Dataset Information

Effectiveness of internet-delivered cognitive behavioural therapy in reducing sickness absence among young employees with depressive symptoms: study protocol for a large-scale pragmatic randomised controlled trial.

ABSTRACT:

Introduction

Depression is a highly prevalent condition with typical onset in early adulthood. Internet-delivered cognitive behavioural therapy (iCBT) is a promising cost-effective and more widely available alternative to face-to-face CBT. However, it is not known whether it can reduce sickness absence in employees showing depressive symptoms. The randomised controlled trial component of the DAQI (Depression and sickness absence in young adults: a quasi-experimental trial and web-based treatment intervention) project aims to investigate if iCBT is effective in reducing sickness absence compared with care as usual (CAU) among young employees with depressive symptoms in primary care provided in an occupational health setting.

Methods and analysis

This study will use a randomised controlled single-centre service-based trial of an existing iCBT programme (Mental Hub iCBT for Depression) to evaluate whether or not this treatment can reduce the number of sickness absence days in public sector employees aged 18-34 years who present at the occupational health service with mild depressive symptoms (score ?9 on the Beck Depression Inventory-IA). Control participants will be offered CAU, with no constraints regarding the range of treatments. The active condition will consist of seven?weekly modules of iCBT, with support from a web therapist. Primary outcome will be participants' all-cause sickness absence as indicated in employer's and national administrative records up to 6 months from study entry. Secondary outcomes relating to long-term sickness absence (over 11 calendar days) for mental and musculoskeletal disorders and psychotropic medication use will be obtained from the Finnish Social Insurance Institution's administrative records; and short sickness absence spells (up to 11 calendar days) will be extracted from employer's records. Analyses will be conducted on an intention-to-treat basis.

Ethics and dissemination

The Coordinating Ethics Committee of the Hospital District of Helsinki and Uusimaa has approved the study (HUS/974/2019). The results will be published in peer-reviewed scientific journals and in publications for lay audience.

Trial registration number

ISRCTN10877837.

SUBMITTER: Kouvonen A

PROVIDER: S-EPMC6858165 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of internet-delivered cognitive behavioural therapy in reducing sickness absence among young employees with depressive symptoms: study protocol for a large-scale pragmatic randomised controlled trial.

Kouvonen Anne A Mänty Minna M Harkko Jaakko J Sumanen Hilla H Konttinen Hanna H Lahti Jouni J Pietilainen Olli O Blomgren Jenni J Tuovinen Eevamaija E Ketonen Eeva-Leena EL Stenberg Jan-Henry JH Donnelly Michael M Sivertsen Børge B Mittendorfer-Rutz Ellenor E Pirkola Sami S Rahkonen Ossi O Lallukka Tea T

BMJ open 20191105 10

<h4>Introduction</h4>Depression is a highly prevalent condition with typical onset in early adulthood. Internet-delivered cognitive behavioural therapy (iCBT) is a promising cost-effective and more widely available alternative to face-to-face CBT. However, it is not known whether it can reduce sickness absence in employees showing depressive symptoms. The randomised controlled trial component of the DAQI (Depression and sickness absence in young adults: a quasi-experimental trial and web-based t ...[more]

PMID: 31690647

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Project description:BackgroundDepression is three to four times more prevalent in patients with neurological and inflammatory disorders than in the general population. For example, in patients with multiple sclerosis, the 12-month prevalence of major depressive disorder is around 25% and it is associated with a lower quality of life, faster disease progression, and higher morbidity and mortality. Despite its clinical relevance, there are few treatment options for depression associated with multiple sclerosis and confirmatory trials are scarce. We aimed to evaluate the safety and efficacy of a multiple sclerosis-specific, internet-based cognitive behavioural therapy (iCBT) programme for the treatment of depressive symptoms associated with the disease.MethodsThis parallel-group, randomised, controlled, phase 3 trial of an iCBT programme to reduce depressive symptoms in patients with multiple sclerosis was carried out at five academic centres with large outpatient care units in Germany and the USA. Patients with a neurologist-confirmed diagnosis of multiple sclerosis and depressive symptoms were randomly assigned (1:1:1; automated assignment, concealed allocation, no stratification, no blocking) to receive treatment as usual plus one of two versions of the iCBT programme Amiria (stand-alone or therapist-guided) or to a control condition, in which participants received treatment as usual and were offered access to the iCBT programme after 6 months. Masking of participants to group assignment between active treatment and control was not possible, although raters were masked to group assignment. The predefined primary endpoint, which was analysed in the intention-to-treat population, was severity of depressive symptoms as measured by the Beck Depression Inventory-II (BDI-II) at week 12 after randomisation. This trial is registered at ClinicalTrials.gov, NCT02740361, and is complete.FindingsBetween May 3, 2017, and Nov 4, 2020, we screened 485 patients for eligibility. 279 participants were enrolled, of whom 101 were allocated to receive stand-alone iCBT, 85 to receive guided iCBT, and 93 to the control condition. The dropout rate at week 12 was 18% (50 participants). Both versions of the iCBT programme significantly reduced depressive symptoms compared with the control group (BDI-II between-group mean differences: control vs stand-alone iCBT 6·32 points [95% CI 3·37-9·27], p<0·0001, effect size d=0·97 [95% CI 0·64-1·30]; control vs guided iCBT 5·80 points [2·71-8·88], p<0·0001, effect size d=0·96 [0·62-1·30]). Clinically relevant worsening of depressive symptoms was observed in three participants in the control group, one in the stand-alone iCBT group, and none in the guided iCBT group. No occurrences of suicidality were observed during the trial and there were no deaths.InterpretationThis trial provides evidence for the safety and efficacy of a multiple sclerosis-specific iCBT tool to reduce depressive symptoms in patients with the disease. This remote-access, scalable intervention increases the therapeutic options in this patient group and could help to overcome treatment barriers.FundingNational Multiple Sclerosis Society (USA).

