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Recently Published Clinical Trials
Use of a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention in a Community Population of Adults With Depression Symptoms: Randomized Controlled Trial
Background: Although internet-based cognitive behavior therapy (iCBT) interventions can reduce depression symptoms, large differences in their effectiveness exist.
Objective: The aim of this study was to evaluate the effectiveness of an iCBT intervention called Thrive, which was designed to enhance engagement when delivered as a fully automated, stand-alone intervention to a rural community population of adults with depression symptoms.
Methods: Using no diagnostic or treatment exclusions, 343 adults with depression symptoms were recruited from communities using an open-access website and randomized 1:1 to the Thrive intervention group or the control group. Using self-reports, participants were evaluated at baseline and 4 and 8 weeks for the primary outcome of depression symptom severity and secondary outcome measures of anxiety symptoms, work and social adjustment, psychological resilience, and suicidal ideation.
Results: Over the 8-week follow-up period, the intervention group (n=181) had significantly lower depression symptom severity than the control group (n=162; P<.001), with a moderate treatment effect size (d=0.63). Moderate to near-moderate effect sizes favoring the intervention group were observed for anxiety symptoms (P<.001; d=0.47), work/social functioning (P<.001; d=0.39), and resilience (P<.001; d=0.55). Although not significant, the intervention group was 45% less likely than the control group to experience increased suicidal ideation (odds ratio 0.55).
Conclusions: These findings suggest that the Thrive intervention was effective in reducing depression and anxiety symptom severity and improving functioning and resilience among a mostly rural community population of US adults. The effect sizes associated with Thrive were generally larger than those of other iCBT interventions delivered as a fully automated, stand-alone intervention.
Schure MB, Lindow JC, Greist JH, Nakonezny PA, Bailey SJ, Bryan WL, Byerly MJ. Use of a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention in a Community Population of Adults With Depression Symptoms: Randomized Controlled Trial. J Med Internet Res 2019;21(11):e14754 DOI: 10.2196/14754
Twelve-month follow-up to a fully automated internet-based cognitive behavior therapy intervention for community-dwelling adults with depression symptoms
Background: Internet-based cognitive behavior therapy (iCBT) interventions have the potential to help individuals suffering from depression, regardless of time and location. Yet, limited information exists on the longer-term effects of iCBT and adherence to these interventions.
Objective: The primary aim of this study was to evaluate the longitudinal (one year) effectiveness of a fully automated, self-guided iCBT intervention called Thrive, designed to enhance engagement for a rural community population of adults with depression symptoms. The secondary aim was to determine whether program adherence enhanced effectiveness of the Thrive intervention.
Methods: We analyzed data from 181 adults who were randomized to the Thrive intervention group. Using self-reports, intervention group participants were evaluated at baseline, 8 weeks, 6 months, and 12 months for the primary outcome of depression symptom severity (Patient Health Questionnaire [PHQ-9]) and secondary outcome measures including the Generalized Anxiety Disorder Scale (GADS-7), Work and Social Adjustment Scale (WSAS), Connor-Davidson Resilience Scale (CD-RISC-10), and suicidal ideation (PHQ-9 ninth item). Thrive program adherence was measured using number of program logins, pages views and lessons completed.
Results: By 8 weeks, significant improvements were observed for all outcome measures. These improvements were maintained at 12 months with mean reductions in depression and anxiety symptom severity (M = -6.5, P<.001 and M = -4.3, P<.001, respectively). Improvements were also observed in work and social functioning (M = -6.9, P<.001) and resilience (M = 4.3, P<.001). Twenty-two percent fewer participants endorsed suicidal ideation (PHQ-9 ninth item score >1) at 12 months (17.2%) compared to baseline (39.8%; P<.001) In regard to program adherence, the cumulative count of page views and lessons completed were significantly related to lower PHQ-9, GAD-7, WSAS scores, and higher CD-RISC-10 scores.
Conclusions: The Thrive intervention was effective at reducing depression and anxiety symptom severity and improving functioning and resilience among a mostly rural community population of US adults. These gains were maintained at one year. Program adherence measured by number of logins and lessons completed indicate that users who engage more with the program benefit more.
Schure M, McCrory B, Tuchscherer Franklin K, Greist J, Weissman RS. Twelve-Month Follow-Up to a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention for Rural Adults With Depression Symptoms: Single-Arm Longitudinal Study. J Med Internet Res. 2020 Oct 2;22(10):e21336. doi: 10.2196/21336. Erratum in: J Med Internet Res. 2020 Oct 23;22(10):e25146.
