Metacognitive Therapy for Depression and Generalized Anxiety Disorder in Primary Care, Blended Version of Mediated Treatment

Summary

The goal of this clinical trial is to investigate a new format of metacognitive therapy (MCT) for primary care patients with depression or generalized anxiety disorder (GAD) called blended MCT (bMCT). What is new about bMCT is that it is given both via the internet and through meetings with a therapist. In this study, we first want to investigate if it is feasible to deliver bMCT in primary health care to patients with depression or GAD. Secondly, we want to investigate whether the format of bMCT can provide as good treatment effects as only personally mediated MCT.

The content of both formats of treatment is based on MCT methods for depression and GAD which have shown to be effective in previous research studies. bMCT means to work with the treatment independently via an internet platform and to meet the therapist for therapy sessions up to 6 times during the course of the treatment. Meetings will take place at the primary care center or via video call. As part of the treatment are mediated via the internet, participants need to have access to an Internet-connected computer/electronic device and be able to work with the material about 3 hours per week during the course of the treatment. Standard MCT involves seeing the therapist for 8-12 treatment sessions at the primary care center or via video call.

In the first study, all patients diagnosed with depression or GAD at Liljeholmen primary care center, after giving informed consent, will receive bMCT. In the second study, more primary health care centers will be involved and participants will be randomly allocated to either bMCT or standard MCT.

The active treatment lasts for 8-12 weeks. The treatment is estimated to involve approximately 3 hours of therapy work per week. Participants will be asked to fill in questionnaires before the treatment, weekly during the treatment, immediately after the treatment (post-treatment) and follow-ups at 6 and 12 months after post-treatment. The forms contain questions about your well-being, background and experience of the treatment. Filling in questionnaires is estimated to take 30 minutes on four measurement occasions. Participating also means giving permission for treatment conversations to be audio recorded. The recording is coded so that independent assessors can examine the therapists' competence, and see that the therapists follow the instructions for the current treatment method.

Conditions

• Depression NOS
• Generalized Anxiety Disorder

Interventions

BEHAVIORAL

Metacognitive therapy, blended format

Blended metacognitive therapy (bMCT): New about this treatment is that it is given both via the internet and through meetings with a therapist. Participants work with the treatment independently via an internet platform and meets their therapist for therapy sessions up to 6 times during the course of the treatment. Key components of the original manual are retained, but adapted to better fit the digital format. A handbook for therapists is developed to facilitate the implementation of the blended format and optimize execution. The digital parts of the treatment for depression and GAD consist of 10 interactive modules located in the Support and Treatment (SoB) platform. The sessions are divided in a flexible way between physical and digital sessions that therapist and patient agree on. The patient has access to all modules but receive instructions from their therapist which module is relevant for each week. During the treatment, the patient can write text messages to his/her therapist.

Sponsors & Collaborators

• Karolinska Institutet

  collaborator OTHER

• Region Stockholm

  lead OTHER_GOV

Principal Investigators

• Sandra af Winklerfelt Hammarberg, MD, PhD · Region Stockholm and Karolinska Institutet

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-10

Primary Completion

2026-06-30

Completion

2027-12-01

Countries

• Sweden

Study Locations