Project description:BACKGROUND:Depression is a highly prevalent mental health issue that exacts significant economic, societal, personal, and interpersonal costs. Innovative internet-delivered interventions have been designed to increase accessibility to and cost-effectiveness of treatments. These treatments have mainly targeted mild to moderate levels of depression. The increased risk associated with severe depression, particularly of suicidal ideation often results in this population being excluded from research studies. As a result, the effectiveness of internet-delivered cognitive behavioral therapy (iCBT) in more severely depressed cohorts is less researched. OBJECTIVE:The aim of this study is to examine the effect of iCBT on symptoms of severe depression, comorbid symptoms of anxiety, and levels of work and social functioning. METHODS:Retrospective consent was provided by participants with elevated scores (>28 severe depression symptoms) on the Beck Depression Inventory (BDI-II) who accessed an iCBT intervention (Space from Depression) with support for up to 8 weeks. Data were collected at baseline, posttreatment, and 3-month follow-up on the primary outcome (BDI-II), and secondary outcomes (the Generalized Anxiety Disorder-7 and the Work and Social Adjustment Scale). RESULTS:A significant change was observed on all measures between pre- and postmeasurement and maintained at 3-month follow-up. Clinical improvement was observed for participants on the BDI-II from pre- to postmeasurement, and suicidal ideation also reduced from pre- to postmeasurement. CONCLUSIONS:Users of Space from Depression with symptoms of severe depression were found to have decreased symptoms of depression and anxiety and increased levels of work and social functioning. The intervention also demonstrated its potential to decrease suicidal ideation. Further investigation is required to determine why some individuals improve, and others do not. iCBT may have the potential to be used as an adjunct treatment for severe depression symptoms, but participants may require further treatment if they receive iCBT as a standalone intervention. Although promising, further research incorporating control groups is needed to support the utility of Space from Depression for use in or as an adjunct to treatment for severe depression.

Project description:BackgroundFrequent sickness absence-that is, 3 or more episodes of sickness absence in 1 year-is a problem for employers and employees. Many employees who have had frequent sickness absence in a prior year also have frequent sickness absence in subsequent years: 39% in the first follow-up year and 61% within 4 years. Moreover, 19% have long-term sickness absence (≥6 weeks) in the first follow-up year and 50% within 4 years. We developed an electronic health (eHealth) intervention, consisting of fully automated feedback and advice, to use either as a stand-alone tool (eHealth intervention-only) or combined with consultation with an occupational physician (eHealth intervention-occupational physician).ObjectiveThis study aimed to evaluate the effect of the eHealth intervention, with or without additional occupational physician consultation, to reduce sickness absence frequency for employees with frequent sickness absence, versus care as usual (CAU).MethodsThis study was a three-armed randomized controlled trial. Employees with frequent sickness absence received invitational letters, which were distributed by their employers. The primary outcome measure was the number of register-based sickness absence episodes 12 months after completing the baseline questionnaire. Secondary outcome measures were register-based total sickness absence days and self-assessed burnout, engagement, and work ability. In a process evaluation 3 months after baseline, we examined adherence to the intervention and additional actions such as general practitioner and occupational physician visit, communication with the manager, and lifestyle change.ResultsA total of 82 participants were included in the analyses, 21 in the eHealth intervention-only group, 31 in the eHealth intervention-occupational physician group, and 30 in the CAU group. We found no significant difference in sickness absence frequency between the groups at 1-year follow-up. Sickness absence frequency decreased in the eHealth intervention-only group from 3 (interquartile range, IQR 3-4) to 1 episode (IQR 0.3-2.8), in the eHealth intervention-occupational physician group from 4 (IQR 3-5) to 3 episodes (IQR 1-4), and in the CAU group from 3 (IQR 3-4) to 2 episodes (IQR 1-3). For secondary outcomes, we found no significant differences between the intervention groups and the control group. The process evaluation showed that only 3 participants from the eHealth intervention-occupational physician group visited the occupational physician on invitation.ConclusionsAmong employees with frequent sickness absence, we found no effect from the eHealth intervention as a stand-alone tool in reducing sickness absence frequency, nor on total sickness absence days, burnout, engagement, or work ability. This might be due to low adherence to the intervention because of insufficient urgency to act. We cannot draw any conclusion on the effect of the eHealth intervention tool combined with an occupational physician consultation (eHealth intervention-occupational physician), due to very low adherence to the occupational physician consultation. An occupational physician consultation could increase a sense of urgency and lead to more focus and appropriate support. As this was the first effectiveness study among employees with frequent sickness absence, strategies to improve recruitment and adherence in occupational eHealth are included.Trial registrationNetherlands Trial Register NTR4316; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4316 (Archived by WebCite at http://www.webcitation.org/713DHhOFU).

