Clinical trial NCT05016843: The Study of Internet-delivered, Transdiagnostic Treatments for Anxiety and Depression
Official title: The Study of Internet-delivered, Transdiagnostic Treatments for Anxiety and Depression ("TRAnsdiagnostisk BEhandling (Elektronisk)")
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Depression
Lead sponsor: Stockholm University
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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).

Primary outcomes:
measure: Patient Health Questionnaire 9-item scale (PHQ-9)
timeFrame: Through study completion, an average of 2 years.
measure: Generalised Anxiety Disorder 7- item scale (GAD-7)
timeFrame: Through study completion, an average of 2 years.
measure: Brunnsviken Brief Quality of Life Scale (BBQ)
timeFrame: Through study completion, an average of 2 years.
Secondary outcomes:
measure: The Personality Inventory for DSM Short Form (PID-5)
timeFrame: Baseline only.
measure: Negative Effects Questionnaire (NEQ)
timeFrame: At post-treatment only (which is week 8 or 16 depending on treatment allocation).
measure: Reflective Functioning Questionnaire 8 (RFQ-8)
timeFrame: Through study completion, an average of 2 years.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Psychology
Study officials:
References: