The Study of Internet-delivered, Transdiagnostic Treatments for Anxiety and Depression

NCT ID: NCT05016843

Last Updated: 2026-01-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2477 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-25

Study Completion Date

2026-01-22

Brief Summary

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Anxiety and depression are common psychiatric disorders, resulting in suffering and impaired functioning for the individual. Today, most psychological treatments are disorder specific, even tough comorbidity between depression and anxiety and different anxiety disorders is rule rather than exception. Transdiagnostic treatments target the common features between depression and anxiety disorders and has shown to be as effective as disorder specific treatments in reducing symptoms of the disorders. Unified protocol and Affect phobia treatment are two types of transdiagnostic treatments that, to our knowledge, never been compared in research before. Internet-administered treatment presents a promising way to increase availability of psychotherapeutic interventions such as transdiagnostic treatments. However, questions regarding the optimal treatment length and level of support remain unanswered. The aim of this study is to examine two internet-administered transdiagnostic treatments and their effect on anxiety and depression, and to investigate the impact of treatment length and access to a moderated forum.

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).

Detailed Description

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Conditions

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Anxiety Disorders Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBT, 8 weeks and access to forum.

Group Type EXPERIMENTAL

Treatment condition: Internet-administered Unified protocol

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Participants will partake in their treatment condition for 8 weeks.

Access to a moderated forum

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Treatment condition: Internet-administered Unified protocol

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Participants will partake in their treatment condition for 16 weeks.

No access to a moderated forum

Intervention Type OTHER

Participants will not have access to a moderated forum, hence their treatment is self-guided.

CBT, 8 weeks and no access to forum.

Group Type EXPERIMENTAL

Treatment condition: Internet-administered Unified protocol

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Participants will partake in their treatment condition for 8 weeks.

No access to a moderated forum

Intervention Type OTHER

Participants will not have access to a moderated forum, hence their treatment is self-guided.

CBT, 16 weeks and no access to forum.

Group Type EXPERIMENTAL

Treatment condition: Internet-administered Unified protocol

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Participants will partake in their treatment condition for 16 weeks.

Access to a moderated forum

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Treatment condition: Internet-administered Affect phobia treatment

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Participants will partake in their treatment condition for 8 weeks.

Access to a moderated forum

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Treatment condition: Internet-administered Affect phobia treatment

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Participants will partake in their treatment condition for 16 weeks.

Access to a moderated forum

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Treatment condition: Internet-administered Affect phobia treatment

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Participants will partake in their treatment condition for 8 weeks.

No access to a moderated forum

Intervention Type OTHER

Participants will not have access to a moderated forum, hence their treatment is self-guided.

Psychodynamic therapy, 16 weeks and no access to forum.

Group Type EXPERIMENTAL

Treatment condition: Internet-administered Affect phobia treatment

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Participants will partake in their treatment condition for 16 weeks.

No access to a moderated forum

Intervention Type OTHER

Participants will not have access to a moderated forum, hence their treatment is self-guided.

Waitlist, 8 weeks and access to forum.

Group Type EXPERIMENTAL

Treatment condition: Waitlist control

Intervention Type OTHER

The waitlist condition is a control condition without any intervention.

Treatment length: 8 weeks

Intervention Type OTHER

Participants will partake in their treatment condition for 8 weeks.

Access to a moderated forum

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Treatment condition: Waitlist control

Intervention Type OTHER

The waitlist condition is a control condition without any intervention.

Treatment length: 16 weeks

Intervention Type OTHER

Participants will partake in their treatment condition for 16 weeks.

Access to a moderated forum

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Treatment condition: Waitlist control

Intervention Type OTHER

The waitlist condition is a control condition without any intervention.

Treatment length: 8 weeks

Intervention Type OTHER

Participants will partake in their treatment condition for 8 weeks.

No access to a moderated forum

Intervention Type OTHER

Participants will not have access to a moderated forum, hence their treatment is self-guided.

Waitlist, 16 weeks and no access to forum.

Group Type EXPERIMENTAL

Treatment condition: Waitlist control

Intervention Type OTHER

The waitlist condition is a control condition without any intervention.

Treatment length: 16 weeks

Intervention Type OTHER

Participants will partake in their treatment condition for 16 weeks.

No access to a moderated forum

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Treatment condition: Waitlist control

The waitlist condition is a control condition without any intervention.

Intervention Type OTHER

Treatment length: 8 weeks

Participants will partake in their treatment condition for 8 weeks.

Intervention Type OTHER

Treatment length: 16 weeks

Participants will partake in their treatment condition for 16 weeks.

Intervention Type OTHER

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.

Intervention Type OTHER

No access to a moderated forum

Participants will not have access to a moderated forum, hence their treatment is self-guided.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Be able to read and write Swedish,
* access to a mobile phone/computer,
* 18 years or older,
* GAD-7 ≥ 5 and/or
* PHQ-9 ≥ 10.

Exclusion Criteria

* Partaking in other psychological treatment,
* 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stockholm University

OTHER

Sponsor Role lead

Responsible Party

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Per Carlbring

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Psychology

Stockholm, Stockholm County, Sweden

Site Status

Countries

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Sweden

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.

Reference Type DERIVED
PMID: 38800678 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38259555 (View on PubMed)

Other Identifiers

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TRAbee

Identifier Type: -

Identifier Source: org_study_id

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