Depression/AnxietyNCT06920888
Is Less More? Dosing and Sequencing Effect
A study testing Cognitive restructuring and Attention allocation in people with Depression/Anxiety, run by University of Aarhus.
Trial summary
The investigators want to evaluate core components from cognitive behavioral psychotherapies (CBTs) with the aim of investigating dosing and combinatory effects on conditions of anxiety and depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression/Anxiety
- What is being tested?
- Cognitive restructuring and Attention allocation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years, (ii) Clinically relevant symptoms of an anxiety disorder (with the exception of specific phobia) and/or depressive disorder according to GAD-7≥10, SIAS ≥37, PHQ-9 ≥10, or PDSS ≥9, (iii) Danish language proficiency, (iv) ability and willingness to give informed consent, (v) no or stable antidepressant/antianxiety medication (i.e., same dosage for ≥ 6 weeks), (vi) access to either a smartphone, tablet, or computer with video camera.
Who cannot join
- severe depression deemed to require more intense psychotherapy or medication (PHQ-9-score of 20 or more combined with a clinical evaluation), (ii) currently receiving other psychotherapy or counseling, (iii) a history of bipolar disorder, (iv) current or past psychotic episode, (v) substance abuse or dependence judged to require treatment, (vi) suicide risk requiring immediate hospitalization.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Emma Elkjær, PhD, MSc contact
About this study
Official title: Is Less More? Dosing and Sequencing Effects of Cognitive Therapies for Anxiety and Depression
The investigators want to evaluate core components from cognitive behavioral psychotherapies (CBTs) with the aim of investigating dosing and combinatory effects on conditions of anxiety and depression.
Read the detailed description
In the present study, participants will be randomly assigned to one of four groups, receiving one or both treatment components under investigation, all over the course of six sessions of treatment.
- It is hypothesized that both component A (Cognitive Restructuring) and component B (External Attention Allocation) will be efficient in reducing symptoms of depression and anxiety when delivered separately, both when delivered over 3 and 6 sessions. The difference between components as well as between the number of sessions on primary and secondary outcomes will be explored.
- The combinatory effects, comparing the effect of receiving Component A subsequent to Component B and vice versa will be explored.
- The process of change in both components will be explored.
- Group differences in participants' experience of being the recipient of the components (either individually or combination) both qualitatively (free descriptions of their experience with using them) and quantitatively (questionnaires concerning the understanding and employment) will be explored.
- The moderating effect of baseline characteristics including baseline symptomatology, diagnoses, personality functioning, and working alliance will be explored.
- Potential harmful effects will be explored in each group.
- Conditions
- Depression/Anxiety
- Being tested
- Cognitive restructuring, Attention allocation
- Keywords
- CBT, Combinatory effects, MOST, Optimizing, Dosing, Sequencing effects
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive restructuringBehavioural
CR drawn from classic CBT
Attention allocationBehavioural
AA drawn from contemporary CBTs
| Study group | Role | What they receive |
|---|---|---|
| Cognitive restructuring (CR) | Experimental | 6 sessions of CR drawn from classic Cognitive Behavioral Therapy (CBT) Receives: Behavioral: Cognitive restructuring |
| Attention allocation (AA) | Experimental | 6 sessions of AA building on contemporary CBTs Receives: Behavioral: Attention allocation |
| CR followed by AA | Experimental | 3 sessions of CR followed by 3 sessions of AA Receives: Behavioral: Cognitive restructuring; Behavioral: Attention allocation |
| AA followed by CR | Experimental | 3 sessions of AA followed by 3 sessions of CR Receives: Behavioral: Cognitive restructuring; Behavioral: Attention allocation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Patient Health Questionnaire-9 (Kroenke et al., 2001; Spitzer et al., 1999; Spitzer et al., 2000; PHQ-9). 9 items are rated on a scale from 0 to 3, with a potential total range from 0 to 27. Larger scores mean more depressive symptoms (i.e., a negative outcome).
Measured: Change from pre (just prior to session 1) to post treatment (after session 6), app. 7 weeks in total.
