Anxiety DisordersNCT02410265
Online, Guided Interventions to Reduce Generalized Anxiety Disorder Among Indian University Students
A study testing Lantern: Guided self-help program and Mental Health Online: Self-help program in people with Anxiety Disorders, run by Stanford University.
Trial summary
This controlled, three-arm, randomized (1:1:1), multi-site trial will evaluate the efficacy, feasibility and acceptability of cognitive-behavioral therapy (CBT)-based online guided and unguided self-help intervention to reduce Generalized Anxiety Disorder (GAD) in Indian university students. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Lantern: Guided self-help program and Mental Health Online: Self-help program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current student of one of the 3 college sites
- Subjects must have a clinical or subclinical diagnosis of Generalized Anxiety Disorder (GAD); clinical diagnosis is met by self-reporting DSM-IV criteria for GAD; subclinical diagnosis is met by scoring a 5.7 or above using diagnostic scoring of the GAD-Q-IV
Who cannot join
- Unable to give informed consent.
- Is currently receiving mental health treatment.
- Has clinical PTSD (a score of 38 or above on the PCL5)
About this study
Official title: Using Technology to Address Anxiety and Stress in Indian University Students
This controlled, three-arm, randomized (1:1:1), multi-site trial will evaluate the efficacy, feasibility and acceptability of cognitive-behavioral therapy (CBT)-based online guided and unguided self-help intervention to reduce Generalized Anxiety Disorder (GAD) in Indian university students. The investigators aim to assess if these novel electronic health (eHealth) interventions can be integrated into Indian university systems to increase access to efficacious, less stigmatized, and cost-effective mental healthcare.
Read the detailed description
Students from three Indian colleges will be invited to complete an online, self-report survey. Based on their answers, they are categorized into clinical, subclinical, and asymptomatic for Generalized Anxiety Disorder (GAD). Those who meet the diagnostic criteria for GAD as detailed in the Diagnostic and Statistical Manual of Mental Disorders (DSM), 4th Edition are classified as clinical. Those who score a 5.7 or above using dimensional scoring of the GAD-Q-IV but are not "clinical" are classified as subclinical. All others are asymptomatic. After ruling out those with a clinical PTSD diagnosis (scoring 38 or above on the PCL5) and those currently receiving mental healthcare treatment, those who are clinical and subclinical are offered the opportunity to use one of the online programs. Those who accept are randomized between a guided self-help program, a self-help program, and a waitlist control group. Each student who enrolls will be reassessed at post-intervention (3 months) and followup (6 months later, or 9 months after completing baseline). Additionally, those who are classified as asymptomatic are invited to complete additional followup surveys at 3 and 9 months to provide data on anxiety symptom change over time.
- Conditions
- Anxiety Disorders
- Being tested
- Lantern: Guided self-help program, Mental Health Online: Self-help program
- Keywords
- guided self-help, student mental health, task shifting, prevention
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lantern: Guided self-help programBehavioural
Subject assigned to the Lantern intervention will receive 3-month access to a web-based, CBT-based guided self-help intervention for GAD. In the program, they receive psycho-education about GAD and the management of symptoms of GAD along with access to an "e-coach" who can monitor their progress in the program and provide feedback and encouragement via messaging and one voice call.
Mental Health Online: Self-help programBehavioural
Subject assigned to the Mental Health Online (MHO) intervention will receive 3-month access to a web-based, CBT-based self-help intervention for GAD. In the program, they receive psycho-education about GAD and the management of symptoms of GAD.