Project description:BACKGROUND:Internet-delivered treatments for depressive symptoms have proved to be successful in high-income Western countries. There may be potential for implementing such treatments in low- and middle-income countries such as Colombia, where access to mental health services is limited. OBJECTIVE:The objective of this study was to assess the efficacy of a culturally adapted cognitive behavioral internet-delivered treatment for college students with depressive symptoms in Colombia. METHODS:This was a randomized controlled trial with a 3-month follow-up. The program comprised seven modules. A total of 214 Colombian college students were recruited. They were assessed and randomly assigned to either the treatment group (n=107) or a waiting list (WL) control group (n=107). Participants received weekly support from a trained supporter. The primary outcome was symptoms of depression, as measured by the Patient Health Questionnaire - 9, and the secondary outcomes were anxiety symptoms assessed by the Generalized Anxiety Disorder questionnaire - 7. Other measures, including satisfaction with treatment, were evaluated after 7 weeks. RESULTS:Research attrition and treatment dropouts were high in this study. On average, 7.6 sessions were completed per user. The mean time spent on the program was 3 hours and 18 min. The linear mixed model (LMM) showed significant effects after treatment (t197.54=-5.189; P<.001) for the treatment group, and these effects were maintained at the 3-month follow-up (t39.62=4.668; P<.001). Within-group results for the treatment group yielded a large effect size post treatment (d=1.44; P<.001), and this was maintained at the 3-month follow-up (d=1.81; P<.001). In addition, the LMM showed significant differences between the groups (t197.54=-5.189; P<.001). The results showed a large effect size between the groups (d=0.91; P<.001). In the treatment group, 76.0% (16/107) achieved a reliable change, compared with 32.0% (17/107) in the WL control group. The difference between groups was statistically significant (X22=10.5; P=.001). CONCLUSIONS:This study was the first contribution to investigating the potential impact of a culturally adapted internet-delivered treatment on depressive symptoms for college students as compared with a WL control group in South America. Future research should focus on identifying variables associated both with premature dropout and treatment withdrawal at follow-up. TRIAL REGISTRATION:ClinicalTrials.gov NCT03062215; https://clinicaltrials.gov/ct2/show/NCT03062215.

Project description:BackgroundDepressive symptoms in patients with cardiovascular disease (CVD) can lead to increased healthcare use. In a randomized controlled trial (ClinicalTrials.gov, NCT02778074), we reported that a 9-week internet-delivered cognitive behavioural therapy (iCBT) program (n = 72) compared to an online discussion forum (ODF) (n = 72) had moderate to large effect on depression in CVD outpatients. In this secondary analysis, we aimed to describe and compare the effect of iCBT compared to ODF regarding healthcare use and to identify factors impacting healthcare use in these groups.MethodsData on healthcare use were retrieved from care data registries in five hospitals in Southeastern Sweden.ResultsThe year prior to intervention, the iCBT group had a mean of 31 outpatient clinic/primary care contacts per patient compared with 21 contacts the year after. The corresponding numbers for the ODF group were 37 and 25. The decrease was 32 % in both groups and did not differ significantly (p = 0.261 and p = 0.354) between the groups. Regarding hospital admissions, the iCBT group had 0.8 admissions per patient the year before and 0.6 the year after the intervention, a decrease by 25 %, whereas the ODF group had 1.1 and 0.6 admissions respectively, a decrease by 45 %. The difference was not statistically significant (p = 0.270 and p = 0.883) between the groups. Improvement in depressive symptoms post intervention were significantly (Beta = 0.459, p = 0.047) associated with a decrease in number of outpatient contacts in the iCBT group. In the ODF group, better mental health-related quality of life post intervention was significantly (Beta = -0.429, p = 0.045) associated with a decrease in number of hospital admissions.ConclusionReduced depressive symptom scores following intervention were associated with lower outpatient service use, but iCBT was not superior compared to ODF. This implicates that reducing depression in CVD patients, regardless of the type of internet-delivered intervention used, is important since it may reduce healthcare use in these patients.

Dataset Information

Effectiveness of internet-delivered cognitive behavioural therapy in reducing sickness absence among young employees with depressive symptoms: study protocol for a large-scale pragmatic randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Effectiveness of internet-delivered cognitive behavioural therapy in reducing sickness absence among young employees with depressive symptoms: study protocol for a large-scale pragmatic randomised controlled trial.

Similar Datasets

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