Anxiety symptoms
Beck's Anxiety Inventory (Beck et al., 1988; Beck \& Steer, 1991; BAI). 21 items are rated on a scale from 0 to 3 with a total score thus ranging from 0 to 63. A higher score is indicative of more anxiety symptoms (i.e., a negative outcome).
Measured: Change from pre (just prior to session 1) to post treatment (after session 6), app. 7 weeks in total.
Secondary outcomes (16)
Depressive symptoms
PHQ-9
Measured: Change from pre treatment (just prior to session 1) through follow-up (6 months after treatment has ended), app. 33 weeks in total.
Anxiety symptoms
BAI
Measured: Change from pre treatment (just prior to session 1) through follow-up (6 months after treatment has ended), app. 33 weeks in total.
Symptoms of generalized anxiety disorder
General Anxiety Disorder-7 (Spitzer et al., 2006; GAD-7). 7 items are rated on scale from 0 to 7 with total scores ranging from 0 to 21. Higher scores are indicative of more symptoms of GAD (i.e., a negative outcome).
Measured: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment has ended) only for those individuals that scores above cut-off during the screening process, app. 33 weeks in total.
Symptoms of panic disorder
The Panic Disorder Severity Scale - Self-Report Version (Houck et al., 2002; PDSS-SR). 7 items are rated on a scale form 0 to 4, with total scores ranging from 0 to 28. Higher scores are indicative of more symptoms of panic disorder (i.e., a negative outcome).
Measured: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment has ended) only for those individuals that scores above cut-off during the screening process, app. 33 weeks in total.
Symptoms of social anxiety disorder
The Social Interaction Anxiety Scale (Mattick \& Clarke, 1998, SIAS). 20 items are rated on a scale from 0 to 4 with total scores ranging form 0 to 80. Higher scores are indicative of more symptoms of social anxiety disorder (i.e., a negative outcome).
Measured: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment has ended) only for those individuals that scores above cut-off during the screening process, app. 33 weeks in total.
Worry
The Penn State Worry Questionnaire (Meyer et al., 1990; PSWQ). 16 items are rated on a 5-point scale, with total scores ranging from 16 to 75. Higher scores indicate more worry (i.e., a negative outcome).
Measured: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.
Decentering
The Experiences Questionnaire (Fresco et al., 2007; EQ), decentering subscale. 11 items are rated on a scale from 1 to 5, with total scores ranging from 11 to 55. Higher scores mean better ability to decenter (i.e., a positive outcome).
Measured: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.
Cognitive change
The Cognitive Change - sustained scale (Schmidt et al., 2019; CC). 9 items rated on a scale from 0 to 6 with total scores ranging from 0 to 63. Higher scores mean better ability to employ cognitive change (i.e., a positive outcome).
Measured: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.
Cognitive reappraisal
ERQ-reappraisal = Emotion Regulation Questionnaire - reappraisal subscale (Gross \& John, 2003; ERQ-r). 6 items are rated on a scale from 1 to 7 with total scores ranging from 6 to 42. Higher scores mean better ability to employ cognitive reappraisal (i.e., a positive outcome).
Measured: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.
Mindfulness
Five Facet Mindfulness Questionnaire-15 (Baer et al., 2006; FFMQ-15). 15 items are rated on a scale from 1 to 5 with total scores ranging from 15 to 75. Higher scores mean higher levels of mindfulness (i.e., a positive outcome).
Measured: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.
Attention control
The Attention Control Scale (Derryberry \& Reed, 2002; ATQ-short form. 10 items are rated on a scale from 1 to 4 with total scores ranging from 10 to 40. Higher scores are indicative of better attention control (i.e., a positive outcome).
Measured: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.
Valued Living
Valuing Questionnaire (Smout et al., 2014; VQ). 10 items are rated on a scale from 0 to 6 with total scores ranging from 0 to 60. Higher scores a indicative of actions/life being guided by personally held values (i.e., a positive outcome).
Measured: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.
