Depression NOSNCT06928428
Metacognitive Therapy for Depression and Generalized Anxiety Disorder in Primary Care, Blended Version of Mediated Treatment
A study testing Metacognitive therapy, blended format in people with Depression NOS and Generalized Anxiety Disorder, run by Region Stockholm at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression NOS, Generalized Anxiety Disorder
- What is being tested?
- Metacognitive therapy, blended format
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 10 Feb 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Liljeholmen primary care center, Academic Primary care center, SLSO, Region Stockholm
Stockholm, Stockholm County, 11794
About this study
Official title: Metacognitive Therapy for Depression and Generalized Anxiety Disorder in Primary Health Care, Feasibility of a Blended Mediated Treatment
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.
Read more
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.
Read the detailed description
Study 1. Feasibility study: Outcome measures of acceptability, feasibility and compliance:
- 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:
- How are bMCT and treatment materials experienced by patients and therapists respectively?
- What facilitates and hinders the implementation of bMCT?
Study1: Preliminary clinical effects:
- symptoms of depression (PHQ-9, 0-27), symptoms of GAD (PSWQ, 16-80)
- quality of life (5-item Satisfaction with Life Scale, SWLS, 0-35)
- 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
- proportion completed modules between groups?
- percentage dropouts between groups?
- therapist competence and adherence to MCT between groups?
- patient satisfaction with treatment (CSQ-8, range from 8 low satisfaction to 32 high satisfaction)
- Conditions
- Depression NOS, Generalized Anxiety Disorder
- Being tested
- Metacognitive therapy, blended format
- Keywords
- primary care, depression, generalized anxiety disorder, metacognitive therapy, blended treatment
- Medical subject headings
- Depression, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive therapy, blended formatBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Blended metacognitive therapy (bMCT) | Experimental | 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. Receives: Behavioral: Metacognitive therapy, blended format |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability, is bMCT an acceptable treatment for primary care patients with depression or GAD?
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.
Measured: Measurements are delivered at enrollment before treatment, during treatment week 1 to 12, and post-treatment after 12 weeks.
Adherence, do the participating patients fulfill the bMCT modules?
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.
Measured: 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.
What is the dropout rate of included patients in bMCT?
Dropout rate is measured as percentage of included patients who choose to drop out before the completion of bMCT treatment.
Measured: 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).
Satisfaction with bMCT treatment
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.
Measured: Measurements are delivered at post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions).
Any reported negative effects of bMCT?
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".
Measured: Measurements are delivered at post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions).
The therapists' competence in carrying out the bMCT 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.
Measured: 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.
Patients experience of bMCT, qualitative method
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.
Measured: 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).
Therapists' experience of carrying out bMCT, qualitative method
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.
Measured: 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.
What facilitates the implementation of bMCT? Qualitative method
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.
Measured: 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.
What hinders the implementation of bMCT? Qualitative method
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.
Measured: 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 (6)
Preliminary clinical effects of bMCT, change in depressive symptoms
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"
Measured: 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, change in symptoms of generalized anxiety disorder (GAD)
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"
Measured: 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, change in quality of life
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".
Measured: 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, change in functional level
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".
Measured: 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, self-assessed ability to work
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"
Measured: 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, change in symptoms of insomnia
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"
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start10 Feb 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Depression NOSStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study 1: Feasibility will be performed in single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Sandra af Winklerfelt Hammarberg, MD, PhD, Principal investigator, Region Stockholm and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928428
- Sponsor's protocol ID
- FoUI-990130
- Status last verified
- Mar 2025
- First submitted
- 2 Oct 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to legal reasons in Sweden we are not able to share IPD, but we will try to give access for other researchers to anonymized data upon legitimate request.
Publications
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.
PubMed 26978655Cuijpers 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.
PubMed 23870719van 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.
PubMed 22222208Andersson 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.
PubMed 30600624Hedman 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.
PubMed 23252357Af 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.
PubMed 37315099Cuijpers 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.
PubMed 20406528
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metacognitive Therapy for Depression and Generalized Anxiety Disorder in Primary Health Care, Feasibility of a Blended Mediated Treatment
- ClinicalTrials.gov ID
- NCT06928428
- Acronym / sponsor ID
- FoUI-990130
- Conditions
- Depression NOS, Generalized Anxiety Disorder
- Keywords
- primary care, depression, generalized anxiety disorder, metacognitive therapy, blended treatment
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- How are bMCT and treatment materials experienced by patients and therapists respectively?
- What facilitates and hinders the implementation of bMCT?
Study1: Preliminary clinical effects:
- symptoms of depression (PHQ-9, 0-27), symptoms of GAD (PSWQ, 16-80)
- quality of life (5-item Satisfaction with Life Scale, SWLS, 0-35)
- 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
- proportion completed modules between groups?
- percentage dropouts between groups?
- therapist competence and adherence to MCT between groups?
- patient satisfaction with treatment (CSQ-8, range from 8 low satisfaction to 32 high satisfaction)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study 1: Feasibility will be performed in single group
| Arm | Type | Receives |
|---|---|---|
| Blended metacognitive therapy (bMCT) | Experimental | Behavioral: Metacognitive therapy, blended formatBlended 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive therapy, blended formatBlended 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. | Behavioural | Blended metacognitive therapy (bMCT) |
Primary outcome
Acceptability, is bMCT an acceptable treatment for primary care patients with depression or GAD?
Time frame: 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?
Time frame: 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?
Time frame: 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
Time frame: 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?
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
6 secondary outcomes
Preliminary clinical effects of bMCT, change in depressive symptoms
Time frame: 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, change in symptoms of generalized anxiety disorder (GAD)
Time frame: 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, change in quality of life
Time frame: 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, change in functional level
Time frame: 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, self-assessed ability to work
Time frame: 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, change in symptoms of insomnia
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Background: PubMed 26978655Eldridge 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.
- Background: PubMed 23870719Cuijpers 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.
- Background: PubMed 22222208van 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.
- Background: PubMed 30600624Andersson 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.
- Background: PubMed 23252357Hedman 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.
- Background: PubMed 37315099Af 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.
- Background: PubMed 20406528Cuijpers 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.
- Individual participant dataSharing planned: No. Due to legal reasons in Sweden we are not able to share IPD, but we will try to give access for other researchers to anonymized data upon legitimate request.
Related trials for Depression NOS
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandra af Winklerfelt Hammarberg, MD, PhD principal investigator
Region Stockholm and Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive therapy, blended format in people with Depression NOS and Generalized Anxiety Disorder, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability, is bMCT an acceptable treatment for primary care patients with depression or GAD? (time frame: Measurements are delivered at enrollment before treatment, during treatment week 1 to 12, and post-treatment after 12 weeks.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06928428, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.