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

Depression Clinical Trial

— TRAbee  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05016843
• Other study ID #: TRAbee
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 25, 2021
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2024
• Source: Stockholm University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2400
• Est. completion date: January 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

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.
• 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.

Other:
• Treatment condition: Waitlist control
The waitlist condition is a control condition without any intervention.
• Treatment length: 8 weeks
Participants will partake in their treatment condition for 8 weeks.
• Treatment length: 16 weeks
Participants will partake in their treatment condition for 16 weeks.
• 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.
• No access to a moderated forum
Participants will not have access to a moderated forum, hence their treatment is self-guided.

Locations

Country	Name	City	State
Sweden	Department of Psychology	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Stockholm University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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).
Secondary	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.