Current Clinical Trials
Thrive Care Study
Evaluation of Thrive‘s impact on depression symptoms among primary care patients at a large integrated health system. Randomized controlled design, 300 participants.
Data collection has ended. Publication pending.
Thrive for Montana Study #2
Evaluation of Thrive‘s impact on depression symptoms, suicide risk, anxiety symptoms, functioning, and resilience among adult Montanans. Randomized controlled trial with 450 participants .
Data collection has ended. Publication pending.
Computer-assisted cognitive behavior therapy for obsessive-compulsive disorder: a randomized trial on the impact of lay vs. professional coaching
Results: All three treatment arms showed a significant reduction in Yale-Brown Obsessive Compulsive Scale (YBOCS) scores, with mean (SD) changes of 6.5 (5.7), 7.1 (6.1), and 6.5 (6.1) for the no coaching, lay coaching, and therapist coaching arms, respectively (all p’s < .001). These represent effect sizes of 1.16, 1.41, and 1.12, respectively. No significant differences were found between treatment arms on YBOCS change scores, F(2) = 0.10, p = .904, or number of exposures sessions done (F(2) = 0.033, p = .967). When asked which method of therapy (computer vs. clinician) they preferred, 48% said computer, 33% said face-to-face therapy, and 19% had no preference.
Conclusions: Results support the use of online self-help for the treatment of moderate OCD. The addition of coaching by either a lay coach or a CBT therapist coach did not significantly improve outcomes.
Kobak KA, Greist R, Jacobi DM, Levy-Mack H, Greist JH. Computer-assisted cognitive behavior therapy for obsessive-compulsive disorder: a randomized trial on the impact of lay vs. professional coaching. Ann Gen Psychiatry. 2015 Feb 22;14:10.
Online cognitive behavioral therapy for depressed primary care patients: a pilot feasibility project
Results: Of 196 eligible patients who were sent an invitation, 39 (20%) enrolled in the Internet-delivered CBT program. At follow-up, enrolled patients experienced a clinically significant decrease (average = 46%) in depressive symptoms. Suicidal thoughts also decreased both overall and by severity.
Conclusions: Seamless, scalable integration of Internet delivered CBT into health care systems is feasible. The 20% uptake rate suggests that future work should focus on strategies to increase the initial response rate. One promising direction is the addition of “human touch” to the secure message invitation. Depression outcomes suggest promise for system-wide implementation of Internet-delivered CBT programs.
Whiteside U, Richards J, Steinfeld B, Simon G, Caka S, Tachibana C, Stuckey S, Ludman E. Online cognitive behavioral therapy for depressed primary care patients: a pilot feasibility project. Perm J. 2014 Spring;18(2):21-7.
Cost-effectiveness of computer-aided behaviour therapy for obsessive-compulsive disorder
In the original RCT, BT Steps and clinician-guided therapy were more effective than relaxation, and BT Steps was less effective than clinician-guided ERP. However, BT Steps costs less, and there is a high probability that BT Steps is the most cost-effective option for modest values placed on a one-unit fall in the YBOCS. Clinician-guided therapy would be more cost-effective than BT Steps only if a unit reduction in the YBOCS was valued at around GBP 133 (EUR 192) or above. However, even if this were acceptable it ignores the fact that there is likely to be a limit on the number of therapists available. Therefore, the difference in cost-effectiveness may be greater than presented here. This study suggests that computer-aided therapy can be a cost-effective alternative for OCD.
McCrone P, Marks IM, Greist JH, Baer L, Kobak KA, Wenzel KW, Hirsch MJ. Cost-effectiveness of computer-aided behaviour therapy for obsessive-compulsive disorder. Psychother Psychosom. 2007;76(4):249-50.
Brief scheduled phone support from a clinician to enhance computer-aided self-help for obsessive-compulsive disorder: randomized controlled trial
Treatment-resistant obsessive-compulsive disorder (OCD) patients from around the United Kingdom who employed computer-guided self-help by using BT Steps over 17 weeks were randomized to have brief live phone support from a clinician either (1) in nine Scheduled clinician-initiated calls or (2) only in calls Requested by the patient (n=22 per condition). Call content and mean duration were similar across conditions. Scheduled-support patients dropped out significantly less often, did more homework of self-exposure and self-imposed ritual prevention (95% vs. 57%), and showed more improvement in OCD symptoms and disability. Mean total support time per patient over 17 weeks was 76 minutes for Scheduled and 16 minutes for Requested patients. Giving brief support proactively by phone enhanced OCD patients’ completion of and improvement with computer-aided self-help.
