Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care: Results of a Multicenter Stepped-Wedge Cluster Randomized Trial.

BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for strategies that improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective. Tailored implementation is considered as a promising approach. The self-guided integrated theory-based Framework for intervention tailoring strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves identifying local barriers; matching selected barriers to implementation strategies; developing an actionable work plan; and applying, monitoring, and adapting where necessary. OBJECTIVE: This study aimed to compare the effectiveness of the ItFits-toolkit with implementation-as-usual (IAU) in implementing iCBT services in 12 routine mental health care organizations in 9 countries in Europe and Australia. METHODS: A stepped-wedge cluster randomized trial design with repeated measures was applied. The trial period lasted 30 months. The primary outcome was the normalization of iCBT delivery by service providers (therapists, referrers, IT developers, and administrators), which was measured with the Normalization Measure Development as a proxy for implementation success. A 3-level linear mixed-effects modeling was applied to estimate the effects. iCBT service uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. The perceived satisfaction (Client Satisfaction Questionnaire), usability (System Usability Scale), and impact of the ItFits-toolkit by implementers were used to assess the acceptability of the ItFits-toolkit. RESULTS: In total, 456 mental health service providers were included in this study. Compared with IAU, the ItFits-toolkit had a small positive statistically significant effect on normalization levels in service providers (mean 0.09, SD 0.04; P=.02; Cohen d=0.12). The uptake of iCBT by patients was similar to that of IAU. Implementers did not spend more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it. CONCLUSIONS: The ItFits-toolkit performed better than the usual implementation activities in implementing iCBT services in routine practice. There is practical utility in the ItFits-toolkit for supporting implementers in developing and applying effective tailored implementation strategies. However, the effect on normalization levels among mental health service providers was small. These findings warrant modesty regarding the effectiveness of self-guided tailored implementation of iCBT services in routine practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-020-04686-4.

Pilot Study of Blended-Format Interpersonal Psychotherapy for Major Depressive Disorder.

OBJECTIVE: Blended-format interpersonal psychotherapy (IPT) is an integrated approach consisting of alternating face-to-face (in person or videoconferencing) and online sessions, and this format may increase access to care, empower patients, and improve quality and cost-effectiveness of care. This study, conducted in the Netherlands, was one of the first to investigate the feasibility of blended-format IPT in specialized mental health care. METHODS: Participants (ages 18-64, N=21) with a unipolar depressive episode were recruited at an outpatient mood disorder clinic. In this pre-post nonrandomized pilot study, the blended IPT consisted of six online sessions alternated with six to 10 in-person or videoconferencing sessions. Feasibility (defined as >60% of the participants having completed >50% of the online sessions), usability (via the System Usability Scale [SUS]), satisfaction (via the Client Satisfaction Questionnaire-8 [CSQ-8] and qualitative interviewing), and symptom reduction (via the nine-item Patient Health Questionnaire [PHQ-9]) were assessed. RESULTS: Of the participants, 90% (95% CI=70%-99%) completed all online sessions. Mean±SD scores were 25.12±3.55 (of 32) on the CSQ-8 and 66.0±12.4 (of 100) on the SUS. PHQ-9 scores (N=21) decreased significantly, from 17.48±5.41 at baseline to 11.90±6.45 postintervention, indicating improvement (t=4.86, df=20, p=0.001). Hedges' g was 0.90 (95% CI=0.44-1.41), indicating a large effect size. The treatment response rate was 33% (95% CI=15%-57%); the remission rate was 19% (95% CI=6%-42%). CONCLUSIONS: Blended-format IPT was feasible, and patients were satisfied with the intervention. The therapy described here may serve as a starting point for cost-effectiveness research on this promising format.

Dimensionality of the system usability scale among professionals using internet-based interventions for depression: a confirmatory factor analysis.

