Depression, AnxietyNCT04226742

Evaluation of a Crowd-Powered Web Platform for Depression and Anxiety

A study testing ADAPT Platform (Treatment) in people with Depression, Anxiety, run by University of California, Irvine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Depression, Anxiety
What is being tested?: ADAPT Platform (Treatment)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 107 participants
Where: 1 siteUnited States
Study dates: 18 Feb 2021to 4 Jan 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1) Completion of the Mental Health America Screening to Supports (MHA S2S) or significant mood and anxiety symptoms as defined by an accepted cut-off on a validated measure the Depression Anxiety and Stress Scale (DASS). The accepted cut-off is scores greater than 22;
2) able to speak and read English;
3) at least 18 years of age.

Who cannot join

1) severe suicidality (has ideation, plan, and intent)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California Irvine
Irvine, California, 92697

Other trials in United States

About this study

Official title: Evaluation of the Crowd-Powered Web Platform for Accumulative Depression and Anxiety Plans and Treatment (ADAPT)

100 participants will be enrolled in a two-armed randomized controlled trial of the Accumulated Depression and Anxiety Plans and Treatments (ADAPT) platform which integrates internet Cognitive Behavioral Therapy (iCBT) to determine impact on symptoms of depression and anxiety. This trial will pilot the effectiveness of the ADAPT platform, and evaluate the extent to which the ADAPT platform engages putative targets of personal relevance, skills use, and skills mastery.

Read the detailed description

The investigators will enroll 100 participants in a two-armed randomized controlled trial of the ADAPT platform (iCBT). Participants will be randomly assigned to receive either the ADAPT platform (treatment) or a similar self-guided platform (control) that contains the didactic material (learning) but lacks the ADAPT platforms "crowd" features. Participants will use their assigned platform for a treatment period of 8 weeks. Participants will receive trial assessments at baseline, week 4, and week 8 (post-treatment). Follow-up evaluations will occur at 16 weeks to evaluate maintenance of gains. This pilot effectiveness trial aims to determine the impact on symptoms of depression and anxiety and whether the platform engages the putative targets of personal relevance, relationship, resulting in increased skills mastery and skills use.

Conditions: Depression, Anxiety
Being tested: ADAPT Platform (Treatment), ADAPT Comparison (Control)
Medical subject headings: Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ADAPT Platform (Treatment)Behavioural
The ADAPT platform consists of 2 modules based on evidence-based strategies from cognitive-behavioral therapy including cognitive restructuring and behavioral experiments. The platform includes didactic material, interactive tools, and crowd-features. Crowd-features are present to increase personal relevance of content and to promote engagement with the ADAPT platform through accountability. Crowd-features include requesting, responding, and exemplars.
ADAPT Comparison (Control)Behavioural
The control platform is a self-guided version of the ADAPT platform that includes no crowd-features. As such it will include only didactic material on cognitive restructuring and behavioral experiments and interactive tools.

Study groups in NCT04226742
Study group	Role	What they receive
Treatment	Experimental	Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks. Receives: Behavioral: ADAPT Platform (Treatment)
Control	Active comparator	Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks. Receives: Behavioral: ADAPT Comparison (Control)

What is being measured

The primary outcome is the main question the study is designed to answer.

Depression Scores at Week 16
The primary outcome of symptoms of depression will be measured with the self-report depression subscale of the Depression Anxiety Stress Scale (DASS). The subscale for depression ranges from 7 to 28 with lower values (lowest value = 7) indicating lower levels of depression and higher values (highest value = 28) indicating higher levels of depression.
Measured: Absolute scores at Week 16
Anxiety Scores at 16 Weeks
The primary outcome of symptoms of anxiety will be measured with the self-report anxiety subscale of the Depression Anxiety Stress Scale (DASS). The subscale for anxiety ranges from 7 to 28 with lower values (lowest value = 7) indicating lower levels of anxiety and higher values (highest value = 28) indicating higher levels of anxiety.
Measured: Absolute scores at Week 16

Secondary outcomes (4)

