Clinical trial NCT06928428: Metacognitive Therapy for Depression and Generalized Anxiety Disorder in Primary Care, Blended Version of Mediated Treatment
Official title: Metacognitive Therapy for Depression and Generalized Anxiety Disorder in Primary Health Care, Feasibility of a Blended Mediated Treatment
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression NOS
Generalized Anxiety Disorder
Keywords: primary care
depression
generalized anxiety disorder
metacognitive therapy
blended treatment
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2025-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study 1: Feasibility will be performed in single group
Primary purpose: OTHER

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)

Eligibility criteria: 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\&#39;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.

Primary outcomes:
measure: Acceptability, is bMCT an acceptable treatment for primary care patients with depression or GAD?
timeFrame: Measurements are delivered at enrollment before treatment, during treatment week 1 to 12, and post-treatment after 12 weeks.
measure: Adherence, do the participating patients fulfill the bMCT modules?
timeFrame: 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.
measure: What is the dropout rate of included patients in bMCT?
timeFrame: 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).
measure: Satisfaction with bMCT treatment
timeFrame: Measurements are delivered at post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions).
measure: Any reported negative effects of bMCT?
timeFrame: Measurements are delivered at post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions).
measure: The therapists' competence in carrying out the bMCT treatment
timeFrame: 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.
measure: Patients experience of bMCT, qualitative method
timeFrame: 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).
measure: Therapists' experience of carrying out bMCT, qualitative method
timeFrame: 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.
measure: What facilitates the implementation of bMCT? Qualitative method
timeFrame: 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.
measure: What hinders the implementation of bMCT? Qualitative method
timeFrame: 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.
Secondary outcomes:
measure: Preliminary clinical effects of bMCT, change in depressive symptoms
timeFrame: 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.
measure: Preliminary clinical effects of bMCT, change in symptoms of generalized anxiety disorder (GAD)
timeFrame: 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.
measure: Preliminary clinical effects of bMCT, change in quality of life
timeFrame: 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.
measure: Preliminary clinical effects of bMCT, change in functional level
timeFrame: 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.
measure: Preliminary clinical effects of bMCT, self-assessed ability to work
timeFrame: 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.
measure: Preliminary clinical effects of bMCT, change in symptoms of insomnia
timeFrame: 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.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Liljeholmen primary care center, Academic Primary care center, SLSO, Region Stockholm
Study officials:
affiliation: Region Stockholm and Karolinska Institutet
name: Sandra af Winklerfelt Hammarberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.
citation: Cuijpers P, Berking M, Andersson G, Quigley L, Kleiboer A, Dobson KS. A meta-analysis of cognitive-behavioural therapy for adult depression, alone and in comparison with other treatments. Can J Psychiatry. 2013 Jul;58(7):376-85. doi: 10.1177/070674371305800702.
citation: van der Heiden C, Muris P, van der Molen HT. Randomized controlled trial on the effectiveness of metacognitive therapy and intolerance-of-uncertainty therapy for generalized anxiety disorder. Behav Res Ther. 2012 Feb;50(2):100-9. doi: 10.1016/j.brat.2011.12.005. Epub 2011 Dec 21.
citation: Andersson G, Titov N, Dear BF, Rozental A, Carlbring P. Internet-delivered psychological treatments: from innovation to implementation. World Psychiatry. 2019 Feb;18(1):20-28. doi: 10.1002/wps.20610.
citation: Hedman E, Ljotsson B, Lindefors N. Cognitive behavior therapy via the Internet: a systematic review of applications, clinical efficacy and cost-effectiveness. Expert Rev Pharmacoecon Outcomes Res. 2012 Dec;12(6):745-64. doi: 10.1586/erp.12.67.
citation: Af Winklerfelt Hammarberg S, Toth-Pal E, Jansson-Frojmark M, Lundgren T, Westman J, Bohman B. Intolerance-of-uncertainty therapy versus metacognitive therapy for generalized anxiety disorder in primary health care: A randomized controlled pilot trial. PLoS One. 2023 Jun 14;18(6):e0287171. doi: 10.1371/journal.pone.0287171. eCollection 2023.
citation: Cuijpers P, Donker T, van Straten A, Li J, Andersson G. Is guided self-help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies. Psychol Med. 2010 Dec;40(12):1943-57. doi: 10.1017/S0033291710000772. Epub 2010 Apr 21.