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Anxiety DisordersTRAbeeNCT05016843

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

A study testing Treatment condition: Internet-administered Unified protocol, Treatment condition: Internet-administered Affect phobia treatment and Treatment length: 8 weeks in people with Anxiety Disorders and Depression, run by Stockholm University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anxiety Disorders, Depression
What is being tested?
Treatment condition: Internet-administered Unified protocol, Treatment condition: Internet-administered Affect phobia treatment and Treatment length: 8 weeks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,477 participants
Where
1 siteSweden
Study dates
25 Aug 2021to 22 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

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

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Department of Psychology

    Stockholm, Stockholm County, 10691

Other trials in Sweden

About this study

Official title: The Study of Internet-delivered, Transdiagnostic Treatments for Anxiety and Depression ("TRAnsdiagnostisk BEhandling (Elektronisk)")

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).

Being tested
Treatment condition: Internet-administered Unified protocol, Treatment condition: Internet-administered Affect phobia treatment, Treatment condition: Waitlist control, Treatment length: 8 weeks, Treatment length: 16 weeks
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment condition: Internet-administered Unified protocolBehavioural

    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 treatmentBehavioural

    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 controlOther

    The waitlist condition is a control condition without any intervention.

  • Treatment length: 8 weeksOther

    Participants will partake in their treatment condition for 8 weeks.

  • Treatment length: 16 weeksOther

    Participants will partake in their treatment condition for 16 weeks.

  • Access to a moderated forumOther

    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 forumOther

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

Study groups in NCT05016843
Study groupRoleWhat they receive
CBT, 8 weeks and access to forum.ExperimentalNot described
Receives: Behavioral: Treatment condition: Internet-administered Unified protocol; Other: Treatment length: 8 weeks; Other: Access to a moderated forum
CBT, 16 weeks and access to forum.ExperimentalNot described
Receives: Behavioral: Treatment condition: Internet-administered Unified protocol; Other: Treatment length: 16 weeks; Other: No access to a moderated forum
CBT, 8 weeks and no access to forum.ExperimentalNot described
Receives: Behavioral: Treatment condition: Internet-administered Unified protocol; Other: Treatment length: 8 weeks; Other: No access to a moderated forum
CBT, 16 weeks and no access to forum.ExperimentalNot described
Receives: Behavioral: Treatment condition: Internet-administered Unified protocol; Other: Treatment length: 16 weeks; Other: Access to a moderated forum
Psychodynamic therapy, 8 weeks and access to forum.ExperimentalNot described
Receives: Behavioral: Treatment condition: Internet-administered Affect phobia treatment; Other: Treatment length: 8 weeks; Other: Access to a moderated forum
Psychodynamic therapy, 16 weeks and access to forum.ExperimentalNot described
Receives: Behavioral: Treatment condition: Internet-administered Affect phobia treatment; Other: Treatment length: 16 weeks; Other: Access to a moderated forum
Psychodynamic therapy, 8 weeks and no access to forum.ExperimentalNot described
Receives: Behavioral: Treatment condition: Internet-administered Affect phobia treatment; Other: Treatment length: 8 weeks; Other: No access to a moderated forum
Psychodynamic therapy, 16 weeks and no access to forum.ExperimentalNot described
Receives: Behavioral: Treatment condition: Internet-administered Affect phobia treatment; Other: Treatment length: 16 weeks; Other: No access to a moderated forum
Waitlist, 8 weeks and access to forum.ExperimentalNot described
Receives: Other: Treatment condition: Waitlist control; Other: Treatment length: 8 weeks; Other: Access to a moderated forum
Waitlist, 16 weeks and access to forum.ExperimentalNot described
Receives: Other: Treatment condition: Waitlist control; Other: Treatment length: 16 weeks; Other: Access to a moderated forum
Waitlist, 8 weeks and no access to forum.ExperimentalNot described
Receives: Other: Treatment condition: Waitlist control; Other: Treatment length: 8 weeks; Other: No access to a moderated forum
Waitlist, 16 weeks and no access to forum.ExperimentalNot described
Receives: Other: Treatment condition: Waitlist control; Other: Treatment length: 16 weeks; Other: No access to a moderated forum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Health Questionnaire 9-item scale (PHQ-9)

    The PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.

    Measured: Through study completion, an average of 2 years.

  2. Generalised Anxiety Disorder 7- item scale (GAD-7)

    The GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.

    Measured: Through study completion, an average of 2 years.

  3. Brunnsviken Brief Quality of Life Scale (BBQ)

    The BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.

    Measured: Through study completion, an average of 2 years.

Secondary outcomes (3)
  1. The Personality Inventory for DSM Short Form (PID-5)

    The PID-5 is a self-rated measure of personality-related problems featuring 25 items.

    Measured: Baseline only.

  2. Negative Effects Questionnaire (NEQ)

    The NEQ measures unwanted effects of treatments.

    Measured: At post-treatment only (which is week 8 or 16 depending on treatment allocation).

  3. Reflective Functioning Questionnaire 8 (RFQ-8)

    RFQ features 8 items assessing the ability to understand mental states of the self and others.

    Measured: Through study completion, an average of 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2021
  2. Study start25 Aug 2021
  3. Primary completion22 Jan 2026
  4. Study completion22 Jan 2026

Resources

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
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
2,477 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05016843
Sponsor's protocol ID
TRAbee
Acronym
TRAbee
Status last verified
Jan 2026
First submitted
8 Aug 2021
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lindqvist K, Mechler J, Hlynsson JI, Andersson G, Carlbring P. Internet-delivered unguided psychodynamic vs. cognitive behavior therapy for anxiety and depression symptoms: A large, full factorial randomized controlled trial on treatment length and peer support. Internet Interv. 2026 Jul 16;45:100980. doi: 10.1016/j.invent.2026.100980. eCollection 2026 Sep.

    PubMed 42633284
  • 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.

    PubMed 38800678
  • 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.

    PubMed 38259555

Questions about this trial

What is this clinical trial studying?

A study testing Treatment condition: Internet-administered Unified protocol, Treatment condition: Internet-administered Affect phobia treatment and Treatment length: 8 weeks in people with Anxiety Disorders and Depression, run by Stockholm University 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: finished, as of the sponsor's last update on 26 Jan 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Patient Health Questionnaire 9-item scale (PHQ-9) (time frame: Through study completion, an average of 2 years.). The study lists 3 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 NCT05016843, which also lists 3 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 26 Jan 2026.

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