| Study group | Role | What they receive |
|---|---|---|
| Lantern: Guided self-help program | Experimental | Subject assigned to the Lantern intervention will receive 3-month access to a web-based, CBT-based guided self-help intervention for GAD. In the program, they receive psycho-education about GAD and the management of symptoms of GAD along with access to an "e-coach" who can monitor their progress in the program and provide feedback and encouragement via messaging and one voice call. Receives: Behavioral: Lantern: Guided self-help program |
| Mental Health Online: Self-help program | Experimental | Subject assigned to the Mental Health Online (MHO) intervention will receive 3-month access to a web-based, CBT-based self-help intervention for GAD. In the program, they receive psycho-education about GAD and the management of symptoms of GAD. Receives: Behavioral: Mental Health Online: Self-help program |
| Delayed Program | No intervention | Subject assigned to this arm will receive one of the online programs in 9 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GAD symptoms measured by the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV)
Compare GAD symptoms using the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Measured: Baseline to 3-month post-intervention
Secondary outcomes (15)
Sustained change in GAD symptoms measured by the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV)
Compare GAD symptoms using the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Measured: Baseline to 3-month post-intervention, and 6-month follow-up
Change in panic disorder symptoms measured by The Panic Disorder Self-Report (PDSR)
Compare panic disorder symptoms using the The Panic Disorder Self-Report (PDSR) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Measured: Baseline to 3-month post-intervention, and 6-month follow-up
Change in social phobia symptoms measured by the Social Phobia Diagnostic Questionnaire (SPDQ)
Compare social anxiety disorder symptoms using the Social Phobia Diagnostic Questionnaire (SPDQ) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Measured: Baseline to 3-month post-intervention, and 6-month follow-up
Change in post-traumatic stress disorder symptoms measured by the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL5)
Compare post traumatic stress disorder (PTSD) symptoms using the Post Traumatic Stress Disorder Checklist for DSM-5 between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Measured: Baseline to 3-month post-intervention, and 6-month follow-up
Change in obsessive compulsive disorder (OCD) symptoms measured by the LEVEL 2-Repetitive Thoughts and Behaviors-Adult (adapted from the Florida Obsessive-Compulsive Inventory [FOCI] Severity Scale [Part B])
Compare OCD symptoms using the the LEVEL 2-Repetitive Thoughts and Behaviors-Adult (adapted from the Florida Obsessive-Compulsive Inventory [FOCI] Severity Scale [Part B]) measure between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Measured: Baseline to 3-month post-intervention, and 6-month follow-up
Change in specific phobia symptoms measured by questions of distress severity for specific fears
Compare specific phobia symptoms using questions of distress severity for specific fears (dogs, snakes, spiders/bugs/insects, heights, flying, small enclosed spaces, driving, traveling in cars/trains/buses, bridges, tunnels, water, blood, other) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Measured: Baseline to 3-month post-intervention, and 6-month follow-up
Change in depression symptoms measured by the Depression Anxiety Stress Scales (DASS)
Compare depression symptoms using the Depression Anxiety Stress Scales (DASS) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Measured: Baseline to 3-month post-intervention, and 6-month follow-up
Change in worry symptoms measured by the Penn State Worry Questionnaire (PSWQ)
Compare worry symptoms using the Penn State Worry Questionnaire (PSWQ) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Measured: Baseline to 3-month post-intervention, and 6-month follow-up
Change in insomnia symptoms measured by the Insomnia Severity Index (ISI)
Compare insomnia symptoms using the Insomnia Severity Index between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Measured: Baseline to 3-month post-intervention, and 6-month follow-up
Change in subject self-efficacy measured by the General Self-efficacy Scale
Compare subject self-efficacy using the General Self-efficacy Scale between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Measured: Baseline to 3-month post-intervention, and 6-month follow-up
Change in emotional distress from anxiety measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress from Anxiety measure
Compare subject emotional distress from anxiety using the Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress from Anxiety measure between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Measured: Baseline to 3-month post-intervention, and 6-month follow-up
Change in self-report difficulties with emotions, concentration, and relationships measured by the Strengths and Difficulties Questionnaire (SDQ)
Compare subject perception of difficulties with emotions, concentration, and relationships using the Strengths and Difficulties Questionnaire between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Measured: Baseline to 3-month post-intervention, and 6-month follow-up
Change in relationship satisfaction measured by the PROMIS Satisfaction with Social Roles and Activities measure
Compare subject satisfaction with social roles using the PROMIS Satisfaction with Social Roles and Activities measure between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Measured: Baseline to 3-month post-intervention, and 6-month follow-up
Factors associated with poor program engagement and/or discontinuation measured by analysis of self-report assessments of motivation, belief in program efficacy, satisfaction, etc. as well as analysis of demographics, comorbid mental illness, etc.
Determine factors associated with poor program engagement and/or discontinuation in study participants in the guided and self-help intervention arms. Factors associated with poor program engagement and/or discontinuation will include demographics, belief in program efficacy, motivation, comorbid mental illness, socioeconomic status, and English language competence.