BACKGROUND: The System Usability Scale (SUS) is used to measure usability of internet-based Cognitive Behavioural Therapy (iCBT). However, whether the SUS is a valid instrument to measure usability in this context is unclear. The aim of this study is to assess the factor structure of the SUS, measuring usability of iCBT for depression in a sample of professionals. In addition, the psychometric properties (reliability, convergent validity) of the SUS were tested. METHODS: A sample of 242 professionals using iCBT for depression from 6 European countries completed the SUS. Confirmatory Factor Analysis (CFA) was conducted to test whether a one-factor, two-factor, tone-model or bi-direct model would fit the data best. Reliability was assessed using complementary statistical indices (e.g. omega). To assess convergent validity, the SUS total score was correlated with an adapted Client Satisfaction Questionnaire (CSQ-3). RESULTS: CFA supported the one-factor, two-factor and tone-model, but the bi-factor model fitted the data best (Comparative Fit Index = 0.992, Tucker Lewis Index = 0.985, Root Mean Square Error of Approximation = 0.055, Standardized Root Mean Square Residual = 0.042 (respectively χ2diff (9) = 69.82, p < 0.001; χ2diff (8) = 33.04, p < 0.001). Reliability of the SUS was good (ω = 0.91). The total SUS score correlated moderately with the CSQ-3 (CSQ1 rs = .49, p < 0.001; CSQ2 rs = .46, p < 0.001; CSQ3 rs = .38, p < 0.001), indicating convergent validity. CONCLUSIONS: Although the SUS seems to have a multidimensional structure, the best model showed that the total sumscore of the SUS appears to be a valid and interpretable measure to assess the usability of internet-based interventions when used by professionals in mental healthcare.

Why Uptake of Blended Internet-Based Interventions for Depression Is Challenging: A Qualitative Study on Therapists' Perspectives.

(1) Background: Blended cognitive behavioral therapy (bCBT; online and face-to-face sessions) seems a promising alternative alongside regular face-to-face CBT depression treatment in specialized mental health care organizations. Therapists are key in the uptake of bCBT. This study focuses on therapists' perspectives on usability, satisfaction, and factors that promote or hinder the use of bCBT in routine practice; (2) Methods: Three focus groups (n = 8, n = 7, n = 6) and semi-structured in-depth interviews (n = 15) were held throughout the Netherlands. Beforehand, the participating therapists (n = 36) completed online questionnaires on usability and satisfaction. Interviews were analyzed by thematic analysis; (3) Results: Therapists found the usability sufficient and were generally satisfied with providing bCBT. The thematic analysis showed three main themes on promoting and hindering factors: (1) therapists' needs regarding bCBT uptake, (2) therapists' role in motivating patients for bCBT, and (3) therapists' experiences with bCBT; (4) Conclusions: Overall, therapists were positive; bCBT can be offered by all CBT-trained therapists and future higher uptake is expected. Especially the pre-set structure of bCBT was found beneficial for both therapists and patients. Nevertheless, therapists did not experience promised time-savings-rather, the opposite. Besides, there are still teething problems and therapeutic shortcomings that need improvement in order to motivate therapists to use bCBT.

Implementing internet-delivered cognitive behavior therapy for common mental health disorders: A comparative case study of implementation challenges perceived by therapists and managers in five European internet services.

OBJECTIVE: Internet-delivered cognitive behavior therapy programs have been developed and evaluated in randomized controlled trials during the past two decades to alleviate the rising demand for effective treatment of common mental health disorders such as anxiety and depression. While most of the research on internet-based cognitive behavior therapy (iCBT) has focused on efficacy and effectiveness only little attention has been devoted to the implementation of iCBT. The aim of this study was to identify the main implementation challenges perceived by therapists and managers involved in the practical operation of iCBT services in routine care settings in five European countries. METHOD: The study was designed as a multiple comparative case study to explore differences and similarities between five different iCBT services in Sweden, Norway, Denmark, The Netherlands and Scotland. Field visits were carried out to each of the five services including interviews with the management of the service (n = 9), focus group interviews with key staff (n = 15) and demonstration of online programs. The data material was processed through thematic, comparative analysis. RESULTS: The analysis generated four transversal themes: 1) integration in the mental health care system; 2) recruitment of patients; 3) working practice of therapists; and 4) long-term sustainability of service. The main results concerned the need to address the informal integration in the health care systems related to the perceived skepticism towards iCBT from GPs and face-to-face therapists, the role of referral models and communication strategies for the stable recruitment of patients, the need for knowledge, standards and material for the training of therapists in the provision of online feedback, the need to improve the possibilities to tailor programs to individual patients, and the need for considerate long-term sustainability planning of the transitions from local projects to permanent regional or national services. CONCLUSION: The present study gives an overview of the main implementation challenges regarding the practical operation of iCBT services perceived by the therapists and managers of the iCBT services. Future studies into specific details of each challenge will be important to strengthen the evidence base of iCBT and to improve uptake and implementation of iCBT in routine care.

Behind the Scenes of Online Therapeutic Feedback in Blended Therapy for Depression: Mixed-Methods Observational Study.

