DepressionCOMET-ProlNCT05379881
Efficacy of COMET on Prolific Participants
A study testing Common Elements Toolbox (COMET) in people with Depression and Anxiety, run by Indiana University at 1 site in United States.
Trial summary
In this study, the investigators will test the effectiveness of a digital, single-session mental health intervention. There will be two conditions: the COMET intervention and the control group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Emotion Regulation
- What is being tested?
- Common Elements Toolbox (COMET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 829 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2022to 3 Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A positive response (i.e., "yes") to the question: "Do you have or have you had a diagnosed, ongoing mental health/illness/condition?"
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Online Wellness Intervention: Investigating the Efficacy of the Common Elements Toolbox
In this study, the investigators will test the effectiveness of a digital, single-session mental health intervention. There will be two conditions: the COMET intervention and the control group. The program, COMET (Common Elements Toolbox), will include a variety of modules which will focus on cognitive restructuring, gratitude, behavioral activation, and self-compassion. A similar intervention has previously been tested with Indian adolescents and adapted for US graduate students.
Read the detailed description
Participants who follow the study link in Prolific will immediately be taken to the Informed Consent Statement (ICS), which will include a description of the study, risks and benefits, payment, and confidentiality. After reading the ICS, participants will confirm their consent by clicking "I consent to participate in this study." They will then be taken to the welcome page for the study and confirm that they will provide their best answers. Once participants have confirmed their consent, they will be taken to the rest of the survey.
All participants will fill out a series of questionnaires including: the Generalized Anxiety Disorder 7-item (GAD-7), Patient Health Questionnaire 8-item (PHQ-8), WHO-5 Wellbeing Index (WHO-5), 3 questions from the Insomnia Severity Index (ISI), Emotion Regulation Questionnaire (ERQ), Ten-Item Personality Inventory (TIPI), Adverse Childhood Experiences Scale (ACES), Work and Social Adjustment Scale (WSAS), 4 mechanisms questions, 3 items from the Secondary Control Scale (SCS), Module preferences and the System Usability Scale (SUS). After completing these questionnaires participants will be randomized to either the COMET intervention condition (who receive the intervention immediately) or the control condition (who will receive the intervention after 8 weeks). they will be randomized to one of two conditions: COMET (will receive the COMET intervention immediately) or a waitlist control (will receive the COMET intervention in 8 weeks). This randomization will be completed via the Qualtrics randomizer function - which randomly and evenly assigns participants to the two conditions.
Participants who are assigned to the COMET condition will then be taken to the intervention introduction. They will then receive the following modules: cognitive restructuring (labeled "flexible thinking"), behavioral activation (labeled "positive activities"), gratitude, and self-compassion. In the flexible thinking module, participants will learn to identify and reframe negative beliefs. They will first read about a hypothetical character who is adjusting to changes in their routine. Then, using the character's story as an example, they will try to identify negative beliefs that the character may be experiencing and ways the character could reframe the belief. Then, they will apply this technique to a situation in their own life. In the positive activities module, participants will identify and reflect on activities that are important to them. They will list activities they find enjoyable and meaningful. Then, they will reflect on why these activities matter to them and schedule in time to perform these activities in the weeks ahead. In the gratitude module, participants will be asked to reflect and write about 3 things they are grateful about. They will then be asked to think and write about things they notice around them that they enjoy and are grateful for. In the self-compassion module, participants will be asked to write a self-compassion letter to themselves, expressing compassion towards themselves just as they would towards a friend or family member. They will also be requested to create a few sentences that they would like to hear when feeling self-critical.
After completing the COMET intervention, participants will complete the post-intervention questions. A mental wellbeing resource list will be provided at the end of the session.
Participants who are assigned to the control condition will complete a separate series of questionnaires: hypothetical questions about emotional experiences using questions from the GAD-7 (Hypothetical Questions - GAD-7) and hypothetical questions about emotional experiences using questions from the PHQ-9 (Hypothetical Questions - PHQ-9).