Measured: Baseline to 3-month post-intervention
Change in non-specific distress measured by the Kessler Distress Measure (K10)
Compare subject perception of non-specific distress using the Kessler Distress measure (K10) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Measured: Baseline to 3-month post-intervention, and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health and Neuro Sciences, India
- Responsible party
- Principal investigator, Craig Barr Taylor, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410265
- Sponsor's protocol ID
- 31629
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2015
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Newman MG, Kanuri N, Rackoff GN, Jacobson NC, Bell MJ, Taylor CB. A randomized controlled feasibility trial of internet-delivered guided self-help for generalized anxiety disorder (GAD) among university students in India. Psychotherapy (Chic). 2021 Dec;58(4):591-601. doi: 10.1037/pst0000383.
PubMed 34881930Kanuri N, Newman MG, Ruzek JI, Kuhn E, Manjula M, Jones M, Thomas N, Abbott JA, Sharma S, Taylor CB. The Feasibility, Acceptability, and Efficacy of Delivering Internet-Based Self-Help and Guided Self-Help Interventions for Generalized Anxiety Disorder to Indian University Students: Design of a Randomized Controlled Trial. JMIR Res Protoc. 2015 Dec 11;4(4):e136. doi: 10.2196/resprot.4783.
PubMed 26679295
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Technology to Address Anxiety and Stress in Indian University Students
- ClinicalTrials.gov ID
- NCT02410265
- Acronym / sponsor ID
- 31629
- Conditions
- Anxiety Disorders
- Keywords
- guided self-help, student mental health, task shifting, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health and Neuro Sciences, India
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Apr 2015 (estimated)
- 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 controlled, three-arm, randomized (1:1:1), multi-site trial will evaluate the efficacy, feasibility and acceptability of cognitive-behavioral therapy (CBT)-based online guided and unguided self-help intervention to reduce Generalized Anxiety Disorder (GAD) in Indian university students. The investigators aim to assess if these novel electronic health (eHealth) interventions can be integrated into Indian university systems to increase access to efficacious, less stigmatized, and cost-effective mental healthcare.
Detailed description
Students from three Indian colleges will be invited to complete an online, self-report survey. Based on their answers, they are categorized into clinical, subclinical, and asymptomatic for Generalized Anxiety Disorder (GAD). Those who meet the diagnostic criteria for GAD as detailed in the Diagnostic and Statistical Manual of Mental Disorders (DSM), 4th Edition are classified as clinical. Those who score a 5.7 or above using dimensional scoring of the GAD-Q-IV but are not "clinical" are classified as subclinical. All others are asymptomatic. After ruling out those with a clinical PTSD diagnosis (scoring 38 or above on the PCL5) and those currently receiving mental healthcare treatment, those who are clinical and subclinical are offered the opportunity to use one of the online programs. Those who accept are randomized between a guided self-help program, a self-help program, and a waitlist control group. Each student who enrolls will be reassessed at post-intervention (3 months) and followup (6 months later, or 9 months after completing baseline). Additionally, those who are classified as asymptomatic are invited to complete additional followup surveys at 3 and 9 months to provide data on anxiety symptom change over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lantern: Guided self-help program | Experimental | Behavioral: Lantern: Guided self-help programSubject assigned to the Lantern intervention will receive 3-month access to a web-based, CBT-based guided self-help intervention for GAD. In the program, they receive psycho-education about GAD and the management of symptoms of GAD along with access to an "e-coach" who can monitor their progress in the program and provide feedback and encouragement via messaging and one voice call. |
| Mental Health Online: Self-help program | Experimental | Behavioral: Mental Health Online: Self-help programSubject assigned to the Mental Health Online (MHO) intervention will receive 3-month access to a web-based, CBT-based self-help intervention for GAD. In the program, they receive psycho-education about GAD and the management of symptoms of GAD. |
| Delayed Program | No intervention | –Subject assigned to this arm will receive one of the online programs in 9 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current student of one of the 3 college sites
- Subjects must have a clinical or subclinical diagnosis of Generalized Anxiety Disorder (GAD); clinical diagnosis is met by self-reporting DSM-IV criteria for GAD; subclinical diagnosis is met by scoring a 5.7 or above using diagnostic scoring of the GAD-Q-IV
Key exclusion criteria (3 listed)
- Unable to give informed consent.
- Is currently receiving mental health treatment.
