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

Region Stockholm

Status: Invitation-only

Conditions: Depression NOS; Generalized Anxiety Disorder

Treatments: Behavioral: Metacognitive therapy, blended format

Study type: Interventional

Funder types: Other

Identifiers

NCT06928428

FoUI-990130

Details and patient eligibility

About

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.

Full 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)

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed depressive episode/recurrent depression (ICD code F32., F33.), or generalized anxiety disorder (ICD code F41.1) as primary diagnosis
• Informed consent
• Access to the internet
• Age ≥18 years
• In the event of psychopharmaceutical medication (e.g. antidepressants), the dosage must have been stable at least 4 years before inclusion

Exclusion criteria

• Other psychiatric condition in need of immediate treatment and/or assessed to be the patient's primary problem (e.g. bipolar disorder, psychosis, alcohol or substance use syndrome or severe eating disorder),
• Other ongoing psychological treatment
• Insufficient knowledge of the Swedish language (e.g. that an interpreter is needed during patient visits), cognitive failure or insufficient computer skills to be able to assimilate the text-based digital part of the treatment.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Blended metacognitive therapy (bMCT)

Experimental group

Description:

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 meet their therapist for therapy sessions up to 6 times during the course of the treatment.

Treatment:

Behavioral: Metacognitive therapy, blended format