After completing the COMET intervention or completing the control questions, all participants will fill out demographic information including age, sex assigned at birth, gender, race/ethnicity, sexual orientation, relationship status, how often they attend religious services, education level, annual income, employment status, if they have ever taken anti-depressants or other psychiatric medication, how many people they can rely on for social support, physical health, how often they drink alcohol, and how old they were when they first struggled with depression, anxiety, or stress.
All participants in both conditions will be invited via Prolific to continue to complete measures at follow-up time points of 2 weeks, 4 weeks, and 8 weeks post-baseline (approx. 10-15 minutes each). In the informed consent statement, participants will be informed that there are follow-up assessments that they can receive additional compensation for. There will also be reminders at the end of the baseline assessment reminding them to watch for the follow ups. They will not be notified of these follow-up assessments, but will be able to see the follow-up assessments posted on Prolific. During these follow-ups all participants (e.g., those in both the intervention and control conditions) will complete the following questionnaires: GAD-7, PHQ-8, WHO-5, ISI, ERQ, WSAS, and SCS.
After completing the follow-up measure at 8 weeks, enrollment in the study will end. At this point, participants in the control condition will receive the intervention modules. Their use of the COMET intervention is entirely optional and will not be recorded by the research team. They will not fill out any follow up measures after completing or not completing the COMET intervention.
Below is a complete schedule for participants in the study, separated by condition (e.g., COMET vs control).
COMET INTERVENTION
Baseline:
Measures/questionnaires (pre-intervention): Informed consent statement --> Intro Text --> Generalized Anxiety Disorder 7-item (GAD-7), Patient Health Questionnaire 8-item (PHQ-8), WHO-5 Wellbeing Index (WHO-5), 3 questions from the Insomnia Severity Index (ISI), Emotion Regulation Questionnaire (ERQ), Ten-Item Personality Inventory (TIPI), Adverse Childhood Experiences Scale (ACES), Work and Social Adjustment Scale (WSAS), 4 mechanisms questions, 3 items from the Secondary Control Scale (SCS), Module preferences and the System Usability Scale (SUS).
Intervention: After filling out these questionnaires, they will proceed to the COMET intervention content, which consists of the intervention introduction and 4 modules - cognitive restructuring (labeled "flexible thinking"), behavioral activation (labeled "positive activities"), gratitude, and self-compassion.
Measures/questionnaires (post-intervention): Post Intervention Questions, demographic information.
Time to complete: approximately 60-80 minutes.
2-week follow up: Measures/questionnaires: GAD-7, PHQ-8, WHO-5, ISI, ERQ, WSAS, and SCS. Time to complete: approximately 10-15 minutes.
4-week follow up: Measures/questionnaires: GAD-7, PHQ-8, WHO-5, ISI, ERQ, WSAS, and SCS. Time to complete: approximately 10-15 minutes.
8-week follow up: Measures/questionnaires: GAD-7, PHQ-8, WHO-5, ISI, ERQ, WSAS, and SCS. Time to complete: approximately 10-15 minutes.
CONTROL CONDITION
Baseline:
Measures/questionnaires: Informed consent statement --> Intro Text --> Generalized Anxiety Disorder 7-item (GAD-7), Patient Health Questionnaire 8-item (PHQ-8), WHO-5 Wellbeing Index (WHO-5), 3 questions from the Insomnia Severity Index (ISI), Emotion Regulation Questionnaire (ERQ), Ten-Item Personality Inventory (TIPI), Adverse Childhood Experiences Scale (ACES), Work and Social Adjustment Scale (WSAS), 4 mechanisms questions, 3 items from the Secondary Control Scale (SCS), Module preferences and the System Usability Scale (SUS); hypothetical questions about emotional experiences using questions from the GAD-7 (Hypothetical Questions - GAD-7); hypothetical questions about emotional experiences using questions from the PHQ-9 (Hypothetical Questions - PHQ-9); demographic information.
Time to complete: approximately 15-20 minutes.
2-week follow up: GAD-7, PHQ-8, WHO-5, ISI, ERQ, WSAS, and SCS. Time to complete: approximately 10-15 minutes.
4-week follow up: GAD-7, PHQ-8, WHO-5, ISI, ERQ, WSAS, and SCS. Time to complete: approximately 10-15 minutes.
