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NCT Number: NCT05016843

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

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).

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Key information

Conditions

Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychology

Stockholm, Stockholm County, 10691, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Treatment condition: Internet-administered Unified protocol

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 condition: Internet-administered Affect phobia treatment

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 condition: Waitlist control

Other

The waitlist condition is a control condition without any intervention.

Treatment length: 8 weeks

Other

Participants will partake in their treatment condition for 8 weeks.

Treatment length: 16 weeks

Other

Participants will partake in their treatment condition for 16 weeks.

Access to a moderated forum

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.

No access to a moderated forum

Other

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

Primary outcomes

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

    Time frame: Through study completion, an average of 2 years.

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

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

    Time frame: Through study completion, an average of 2 years.

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

  3. Brunnsviken Brief Quality of Life Scale (BBQ)

    Time frame: Through study completion, an average of 2 years.

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

Secondary outcomes

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

    Time frame: Baseline only.

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

  2. Negative Effects Questionnaire (NEQ)

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

    The NEQ measures unwanted effects of treatments.

  3. Reflective Functioning Questionnaire 8 (RFQ-8)

    Time frame: Through study completion, an average of 2 years.

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

Sponsors and collaborators

Lead sponsor

Stockholm University

Other

Registry information

Official study title

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

Acronym: TRAbee

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 23, 2021
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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