
- Interpersonal Psychotherapy for Adolescents (IPT-A)
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Psychotherapy for Adolescents (IPT-A)Behavioural
Interpersonal Psychotherapy (IPT) is a psychotherapeutic treatment originally developed for treating depression in adults. It is a brief, structured treatment based on the idea of mobilizing the patient's social network, increasing his/her capacity to accept and seek support from others, and to process interpersonal difficulties, in order to improve depressive symptoms. Interpersonal psychotherapy for adolescents (IPT-A) is a version of IPT designed for young people between the age of 12-18 years with depression (Mufson, 2004), and is in many respects similar to IPT although with some modifications (e.g., a few scheduled meetings with parents during the course of treatment).
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal Psychotherapy | Experimental | Interpersonal Psychotherapy for Adolescents according to the manual by Mufson (2004).
Mufson, L. (2004). Interpersonal psychotherapy for depressed adolescents. Guilford Press. Receives: Behavioral: Interpersonal Psychotherapy for Adolescents (IPT-A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire - 9 for depression/Eating Disorder Inventory - Very Short for eating disorder patients
Patient-rated depression/eating disorder severity. Scale from 0-27 points, with higher scores indicating more severe symptoms.
Measured: Change from treatment start to week 12 compared to change from before waiting-list to treatment start. In the multiple baseline design, the time for the waiting list varies, in this case about 4-25 weeks.
Montgomery Åsberg Depression Rating Scale (observer version) for depression/Eating Disorder Inventory for eating disorders
Depression/eating disorder severity measures. Scale from 0-60 points, with higher scores indicating more severe symptoms..
Measured: Change from treatment start to week 12 compared to change from before waiting-list to treatment start. In the multiple baseline design, the time for the waiting list varies, in this case about 4-25 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start3 Oct 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Multiple Baseline Design
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linnaeus University
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Fredrik Falkenstrom, Linnaeus University
- Investigators
- Fredrik Falkenström, PhD, Principal investigator, Linnaeus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575960
- Sponsor's protocol ID
- 2022-00983
- Status last verified
- May 2024
- First submitted
- 4 Oct 2022
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interpersonal Psychotherapy for Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT05575960
- Acronym / sponsor ID
- 2022-00983
- Conditions
- Major Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Linnaeus UniversityUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 12 Oct 2022 (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 purpose of the project is to study the effectiveness of Interpersonal Psychotherapy (IPT) for adolescents with depression. Specific aims are to analyze the effects, change mechanisms, predictors, and implementation of IPT for youth. In this four-year project we will include 60 patients with depression. Outcome will be studied using a quasi-experimental multiple-baseline design. Change mechanisms will be studied in the form of mentalizing, emotion regulation, social support, and working alliance session-by-session, and with post-treatment qualitative interviews about the participants' experiences of change. Predictors of effectiveness of IPT for adolescents will be explored by measuring severity of symptoms, anxiety symptoms, presence and severity of parent-child conflicts, quality of interpersonal relationships, experiences of bullying, and school functioning. The implementation process of IPT for youth will be studied through interviews with adolescents, parents, therapists, co-workers, and local managers.
The study is conducted within child and adolescent psychiatric services in Norrköping using a practice-oriented research strategy which emphasizes close collaboration with clinicians. The project is a collaboration between researchers at Linnaeus University and Linköping University, and clinicians at BUP Norrköping.
Detailed description
Aim: To analyze the effects and the usefulness of IPT for adolescents with depression .
Site Norrköping Child and Adolescent Psychiatric Services BUP Norrköping receives approximately 820 new patient every year, and about 285 of these are diagnosed with depression. Seven therapists are working with IPT for adolescents. (Depression data)
Patients Inclusion and exclusion criteria will be evaluated using the Mini-International Neuropsychiatric Interview.
Therapists The requirement of therapists is to have IPT training of at least level B. All therapists will be employed within the Child and Adolescent Psychiatric Services, and work under the regulations of the Health Care Act.