8-week follow up: GAD-7, PHQ-8, WHO-5, ISI, ERQ, WSAS, and SCS. Time to complete: approximately 10-15 minutes.
After completing the 8-week follow up, participants in the control condition will be sent the COMET intervention modules. Whether they complete the intervention or not is entirely up to them and it will not be tracked by the research team.
- Conditions
- Depression, Anxiety, Emotion Regulation
- Being tested
- Common Elements Toolbox (COMET)
- Medical subject headings
- Depression, Anxiety Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Common Elements Toolbox (COMET)Behavioural
Also called single session intervention, unguided self-help, internet-based CBT
COMET is an unguided single-session intervention (SSI) combining elements of cognitive-behavioral therapy (CBT) and positive psychology.
| Study group | Role | What they receive |
|---|---|---|
| Waiting list control (WLC) | No intervention | Participants who are assigned to the control condition will complete the baseline questionnaires and assessments at weeks 2, 4, and 8. After the last assessment, they will be given access to COMET. |
| Common Elements Toolbox (COMET) | Experimental | COMET consists of the following modules: cognitive restructuring (labeled "flexible thinking"), behavioral activation (labeled "positive activities"), gratitude, and self-compassion. Participants complete these COMET modules by themselves. The format is reading psychoeducational along with completing specific activities. Receives: Behavioral: Common Elements Toolbox (COMET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-week change in the Patient Health Questionnaire
Changes in PHQ8 from baseline to Week 2. The PHQ8 is a measure of depression and the measure is scored on a scale of 0 - 24 where higher scores indicate higher depression (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.
Measured: 2 weeks
2-week change in the Generalized Anxiety Disorder 7 scale (GAD7)
Changes in GAD7 from baseline to Week 2. The GAD7 is a measure of anxiety and the measure is scored on a scale of 0 - 21 where higher scores indicate higher anxiety (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.
Measured: 2 weeks
8-week change in the Patient Health Questionnaire
Changes in PHQ8 from baseline to Week 8. The PHQ8 is a measure of depression and the measure is scored on a scale of 0 - 24 where higher scores indicate higher depression (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.
Measured: 8 weeks
8-week change in the Generalized Anxiety Disorder 7 scale (GAD7) 8-week change in the Generalized Anxiety Disorder 7 scale (GAD7)
Changes in GAD7 from baseline to Week 2. The GAD7 is a measure of anxiety and the measure is scored on a scale of 0 - 21 where higher scores indicate higher anxiety (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.
Measured: 8 weeks
Secondary outcomes (4)
8-week change in the World Health Organization Well-being Index 5 (WHO5)
Changes in WHO-5 from baseline to 8 weeks after the termination of the study. The WHO-5 is a measure of well-being and the measure is scored on a scale of 0 - 100 where higher scores indicate higher satisfaction with life (i.e., are positive). Thus, higher scores relative to baseline indicate more positive outcomes.
Measured: 8 weeks
8-week change in the Work and Social Adjustment Scale (WSAS)
Changes in WSAS from baseline to Week 8. The WSAS is a measure of impairment in functioning and the measure is scored on a scale of 0 - 40 where higher scores indicate great dysfunction (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.
Measured: 8 weeks
8-week change in Emotion Regulation Scale (ERQ) - Reappraisal subscale
Changes in the ERQ Reappraisal subscale from baseline to Week 8. The Reappraisal scale is a measure of regulating emotions by engaging in reappraisal (i.e., changing the one one thinks about an emotion evoking stimuli), widely considered an adaptive strategy. The measured is scored on a 1-7 scale where higher scores indicate greater use of adaptive emotion regulation strategies (i.e., positive). Thus, higher scores relative to baseline indicate more positive outcomes.