BACKGROUND: In Internet-delivered cognitive behavioral therapies (iCBT), written feedback by therapists is a substantial part of therapy. However, it is not yet known how this feedback should be given best and which specific therapist behaviors and content are most beneficial for patients. General instructions for written feedback are available, but the uptake and effectiveness of these instructions in iCBT have not been studied yet. OBJECTIVE: This study aimed to identify therapist behaviors in written online communication with patients in blended CBT for adult depression in routine secondary mental health care, to identify the extent to which the therapists adhere to feedback instructions, and to explore whether therapist behaviors and adherence to feedback instructions are associated with patient outcome. METHODS: Adults receiving blended CBT (10 online sessions in combination with 5 face-to-face sessions) for depression in routine mental health care were recruited in the context of the European implementation project MasterMind. A qualitative content analysis was used to identify therapist behaviors in online written feedback messages, and a checklist for the feedback instruction adherence of the therapists was developed. Correlations were explored between the therapist behaviors, therapist instruction adherence, and patient outcomes (number of completed online sessions and symptom change scores). RESULTS: A total of 45 patients (73%, 33/45 female, mean age 35.9 years) received 219 feedback messages given by 19 therapists (84%, 16/19 female). The most frequently used therapist behaviors were informing, encouraging, and affirming. However, these were not related to patient outcomes. Although infrequently used, confronting was positively correlated with session completion (ρ=.342, P=.02). Therapists adhered to most of the feedback instructions. Only 2 feedback aspects were correlated with session completion: the more therapists adhere to instructions containing structure (limiting to 2 subjects and sending feedback within 3 working days) and readability (short sentences and short paragraphs), the less online sessions were completed (ρ=-.340, P=.02 and ρ=-.361, P=.02, respectively). No associations were found with depression symptom change scores. CONCLUSIONS: The therapist behaviors found in this study are comparable to previous research. The findings suggest that online feedback instructions for therapists provide sufficient guidance to communicate in a supportive and positive manner with patients. However, the instructions might be improved by adding more therapeutic techniques besides the focus on style and form.

Guided web-based intervention for insomnia targeting breast cancer patients: Feasibility and effect.

BACKGROUND: Insomnia is highly prevalent in breast cancer (BRC) patients, but non-pharmacological treatment is not widely available. The aim of this preliminary study was to investigate whether guided cognitive behavioral therapy via the Internet (I-CBT) is a feasible and effective solution for this undertreated condition in BRC patients, and to investigate who benefits most. METHODS: An existing evidence based I-CBT sleep intervention (I-Sleep) was adapted for BRC patients. An open mixed methods design was used including qualitative interviews and pre- and post-test questionnaires measuring sleep, fatigue, daily functioning, and psychological distress. RESULTS: 100 of the 171 participants (59%) completed the intervention fully and participants highly valued the intervention (7.5 out of 10). Large to small pre-post effect sizes were found on insomnia severity (d = 1.33) fatigue (d = 0.24), and daytime functioning (d = 0.30). Younger patients and patients with more severe insomnia at baseline benefited most from the intervention. CONCLUSION: The I-CBT intervention I-Sleep is feasible, well-accepted, and effective for BRC patients who suffer from insomnia, especially for younger patients and those with more severe insomnia.

The therapist's role in the implementation of internet-based cognitive behavioural therapy for patients with depression: study protocol.

BACKGROUND: Internet-based Cognitive Behavioural Therapy (iCBT) for the treatment of depressive disorders is innovative and promising. Various studies have demonstrated large effect sizes up to 2.27, but implementation in routine practice lags behind. Mental health therapists play a significant role in the uptake of internet-based interventions. Therefore, it is interesting to study factors that influence the therapists in whether they apply internet-based therapy or not. This study, as part of the European implementation project MasterMind, aims to identity the factors that promote or hinder therapists in the use of iCBT in depression care. METHODS/DESIGN: The uptake of iCBT by therapists in routine mental health care practice for the treatment of depression will be evaluated by a mixed method approach, to provide an understanding of the implementation factors (quantitative), and to ascertain the facilitating and hindering factors in the involvement of therapists in the implementation of iCBT (qualitative). The involvement of therapists in the implementation of iCBT is analysed following the RE-AIM framework on the five dimensions Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance. This enables us to evaluate the reach of therapists, the impact of iCBT on depression care, the extent to which therapists adopt iCBT, the extent to which iCBT is delivered as intended, and how iCBT can be maintained over time. DISCUSSION: The results will provide valuable insight into the role of therapists in the implementation of iCBT for depression in secondary mental health care settings. They will result in concrete recommendations for how therapists can be facilitated in implementing and up-scaling iCBT for depression.