Sample Size It is estimated that recruiting and treating 15-20 patients a year will be feasible. In four years, 60 adolescents with depression will be recruited.
Statistical Power Power was calculated by running Monte Carlo simulation analyses. The difference between treatment and baseline was assumed to be similar to the difference between treatment and waiting lists in between-group randomized trials, which is usually above d = 0.80. Power was evaluated for the same statistical method that will be used in outcome analysis. Assuming an effect size of d = 0.80 and a sample size of 60, statistical power for the difference between the treatment and baseline slopes was 84%.
Measurement Instruments For outcome measures, longer scales are used before starting and at the end of treatment, and shorter measures are filled out prior to each session. The process measures are used each session, and match roughly the theoretically identified IPT change mechanisms (Lipsitz \& Markowitz, 2013).
Outcome Measures: Depression (i) Montgomery Åsberg Depression Rating Scale is a widely used measurement instrument for depressive symptoms. It has been validated for use with adolescents. The observer version of MADRS will be administered before waiting list, at treatment start, and at termination, using the structured interview SIGMA.
(ii) Patient Health Questionnaire - 9M is based on the DSM criteria for major depressive disorder, with nine items focusing on depressive symptoms and ask the individual to rate the duration for which they experienced each symptom. The 9M version is adjusted specifically to the diagnostic criteria for adolescent depression. Items are scored on a Likert scale of 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 27. The PHQ-9 has demonstrated high sensitivity (89.5%) and good specificity (78.8%) in detecting depression in adolescents in a care sample. The PHQ-9 will be administered before the start of each session.
Change Process Measures Rated by External Observers (i) Symptom-Specific Reflective Functioning is a measure of the capacity for understanding connections between psychiatric symptoms, mental states, and interpersonal relationships; in other words, mentalizing about psychiatric symptoms. This capacity has been postulated to be especially relevant for IPT, due to its focus on connecting symptoms with interpersonal relationships and emotions. External raters will rate SSRF from the first few minutes of each session, in which IPT therapists ask about symptoms and interpersonal relationships from the previous week.
Change Process Measures Rated by Therapists (i) Working Alliance Inventory - Short form Revised, therapist version is a 12-item measure of the quality of the working alliance, i.e., collaborative relationship, between therapist and patient. This measure is administered to therapists immediately after each session.
Change Process Measures Rated by Patients (i) Session Alliance Inventory is a six-item patient-report measure of the quality of the working alliance, i.e., collaborative relationship, between therapist and patient during the previous session. This measure is administered to both patients and therapists immediately after each session.
(ii) Brief Mentalized Affectivity Scale is a validated patient-report measure for assessing emotion regulation. The short version (12 items) will be filled out immediately before each session.
(iii) Social Support Questionnaire - 6 asks about the person's available network for social support, the availability and quality of support from the network. This will be filled out at treatment start, at mid-treatment, and at treatment termination.
Study 1: Test the Effectiveness of IPT using a Quasi-Experimental Multiple-Baseline Design.
A non-concurrent multiple baseline design will be used, that is, not all patients start treatment at the same time. The sequence will be an A1BA2 design, in which A means no treatment and B means treatment. A1 is the baseline and A2 is the follow-up period. The distinction between A1 and A2 is due to the fact that reversibility of effects in the follow-up phase are not expected. The fact that waiting times vary quasi-randomly according to availability in the therapists' calendars will be utilized, with a minimum waiting of three weeks to establish a slope for the baseline period. Data for Study 1 will be analyzed using a piecewise multilevel growth curve model, in which two separate slopes for change over time in the outcome measure - one for the baseline phase and one for the treatment phase - are compared. If treatment is effective, symptoms should improve at a faster rate during treatment than before treatment. Thus, the test is the average change rate during the treatment phase minus the average change rate during the baseline phase.