Measured: 8 weeks
8-week change in the Emotion Regulation Scale (ERQ) - Suppression subscale
Changes in the ERQ Suppression Scale from baseline to Week 8. The ERQ Suppression scale is a measure of regulating emotions by engaging in suppression (i.e., trying not to think or feel), which is considered a maladaptive emotion regulation strategy. The measure is scored on a scale of 1 - 7 where higher scores indicate higher use of suppression (i.e., negative). Thus, lower scores relative to baseline indicate more positive outcomes.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start5 Jul 2022
- Primary completion3 Sep 2022
- Study completion3 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 829 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Lorenzo-Luaces, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379881
- Sponsor's protocol ID
- 12290
- Acronym
- COMET-Prol
- Status last verified
- Oct 2022
- First submitted
- 13 May 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lorenzo-Luaces L, Howard J. Efficacy of an Unguided, Digital Single-Session Intervention for Internalizing Symptoms in Web-Based Workers: Randomized Controlled Trial. J Med Internet Res. 2023 Jul 7;25:e45411. doi: 10.2196/45411.
PubMed 37418303
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Wellness Intervention: Investigating the Efficacy of the Common Elements Toolbox
- ClinicalTrials.gov ID
- NCT05379881
- Acronym / sponsor ID
- COMET-Prol / 12290
- Conditions
- Depression, Anxiety, Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 829 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 3 Sep 2022 (actual)
- Study completion
- 3 Sep 2022 (actual)
- First posted
- 18 May 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.
In this study, the investigators will test the effectiveness of a digital, single-session mental health intervention. There will be two conditions: the COMET intervention and the control group. The program, COMET (Common Elements Toolbox), will include a variety of modules which will focus on cognitive restructuring, gratitude, behavioral activation, and self-compassion. A similar intervention has previously been tested with Indian adolescents and adapted for US graduate students.
Detailed description
Participants who follow the study link in Prolific will immediately be taken to the Informed Consent Statement (ICS), which will include a description of the study, risks and benefits, payment, and confidentiality. After reading the ICS, participants will confirm their consent by clicking "I consent to participate in this study." They will then be taken to the welcome page for the study and confirm that they will provide their best answers. Once participants have confirmed their consent, they will be taken to the rest of the survey.
All participants will fill out a series of questionnaires including: the Generalized Anxiety Disorder 7-item (GAD-7), Patient Health Questionnaire 8-item (PHQ-8), WHO-5 Wellbeing Index (WHO-5), 3 questions from the Insomnia Severity Index (ISI), Emotion Regulation Questionnaire (ERQ), Ten-Item Personality Inventory (TIPI), Adverse Childhood Experiences Scale (ACES), Work and Social Adjustment Scale (WSAS), 4 mechanisms questions, 3 items from the Secondary Control Scale (SCS), Module preferences and the System Usability Scale (SUS). After completing these questionnaires participants will be randomized to either the COMET intervention condition (who receive the intervention immediately) or the control condition (who will receive the intervention after 8 weeks). they will be randomized to one of two conditions: COMET (will receive the COMET intervention immediately) or a waitlist control (will receive the COMET intervention in 8 weeks). This randomization will be completed via the Qualtrics randomizer function - which randomly and evenly assigns participants to the two conditions.
Participants who are assigned to the COMET condition will then be taken to the intervention introduction. They will then receive the following modules: cognitive restructuring (labeled "flexible thinking"), behavioral activation (labeled "positive activities"), gratitude, and self-compassion. In the flexible thinking module, participants will learn to identify and reframe negative beliefs. They will first read about a hypothetical character who is adjusting to changes in their routine. Then, using the character's story as an example, they will try to identify negative beliefs that the character may be experiencing and ways the character could reframe the belief. Then, they will apply this technique to a situation in their own life. In the positive activities module, participants will identify and reflect on activities that are important to them. They will list activities they find enjoyable and meaningful. Then, they will reflect on why these activities matter to them and schedule in time to perform these activities in the weeks ahead. In the gratitude module, participants will be asked to reflect and write about 3 things they are grateful about. They will then be asked to think and write about things they notice around them that they enjoy and are grateful for. In the self-compassion module, participants will be asked to write a self-compassion letter to themselves, expressing compassion towards themselves just as they would towards a friend or family member. They will also be requested to create a few sentences that they would like to hear when feeling self-critical.
After completing the COMET intervention, participants will complete the post-intervention questions. A mental wellbeing resource list will be provided at the end of the session.