Cognitive and Behavioral Skills Scores at 16 Weeks
A secondary outcome is the Frequency of Actions and Thoughts (FATS), which assesses the use of cognitive and behavioral skills. Total scores indicate the average of each item rating and range from 0-4. Lower scores indicate less frequent use of cognitive and behavioral skills and higher scores indicate more frequent use of cognitive and behavioral skills.
Measured: Absolute scores at Week 16
Self-efficacy Scores at 16 Weeks
A secondary outcome is the Coping Self-Efficacy (CSE), which produces a single score that ranges from 0-260 with lower scores representing lower coping self-efficacy and higher scores indicating higher coping self-efficacy.
Measured: Absolute scores at Week 16
Accountability Scores at 16 Weeks
A secondary outcome is the Supportive Accountability Questionnaire (SAQ), which produces a single score than ranges from 7-91. Data reported are the SAQ total scores with lower levels indicating less supportive accountability and higher values indicating greater supportive accountability.
Measured: Absolute scores at Week 16
Social Functioning Scores at 16 Weeks
Functioning will be assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Scale which produces T-scores that have a mean of 50 and a standard deviation of 10. Lower scores indicate lower participation in social roles and activities and higher scores indicate higher participation in social roles and activities.
Measured: Absolute scores at Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Feb 20214 Jan 2022

First posted13 Jan 2020
Study start18 Feb 2021
Primary completion5 Nov 2021
Study completion4 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (34)Papers the sponsor has linked to this study.
Other trials for Depression, AnxietyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomly assigned to receive either the treatment condition (ADAPT platform, iCBT platform comprised of didactic and interactive content), or a control condition (iCBT comparison platform comprised only of didactic content).
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04226742
Sponsor's protocol ID: HS#2019-4901, HS#2020-6071
Other IDs: 1R34MH113616-01A1
Status last verified: Jun 2023
First submitted: 8 Jan 2020
Last updated: 29 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual Participant Data will be deposited into the NIH data repository.

Publications

Dear BF, Titov N, Schwencke G, Andrews G, Johnston L, Craske MG, McEvoy P. An open trial of a brief transdiagnostic internet treatment for anxiety and depression. Behav Res Ther. 2011 Dec;49(12):830-7. doi: 10.1016/j.brat.2011.09.007. Epub 2011 Sep 28.
PubMed 21993153
Titov N, Dear BF, Schwencke G, Andrews G, Johnston L, Craske MG, McEvoy P. Transdiagnostic internet treatment for anxiety and depression: a randomised controlled trial. Behav Res Ther. 2011 Aug;49(8):441-52. doi: 10.1016/j.brat.2011.03.007. Epub 2011 Apr 3.
PubMed 21679925
van Ballegooijen W, Cuijpers P, van Straten A, Karyotaki E, Andersson G, Smit JH, Riper H. Adherence to Internet-based and face-to-face cognitive behavioural therapy for depression: a meta-analysis. PLoS One. 2014 Jul 16;9(7):e100674. doi: 10.1371/journal.pone.0100674. eCollection 2014.
PubMed 25029507
Schueller SM, Mohr DC. Initial Field Trial of a Coach-Supported Web-Based Depression Treatment. Int Conf Pervasive Comput Technol Healthc. 2015 Aug;2015:10.4108/icst.pervasivehealth.2015.260115. doi: 10.4108/icst.pervasivehealth.2015.260115. Epub 2015 Aug 3.
PubMed 26640741
Munoz RF. Using evidence-based internet interventions to reduce health disparities worldwide. J Med Internet Res. 2010 Dec 17;12(5):e60. doi: 10.2196/jmir.1463.
PubMed 21169162
Munoz RF, Aguilera A, Schueller SM, Leykin Y, Perez-Stable EJ. From online randomized controlled trials to participant preference studies: morphing the San Francisco Stop Smoking site into a worldwide smoking cessation resource. J Med Internet Res. 2012 Jun 27;14(3):e64. doi: 10.2196/jmir.1852.
PubMed 22739225
Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
PubMed 17339617
Lovibond, S. H., & Lovibond, P. F. (1993). Manual for the Depression Anxiety Stress Scales (DASS). Psychology Foundation Monograph, University of New South Wales.
Muñoz, R. F., Bunge, E. L., Chen, K., Schueller, S. M., Bravin, J. I., Shaughnessy, E. A., & Pérez- Stable, E. J. (2015). Massive open online interventions: A novel model for delivering behavioral-health services worldwide. Clinical Psychological Science. Advanced Online Publication. http://doi.org/10.1177/2167702615583840
MacArthur Foundation's Initiative (2004). The Macarthur initiative on depression and primary care at Dartmouth and Duke: Depression management toolkit. Hanover, NH: Dartmouth.
First, M. B., Williams, J. B. W., Karg, R. S., & Spitzer, R. L. (2015). Structured clinical interview for DSM-5 disorders, clinician version (SCID-5-CV). Arlington, VA: American Psychiatric Association.
Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
PubMed 7726811
Gorka SM, Lieberman L, Klumpp H, Kinney KL, Kennedy AE, Ajilore O, Francis J, Duffecy J, Craske MG, Nathan J, Langenecker S, Shankman SA, Phan KL. Reactivity to unpredictable threat as a treatment target for fear-based anxiety disorders. Psychol Med. 2017 Oct;47(14):2450-2460. doi: 10.1017/S0033291717000964. Epub 2017 Apr 24.
PubMed 28436351
Gorka SM, Burkhouse KL, Afshar K, Phan KL. Error-related brain activity and internalizing disorder symptom dimensions in depression and anxiety. Depress Anxiety. 2017 Nov;34(11):985-995. doi: 10.1002/da.22648. Epub 2017 Sep 20.
PubMed 28940987
Burkhouse KL, Gorka SM, Afshar K, Phan KL. Neural reactivity to reward and internalizing symptom dimensions. J Affect Disord. 2017 Aug 1;217:73-79. doi: 10.1016/j.jad.2017.03.061. Epub 2017 Mar 29.
PubMed 28391111

