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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Anxiety Disorders
• Intervention / Treatment: Behavioral: Treatment condition: Internet-administered Unified protocol; Other: Treatment length: 8 weeks; Other: Access to a moderated forum; Other: Treatment length: 16 weeks; Other: No access to a moderated forum; Behavioral: Treatment condition: Internet-administered Affect phobia treatment; Other: Treatment condition: Waitlist control

• Study Type: Interventional
• Enrollment (Estimated): 2400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 10691
    • Department of Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT, 8 weeks and access to forum.	Behavioral: 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.; Other: Treatment length: 8 weeks; Participants will partake in their treatment condition for 8 weeks.; 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.
Experimental: CBT, 16 weeks and access to forum.	Behavioral: 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.; Other: Treatment length: 16 weeks; Participants will partake in their treatment condition for 16 weeks.; Other: No access to a moderated forum; Participants will not have access to a moderated forum, hence their treatment is self-guided.
Experimental: CBT, 8 weeks and no access to forum.	Behavioral: 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.; Other: Treatment length: 8 weeks; Participants will partake in their treatment condition for 8 weeks.; Other: No access to a moderated forum; Participants will not have access to a moderated forum, hence their treatment is self-guided.
Experimental: CBT, 16 weeks and no access to forum.	Behavioral: 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.; 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.; Other: Treatment length: 16 weeks; Participants will partake in their treatment condition for 16 weeks.
Experimental: Psychodynamic therapy, 8 weeks and access to forum.	Other: Treatment length: 8 weeks; Participants will partake in their treatment condition for 8 weeks.; 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.; 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.
Experimental: Psychodynamic therapy, 16 weeks and access to forum.	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.; Other: Treatment length: 16 weeks; Participants will partake in their treatment condition for 16 weeks.; 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.
Experimental: Psychodynamic therapy, 8 weeks and no access to forum.	Other: Treatment length: 8 weeks; Participants will partake in their treatment condition for 8 weeks.; Other: No access to a moderated forum; Participants will not have access to a moderated forum, hence their treatment is self-guided.; 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.
Experimental: Psychodynamic therapy, 16 weeks and no access to forum.	Other: Treatment length: 16 weeks; Participants will partake in their treatment condition for 16 weeks.; Other: No access to a moderated forum; Participants will not have access to a moderated forum, hence their treatment is self-guided.; 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.
Experimental: Waitlist, 8 weeks and access to forum.	Other: Treatment length: 8 weeks; Participants will partake in their treatment condition for 8 weeks.; 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.; Other: Treatment condition: Waitlist control; The waitlist condition is a control condition without any intervention.
Experimental: Waitlist, 16 weeks and access to forum.	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.; Other: Treatment length: 16 weeks; Participants will partake in their treatment condition for 16 weeks.; Other: Treatment condition: Waitlist control; The waitlist condition is a control condition without any intervention.
Experimental: Waitlist, 8 weeks and no access to forum.	Other: Treatment length: 8 weeks; Participants will partake in their treatment condition for 8 weeks.; Other: No access to a moderated forum; Participants will not have access to a moderated forum, hence their treatment is self-guided.; Other: Treatment condition: Waitlist control; The waitlist condition is a control condition without any intervention.
Experimental: Waitlist, 16 weeks and no access to forum.	Other: Treatment length: 16 weeks; Participants will partake in their treatment condition for 16 weeks.; Other: No access to a moderated forum; Participants will not have access to a moderated forum, hence their treatment is self-guided.; Other: Treatment condition: Waitlist control; The waitlist condition is a control condition without any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion, an average of 2 years.
Generalised Anxiety Disorder 7- item scale (GAD-7)	The GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.	Through study completion, an average of 2 years.
Brunnsviken Brief Quality of Life Scale (BBQ)	The BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.	Through study completion, an average of 2 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Personality Inventory for DSM Short Form (PID-5)	The PID-5 is a self-rated measure of personality-related problems featuring 25 items.	Baseline only.
Negative Effects Questionnaire (NEQ)	The NEQ measures unwanted effects of treatments.	At post-treatment only (which is week 8 or 16 depending on treatment allocation).
Reflective Functioning Questionnaire 8 (RFQ-8)	RFQ features 8 items assessing the ability to understand mental states of the self and others.	Through study completion, an average of 2 years.

Collaborators and Investigators

• Sponsor: Stockholm University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2021
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: August 8, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: TRAbee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No