Participants who are assigned to the control condition will complete a separate series of questionnaires: hypothetical questions about emotional experiences using questions from the GAD-7 (Hypothetical Questions - GAD-7) and hypothetical questions about emotional experiences using questions from the PHQ-9 (Hypothetical Questions - PHQ-9).
After completing the COMET intervention or completing the control questions, all participants will fill out demographic information including age, sex assigned at birth, gender, race/ethnicity, sexual orientation, relationship status, how often they attend religious services, education level, annual income, employment status, if they have ever taken anti-depressants or other psychiatric medication, how many people they can rely on for social support, physical health, how often they drink alcohol, and how old they were when they first struggled with depression, anxiety, or stress.
All participants in both conditions will be invited via Prolific to continue to complete measures at follow-up time points of 2 weeks, 4 weeks, and 8 weeks post-baseline (approx. 10-15 minutes each). In the informed consent statement, participants will be informed that there are follow-up assessments that they can receive additional compensation for. There will also be reminders at the end of the baseline assessment reminding them to watch for the follow ups. They will not be notified of these follow-up assessments, but will be able to see the follow-up assessments posted on Prolific. During these follow-ups all participants (e.g., those in both the intervention and control conditions) will complete the following questionnaires: GAD-7, PHQ-8, WHO-5, ISI, ERQ, WSAS, and SCS.
After completing the follow-up measure at 8 weeks, enrollment in the study will end. At this point, participants in the control condition will receive the intervention modules. Their use of the COMET intervention is entirely optional and will not be recorded by the research team. They will not fill out any follow up measures after completing or not completing the COMET intervention.
Below is a complete schedule for participants in the study, separated by condition (e.g., COMET vs control).
COMET INTERVENTION
Baseline:
Measures/questionnaires (pre-intervention): Informed consent statement --> Intro Text --> Generalized Anxiety Disorder 7-item (GAD-7), Patient Health Questionnaire 8-item (PHQ-8), WHO-5 Wellbeing Index (WHO-5), 3 questions from the Insomnia Severity Index (ISI), Emotion Regulation Questionnaire (ERQ), Ten-Item Personality Inventory (TIPI), Adverse Childhood Experiences Scale (ACES), Work and Social Adjustment Scale (WSAS), 4 mechanisms questions, 3 items from the Secondary Control Scale (SCS), Module preferences and the System Usability Scale (SUS).
Intervention: After filling out these questionnaires, they will proceed to the COMET intervention content, which consists of the intervention introduction and 4 modules - cognitive restructuring (labeled "flexible thinking"), behavioral activation (labeled "positive activities"), gratitude, and self-compassion.
Measures/questionnaires (post-intervention): Post Intervention Questions, demographic information.
Time to complete: approximately 60-80 minutes.
2-week follow up: Measures/questionnaires: GAD-7, PHQ-8, WHO-5, ISI, ERQ, WSAS, and SCS. Time to complete: approximately 10-15 minutes.
4-week follow up: Measures/questionnaires: GAD-7, PHQ-8, WHO-5, ISI, ERQ, WSAS, and SCS. Time to complete: approximately 10-15 minutes.
8-week follow up: Measures/questionnaires: GAD-7, PHQ-8, WHO-5, ISI, ERQ, WSAS, and SCS. Time to complete: approximately 10-15 minutes.
CONTROL CONDITION
Baseline:
Measures/questionnaires: Informed consent statement --> Intro Text --> Generalized Anxiety Disorder 7-item (GAD-7), Patient Health Questionnaire 8-item (PHQ-8), WHO-5 Wellbeing Index (WHO-5), 3 questions from the Insomnia Severity Index (ISI), Emotion Regulation Questionnaire (ERQ), Ten-Item Personality Inventory (TIPI), Adverse Childhood Experiences Scale (ACES), Work and Social Adjustment Scale (WSAS), 4 mechanisms questions, 3 items from the Secondary Control Scale (SCS), Module preferences and the System Usability Scale (SUS); hypothetical questions about emotional experiences using questions from the GAD-7 (Hypothetical Questions - GAD-7); hypothetical questions about emotional experiences using questions from the PHQ-9 (Hypothetical Questions - PHQ-9); demographic information.
