NCT06928428

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Region Stockholm · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study 1. Feasibility study: Outcome measures of acceptability, feasibility and compliance: a. What percentage of surveyed patients choose to participate in bMCT? b. What is the dropout rate, given reasons for dropping out? c. How many modules do the patients complete, from 1 to 8? d. patient satisfaction with treatment (Client Satisfaction Questionnaire, CSQ-8, range from 8 low satisfaction to 32 high satisfaction) d. Any reported negative effects of treatment e. Adherence and competence in delivering MCT sessions (MCT-Competence Scale, MCT-CS, 18 items, scale 0-5) Study1: Experience and Usability, qualitative method: 1. How are bMCT and treatment materials experienced by patients and therapists respectively? 2. What facilitates and hinders the implementation of bMCT? Study1: Preliminary clinical effects: 1. symptoms of depression (PHQ-9, 0-27), symptoms of GAD (PSWQ, 16-80) 2. quality of life (5-item Satisfaction with Life Scale, SWLS, 0-35) d. functional level (WHO Disability Assessment Schedule 2.0, WHODAS, 0-48) e. self-assessed ability to work (Work Ability Index, WAI 0-10) Study 2: randomized controlled study, additional measurements of acceptability, feasibility, compliance: Varies 1. proportion completed modules between groups? 2. percentage dropouts between groups? 3. therapist competence and adherence to MCT between groups? 4. patient satisfaction with treatment (CSQ-8, range from 8 low satisfaction to 32 high satisfaction)

Conditions

• Depression NOS
• Generalized Anxiety Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-10
• Primary completion: 2026-06-30
• Completion: 2027-12-01
• First posted: 2025-04-15
• Last updated: 2025-04-15

Locations

1 site across 1 country: Sweden