The Study of Internet-delivered, Transdiagnostic Treatments for Anxiety and Depression
NCT ID: NCT05016843
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2477 participants
INTERVENTIONAL
2021-08-25
2026-01-22
Brief Summary
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The study will investigate three factors: type of transdiagnostic treatment, length of treatment and whether patients have access to a moderated forum or not. 2400 participants with anxiety and/or depression will be randomly assigned to one of 12 subgroups and subsequently offered treatment based on differing combinations of the previously mentioned factors (200 participants/arm). The treatment conditions are internet-administered cognitive, behavioral treatment (CBT) Unified protocol and the psychodynamic Affect phobia treatment as well as a waitlist control group. Participants will also be randomized to either 8 or 16 weeks of treatment and access to a moderated forum or not.
Primary outcome measures will be the Patient Health Questionnaire, the Generalized Anxiety Disorder 7-item scale and the Brief Quality of Life scale. Negative effects of treatment will also be assessed. In addition to pre- and post-treatment measurements, the study includes one mid-treatment and three follow-up assessments (6, 12 and 24 months).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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CBT, 8 weeks and access to forum.
Treatment condition: Internet-administered Unified protocol
Treatment condition:
The cognitive, behavioral treatment Unified protocol is a transdiagnostic treatment for anxiety and depression. Participants are taught five techniques in order to find new and more helpful ways to react to hindering thoughts and feelings: mindfulness, cognitive flexibility, identify and reduce behavioral avoidance, increase willingness to experience physiological sensations and exposure. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.
Treatment length: 8 weeks
Participants will partake in their treatment condition for 8 weeks.
Access to a moderated forum
During their treatment, participants will have access to a discussion forum moderated by a clinician. Participants are encouraged to discuss questions and experiences related to their treatment condition.
CBT, 16 weeks and access to forum.
Treatment condition: Internet-administered Unified protocol
Treatment condition:
The cognitive, behavioral treatment Unified protocol is a transdiagnostic treatment for anxiety and depression. Participants are taught five techniques in order to find new and more helpful ways to react to hindering thoughts and feelings: mindfulness, cognitive flexibility, identify and reduce behavioral avoidance, increase willingness to experience physiological sensations and exposure. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.
Treatment length: 16 weeks
Participants will partake in their treatment condition for 16 weeks.
No access to a moderated forum
Participants will not have access to a moderated forum, hence their treatment is self-guided.
CBT, 8 weeks and no access to forum.
Treatment condition: Internet-administered Unified protocol
Treatment condition:
The cognitive, behavioral treatment Unified protocol is a transdiagnostic treatment for anxiety and depression. Participants are taught five techniques in order to find new and more helpful ways to react to hindering thoughts and feelings: mindfulness, cognitive flexibility, identify and reduce behavioral avoidance, increase willingness to experience physiological sensations and exposure. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.
Treatment length: 8 weeks
Participants will partake in their treatment condition for 8 weeks.
No access to a moderated forum
Participants will not have access to a moderated forum, hence their treatment is self-guided.
CBT, 16 weeks and no access to forum.
Treatment condition: Internet-administered Unified protocol
Treatment condition:
The cognitive, behavioral treatment Unified protocol is a transdiagnostic treatment for anxiety and depression. Participants are taught five techniques in order to find new and more helpful ways to react to hindering thoughts and feelings: mindfulness, cognitive flexibility, identify and reduce behavioral avoidance, increase willingness to experience physiological sensations and exposure. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.
Treatment length: 16 weeks
Participants will partake in their treatment condition for 16 weeks.
Access to a moderated forum
During their treatment, participants will have access to a discussion forum moderated by a clinician. Participants are encouraged to discuss questions and experiences related to their treatment condition.
Psychodynamic therapy, 8 weeks and access to forum.
Treatment condition: Internet-administered Affect phobia treatment
The aim of psychodynamic Affect phobia treatment is for the patient to reach an intellectual and emotional understanding of his/hers problems. The goal of the treatment is for participants to decrease emotional avoidance and start to approach emotions and increase emotional awareness. Participants are taught this through linking their symptoms to their emotional avoidance, observe frequent and maladaptive patterns in relationships and see how these are linked to emotional avoidance. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.
Treatment length: 8 weeks
Participants will partake in their treatment condition for 8 weeks.
Access to a moderated forum
During their treatment, participants will have access to a discussion forum moderated by a clinician. Participants are encouraged to discuss questions and experiences related to their treatment condition.
Psychodynamic therapy, 16 weeks and access to forum.
Treatment condition: Internet-administered Affect phobia treatment
The aim of psychodynamic Affect phobia treatment is for the patient to reach an intellectual and emotional understanding of his/hers problems. The goal of the treatment is for participants to decrease emotional avoidance and start to approach emotions and increase emotional awareness. Participants are taught this through linking their symptoms to their emotional avoidance, observe frequent and maladaptive patterns in relationships and see how these are linked to emotional avoidance. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.
Treatment length: 16 weeks
Participants will partake in their treatment condition for 16 weeks.
Access to a moderated forum
During their treatment, participants will have access to a discussion forum moderated by a clinician. Participants are encouraged to discuss questions and experiences related to their treatment condition.
Psychodynamic therapy, 8 weeks and no access to forum.
Treatment condition: Internet-administered Affect phobia treatment
The aim of psychodynamic Affect phobia treatment is for the patient to reach an intellectual and emotional understanding of his/hers problems. The goal of the treatment is for participants to decrease emotional avoidance and start to approach emotions and increase emotional awareness. Participants are taught this through linking their symptoms to their emotional avoidance, observe frequent and maladaptive patterns in relationships and see how these are linked to emotional avoidance. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.
Treatment length: 8 weeks
Participants will partake in their treatment condition for 8 weeks.
No access to a moderated forum
Participants will not have access to a moderated forum, hence their treatment is self-guided.
Psychodynamic therapy, 16 weeks and no access to forum.
Treatment condition: Internet-administered Affect phobia treatment
The aim of psychodynamic Affect phobia treatment is for the patient to reach an intellectual and emotional understanding of his/hers problems. The goal of the treatment is for participants to decrease emotional avoidance and start to approach emotions and increase emotional awareness. Participants are taught this through linking their symptoms to their emotional avoidance, observe frequent and maladaptive patterns in relationships and see how these are linked to emotional avoidance. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.
Treatment length: 16 weeks
Participants will partake in their treatment condition for 16 weeks.
No access to a moderated forum
Participants will not have access to a moderated forum, hence their treatment is self-guided.
Waitlist, 8 weeks and access to forum.
Treatment condition: Waitlist control
The waitlist condition is a control condition without any intervention.
Treatment length: 8 weeks
Participants will partake in their treatment condition for 8 weeks.
Access to a moderated forum
During their treatment, participants will have access to a discussion forum moderated by a clinician. Participants are encouraged to discuss questions and experiences related to their treatment condition.
Waitlist, 16 weeks and access to forum.
Treatment condition: Waitlist control
The waitlist condition is a control condition without any intervention.
Treatment length: 16 weeks
Participants will partake in their treatment condition for 16 weeks.
Access to a moderated forum
During their treatment, participants will have access to a discussion forum moderated by a clinician. Participants are encouraged to discuss questions and experiences related to their treatment condition.
Waitlist, 8 weeks and no access to forum.
Treatment condition: Waitlist control
The waitlist condition is a control condition without any intervention.
Treatment length: 8 weeks
Participants will partake in their treatment condition for 8 weeks.
No access to a moderated forum
Participants will not have access to a moderated forum, hence their treatment is self-guided.
Waitlist, 16 weeks and no access to forum.
Treatment condition: Waitlist control
The waitlist condition is a control condition without any intervention.
Treatment length: 16 weeks
Participants will partake in their treatment condition for 16 weeks.
No access to a moderated forum
Participants will not have access to a moderated forum, hence their treatment is self-guided.
Interventions
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Treatment condition: Internet-administered Unified protocol
Treatment condition:
The cognitive, behavioral treatment Unified protocol is a transdiagnostic treatment for anxiety and depression. Participants are taught five techniques in order to find new and more helpful ways to react to hindering thoughts and feelings: mindfulness, cognitive flexibility, identify and reduce behavioral avoidance, increase willingness to experience physiological sensations and exposure. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.
Treatment condition: Internet-administered Affect phobia treatment
The aim of psychodynamic Affect phobia treatment is for the patient to reach an intellectual and emotional understanding of his/hers problems. The goal of the treatment is for participants to decrease emotional avoidance and start to approach emotions and increase emotional awareness. Participants are taught this through linking their symptoms to their emotional avoidance, observe frequent and maladaptive patterns in relationships and see how these are linked to emotional avoidance. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.
Treatment condition: Waitlist control
The waitlist condition is a control condition without any intervention.
Treatment length: 8 weeks
Participants will partake in their treatment condition for 8 weeks.
Treatment length: 16 weeks
Participants will partake in their treatment condition for 16 weeks.
Access to a moderated forum
During their treatment, participants will have access to a discussion forum moderated by a clinician. Participants are encouraged to discuss questions and experiences related to their treatment condition.
No access to a moderated forum
Participants will not have access to a moderated forum, hence their treatment is self-guided.
Eligibility Criteria
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Inclusion Criteria
* access to a mobile phone/computer,
* 18 years or older,
* GAD-7 ≥ 5 and/or
* PHQ-9 ≥ 10.
Exclusion Criteria
* has started or adjusted treatment with psychopharmacological drugs for anxiety, worry or depression within the nearest month,
* severe depression (PHQ-9 ≥ 20) or suicidal (PHQ-9, item 9\>2).
18 Years
ALL
No
Sponsors
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Stockholm University
OTHER
Responsible Party
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Per Carlbring
Professor
Locations
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Department of Psychology
Stockholm, Stockholm County, Sweden
Countries
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References
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Hlynsson JI, Carlbring P. Diagnostic accuracy and clinical utility of the PHQ-2 and GAD-2: a comparison with long-format measures for depression and anxiety. Front Psychol. 2024 May 10;15:1259997. doi: 10.3389/fpsyg.2024.1259997. eCollection 2024.
Hlynsson JI, Lindner P, Barri B, Carlbring P. Exploring cutoff points and measurement invariance of the Brunnsviken brief quality of life inventory. Front Psychol. 2024 Jan 8;14:1305682. doi: 10.3389/fpsyg.2023.1305682. eCollection 2023.
Other Identifiers
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TRAbee
Identifier Type: -
Identifier Source: org_study_id
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