Quality of life (well-being)
the World Health Organization-5 questionnaire (Bech, 1999; Topp et al., 2015; WHO-5). 5 items are rated on a scale from 0 to 5 with total scores ranging from 0 to 25. Higher scores are indicative of higher levels of life quality (i.e., a positive outcome).
Measured: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.
Personality functioning
Level of Personality Function Scale-Brief Form 2.0 (Weekers et al., 2019; LPFS-BF). 12 items are rated from 1 to 4 with total scores ranging from 12 to 48. Higher scores are indicative of better personality functioning (i.e., a positive outcome).
Measured: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.
Harm/negative effects
The Negative Effects Questionnaire (Rozental et al., 2019; NEQ). 32 questions are answered yes/no. If yes, items are rated on a scale from 1 to 5 and participants are asked if the negative effect experience can be attrubuted to the treatment or other crcumstances. Total scores range from 32 to 160 with higher scores indicating more negative effects (i.e., a negative outcome).
Measured: Measured only one time, that is, post treatment (just after the 6 sessions).
Information overload
Information Overload scale (adapted from Jensen et al., 2014; IO). 8 items are rated from 1 to 4 with total scores ranging from 8 to 32. Higher scores are indicative of more information overload (i.e., a negative outcome).
Measured: Measured only one time, that is, post treatment (just after the 6 sessions).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression/AnxietyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of four groups, receiving one or both components (CR \[A\] and AA \[B\]) under investigation, all over the course of six sessions of treatment. One group will receive component A for 6 sessions, another group will receive component B for 6 sessions, a third group will receive component A for 3 sessions followed by component B for 3 sessions, and a fourth group will receive component B for 3 sessions followed by component A for 3 sessions. All groups will begin with a 3-week waiting period, thus employing a multiple baseline design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920888
- Sponsor's protocol ID
- 4282-00031B
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Less More? Dosing and Sequencing Effects of Cognitive Therapies for Anxiety and Depression
- ClinicalTrials.gov ID
- NCT06920888
- Acronym / sponsor ID
- 4282-00031B
- Conditions
- Depression/Anxiety
- Keywords
- CBT, Combinatory effects, MOST, Optimizing, Dosing, Sequencing effects
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators want to evaluate core components from cognitive behavioral psychotherapies (CBTs) with the aim of investigating dosing and combinatory effects on conditions of anxiety and depression.
Detailed description
In the present study, participants will be randomly assigned to one of four groups, receiving one or both treatment components under investigation, all over the course of six sessions of treatment.
- It is hypothesized that both component A (Cognitive Restructuring) and component B (External Attention Allocation) will be efficient in reducing symptoms of depression and anxiety when delivered separately, both when delivered over 3 and 6 sessions. The difference between components as well as between the number of sessions on primary and secondary outcomes will be explored.
- The combinatory effects, comparing the effect of receiving Component A subsequent to Component B and vice versa will be explored.
- The process of change in both components will be explored.
- Group differences in participants' experience of being the recipient of the components (either individually or combination) both qualitatively (free descriptions of their experience with using them) and quantitatively (questionnaires concerning the understanding and employment) will be explored.
- The moderating effect of baseline characteristics including baseline symptomatology, diagnoses, personality functioning, and working alliance will be explored.
- Potential harmful effects will be explored in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Participants will be randomized to one of four groups, receiving one or both components (CR [A] and AA [B]) under investigation, all over the course of six sessions of treatment. One group will receive component A for 6 sessions, another group will receive component B for 6 sessions, a third group will receive component A for 3 sessions followed by component B for 3 sessions, and a fourth group will receive component B for 3 sessions followed by component A for 3 sessions. All groups will begin with a 3-week waiting period, thus employing a multiple baseline design.