Preventing depression in homes for older adults: are effects sustained over 2 years?

OBJECTIVES: The objective of this study was to evaluate the 2-year effects of a stepped-care programme to prevent the onset of a major depressive disorder (MDD) in older people living in residential homes. METHODS: A 2-year follow-up study of a pragmatic randomised controlled trial was conducted in 14 residential homes in the Netherlands. A total of 185 residents (Center for Epidemiologic Studies Depression Scale score >7), who did not meet the diagnostic criteria for MDD, were randomised to a stepped-care programme (n = 93) or to usual care (n = 92). Stepped-care participants sequentially underwent watchful waiting, a self-help intervention, life review and a consultation with the general practitioner. The primary outcome measure was the incidence of MDD during a period of 2 years, according to the Mini International Neuropsychiatric Interview. RESULTS: After 2 years, the incidence of MDD was not significantly reduced in the intervention group compared with the control group (incidence rate ratio: 0.98; 95% confidence interval (CI) [0.54, 1.81]). However, in the completer analysis, on the basis of 79 residents who completed the 2-year measurements, there was a significant difference in favour of the intervention group (incidence rate ratio: 0.53; 95% CI [0.32, 0.87]). Dropout percentages were high (44%), mostly accounted for by illness and death (68%). CONCLUSION: A minority of residents had benefit from the intervention that sustained after 2 years in the completer group. Yet, these findings cannot be generalised as the majority of the residents did not opt for participation in the project and many dropped out. Ways should be sought to motivate residents with depressive symptoms to engage in preventive interventions.

Contradictory effects for prevention of depression and anxiety in residents in homes for the elderly: a pragmatic randomized controlled trial.

BACKGROUND: The aim of this study was to evaluate the effectiveness of a stepped-care program to prevent the onset of depression and anxiety disorders in elderly people living in residential homes. METHODS: A pragmatic randomized controlled trial was conducted to compare the intervention with usual care in 14 residential homes in the Netherlands. A total of 185 residents with a minimum score of 8 on the Centre for Epidemiologic Studies Depression Scale, who did not meet the diagnostic criteria for a depressive or anxiety disorder, and were not suffering from severe cognitive impairment, were recruited between April 2007 and December 2008. They were randomized to a stepped-care program (N = 93) or to usual care (N = 92). The stepped-care participants sequentially underwent watchful waiting, a self-help intervention, life review, and a consultation with the general practitioner. The primary outcome measure was the incidence of a major depressive disorder (MDD) or anxiety disorder during a period of one year according to the Mini International Neuropsychiatric Interview. RESULTS: The intervention was not effective in reducing the incidence of the combined outcome of depression and anxiety (incidence rate ratio (IRR) = 0.50; 95% confidence interval (CI) = 0.23-1.12). However, the intervention was superior to usual care in reducing the risk of MDD incidence (IRR = 0.26; 95% CI = 0.12-0.80) contrary to anxiety incidence (IRR = 1.32; 95% CI = 0.48-3.62). CONCLUSIONS: These results suggest that the stepped-care program is effective in reducing the incidence of depression, but is not effective in preventing the onset of anxiety disorders in elderly people living in residential homes.

Feasibility and effectiveness of activity-scheduling as a guided self-help intervention for the prevention of depression and anxiety in residents in homes for the elderly: a pragmatic randomized controlled trial.

BACKGROUND: Elderly people living in residential homes are at high risk for developing major depressive and anxiety disorders, and therefore deserve attention in terms of preventive interventions. We evaluated the feasibility and effectiveness of a guided self-help intervention for the prevention of depression and anxiety in these residents. METHODS: We conducted a pragmatic randomized controlled trial in two parallel groups comparing the intervention with usual care in 14 residential homes in and surrounding the city of Amsterdam in the Netherlands. A total of 129 residents with a score of 8 or more on the Centre for Epidemiologic Studies Depression Scale (CES-D) screening instrument, who did not meet the full diagnostic criteria for disorders, and were not suffering from cognitive impairment were recruited between April 2007 and December 2008. Participants were randomized to a guided self-help intervention (n = 67) or to usual care (n = 62). The main outcome measures were improvement in the level of symptoms of depression and anxiety. The secondary outcome was improvement in participation in organized activities in the residential homes. The study is registered in de Dutch Cochrane Centre, under number ISRCTN27540731. RESULTS: Only 21% of the participants (mean age 84.0 years (SD 6.7), 72.1% suffering from two or more chronic illnesses) completed the intervention. Although we found some large positive effect sizes on the CES-D, none of these effects was statistically significant. CONCLUSION: Although guided self-help may be promising in the prevention of depression and anxiety, it proved to be difficult to apply in this very old and vulnerable group of people living in residential homes.

