The goal of this randomized controlled trial is to investigate if online transdiagnostic cognitive behavior therapy (CBT) can be effective in the treatment of subsyndromal mental ill-health in adult primary care patients. The main aim is to investigate:
if online transdiagnostic CBT yields superior symptomatic improvement compared to care-as-usual when given in a primary care context to patients with mental ill-health.
Researchers will compare online transdiagnostic CBT to primary care as usual to see if psychiatric symptoms can be reduced.
Participants will be randomized to online transdiagnostic CBT or primary care as usual. Participants in online transdiagnostic CBT will receive a cognitive behavioral treatment provided through a secure web platform in which psychoeducation, worksheets, and exercises are presented in online modules similar to chapters in a book. Participants will receive weekly written feedback on their work and progress by a therapist who gives gradual access to the treatment modules. The lion's share of the contact between the therapist and the patient thus takes place through messages (similar to email) in the online treatment platform.
Participants randomized to care as usual will receive health care services as usual in primary care. As this comparator is intended to reflect real routine primary care, the interventions will not be controlled by the research project, but the investigators expect that participants will receive an active treatment.
To be included patients have to: (a) have a subsyndromal mental health problem concerning anxiety, depressive symptoms, or stress-related ill-health that warrants treatment,
be at least 18 years old,
have regular access to a device with an Internet connection,
be able to read and write in Swedish,
None
Parallel
Online transdiagnostic CBT
BehavioralThis treatment is provided through a secure web platform in which psychoeducation, worksheets, and exercises are presented in online modules similar to chapters in a book. Participants will receive weekly written feedback on their work and progress by a therapist who gives gradual access to the treatment modules. The lion's share of the contact between the therapist and the patient thus takes place through messages (similar to email) in the online treatment platform. It is however allowed to also have one to three face-to-face sessions on-site or through video calls to provide technical assistance and therapeutic support in accordance with the treatment model. Core components are: (a) psychoeducation about emotions and CBT, (b) functional analysis, (c) mindfulness practice, (d) breaking dysfunctional emotion-driven behaviors, and (e) exposure exercises.
Primary care as usual
Other interventionIt is mandatory for primary care services in Stockholm, Sweden, to have staff with adequate competence in the assessment and treatment of common mental disorders. Typically, these patients are handled by general practitioners, psychologists, nurses, or social workers. As this comparator is intended to reflect real routine primary care, the interventions will not be controlled by the research project. We expect that participants allocated to this condition will receive an active treatment.
Change from baseline in Depression Anxiety Stress Scales-21 (DASS-21) to 10-week, and 1-and 2- year follow-ups
This is a 21-item scale with a sum score range 0 to 126 where a higher score indicates more symptoms.
Change in WHODAS from baseline to 10-week, and 1- and 2-year follow-ups
WHODAS is a 12-item measure of disability with a sum score range 0 to 100 where a higher score indicates more disability
Change in Work Ability Index from baseline to 10-week, and 1- and 2-year follow-ups
The Work Ability Index measures work ability with a sum score range 7 to 49 where a higher score indicates higher work ability
Change in Brunnsviken Brief Quality of Life Index from baseline to 10-week, and 1- and 2-year follow-ups
This is a measure of quality of life with a sum score range 0 to 96 where a higher score indicates higher quality of life
Change in sickness absence from 1 year before baseline to 1- and 2-year follow-ups
Net days of sickness absence (including disability pension) will be calculated based on data from the Swedish Microdata for Analysis of Social Security (MiDAS) registry of the National Insurance Agency.
Client Satisfaction Questionnaire at 10-week follow-up
This is an 8-item measure of client satisfaction with the care received with a sum score range 8 to 32 where a higher score indicates higher client satisfaction
Negative Effects Questionnaire at 10-week follow-up
The Negative Effects Questionnaire is a 20-item measure of potential negative effects related to the received treatment. The participant marks (yes/no) if a negative effect has occurred from a list of common negative effects and rate to what extent this has affected the participant and to what extent it was related to treatment.
Credibility Scale (C-scale) 2 weeks after baseline
The C-scale is a measure of treatment credibility with a sum score range 0 to 50 where a higher score indicates higher treatment credibility
Change in EQ5D from baseline to 10-week, and 1- and 2-year follow-up
The EQ5D is a measure of health-related quality of life with a score range 0 to 1 where a higher score indicates higher quality of life. This measure will be used when calculating cost-utility in the health economic analysis.
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Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator
