Clinical trial NCT06920888: Is Less More? Dosing and Sequencing Effect
Official title: Is Less More? Dosing and Sequencing Effects of Cognitive Therapies for Anxiety and Depression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression/Anxiety
Keywords: CBT
Combinatory effects
MOST
Optimizing
Dosing
Sequencing effects
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

1. 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.
2. The combinatory effects, comparing the effect of receiving Component A subsequent to Component B and vice versa will be explored.
3. The process of change in both components will be explored.
4. 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.
5. The moderating effect of baseline characteristics including baseline symptomatology, diagnoses, personality functioning, and working alliance will be explored.
6. Potential harmful effects will be explored in each group.

Eligibility criteria: Inclusion Criteria:

(i) 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.

Exclusion Criteria:

(i) 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.

Primary outcomes:
measure: Depressive symptoms
timeFrame: Change from pre (just prior to session 1) to post treatment (after session 6), app. 7 weeks in total.
measure: Anxiety symptoms
timeFrame: Change from pre (just prior to session 1) to post treatment (after session 6), app. 7 weeks in total.
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Change from pre treatment (just prior to session 1) through follow-up (6 months after treatment has ended), app. 33 weeks in total.
measure: Anxiety symptoms
timeFrame: Change from pre treatment (just prior to session 1) through follow-up (6 months after treatment has ended), app. 33 weeks in total.
measure: Symptoms of generalized anxiety disorder
timeFrame: 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.
measure: Symptoms of panic disorder
timeFrame: 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.
measure: Symptoms of social anxiety disorder
timeFrame: 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.
measure: Worry
timeFrame: 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.
measure: Decentering
timeFrame: 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.
measure: Cognitive change
timeFrame: 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.
measure: Cognitive reappraisal
timeFrame: 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.
measure: Mindfulness
timeFrame: 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.
measure: Attention control
timeFrame: 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.
measure: Valued Living
timeFrame: 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.
measure: Quality of life (well-being)
timeFrame: 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.
measure: Personality functioning
timeFrame: 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.
measure: Harm/negative effects
timeFrame: Measured only one time, that is, post treatment (just after the 6 sessions).
measure: Information overload
timeFrame: Measured only one time, that is, post treatment (just after the 6 sessions).
Other outcomes:
measure: Depressive symptoms
timeFrame: Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.
measure: Anxiety symptoms
timeFrame: Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.
measure: Decentering
timeFrame: Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.
measure: Cognitive change
timeFrame: Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.
measure: Cognitive reappraisal
timeFrame: Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.
measure: Mindfulness
timeFrame: Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.
measure: Attention control
timeFrame: Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.
measure: Strategy use
timeFrame: Session 3 [app. week 3 of the intervention] and session 6 [app. week 6 of the intervention] (the measure is only obtained at those two time points).
measure: Experience of therapy
timeFrame: Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.
measure: Working alliance
timeFrame: Measure obtained two times; at session 2 [app. week 2 of the intervention] and session 4 [app. week 4 of the intervention].
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