| Arm | Type | Receives |
|---|---|---|
| Cognitive restructuring (CR) | Experimental | Behavioral: Cognitive restructuring6 sessions of CR drawn from classic Cognitive Behavioral Therapy (CBT) |
| Attention allocation (AA) | Experimental | Behavioral: Attention allocation6 sessions of AA building on contemporary CBTs |
| CR followed by AA | Experimental | Behavioral: Cognitive restructuring, Behavioral: Attention allocation3 sessions of CR followed by 3 sessions of AA |
| AA followed by CR | Experimental | Behavioral: Cognitive restructuring, Behavioral: Attention allocation3 sessions of AA followed by 3 sessions of CR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age ≥ 18 years, (ii) Clinically relevant symptoms of an anxiety disorder (with the exception of specific phobia) and/or depressive disorder according to GAD-7≥10, SIAS ≥37, PHQ-9 ≥10, or PDSS ≥9, (iii) Danish language proficiency, (iv) ability and willingness to give informed consent, (v) no or stable antidepressant/antianxiety medication (i.e., same dosage for ≥ 6 weeks), (vi) access to either a smartphone, tablet, or computer with video camera.
Key exclusion criteria (1 listed)
- severe depression deemed to require more intense psychotherapy or medication (PHQ-9-score of 20 or more combined with a clinical evaluation), (ii) currently receiving other psychotherapy or counseling, (iii) a history of bipolar disorder, (iv) current or past psychotic episode, (v) substance abuse or dependence judged to require treatment, (vi) suicide risk requiring immediate hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive restructuringCR drawn from classic CBT | Behavioural | AA followed by CR, CR followed by AA, Cognitive restructuring (CR) |
| Attention allocationAA drawn from contemporary CBTs | Behavioural | AA followed by CR, Attention allocation (AA), CR followed by AA |
Primary outcome
Depressive symptoms
Time frame: Change from pre (just prior to session 1) to post treatment (after session 6), app. 7 weeks in total.
Patient Health Questionnaire-9 (Kroenke et al., 2001; Spitzer et al., 1999; Spitzer et al., 2000; PHQ-9). 9 items are rated on a scale from 0 to 3, with a potential total range from 0 to 27. Larger scores mean more depressive symptoms (i.e., a negative outcome).
Anxiety symptoms
Time frame: Change from pre (just prior to session 1) to post treatment (after session 6), app. 7 weeks in total.
Beck's Anxiety Inventory (Beck et al., 1988; Beck \& Steer, 1991; BAI). 21 items are rated on a scale from 0 to 3 with a total score thus ranging from 0 to 63. A higher score is indicative of more anxiety symptoms (i.e., a negative outcome).
16 secondary outcomes
Depressive symptoms
Time frame: Change from pre treatment (just prior to session 1) through follow-up (6 months after treatment has ended), app. 33 weeks in total.
Anxiety symptoms
Time frame: Change from pre treatment (just prior to session 1) through follow-up (6 months after treatment has ended), app. 33 weeks in total.
Symptoms of generalized anxiety disorder
Time frame: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment has ended) only for those individuals that scores above cut-off during the screening process, app. 33 weeks in total.
Symptoms of panic disorder
Time frame: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment has ended) only for those individuals that scores above cut-off during the screening process, app. 33 weeks in total.
Symptoms of social anxiety disorder
Time frame: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment has ended) only for those individuals that scores above cut-off during the screening process, app. 33 weeks in total.
Worry
Time frame: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.
Decentering
Time frame: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.
Cognitive change
Time frame: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.
Cognitive reappraisal
Time frame: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.
Mindfulness
Time frame: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.
Attention control
Time frame: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.
Valued Living
Time frame: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.
Quality of life (well-being)
Time frame: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.
Personality functioning
Time frame: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.
Harm/negative effects
Time frame: Measured only one time, that is, post treatment (just after the 6 sessions).
Information overload
Time frame: Measured only one time, that is, post treatment (just after the 6 sessions).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emma Elkjær, PhD, MSc contact
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive restructuring and Attention allocation in people with Depression/Anxiety, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mia S O'Toole, PhD, MSc (+4587165289, mia@psy.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: Change from pre (just prior to session 1) to post treatment (after session 6), app. 7 weeks in total.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.