- Has clinical PTSD (a score of 38 or above on the PCL5)
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 |
|---|---|---|
| Lantern: Guided self-help programSubject assigned to the Lantern intervention will receive 3-month access to a web-based, CBT-based guided self-help intervention for GAD. In the program, they receive psycho-education about GAD and the management of symptoms of GAD along with access to an "e-coach" who can monitor their progress in the program and provide feedback and encouragement via messaging and one voice call. | Behavioural | Lantern: Guided self-help program |
| Mental Health Online: Self-help programSubject assigned to the Mental Health Online (MHO) intervention will receive 3-month access to a web-based, CBT-based self-help intervention for GAD. In the program, they receive psycho-education about GAD and the management of symptoms of GAD. | Behavioural | Mental Health Online: Self-help program |
Primary outcome
Change in GAD symptoms measured by the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV)
Time frame: Baseline to 3-month post-intervention
Compare GAD symptoms using the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
15 secondary outcomes
Sustained change in GAD symptoms measured by the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV)
Time frame: Baseline to 3-month post-intervention, and 6-month follow-up
Change in panic disorder symptoms measured by The Panic Disorder Self-Report (PDSR)
Time frame: Baseline to 3-month post-intervention, and 6-month follow-up
Change in social phobia symptoms measured by the Social Phobia Diagnostic Questionnaire (SPDQ)
Time frame: Baseline to 3-month post-intervention, and 6-month follow-up
Change in post-traumatic stress disorder symptoms measured by the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL5)
Time frame: Baseline to 3-month post-intervention, and 6-month follow-up
Change in obsessive compulsive disorder (OCD) symptoms measured by the LEVEL 2-Repetitive Thoughts and Behaviors-Adult (adapted from the Florida Obsessive-Compulsive Inventory [FOCI] Severity Scale [Part B])
Time frame: Baseline to 3-month post-intervention, and 6-month follow-up
Change in specific phobia symptoms measured by questions of distress severity for specific fears
Time frame: Baseline to 3-month post-intervention, and 6-month follow-up
Change in depression symptoms measured by the Depression Anxiety Stress Scales (DASS)
Time frame: Baseline to 3-month post-intervention, and 6-month follow-up
Change in worry symptoms measured by the Penn State Worry Questionnaire (PSWQ)
Time frame: Baseline to 3-month post-intervention, and 6-month follow-up
Change in insomnia symptoms measured by the Insomnia Severity Index (ISI)
Time frame: Baseline to 3-month post-intervention, and 6-month follow-up
Change in subject self-efficacy measured by the General Self-efficacy Scale
Time frame: Baseline to 3-month post-intervention, and 6-month follow-up
Change in emotional distress from anxiety measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress from Anxiety measure
Time frame: Baseline to 3-month post-intervention, and 6-month follow-up
Change in self-report difficulties with emotions, concentration, and relationships measured by the Strengths and Difficulties Questionnaire (SDQ)
Time frame: Baseline to 3-month post-intervention, and 6-month follow-up
Change in relationship satisfaction measured by the PROMIS Satisfaction with Social Roles and Activities measure
Time frame: Baseline to 3-month post-intervention, and 6-month follow-up
Factors associated with poor program engagement and/or discontinuation measured by analysis of self-report assessments of motivation, belief in program efficacy, satisfaction, etc. as well as analysis of demographics, comorbid mental illness, etc.
Time frame: Baseline to 3-month post-intervention
Change in non-specific distress measured by the Kessler Distress Measure (K10)
Time frame: Baseline to 3-month post-intervention, and 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Derived from this study: PubMed 34881930Newman MG, Kanuri N, Rackoff GN, Jacobson NC, Bell MJ, Taylor CB. A randomized controlled feasibility trial of internet-delivered guided self-help for generalized anxiety disorder (GAD) among university students in India. Psychotherapy (Chic). 2021 Dec;58(4):591-601. doi: 10.1037/pst0000383.
- Derived from this study: PubMed 26679295Kanuri N, Newman MG, Ruzek JI, Kuhn E, Manjula M, Jones M, Thomas N, Abbott JA, Sharma S, Taylor CB. The Feasibility, Acceptability, and Efficacy of Delivering Internet-Based Self-Help and Guided Self-Help Interventions for Generalized Anxiety Disorder to Indian University Students: Design of a Randomized Controlled Trial. JMIR Res Protoc. 2015 Dec 11;4(4):e136. doi: 10.2196/resprot.4783.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lantern: Guided self-help program and Mental Health Online: Self-help program in people with Anxiety Disorders, run by Stanford University.
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 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GAD symptoms measured by the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV) (time frame: Baseline to 3-month post-intervention). 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 NCT02410265, which also lists 2 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 18 Mar 2020.