Transdiagnostic Online CBT Vs. Care As Usual for Primary Care Patients with Subsyndromal Mental Ill-health ( PRIMARITA-2 )

NCT06804954 | Recruiting

• 1 other identifier: TRANS SUB 2024-06008-01 RCT-2
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Ill-health

Keywords

Primary Care; Transdiagnostic CBT; Online treatment; Subsyndromal mental ill-health

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, weeks 2, 4, 6, 8, 10 (primary endpoint), and 1-and 2-year follow-up

Secondary Outcomes (5)

• Change in WHODAS from baseline to 10-week, and 1- and 2-year follow-ups

  Baseline, week 10, 1- and 2-year follow-ups

• Change in Work Ability Index from baseline to 10-week, and 1- and 2-year follow-ups

  Baseline, week 10, 1- and 2-year follow-ups

• Change in Brunnsviken Brief Quality of Life Index from baseline to 10-week, and 1- and 2-year follow-ups

  Baseline, week 10, 1- and 2-year follow-ups

• Change in sickness absence from 1 year before baseline to 1- and 2-year follow-ups

  The 1-year period preceding baseline, 1- and 2-year periods after baseline

• Change in EPQR-A Neuroticism scale from baseline to 10-week, and 1-and 2-year follow-ups

  Baseline, week 10, 1- and 2-year follow-ups

Other Outcomes (11)

• Client Satisfaction Questionnaire at 10-week follow-up

  10-week follow-up

• Negative Effects Questionnaire at 10-week follow-up

  10-week follow-up

• Credibility Scale (C-scale) 2 weeks after baseline

  2 weeks after baseline

Study Arms (2)

Online transdiagnostic CBT

EXPERIMENTAL

Participants randomized to this arm will receive the intervention online transdiagnostic CBT (see Interventions).

Behavioral: Online transdiagnostic CBT

Primary care as usual

ACTIVE COMPARATOR

Patients randomized to this study condition will receive health care services as usual in primary care.

Other: Primary care as usual

Interventions

Online transdiagnostic CBT BEHAVIORAL

This 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.

Online transdiagnostic CBT

Primary care as usual OTHER

It 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.

Primary care as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be included patients have to:
• 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,
• have no severe psychiatric disorder that requires specialized psychiatric care, such as psychosis, bipolar disorder, or anorexia nervosa,
• if on medication with monoamine agonist, have stable dosage in the past month,
• have no on-going psychological treatment, and
• provide written informed consent for participation and complete baseline assessment

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Region Stockholm, Gustavsberg Primary Care Center

Gustavsberg, Stockholm County, 134 40, Sweden

RECRUITING

MeSH Terms

Interventions

Primary Health Care

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Erik Hedman-Lagerlöf, PhD, professor

  Region Stockholm and Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mari von Bahr Bentzer, MSc.

CONTACT

+46 8 123 395 50; mari.vonbahr-bentzer@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 3, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): February 6, 2029
• Study Completion (Estimated): February 6, 2029
• Last Updated: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)