scholarly journals Efficacy of a Guided Web-Based Self-Management Intervention for Depression or Dysthymia: Randomized Controlled Trial With a 12-Month Follow-Up Using an Active Control Condition

10.2196/15361 ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. e15361
Author(s):  
Caroline Oehler ◽  
Frauke Görges ◽  
Mandy Rogalla ◽  
Christine Rummel-Kluge ◽  
Ulrich Hegerl

Background An increasing number of studies suggest that web-based interventions for patients with depression can reduce their symptoms and are expected to fill currently existing treatment gaps. However, evidence for their efficacy has mainly been derived from comparisons with wait-list or treatment as usual controls. In particular, designs using wait-list controls are unlikely to induce hope and may even have nocebo effects, making it difficult to draw conclusions about the intervention’s efficacy. Studies using active controls are rare and have not yielded conclusive results. Objective The main objective of this study is to assess the acute and long-term antidepressant efficacy of a 6-week, guided, web-based self-management intervention building on the principles of cognitive behavioral therapy (iFightDepression tool) for patients with depression compared with web-based progressive muscle relaxation as an active control condition. Methods A total of 348 patients with mild-to-moderate depressive symptoms or dysthymia (according to the Mini International Neuropsychiatric Interview) were recruited online and randomly assigned to 1 of the 2 intervention arms. Acute antidepressant effects after 6 weeks and long-term effects at 3-, 6-, and 12-month follow-up were studied using the Inventory of Depressive Symptomatology–self-rating as a primary outcome parameter and change in quality of life (Short Form 12) and user satisfaction (client satisfaction questionnaire) as secondary outcome parameters. Treatment effects were assessed using mixed model analyses. Results Over the entire observation period, a greater reduction in symptoms of depression (P=.01) and a greater improvement of life quality (P<.001) was found in the intervention group compared with the active control group. Separate tests for each time point revealed significant effects on depressive symptoms at the 3-month follow-up (d=0.281; 95% CI 0.069 to 0.493), but not after 6 weeks (main outcome:d=0.192; 95% CI −0.020 to 0.404) and 6 and 12 months. The intervention was significantly superior to the control condition with respect to user satisfaction (25.31 vs 21.97; t259=5.804; P<.01). Conclusions The fact that antidepressant effects have been found for a guided self-management tool in comparison with an active control strengthens the evidence base for the efficacy of web-based interventions. The antidepressant effect became most prominent at the 3-month follow-up. After 6 weeks of intervention, significant positive effects were observed on life quality but not on depressive symptoms. Although the effect size of such web-based interventions on symptoms of depression might be smaller than that suggested by earlier studies using wait-list control conditions, they can be a cost-effective addition to antidepressants and face-to-face psychotherapy. Trial Registration International Clinical Trials Registry Platform ICTRP080-15-09032015; https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00009323

2019 ◽  
Author(s):  
Caroline Oehler ◽  
Frauke Görges ◽  
Mandy Rogalla ◽  
Christine Rummel-Kluge ◽  
Ulrich Hegerl

BACKGROUND An increasing number of studies suggest that web-based interventions for patients with depression can reduce their symptoms and are expected to fill currently existing treatment gaps. However, evidence for their efficacy has mainly been derived from comparisons with wait-list or treatment as usual controls. In particular, designs using wait-list controls are unlikely to induce hope and may even have nocebo effects, making it difficult to draw conclusions about the intervention’s efficacy. Studies using active controls are rare and have not yielded conclusive results. OBJECTIVE The main objective of this study is to assess the acute and long-term antidepressant efficacy of a 6-week, guided, web-based self-management intervention building on the principles of cognitive behavioral therapy (iFightDepression tool) for patients with depression compared with web-based progressive muscle relaxation as an active control condition. METHODS A total of 348 patients with mild-to-moderate depressive symptoms or dysthymia (according to the Mini International Neuropsychiatric Interview) were recruited online and randomly assigned to 1 of the 2 intervention arms. Acute antidepressant effects after 6 weeks and long-term effects at 3-, 6-, and 12-month follow-up were studied using the Inventory of Depressive Symptomatology–self-rating as a primary outcome parameter and change in quality of life (Short Form 12) and user satisfaction (client satisfaction questionnaire) as secondary outcome parameters. Treatment effects were assessed using mixed model analyses. RESULTS Over the entire observation period, a greater reduction in symptoms of depression (<i>P</i>=.01) and a greater improvement of life quality (<i>P</i>&lt;.001) was found in the intervention group compared with the active control group. Separate tests for each time point revealed significant effects on depressive symptoms at the 3-month follow-up (<i>d</i>=0.281; 95% CI 0.069 to 0.493), but not after 6 weeks (<i>main outcome:</i> <i>d</i>=0.192; 95% CI −0.020 to 0.404) and 6 and 12 months. The intervention was significantly superior to the control condition with respect to user satisfaction (25.31 vs 21.97; t<sub>259</sub>=5.804; <i>P</i>&lt;.01). CONCLUSIONS The fact that antidepressant effects have been found for a guided self-management tool in comparison with an active control strengthens the evidence base for the efficacy of web-based interventions. The antidepressant effect became most prominent at the 3-month follow-up. After 6 weeks of intervention, significant positive effects were observed on life quality but not on depressive symptoms. Although the effect size of such web-based interventions on symptoms of depression might be smaller than that suggested by earlier studies using wait-list control conditions, they can be a cost-effective addition to antidepressants and face-to-face psychotherapy. CLINICALTRIAL International Clinical Trials Registry Platform ICTRP080-15-09032015; https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00009323


2016 ◽  
Vol 3 (2) ◽  
pp. e23 ◽  
Author(s):  
Janine Clarke ◽  
Judith Proudfoot ◽  
Howard Ma

Background Depression is often comorbid with diabetes; however, undertreatment of depressive symptoms in people affected is common. Objective We studied preliminary acceptability and effectiveness of a fully automated, mobile phone, and web-based public health intervention, myCompass, for reducing depressive symptoms and improving mental health comorbidities in people with diabetes. Methods In this single-group feasibility study, 89 volunteers with type 1 (n=34) or type 2 (n=55) diabetes and at least mild depressive symptoms used myCompass for 7 weeks. Web-based measures of depressive and anxious symptoms, functional impairment, diabetes-specific variables, and user satisfaction were completed at baseline, postintervention, and 3-month follow-up. Results Retention rates were 54% (n=48) at postintervention and 36% (n=32) at follow-up. Depressive symptoms were significantly improved at postintervention (P<.001; within-group effect size d=1.05), with gains persisting at follow-up. Mental health comorbidities, including anxiety (P<.001), functioning (P<.001), and diabetes-specific distress (P<.001), also showed significant and sustained improvement. Satisfaction with myCompass was high, with convenience and ease of program use, and relevance of program content rated positively by participants. Conclusions The myCompass program shows promise as an acceptable and effective treatment for depression and comorbid mental health problems in people with diabetes. The program is broadly available, free to use, and may benefit patients with diabetes who do not access services and/or wish to manage their mental health themselves. Replication of these findings in a controlled study is warranted.


2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i12-i42
Author(s):  
C Yang ◽  
Z Hui ◽  
S Zhu ◽  
X Wang ◽  
G Tang ◽  
...  

Abstract Introduction Medication self-management support has been recognised as an essential element in primary health care to promote medication adherence and health outcomes for older people with chronic conditions. A patient-centred intervention empowering patients and supporting medication self-management activities could benefit older people. This pilot study tested a newly developed medication self-management intervention for improving medication adherence among older people with multimorbidity. Method This was a two-arm randomised controlled trial. Older people with multimorbidity were recruited from a community healthcare centre in Changsha, China. Participants were randomly allocated to either a control group receiving usual care (n = 14), or to an intervention group receiving three face-to-face medication self-management sessions and two follow-up phone calls over six weeks, targeting behavioural determinants of adherence from the Information-Motivation-Behavioural skills model (n = 14). Feasibility was assessed through recruitment and retention rates, outcome measures collection, and intervention implementation. Follow-up data were measured at six weeks after baseline using patient-reported outcomes including medication adherence, medication self-management capabilities, treatment experiences, and quality of life. Preliminary effectiveness of the intervention was explored using generalised estimating equations. Results Of the 72 approached participants, 28 (38.89%) were eligible for study participation. In the intervention group, 13 participants (92.86%) completed follow-up and 10 (71.42%) completed all intervention sessions. Ten participants (71.42%) in the control group completed follow-up. The intervention was found to be acceptable by participants and the intervention nurse. Comparing with the control group, participants in the intervention group showed significant improvements in medication adherence (β = 0.26, 95%CI 0.12, 0.40, P &lt; 0.001), medication knowledge (β = 4.43, 95%CI 1.11, 7.75, P = 0.009), and perceived necessity of medications (β = −2.84, 95%CI -5.67, −0.01, P = 0.049) at follow-up. Conclusions The nurse-led medication self-management intervention is feasible and acceptable among older people with multimorbidity. Preliminary results showed that the intervention may improve patients’ medication knowledge and beliefs and thus lead to improved adherence.