The center for epidemiological studies depression scale (CES-D) is an adequate screening instrument for depressive and anxiety disorders in a very old population living in residential homes.

OBJECTIVE: The CES-D is an instrument that is commonly used to screen for depression in community-based studies of the elderly, but the characteristics of the CES-D in a residential home population have not yet been studied. The aim of this study was to investigate the criterion validity and the predictive power of the CES-D for both depressive and anxiety disorders in a vulnerable, very old population living in residential homes. METHODS: Two hundred seventy seven residents were screened with the CES-D, and subsequently interviewed with a diagnostic instrument, the Mini International Neuropsychiatric Instrument (MINI). The sensitivity, specificity, and positive and negative predictive value of the CES-D were calculated by cross-tabulation at different cut-off scores. Receiver Operating Characteristics (ROC) curves were used to assess the optimal cut-off point for each disorder and to asses the predictive power of the instrument. RESULTS: In a residential home population the CES-D had satisfactory criterion validity for depressive disorders and for any combination of depressive and/or anxiety disorders. With a desired sensitivity of at least 80%, the optimal cut-off scores varied between 18 and 22. The predictive power of the CES-D in this population was best for major depression and dysthymia (Area Under the Curve, AUC 0.87), closely followed by the score for any combination of depressive and/or anxiety disorder (AUC 0.86). CONCLUSION: The use of one single instrument to screen for both depression and anxiety disorders at the same time has obvious advantages in this very old population. The CES-D seems to be a suitable instrument for this purpose.

High incidence of clinically relevant depressive symptoms in vulnerable persons of 75 years or older living in the community.

OBJECTIVES: Clinically relevant depressive symptoms are highly prevalent in people who are 75 years of age or older. However, very old people with a vulnerable health status are under-represented in studies focussing on incidence and risk factors, while the risk of developing depressive symptoms is expected to be very high in this group. The incidence rates of clinically relevant depressive symptoms and their predictors were investigated in a vulnerable elderly population. METHODS: In a community-based cohort, 651 vulnerable elderly (75+) people were identified by means of the COOP-WONCA charts (Dartmouth Coop Functional Health Assessment Charts/World Organisation of Family Doctors). To study the incidence of clinically relevant symptoms of depression and their predictors, 266 people with no symptoms (Centre for Epidemiologic Studies Depression Scale, CES-D score <16 at baseline) were selected and measured again at six and 18 months. The incidence of clinically relevant symptoms of depression was defined as a CES-D score > or =16, in combination with at least a five-point change between measurements. Logistic regression analyses were applied to determine risk indicators. RESULTS: After 18 months, the incidence rate of all clinically relevant symptoms of depression was 48% (95% confidence interval, CI 44.2-51.8). No specific risk factors were identified within this population. CONCLUSION: Our estimates of the incidence of depressive symptoms were considerably higher than those previously found in elderly populations living in the community. A vulnerable health status is associated with a high risk of depressive symptoms.

Depression and anxiety, an indicated prevention (DIP) protocol in homes for the elderly: feasibility and (cost) effectiveness of a stepped care programme.

BACKGROUND: Depressive and anxiety disorders are a very common, serious and underdetected problem in homes for the elderly. Elderly persons in residential homes are at high risk for developing major depressive and anxiety disorders, and, therefore, deserve attention with regard to prevention. METHODS/DESIGN: This protocol describes a randomised trial on the feasibility and (cost) effectiveness of a stepped-care programme for prevention of depressive and anxiety disorders in homes for the elderly. The main outcome measure is the incidence of depressive and anxiety disorder in one year with a two years follow up. Secondary outcomes are symptoms of depression and anxiety, quality of life, direct health care costs and satisfaction with treatment. DISCUSSION: The number of studies examining the effects of preventive interventions on the incidence of mental disorders in the elderly population is very small. However, indicated prevention by means of a stepped-care programme seems to be an important option for decreasing the burden of illness for residents and their caregivers. This study contributes to the body of knowledge in this field. Positive effects may contribute to further use and development of tailored, (cost-) effective and easy to use interventions in a preventive stepped-care programme.