Combining Treatment Components in Transdiagnostic Therapy for Anxiety and Depression
1 other identifier
interventional
93
1 country
1
Brief Summary
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 disorders. Furthermore, the study aims to explore possible demographic and clinical moderators of the effects to address the question of what works for whom.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started Jun 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2024
CompletedFirst Posted
Study publicly available on registry
May 28, 2024
CompletedStudy Start
First participant enrolled
June 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
November 28, 2025
November 1, 2025
1.9 years
May 13, 2024
November 21, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Depressive symptoms (PHQ-9)
Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001; Spitzer et al., 1999; Spitzer et al., 2000).
Development from pre-treatment to post-treatment (6 weeks)
Anxiety symptoms (BAI)
Beck's Anxiety Inventory (BAI; Beck et al., 1988; Beck \& Steer, 1991).
Development from pre-treatment to post-treatment (6 weeks)
Symptoms of generalized anxiety disorder (GAD-7)
The General Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006).
Development from pre-treatment to post-treatment (6 weeks)
Symptoms of social anxiety disorder (SIAS)
The Social Interaction Anxiety Scale (SIAS; Mattick \& Clarke, 1998).
Development from pre-treatment to post-treatment (6 weeks)
Symptoms of panic disorder (PDSS-SR)
The Panic Disorder Severity Scale - Self-Report Version (PDSS-SR; Houck et al., 2002).
Development from pre-treatment to post-treatment (6 weeks)
Secondary Outcomes (16)
Depressive symptoms (PHQ-9)
Development from pre-treatment through 3-month follow-up
Anxiety symptoms (BAI)
Development from pre-treatment through 3-month follow-up
Symptoms of generalized anxiety disorder (GAD-7)
Development from pre-treatment through 3-month follow-up
Symptoms of social anxiety disorder (SIAS)
Development from pre-treatment through 3-month follow-up
Symptoms of panic disorder (PDSS-SR)
Development from pre-treatment through 3-month follow-up
- +11 more secondary outcomes
Other Outcomes (8)
Clinical diagnosis (ADIS-5)
Baseline only
Objective cognitive function - processing speed (TMT-A)
Baseline only
Objective cognitive function - processing speed (WAIS-IV coding)
Baseline only
- +5 more other outcomes
Study Arms (2)
Order 1 (mindful emotion awareness + cognitive flexibility)
EXPERIMENTALParticipants will receive 6 therapy sessions starting with 3 sessions of mindful emotion awareness followed by 3 sessions of cognitive flexibility. Each session will have a duration of approximately 1 hour. Treatment will follow the UP manual by Barlow et al. (2018).
Order 2 (cognitive flexibility + mindful emotion awareness)
EXPERIMENTALParticipants will receive 6 therapy sessions starting with 3 sessions of cognitive flexibility followed by 3 sessions of mindful emotion awareness. Each session will have a duration of approximately 1 hour. Treatment will follow the UP manual by Barlow et al. (2018).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years.
- 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).
- Danish language proficiency.
- Ability and willingness to give informed consent.
- No or stable antidepressant/antianxiety medication (i.e., same dosage for ≥ 8 weeks).
- Access to either a smartphone, tablet, or computer with video camera.
You may not qualify if:
- Severe depression deemed to require more intense psychotherapy or medication.
- Persistent depressive disorder (i.e., depressive symptoms have persisted for 2 years or more).
- Non-stabilized medication (see above).
- Currently receiving other psychotherapy or counseling.
- Not capable of participating online.
- Lack of Danish proficiency.
- A history of bipolar disorder.
- Current or past psychosis.
- Substance abuse or dependence judged to require treatment.
- Suicide risk requiring immediate hospitalization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychology and Behavioral Sciences
Aarhus, 8000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caroline Nørskov, MSc
University of Aarhus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- It will not be known to participants that we are testing combinatory and sequencing effects and that participants are randomly allocated to receive the treatment modules in a specific order.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2024
First Posted
May 28, 2024
Study Start
June 28, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
November 28, 2025
Record last verified: 2025-11