2017 ◽  
Vol 30 (6) ◽  
pp. 843-862 ◽  
Author(s):  
Rosalba Hernandez ◽  
Elaine Cheung ◽  
Minli Liao ◽  
Seth W. Boughton ◽  
Lisett G. Tito ◽  
...  

Objective: We examined the association between depressive symptoms and cognitive functioning in older Hispanics/Latinos enrolled in an exercise intervention. Method: We analyzed baseline, 1-year, and 2-year in-person interview data collected from Hispanics/Latinos aged ≥60 years participating in an exercise intervention across 27 senior centers ( N = 572). Results: Mean age was 73.13 years; 77% female. At baseline, older adults screening positive for depression were 1.58 times more likely to experience cognitive impairment ( p = .04); controlling for demographics and comorbid chronic conditions. Compared to peers with little to no depressive symptoms, lower cognitive functioning scores were evident at each follow-up assessment point where elevated depressive symptoms were present, but baseline depression was not associated with cognitive function in longitudinal analyses. Discussion: In older Hispanics/Latinos enrolled in an exercise intervention, though baseline depression did not predict cognitive function over time, elevated symptoms of depression were associated with greater cognitive impairment at every point in this study.


BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e047921
Author(s):  
Anna Marcuzzi ◽  
Kerstin Bach ◽  
Anne Lovise Nordstoga ◽  
Gro Falkener Bertheussen ◽  
Ilya Ashikhmin ◽  
...  

IntroductionLow back pain (LBP) and neck pain (NP) are common and costly conditions. Self-management is a key element in the care of persistent LBP and NP. Artificial intelligence can be used to support and tailor self-management interventions, but their effectiveness needs to be ascertained. The aims of this trial are (1) to evaluate the effectiveness of an individually tailored app-based self-management intervention (selfBACK) adjunct to usual care in people with LBP and/or NP in secondary care compared with usual care only, and (2) to compare the effectiveness of selfBACK with a web-based self-management intervention without individual tailoring (e-Help).Methods and analysisThis is a randomised, assessor-blind clinical trial with three parallel arms: (1) selfBACK app adjunct to usual care; (2) e-Help website adjunct to usual care and (3) usual care only. Patients referred to St Olavs Hospital, Trondheim (Norway) with LBP and/or NP and accepted for assessment/treatment at the multidisciplinary outpatient clinic for back or neck rehabilitation are invited to the study. Eligible and consenting participants are randomised to one of the three arms with equal allocation ratio. We aim to include 279 participants (93 in each arm). Outcome variables are assessed at baseline (before randomisation) and at 6-week, 3-month and 6-month follow-up. The primary outcome is musculoskeletal health measured by the Musculoskeletal Health Questionnaire at 3 months. A mixed-methods process evaluation will document patients’ and clinicians’ experiences with the interventions. A health economic evaluation will estimate the cost-effectiveness of both interventions’ adjunct to usual care.Ethics and disseminationThe trial is approved by the Regional Committee for Medical and Health Research Ethics in Central Norway (Ref. 2019/64084). The results of the trial will be published in peer-review journals and presentations at national and international conferences relevant to this topic.Trial registration numberNCT04463043.


2016 ◽  
Vol 43 (5) ◽  
pp. 529-538 ◽  
Author(s):  
Mary H. Wilde ◽  
James M. McMahon ◽  
Eileen Fairbanks ◽  
Judith Brasch ◽  
Robert Parshall ◽  
...  

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