Is Less More? Dosing and Sequencing Effect

NCT06920888 | Not Yet Recruiting

• 1 other identifier: 4282-00031B
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression/Anxiety

Keywords

CBT; Combinatory effects; MOST; Optimizing; Dosing; Sequencing effects

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Change from pre (just prior to session 1) to post treatment (after session 6), app. 7 weeks in total.

Secondary Outcomes (16)

• Depressive symptoms

  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

  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

  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

  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

  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.

Other Outcomes (10)

• Depressive symptoms

  Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.

• Anxiety symptoms

  Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.

• Decentering

  Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.

Study Arms (4)

Cognitive restructuring (CR)

EXPERIMENTAL

6 sessions of CR drawn from classic Cognitive Behavioral Therapy (CBT)

Behavioral: Cognitive restructuring

Attention allocation (AA)

EXPERIMENTAL

6 sessions of AA building on contemporary CBTs

Behavioral: Attention allocation

CR followed by AA

EXPERIMENTAL

3 sessions of CR followed by 3 sessions of AA

Behavioral: Cognitive restructuring; Behavioral: Attention allocation

AA followed by CR

EXPERIMENTAL

3 sessions of AA followed by 3 sessions of CR

Behavioral: Cognitive restructuring; Behavioral: Attention allocation

Interventions

Cognitive restructuring BEHAVIORAL

CR drawn from classic CBT

AA followed by CR; CR followed by AA; Cognitive restructuring (CR)

Attention allocation BEHAVIORAL

AA drawn from contemporary CBTs

AA followed by CR; Attention allocation (AA); CR followed by AA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• University of Aarhus: lead

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Cognitive Restructuring

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Mia S O'Toole, PhD, MSc

CONTACT

+4587165289; mia@psy.au.dk

Emma Elkjær, PhD, MSc

CONTACT

emep@psy.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware both of the planned component comparisons and of the study hypotheses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 10, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-03