Kim Mathiasen

Internet-based CBT for social phobia and panic disorder in a specialised anxiety clinic in routine care: results of a pilot randomised controlled trial

Ample studies have demonstrated that internet-based cognitive behavioural therapy (iCBT) for anxiety disorders is effective and acceptable in controlled settings. Studies assessing the clinical effectiveness of iCBT for anxiety disorders among routine care populations are, however, not as numerous. The purpose of this study was to assess the effectiveness of iCBT among anxiety patients, who were on a waiting list for intensive outpatient treatment, in a specialised routine care clinic.1 A randomised controlled pilot trial was conducted. Recruited patients were on a waiting list and had a primary diagnosis of either social phobia or panic disorder. Participants were randomised into either receiving iCBT with minimal therapist contact (received access to the programme FearFighter® (FF) and received support from a clinician via telephone) or no treatment (stayed on the waiting list). The primary outcome was self-reported symptomatic change of anxiety on Beck Anxiety Inventory (BAI). The secondary outcomes were comorbid depression measured on Beck Depression Inventory (BDI-II) and quality of life measured with the EuroQol one-item visual-analogue scale (EQ-vas). All results were analysed by intention-to-treat analyses using a mixed-effects approach. N = 158 patients were assessed for eligibility of which N = 67 met all eligibility inclusion criteria, signed informed consent forms, and were randomised. Post-treatment assessment was completed by N = 47 (70%). In the intervention group, N = 11 (31%) completed all modules of FF. No significant differences of change of symptomatic levels were found between the intervention and control group for anxiety (BAI: mean diff. = 2.42; 95% CI − 1.03 to 5.86; p = 0.17; d = 0.06) or for depression (BDI-II: mean diff. 1.87; 95% CI − 2.25 to 6.00; p = 0.37; d = 0.02). A large and significant effect was found in self-reported quality of life in favour of the experimental group (EQ-vas: mean diff. − 20.88; 95% CI − 30.64 to − 11.11; p < 0.001; d = 0.81). This study was not able to document statistically significant clinical effect of iCBT with minimal therapist contact compared to a waiting list control group in a specialised anxiety clinic in routine care. However, a large and significant effect was seen on self-reported quality of life. Although these results offer an interesting perspective on iCBT in specialised care, they should be interpreted with caution, due to the limitations of the study. A large scale fully powered RCT is recommended.

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.

Psychometric analysis of the Patient Health Questionnaire in Danish patients with an implantable cardioverter defibrillator (The DEFIB-WOMEN study)

OBJECTIVE To assess the psychometric properties of the Patient Health Questionnaire (PHQ-9), a measure of depressive symptoms, in a large Danish national cohort of patients with heart disease, implanted with an implantable cardioverter defibrillator (ICD), using item response theory. METHODS A prospective cohort of patients implanted with an ICD (n=1531; 80.4% men) completed the PHQ-9 at the time of implant. Data were analyzed using two item response theory models, the partial credit model and the generalized partial credit model. RESULTS The analysis showed disordered response thresholds in eight of nine items for the partial credit model and five of nine items for the generalized partial credit model, indicating that respondents have difficulty discriminating between response options. When collapsing response options 2 and 3, the rescored PHQ-9 had a better fit to both models. The unidimensionality and the precision of the rescored PHQ-9 were confirmed. Items did not have any differential functioning (DIF) across educational level, age, indication for ICD implantation, and severity of heart failure that influence depression outcomes in patients with an ICD. One item exhibited DIF by gender. Three items did not fit the partial credit model, but the generalized partial credit model could be fitted to the full item set. CONCLUSION The unidimensionality and reliability of the Danish version of the PHQ-9 were confirmed. However, the associated consequences of the number of response options (3-point versus 4-point Likert scale) need to be further examined for the PHQ-9 both as a screening tool and outcome measure.

Blended CBT versus face-to-face CBT: a randomised non-inferiority trial

BackgroundInternet based cognitive behavioural therapy (iCBT) has been demonstrated to be cost- and clinically effective. There is a need, however, for increased therapist contact for some patient groups. Combining iCBT with traditional face-to-face (ftf) consultations in a blended format (B-CBT) may produce a new treatment format with multiple benefits from both traditional CBT and iCBT such as individual adaptation, lower costs than traditional therapy, wide geographical and temporal availability, and possibly lower threshold to implementation. The primary aim of the present study is to compare directly the clinical effectiveness of B-CBT with face-to-face CBT for adult major depressive disorder.Methods/DesignThe study is designed as a two arm randomised controlled non-inferiority trial comparing blended CBT for adult depression with treatment as usual (TAU). In the blended condition six sessions of ftf CBT is alternated with six to eight online modules (NoDep). TAU is defined as 12 sessions of ftf CBT. The primary outcome is symptomatic change of depressive symptoms on the patient-health questionnaire (PHQ-9). Additionally, the study will include an economic evaluation. All participants must be 18 years of age or older and meet the diagnostic criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental disorders 4th edition. Participants are randomised on an individual level by a researcher not involved in the project. The primary outcome is analysed by regressing the three-month follow-up PHQ-9 data on the baseline PHQ-9 score and a treatment group indicator using ancova. A sample size of 130 in two balanced groups will yield a power of at least 80% to detect standardised mean differences above 0.5 on a normally distributed variable.DiscussionThis study design will compare B-CBT and ftf CBT in a concise and direct manner with only a minimal of the variance explained by differences in therapeutic content. On the other hand, while situated in routine care, ecological validity is somewhat compromised by the controlled manner in which the study is conducted.Trial registrationClinicalTrials.gov NCT02796573. Registered June 1st 2016. Currently recruiting participants.

