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

Not Applicable

• Conditions: Depression NOS; Generalized Anxiety Disorder

• Registration Number: NCT06928428
• Lead Sponsor: Region Stockholm

Brief 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)

Study Timeline

• Study First Submitted: 2024-10-02
• Study Start: 2025-02-10
• Status Verified: 2025-03
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15
• Primary Completion: 2026-06-30
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Acceptability, is bMCT an acceptable treatment for primary care patients with depression or GAD?	Measurements are delivered at enrollment before treatment, during treatment week 1 to 12, and post-treatment after 12 weeks.	What percentage of surveyed patients choose to participate in bMCT? Measured as percentage of surveyed and eligible patients with a diagnosis of depression or GAD who agree to participate in the treatment study.
Adherence, do the participating patients fulfill the bMCT modules?	Measurements are delivered at enrollment pre-treatment, post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions), six months after post-treatment, and 12 months after post-treatment.	How many modules in the bMCT protocol do the patients complete, from 1 to 8? Measured by number of gathered patient-reported assignments, one for each module out of eight in the SoB-portal.
What is the dropout rate of included patients in bMCT?	Measurements are reported during treatment if interrupted and summarized post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions).	Dropout rate is measured as percentage of included patients who choose to drop out before the completion of bMCT treatment.
Satisfaction with bMCT treatment	Measurements are delivered at post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions).	Patient satisfaction with treatment will be measured with the Client Satisfaction Questionnaire, CSQ-8, which ranges from 8 "low satisfaction" to 32 "high satisfaction" with treatment.
Any reported negative effects of bMCT?	Measurements are delivered at post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions).	Measured with the Negative Effects Questionnaire, NEQ, 32 items where participating patients report on a Likert scale 0 to 4, thus, a total range of 0 "no reported negative effects" to 128 "maximum reported negative effects".
The therapists' competence in carrying out the bMCT treatment	Sessions are audio-recorded during treatment week 1 to 12, assessments of the recordings are carried out post-treatment after 12 weeks up to 6 months post-treatment.	All treatment sessions are audio-recorded. For each therapist three randomly selected recordings are assessed for a total score on the Metacognitive Therapy Competence Scale, MCT-CS, witch includes 18 items and rates competence on a Likert scale that ranges from 0 "not done, not applicable " to 5 "very good level", thus, a total scale ranging from 0 to 90. Assessments are performed by external independent expert assessors with deep knowledge of MCT and prior experience in using the MCT-CS scale.
Patients experience of bMCT, qualitative method	Interviews are carried out post-treatment when treatment is finished after 10 weeks up to two months post treatment (treatment range 6 to maximum of 12 treatment sessions).	Individual semi structured interviews are performed with a selection of participating patients post treatment with questions about their experiences of bMCT. Interviews are audio-recorded and transcribed verbatim for qualitative content analysis.
Therapists' experience of carrying out bMCT, qualitative method	Focus group discussion with participating therapists is carried out post treatment when all patients in the feasibility study have finished treatment 12 weeks up to 6 months post treatment.	Focus group interview with participating therapists. Semi structured questions and discussions about their experiences of mediating bMCT. Audio-recorded discussions are transcribed and analyzed with qualitative content analysis.
What facilitates the implementation of bMCT? Qualitative method	Interviews with patients are carried out post-treatment after 12 weeks up to two months post treatment. Focus group with therapists when all patients in the feasibility study have finished treatment 12 weeks up to 6 months post treatment.	Individual interviews with a selection of participating patients and focus group interview with participating therapists. Semi structured questions about perceived facilitators of bMCT. Audio-recorded discussions are transcribed and analyzed with qualitative content analysis.
What hinders the implementation of bMCT? Qualitative method	Interviews with patients are carried out post-treatment, after 12 weeks, and focus group with therapists when all patients in the feasibility study have finished treatment 12 weeks up to 6 months post treatment.	Individual interviews with a selection of participating patients and focus group interview with participating therapists. Semi structured questions about perceived hindering factors of bMCT. Audio-recorded discussions are transcribed and analyzed with qualitative content analysis.

Secondary Outcome Measures

Name	Time	Method
Preliminary clinical effects of bMCT, change in depressive symptoms	Measurements are delivered at enrollment pre-treatment, post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions), six months efter post-treatment, and 12 months after post-treatment.	Preliminary clinical effects of bMCT regarding change in depressive symptoms measured with Patient Health Questionnaire-9 items, PHQ-9, range from 0 "no depressive symptoms" to 27 "severe depressive symptoms"
Preliminary clinical effects of bMCT, change in symptoms of generalized anxiety disorder (GAD)	Measurements are delivered at enrollment pre-treatment, post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions), six months efter post-treatment, and 12 months after post-treatment.	Preliminary clinical effects of bMCT regarding change in symptoms of GAD measured with Penn State Worry Questionnaire, PSWQ, with a total range from 16 "no GAD symptoms" to 80 "severe GAD symptoms"
Preliminary clinical effects of bMCT, change in quality of life	Measurements are delivered at enrollment pre-treatment, post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions), six months efter post-treatment, and 12 months after post-treatment.	Preliminary clinical effects of bMCT regarding change in patient rated quality of life, measured with the 5-item Satisfaction with Life Scale, SWLS. The total score ranges from 5 "extremely dissatisfied" to 35 "extremely satisfied".
Preliminary clinical effects of bMCT, change in functional level	Measurements are delivered at enrollment pre-treatment, post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions), six months efter post-treatment, and 12 months after post-treatment.	Preliminary clinical effects of bMCT regarding change in patient rated functional level measured with WHO Disability Assessment Schedule 2.0, with 12 items and a total range from 0 "no impairment" to 48 "severe impairment in all daily activities".
Preliminary clinical effects of bMCT, self-assessed ability to work	Measurements are delivered at enrollment pre-treatment, post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions), six months efter post-treatment, and 12 months after post-treatment.	Preliminary clinical effects of bMCT regarding change in self-assessed ability to work measured with Work Ability Index, WAI, a total range from 0 "no ability to work" to 10 "my work ability is at it's best"
Preliminary clinical effects of bMCT, change in symptoms of insomnia	Measurements are delivered at enrollment pre-treatment, post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions), six months efter post-treatment, and 12 months after post-treatment.	Preliminary clinical effects of bMCT regarding change in symptoms of insomnia measured with Insomnia Severity Index, ISI, 5 items with a total range of 0 "no signs of insomnia" to 28 "severe clinical insomnia"

Trial Locations

Locations (1)

Liljeholmen primary care center, Academic Primary care center, SLSO, Region Stockholm; 🇸🇪 Stockholm, Sweden