Is Less More? Dosing and Sequencing Effect
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive restructuring, Attention allocation.
- Who it may be relevant to
- Registry conditions: Depression/Anxiety. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Is Less More? Dosing and Sequencing Effects of Cognitive Therapies for Anxiety and Depression
Overview
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.
Interventions
- Behavioral Cognitive restructuring
CR drawn from classic CBT - Behavioral Attention allocation
AA drawn from contemporary CBTs
Primary outcome measures
- Depressive symptoms [Time frame: Change from pre (just prior to session 1) to post treatment (after session 6), app. 7 weeks in total.]
- Anxiety symptoms [Time frame: Change from pre (just prior to session 1) to post treatment (after session 6), app. 7 weeks in total.]
Secondary outcome measures (12)
- 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.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06920888 · 4282-00031B