Evaluation of Clinical Effect in Routine Secondary Care of Guided Internet Based CBT for Adult Depression and Anxiety: An Observational Study (Preprint)

Background Internet-based cognitive behavioral therapy (iCBT) is a promising new treatment method for depression and anxiety. However, it is important to determine whether its results can be replicated in routine care before its implementation on a large scale. Although many studies have demonstrated the efficacy of iCBT under controlled conditions, only a few studies have investigated its effectiveness in routine care. Furthermore, several effects of iCBT such as treatment effects in routine care are unclear. Objective This study aimed to evaluate the clinical effectiveness of iCBT for depression and anxiety in routine secondary care. Methods n a retrospective cohort study, we analysed patients treated for depression or anxiety in a dedicated iCBT clinic in secondary care in Denmark. Patients were examined before treatment and weekly thereafter by using the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder-7 scales for the diagnoses of depression and anxiety, respectively. Primary analyses were conducted using a linear mixed-effects model with random slope and intercept. Secondary analyses were conducted using baseline characteristics as predictors (gender, age, highest level of education, occupational status, marital status, psychotropic medication use, consumption of alcohol, and leisure drugs). Additionally, logistic regression analyses were used to predict noncompletion of treatment. Results A total of 203 (depression, N=60; anxiety, N=143) patients were included. Participants were mainly female (78.3% with depression and 65.7% with anxiety), with a mean age of 36.03 (SD 10.97) years (range, 19-67 years) for patients with depression and 36.80 (SD 13.55) years (range, 19-69 years) for patients with anxiety. The completion rates were 62% (37) and 40% (57) for depression and anxiety treatments, respectively. The primary analyses revealed large and significant reductions in the symptom levels of depression (beta=-6.27, SE 0.83, P<.001, d=1.0) and anxiety (beta=-3.78, SE 0.43, P<.001, d=1.1). High baseline severity of the primary disorder was associated with high treatment gains (r=-0.31 for depression; r=-0.41 for anxiety). In patients with anxiety, high baseline severity also predicted a high risk of noncompletion (odds ratio=1.08, CI=1.01-1.16, P=.03). An increase in the baseline severity of the comorbid disorder slightly increased the risk of noncompletion for both disorders (depression: odds ratio=1.03, CI=1.01-1.06, P=.02; anxiety: odds ratio=1.08, CI=1.01-1.16, P=.03). Conclusions iCBT can be clinically effective in routine care. Since depression and anxiety are costly and debilitating disorders that are vastly undertreated, this finding is important. Additionally, iCBT may help bridge the gap between the need for treatment and its provision. Our results are comparable to the within-group results of efficacy and effectiveness studies. Our noncompletion rates are similar to those observed in psychotherapy but are higher than those reported in similar clinics. Multiple factors predicted outcome and noncompletion. However, all predictor effects were statistically weak.

ICBT in routine care: A descriptive analysis of successful clinics in five countries

Clinical trials have demonstrated the efficacy of internet delivered cognitive behaviour therapy (ICBT) for anxiety and depression. However, relatively little is known about the context, operations, and outcomes of ICBT when administered as part of routine care. This paper describes the setting, relationship to existing health services, procedures for referral, assessment, treatment, patients and outcomes of ICBT clinics in Sweden, Denmark, Norway, Canada and Australia. All five clinics provide services free or at low cost to patients. All have systems of governance to monitor quality of care, patient safety, therapist performance and data security. All five clinics include initial assessments by clinicians and between 10 and 20 min of therapist support during each week. Published reports of outcomes all demonstrate large clinical improvement, low rates of deterioration, and high levels of patient satisfaction. Services that require a face to face assessment treat smaller numbers of patients and have fewer patients from remote locations. The paper shows that therapist-guided ICBT can be a valuable part of mental health services for anxiety and depression. Important components of successful ICBT services are rigorous governance to maintain a high standard of clinical care, and the measurement and reporting of outcomes.