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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH113616-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Mental Health America | OTHER |
| Northwestern University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks. |
|
| Control | Active Comparator | Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADAPT Platform (Treatment) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Absolute scores at Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen M Schueller, PhD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Irvine | California | 92697 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21993153 | Background | 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. | |
| 21679925 | Background | 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. |
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Individual Participant Data will be deposited into the NIH data repository.
Data will become available immediately following publication, no end date.
Anyone who wishes to access the data.
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Participants were recruited from the Mental Health America screening website between Feburary 2021 and September 2021. The first participant was enrolled on February 18, 2021 and the last participant was enrolled on September September 3, 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks. 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. |
| FG001 | Control | Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis | Posted | Mean | Standard Deviation | score on a scale | Absolute scores at Week 16 |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Schueller | University of California, Irvine | 949-824-3850 | s.schueller@uci.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 14, 2021 | Apr 30, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 14, 2021 | Apr 30, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 15, 2021 | Feb 22, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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).
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Participants will be unaware of which condition they have been assigned.
|
| ADAPT Comparison (Control) | Behavioral | 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. |
|
| 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. | 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. | 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. | Absolute scores at Week 16 |
| 25029507 | Background | 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. |
| 26640741 | Background | 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. |
| 21169162 | Background | 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. |
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| Background | Lovibond, S. H., & Lovibond, P. F. (1993). Manual for the Depression Anxiety Stress Scales (DASS). Psychology Foundation Monograph, University of New South Wales. |
| Background | 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 |
| Background | MacArthur Foundation's Initiative (2004). The Macarthur initiative on depression and primary care at Dartmouth and Duke: Depression management toolkit. Hanover, NH: Dartmouth. |
| Background | 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. |
| 7726811 | Background | 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. |
| 28436351 | Background | 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. |
| 28940987 | Background | 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. |
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| Background | Duffecy, J., Cai, X., & Mohr, D. C. (2013). Supportive accountability: Measurement of a framework for adherence to behavioral intervention technologies. International Society for Research on Internet Interventions, Chicago, IL. |
| 26553147 | Background | Miner AS, Schueller SM, Lattie EG, Mohr DC. Creation and validation of the Cognitive and Behavioral Response to Stress Scale in a depression trial. Psychiatry Res. 2015 Dec 30;230(3):819-25. doi: 10.1016/j.psychres.2015.10.033. Epub 2015 Oct 30. |
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| Background | Nguyen, T., O'Dea, B., Larsen, M., Phung, D., Venkatesh, S., & Christensen, H. (2015, November). Differentiating sub-groups of online depression-related communities using textual cues. In International Conference on Web Information Systems Engineering (pp. 216-224). Springer International Publishing. |
| BG001 | Control | Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Depression Anxiety Stress Scale (DASS) | DASS total score with scores ranging from 21 to 84 with lower values (21 = lowest) indicating lower levels of depression, anxiety, and stress and higher values (84 = highest) indicating higher levels of depression, anxiety, and stress. | Mean | Standard Deviation | scores on a scale |
|
| OG001 | Control | Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks. 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. |
|
|
|
| Primary | 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. | Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis | Posted | Mean | Standard Deviation | score on a scale | Absolute scores at Week 16 |
|
|
|
|
| Secondary | 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. | Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis | Posted | Mean | Standard Deviation | score on a scale | Absolute scores at Week 16 |
|
|
|
|
| Secondary | 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. | Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis | Posted | Mean | Standard Deviation | score on a scale | Absolute scores at Week 16 |
|
|
|
|
| Secondary | 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. | Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis | Posted | Mean | Standard Deviation | score on a scale | Absolute scores at Week 16 |
|
|
|
|
| Secondary | 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. | Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis | Posted | Mean | Standard Deviation | T-score | Absolute scores at Week 16 |
|
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|
|
| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | Control | Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks. 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. | 0 | 51 | 0 | 51 | 0 | 51 |
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