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Crowd-Powered Web Platform for Accumulative Depression and Anxiety Plans and Treatment (ADAPT)
ClinicalTrials.gov ID: NCT04226742
Acronym / sponsor ID: HS#2019-4901, HS#2020-6071
Conditions: Depression, Anxiety
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: University of California, IrvineUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH), Mental Health America, Northwestern University
Study start: 18 Feb 2021 (actual)
Primary completion: 5 Nov 2021 (actual)
Study completion: 4 Jan 2022 (actual)
First posted: 13 Jan 2020 (actual)
Results: Posted 26 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Participants will be randomly assigned to receive either the treatment condition (ADAPT platform, iCBT platform comprised of didactic and interactive content), or a control condition (iCBT comparison platform comprised only of didactic content).

Arm	Type	Receives
Treatment	Experimental	Behavioral: ADAPT Platform (Treatment)Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks.
Control	Active comparator	Behavioral: ADAPT Comparison (Control)Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

1) Completion of the Mental Health America Screening to Supports (MHA S2S) or significant mood and anxiety symptoms as defined by an accepted cut-off on a validated measure the Depression Anxiety and Stress Scale (DASS). The accepted cut-off is scores greater than 22;
2) able to speak and read English;
3) at least 18 years of age.

Key exclusion criteria (1 listed)

1) severe suicidality (has ideation, plan, and intent)

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
ADAPT Platform (Treatment)The ADAPT platform consists of 2 modules based on evidence-based strategies from cognitive-behavioral therapy including cognitive restructuring and behavioral experiments. The platform includes didactic material, interactive tools, and crowd-features. Crowd-features are present to increase personal relevance of content and to promote engagement with the ADAPT platform through accountability. Crowd-features include requesting, responding, and exemplars.	Behavioural	Treatment
ADAPT Comparison (Control)The control platform is a self-guided version of the ADAPT platform that includes no crowd-features. As such it will include only didactic material on cognitive restructuring and behavioral experiments and interactive tools.	Behavioural	Control

Primary outcome

Depression Scores at Week 16
Time frame: Absolute scores at Week 16
The primary outcome of symptoms of depression will be measured with the self-report depression subscale of the Depression Anxiety Stress Scale (DASS). The subscale for depression ranges from 7 to 28 with lower values (lowest value = 7) indicating lower levels of depression and higher values (highest value = 28) indicating higher levels of depression.
Anxiety Scores at 16 Weeks
Time frame: Absolute scores at Week 16
The primary outcome of symptoms of anxiety will be measured with the self-report anxiety subscale of the Depression Anxiety Stress Scale (DASS). The subscale for anxiety ranges from 7 to 28 with lower values (lowest value = 7) indicating lower levels of anxiety and higher values (highest value = 28) indicating higher levels of anxiety.