Kenwright M, Marks I, Graham C, Franses A, Mataix-Cols D. Brief scheduled phone support from a clinician to enhance computer-aided self-help for obsessive-compulsive disorder: randomized controlled trial. J Clin Psychol. 2005 Dec;61(12):1499-508.
Pragmatic evaluation of computer-aided self-help for anxiety and depression
Results: The equivalent of one full-time clinician managed 355 referrals over a year. Of the 266 who had a screening interview 79% were suitable. Completers and non-completers of computer-aided CBT had similar pre-treatment features, with very chronic, moderately severe problems. Completers of the computer-aided self-help had a mean total of an hour’s live therapist support over 12 weeks. They improved significantly and clinically meaningfully with three of the four systems and felt ‘fairly satisfied’. Improvement resembled that in controlled and other trials of computer-aided CBT.
Conclusions: Computer-aided self-help is a ‘clinician extender’ that greatly cuts per-patient therapist time without impairing improvement. It could reduce the per-patient cost of CBT.
Marks IM, Mataix-Cols D, Kenwright M, Cameron R, Hirsch S, Gega L. Pragmatic evaluation of computer-aided self-help for anxiety and depression. Br J Psychiatry. 2003 Jul;183:57-65.
Behavior therapy for obsessive-compulsive disorder guided by a computer or by a clinician compared with relaxation as a control
Results: By week 10, in an intent-to-treat analysis, mean change in score on the Yale-Brown Obsessive Compulsive Scale was significantly greater in clinician-guided behavior therapy (8.0) than in computer-guided (5.6), and changes in scores with both clinician-guided and computer-guided behavior therapy were significantly greater than with relaxation (1.7), which was ineffective. Similarly, the percentage of responders on the Clinical Global Impressions scale was significantly (p < .05) greater with clinician-guided (60%) than computer-guided behavior therapy (38%), and both were significantly greater than with relaxation (14%). Clinician-guided was superior to computer-guided behavior therapy overall, but not when patients completed at least 1 self-exposure session (N = 36 [65%]). At endpoint, patients were more satisfied with either behavior therapy group than with relaxation. Patients assigned to computer-guided behavior therapy improved more the longer they spent telephoning the computer (mostly outside usual office hours) and doing self-exposure. They improved slightly further by week 26 follow-up, unlike the other 2 groups.
Conclusions: For OCD, computer-guided behavior therapy was effective, although clinician-guided behavior therapy was even more effective. Systematic relaxation was ineffective. Computer-guided behavior therapy can be a helpful first step in treating patients with OCD when clinician-guided behavior therapy is unavailable.
Greist JH, Marks IM, Baer L, Kobak KA, Wenzel KW, Hirsch MJ, Mantle JM, Clary CM. Behavior therapy for obsessive-compulsive disorder guided by a computer or by a clinician compared with relaxation as a control. J Clin Psychiatry. 2002 Feb;63(2):138-45.
Self-administered psychotherapy for depression using a telephone-accessed computer system plus booklets: an open U.S.-U.K. study
Results: All 41 patients successfully completed the self-assessment in the booklets and telephone calls. Sixty-eight percent also completed the 12-week self-help program. Hamilton Rating Scale for Depression (HAM-D) and Work and Social Adjustment scores improved significantly (41% and 42% mean reduction in the intent-to-treat sample, respectively, p < .001). Eighteen (64%) of the 28 completers were considered responders on the basis of ≥ 50% reduction in their HAM-D scores. There was a higher percentage of completers in the pooled U.S. sites (82% vs. 43%), and U.S. completers improved more than those in the United Kingdom (73% vs. 43% were responders). Most (68%) of the calls were made outside usual office hours, Monday–Friday, 9:00 a.m. to 5:00 p.m. Expectation of effectiveness and time spent making COPE calls (more treatment modules) correlated positively with improvement over 12 weeks. Mean call length for completers was 14 minutes.
Conclusion: A self-help system comprised of a computer-aided telephone system and a series of booklets was used successfully by people with mild-to-moderate depression. These preliminary results are encouraging for people who cannot otherwise access ongoing, in-person therapy.
Osgood-Hynes DJ, Greist JH, Marks IM, Baer L, Heneman SW, Wenzel KW, Manzo PA, Parkin JR, Spierings CJ, Dottl SL, Vitse HM. Self-administered psychotherapy for depression using a telephone-accessed computer system plus booklets: an open U.S.-U.K. study. J Clin Psychiatry. 1998 Jul;59(7):358-65.
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