Study 2: Mechanisms of change in IPT-A for depression Longitudinal (session-by-session) observation study using data from the treatment phase (B). Specifically, the proposed change mechanisms (mentalization, emotion regulation, social support, and working alliance) are measured each session, and used to predict next-session outcome. In addition, post-treatment qualitative interviews with patients will be used to retrospectively study the participants' experiences of change and what contributed to this. For Study 3, disaggregated time-lagged panel models will be used, in which candidate mechanisms of change are used as predictors of change in the outcome measure from one session to the following session.
Study 3: Predictors of improvement in IPT-A for depression Longitudinal observation design using baseline data on patients to predict differential trajectories during the treatment- and follow-up phases to explore for which patients IPT-A is effective. Session-wise measurements will be used to enable tests of causal direction for the candidate mechanisms. Multilevel growth curve modeling using pre-treatment variables as predictors of the intercepts and slopes of the outcome measure will be used. The cross-level interaction between a pre-treatment variable and the slope of time is the test of interest. Based on previous research, severity of symptoms (depression/eating disorder), comorbid anxiety disorder, the presence and severity of parent-child conflicts, quality of interpersonal relationships, experiences of bullying, and school functioning will be explored as potential predictors of IPT effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multiple Baseline Design
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Psychotherapy | Experimental | Behavioral: Interpersonal Psychotherapy for Adolescents (IPT-A)Interpersonal Psychotherapy for Adolescents according to the manual by Mufson (2004). Mufson, L. (2004). Interpersonal psychotherapy for depressed adolescents. Guilford Press. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Major depressive disorder according to the DSM-V
- Age 15 to 17,5 years.
- Good-enough knowledge in Swedish to be able to read instructions in questionnaires and who do not require an interpreter.
Key exclusion criteria (6 listed)
- Ongoing psychosis
- Drug or alcohol addiction
- Bipolar disorder
- Suspected mental retardation
- Acute suicidality or severe depression requiring hospitalization
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 |
|---|---|---|
| Interpersonal Psychotherapy for Adolescents (IPT-A)Interpersonal Psychotherapy (IPT) is a psychotherapeutic treatment originally developed for treating depression in adults. It is a brief, structured treatment based on the idea of mobilizing the patient's social network, increasing his/her capacity to accept and seek support from others, and to process interpersonal difficulties, in order to improve depressive symptoms. Interpersonal psychotherapy for adolescents (IPT-A) is a version of IPT designed for young people between the age of 12-18 years with depression (Mufson, 2004), and is in many respects similar to IPT although with some modifications (e.g., a few scheduled meetings with parents during the course of treatment). | Behavioural | Interpersonal Psychotherapy |
Primary outcome
Patient Health Questionnaire - 9 for depression/Eating Disorder Inventory - Very Short for eating disorder patients
Time frame: Change from treatment start to week 12 compared to change from before waiting-list to treatment start. In the multiple baseline design, the time for the waiting list varies, in this case about 4-25 weeks.
Patient-rated depression/eating disorder severity. Scale from 0-27 points, with higher scores indicating more severe symptoms.
Montgomery Åsberg Depression Rating Scale (observer version) for depression/Eating Disorder Inventory for eating disorders
Time frame: Change from treatment start to week 12 compared to change from before waiting-list to treatment start. In the multiple baseline design, the time for the waiting list varies, in this case about 4-25 weeks.
Depression/eating disorder severity measures. Scale from 0-60 points, with higher scores indicating more severe symptoms..
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: No
Related trials for Major Depression
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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.
Liselott Lindegren contact
Fredrik Falkenström, PhD principal investigator
Linnaeus 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 Interpersonal Psychotherapy for Adolescents (IPT-A) in people with Major Depression, run by Linnaeus University at 1 site in Sweden.
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 6 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: looking for participants now, as of the sponsor's last update on 20 May 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fredrik Falkenström, PhD (+46701089877, fredrik.falkenstrom@lnu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire - 9 for depression/Eating Disorder Inventory - Very Short for eating disorder patients (time frame: Change from treatment start to week 12 compared to change from before waiting-list to treatment start. In the multiple baseline design, the time for the waiting list varies, in this case about 4-25 weeks.). The study lists 2 primary outcomes in all. 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 20 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.