Time to complete: approximately 15-20 minutes.
2-week follow up: GAD-7, PHQ-8, WHO-5, ISI, ERQ, WSAS, and SCS. Time to complete: approximately 10-15 minutes.
4-week follow up: GAD-7, PHQ-8, WHO-5, ISI, ERQ, WSAS, and SCS. Time to complete: approximately 10-15 minutes.
8-week follow up: GAD-7, PHQ-8, WHO-5, ISI, ERQ, WSAS, and SCS. Time to complete: approximately 10-15 minutes.
After completing the 8-week follow up, participants in the control condition will be sent the COMET intervention modules. Whether they complete the intervention or not is entirely up to them and it will not be tracked by the research team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waiting list control (WLC) | No intervention | –Participants who are assigned to the control condition will complete the baseline questionnaires and assessments at weeks 2, 4, and 8. After the last assessment, they will be given access to COMET. |
| Common Elements Toolbox (COMET) | Experimental | Behavioral: Common Elements Toolbox (COMET)COMET consists of the following modules: cognitive restructuring (labeled "flexible thinking"), behavioral activation (labeled "positive activities"), gratitude, and self-compassion. Participants complete these COMET modules by themselves. The format is reading psychoeducational along with completing specific activities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A positive response (i.e., "yes") to the question: "Do you have or have you had a diagnosed, ongoing mental health/illness/condition?"
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Common Elements Toolbox (COMET)Also: single session intervention, unguided self-help, internet-based CBTCOMET is an unguided single-session intervention (SSI) combining elements of cognitive-behavioral therapy (CBT) and positive psychology. | Behavioural | Common Elements Toolbox (COMET) |
Primary outcome
2-week change in the Patient Health Questionnaire
Time frame: 2 weeks
Changes in PHQ8 from baseline to Week 2. The PHQ8 is a measure of depression and the measure is scored on a scale of 0 - 24 where higher scores indicate higher depression (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.
2-week change in the Generalized Anxiety Disorder 7 scale (GAD7)
Time frame: 2 weeks
Changes in GAD7 from baseline to Week 2. The GAD7 is a measure of anxiety and the measure is scored on a scale of 0 - 21 where higher scores indicate higher anxiety (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.
8-week change in the Patient Health Questionnaire
Time frame: 8 weeks
Changes in PHQ8 from baseline to Week 8. The PHQ8 is a measure of depression and the measure is scored on a scale of 0 - 24 where higher scores indicate higher depression (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.
8-week change in the Generalized Anxiety Disorder 7 scale (GAD7) 8-week change in the Generalized Anxiety Disorder 7 scale (GAD7)
Time frame: 8 weeks
Changes in GAD7 from baseline to Week 2. The GAD7 is a measure of anxiety and the measure is scored on a scale of 0 - 21 where higher scores indicate higher anxiety (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.
4 secondary outcomes
8-week change in the World Health Organization Well-being Index 5 (WHO5)
Time frame: 8 weeks
8-week change in the Work and Social Adjustment Scale (WSAS)
Time frame: 8 weeks
8-week change in Emotion Regulation Scale (ERQ) - Reappraisal subscale
Time frame: 8 weeks
8-week change in the Emotion Regulation Scale (ERQ) - Suppression subscale
Time frame: 8 weeks
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 24 Oct 2022.
- Derived from this study: PubMed 37418303Lorenzo-Luaces L, Howard J. Efficacy of an Unguided, Digital Single-Session Intervention for Internalizing Symptoms in Web-Based Workers: Randomized Controlled Trial. J Med Internet Res. 2023 Jul 7;25:e45411. doi: 10.2196/45411.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Common Elements Toolbox (COMET) in people with Depression and Anxiety, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 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: finished, as of the sponsor's last update on 24 Oct 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 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?
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?
2-week change in the Patient Health Questionnaire (time frame: 2 weeks). 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 NCT05379881, which also lists 1 linked publication.
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 24 Oct 2022.