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

Stockholm University

Status: Completed

Conditions: Depression; Anxiety Disorders

Treatments: Other: No access to a moderated forum; Other: Treatment length: 8 weeks; Other: Access to a moderated forum; Other: Treatment condition: Waitlist control; Behavioral: Treatment condition: Internet-administered Affect phobia treatment; Other: Treatment length: 16 weeks; Behavioral: Treatment condition: Internet-administered Unified protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05016843

TRAbee

Details and patient eligibility

About

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).

Enrollment: 2,477 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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2,477 participants in 12 patient groups

CBT, 8 weeks and access to forum.

Experimental group

Treatment:

Behavioral: Treatment condition: Internet-administered Unified protocol

Other: Access to a moderated forum

Other: Treatment length: 8 weeks

CBT, 16 weeks and access to forum.

Experimental group

Treatment:

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.

Experimental group

Treatment:

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.

Experimental group

Treatment:

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.

Experimental group

Treatment:

Behavioral: Treatment condition: Internet-administered Affect phobia treatment

Other: Access to a moderated forum

Other: Treatment length: 8 weeks

Psychodynamic therapy, 16 weeks and access to forum.

Experimental group

Treatment:

Other: Treatment length: 16 weeks

Behavioral: Treatment condition: Internet-administered Affect phobia treatment

Other: Access to a moderated forum

Psychodynamic therapy, 8 weeks and no access to forum.

Experimental group

Treatment:

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.

Experimental group

Treatment:

Other: Treatment length: 16 weeks

Behavioral: Treatment condition: Internet-administered Affect phobia treatment

Other: No access to a moderated forum

Waitlist, 8 weeks and access to forum.

Experimental group

Treatment:

Other: Access to a moderated forum

Other: Treatment condition: Waitlist control

Other: Treatment length: 8 weeks

Waitlist, 16 weeks and access to forum.

Experimental group

Treatment:

Other: Treatment length: 16 weeks

Other: Access to a moderated forum

Other: Treatment condition: Waitlist control

Waitlist, 8 weeks and no access to forum.

Experimental group

Treatment:

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.

Experimental group

Treatment:

Other: Treatment length: 16 weeks

Other: Treatment condition: Waitlist control

Other: No access to a moderated forum