4 secondary outcomes

Cognitive and Behavioral Skills Scores at 16 Weeks
Time frame: Absolute scores at Week 16
Self-efficacy Scores at 16 Weeks
Time frame: Absolute scores at Week 16
Accountability Scores at 16 Weeks
Time frame: Absolute scores at Week 16
Social Functioning Scores at 16 Weeks
Time frame: Absolute scores at Week 16

Results and safety

Results posted to the registry on 26 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	56	35
Control	51	35

Primary outcome: Depression Scores at Week 16

Time frame: Absolute scores at Week 16. Mean (Standard Deviation). Unit: score on a scale

Measure	Treatment n = 35	Control n = 35
Value	15.7 (12.9)	15.7 (10.3)

Treatment vs Control: Mean Difference (Net): 0.58 (95% CI -3.71 to 4.88), p = 0.79, Mixed Models Analysis

Population analysed: Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis

Primary outcome: Anxiety Scores at 16 Weeks

Time frame: Absolute scores at Week 16. Mean (Standard Deviation). Unit: score on a scale

Measure	Treatment n = 35	Control n = 35
Value	12.4 (10.8)	11.0 (9.77)

Treatment vs Control: Mean Difference (Net): 0.90 (95% CI -2.52 to 4.32), p = .61, Mixed Models Analysis

Population analysed: Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	0 of 56 (0%)	0 of 56 (0%)	0 of 56
Control	0 of 51 (0%)	0 of 51 (0%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21993153Dear BF, Titov N, Schwencke G, Andrews G, Johnston L, Craske MG, McEvoy P. An open trial of a brief transdiagnostic internet treatment for anxiety and depression. Behav Res Ther. 2011 Dec;49(12):830-7. doi: 10.1016/j.brat.2011.09.007. Epub 2011 Sep 28.
Background: PubMed 21679925Titov N, Dear BF, Schwencke G, Andrews G, Johnston L, Craske MG, McEvoy P. Transdiagnostic internet treatment for anxiety and depression: a randomised controlled trial. Behav Res Ther. 2011 Aug;49(8):441-52. doi: 10.1016/j.brat.2011.03.007. Epub 2011 Apr 3.
Background: PubMed 25029507van Ballegooijen W, Cuijpers P, van Straten A, Karyotaki E, Andersson G, Smit JH, Riper H. Adherence to Internet-based and face-to-face cognitive behavioural therapy for depression: a meta-analysis. PLoS One. 2014 Jul 16;9(7):e100674. doi: 10.1371/journal.pone.0100674. eCollection 2014.
Background: PubMed 26640741Schueller SM, Mohr DC. Initial Field Trial of a Coach-Supported Web-Based Depression Treatment. Int Conf Pervasive Comput Technol Healthc. 2015 Aug;2015:10.4108/icst.pervasivehealth.2015.260115. doi: 10.4108/icst.pervasivehealth.2015.260115. Epub 2015 Aug 3.
Background: PubMed 21169162Munoz RF. Using evidence-based internet interventions to reduce health disparities worldwide. J Med Internet Res. 2010 Dec 17;12(5):e60. doi: 10.2196/jmir.1463.
Background: PubMed 22739225Munoz RF, Aguilera A, Schueller SM, Leykin Y, Perez-Stable EJ. From online randomized controlled trials to participant preference studies: morphing the San Francisco Stop Smoking site into a worldwide smoking cessation resource. J Med Internet Res. 2012 Jun 27;14(3):e64. doi: 10.2196/jmir.1852.
Background: PubMed 17339617Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
BackgroundLovibond, S. H., & Lovibond, P. F. (1993). Manual for the Depression Anxiety Stress Scales (DASS). Psychology Foundation Monograph, University of New South Wales.
BackgroundMuñoz, R. F., Bunge, E. L., Chen, K., Schueller, S. M., Bravin, J. I., Shaughnessy, E. A., & Pérez- Stable, E. J. (2015). Massive open online interventions: A novel model for delivering behavioral-health services worldwide. Clinical Psychological Science. Advanced Online Publication. http://doi.org/10.1177/2167702615583840
BackgroundMacArthur Foundation's Initiative (2004). The Macarthur initiative on depression and primary care at Dartmouth and Duke: Depression management toolkit. Hanover, NH: Dartmouth.
BackgroundFirst, M. B., Williams, J. B. W., Karg, R. S., & Spitzer, R. L. (2015). Structured clinical interview for DSM-5 disorders, clinician version (SCID-5-CV). Arlington, VA: American Psychiatric Association.
Background: PubMed 7726811Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
Individual participant dataSharing planned: Yes. Individual Participant Data will be deposited into the NIH data repository.

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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.

Stephen M Schueller, PhD principal investigator

University of California, Irvine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ADAPT Platform (Treatment) in people with Depression, Anxiety, run by University of California, Irvine 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 3 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 29 Jun 2023. 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?

Yes. Results are posted in the registry (first posted 26 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Depression Scores at Week 16 (time frame: Absolute scores at Week 16). 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?

On the ClinicalTrials.gov record for NCT04226742, which also lists 34 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 29 Jun 2023.