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Combining Treatment Components in Transdiagnostic Therapy for Anxiety and Depression

The present study is a randomized controlled trial that will evaluate the effect of combining two treatment components (i.e., cognitive restructuring and detached mindfulness) drawn from cognitive behavioral therapies (CBTs) that are often combined in clinical practice. However, knowledge about the effect of combining these treatment components is lacking. Therefore, this study aims to explore single, combined, and sequencing effects of these two treatment components in patients with depression and/or anxiety…

ClinicalTrials.gov IDNCT06429956

PhaseNA

Enrollment93

SponsorUniversity of Aarhus

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Depression, Anxiety

About this study

Interventions

Behavioral: Mindful emotion awareness — The mindful emotion awareness module will follow the manual by Barlow et al. (2018). In session 1, the participant will receive psychoeducation about the purpose of mindful emotion awareness (i.e., to cultivate present-focused, non-judgmental attention to one's emotional experiences) and will complete an in-session guided meditation exercise which they will be asked to practice daily using an audio file. In session 2 and 3, two additional exercises are introduced. With "mindful mood induction", the participant is instructed to induce emotions and then practice mindful emotion awareness in this context. With "anchoring in the present", the participant is taught four steps to help them use mindful emotion awareness to pull themself back to the present whenever they feel an emotional response start to build in their everyday life. For homework, the participant will practice mindful emotion using these exercises and the audio file.
Behavioral: Cognitive flexibility — The cognitive flexibility module will follow the manual by Barlow et al. (2018) which is based on the principles by Beck (1976). In session 1, the participant will be psychoeducated about the purpose of cognitive flexibility (i.e., to encourage flexible thinking through reappraisal of one's automatic thinking), and how their thoughts influence their emotional reactions. For homework, the participant will be asked to monitor their automatic thoughts. In session 2, the participant will be introduced to the technique of cognitive flexibility (i.e., generating other possible interpretations), and this technique will be practiced throughout session 2 and 3. For homework, the participant will continue to monitor their automatic thoughts and generate and record other possible interpretations.

Primary outcomes

Depressive symptoms (PHQ-9) (Development from pre-treatment to post-treatment (6 weeks))
Anxiety symptoms (BAI) (Development from pre-treatment to post-treatment (6 weeks))
Symptoms of generalized anxiety disorder (GAD-7) (Development from pre-treatment to post-treatment (6 weeks))
Symptoms of social anxiety disorder (SIAS) (Development from pre-treatment to post-treatment (6 weeks))
Symptoms of panic disorder (PDSS-SR) (Development from pre-treatment to post-treatment (6 weeks))

Eligibility information

Inclusion Criteria: 1. Age ≥ 18 years. 2. A diagnosis of an anxiety disorder (generalized anxiety disorder, social anxiety disorder, or panic disorder with or without agoraphobia) and/or mild to moderate major depressive disorder (MDD) according to DSM-5 (American Psychiatric Association, 2022). 3. Danish language proficiency. 4. Ability and willingness to give informed consent. 5. No or stable antidepressant/antianxiety medication (i.e., same dosage for ≥ 8 weeks). 6. Access to either a smartphone, tablet, or computer with video camera. Exclusion Criteria: 1. Severe depression deemed to require more intense psychotherapy or medication. 2. Persistent depressive disorder (i.e., depressive symptoms have persisted for 2 years or more). 3. Non-stabilized medication (see above). 4. Currently receiving other psychotherapy or counseling. 5. Not capable of participating online. 6. Lack of Danish proficiency. 7. A history of bipolar disorder. 8. Current or past psychosis. 9. Substance abuse or dependence judged to require treatment. 10. Suicide risk requiring immediate hospitalization.

Study locations

Department of Psychology and Behavioral Sciences, Aarhus, 8000 Denmark

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.