Is Less More? Dosing and Sequencing Effect

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression/Anxiety
• Intervention / Treatment: Behavioral: Cognitive restructuring; Behavioral: Attention allocation

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mia S O'Toole, PhD, MSc; Phone Number: +4587165289; Email: mia@psy.au.dk
• Study Contact Backup: Name: Emma Elkjær, PhD, MSc; Email: emep@psy.au.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive restructuring (CR); 6 sessions of CR drawn from classic Cognitive Behavioral Therapy (CBT)	Behavioral: Cognitive restructuring; CR drawn from classic CBT
Experimental: Attention allocation (AA); 6 sessions of AA building on contemporary CBTs	Behavioral: Attention allocation; AA drawn from contemporary CBTs
Experimental: CR followed by AA; 3 sessions of CR followed by 3 sessions of AA	Behavioral: Cognitive restructuring; CR drawn from classic CBT; Behavioral: Attention allocation; AA drawn from contemporary CBTs
Experimental: AA followed by CR; 3 sessions of AA followed by 3 sessions of CR	Behavioral: Cognitive restructuring; CR drawn from classic CBT; Behavioral: Attention allocation; AA drawn from contemporary CBTs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms	PHQ-9	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	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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 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 only one time, that is, post treatment (just after the 6 sessions).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms	PHQ-9, rated as noted above.	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	BAI, rated as noted above.	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	EQ, rated as noted above.	Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.
Cognitive change	CC (5 items), rated as noted above but only five items are evaluated on a session-by-session basis.	Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.
Cognitive reappraisal	ERQ-r, rated as noted above.	Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.
Mindfulness	FFMQ-15, rated as noted above.	Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.
Attention control	ATQ-short, rated as noted above.	Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.
Strategy use	Description [free text] of a situation in the past week where participants used or could have used the treatment component (CR or AA). Individuals in the combined arms (receiving both components) will also describe [free text] how they see themselves using the two strategies.	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).
Experience of therapy	The participant will report on 1) the extent to which the individual understands the treatment component, 2) how competent they feel about being able to apply the treatment component in everyday life, 3) how useful they consider the treatment component to be, 4) how much they want to use the component, and 5) how often they actually used the treatment component in everyday life. They will do so retro and prospectively and for both components when relevant.	Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.
Working alliance	Working Alliance Inventory - Short Revised (Munder et al., 2010; WAI-SR). 12 items rated on a scale from 1 to 5 with total scores ranging from 12 to 60. Higher scores indicate better working alliance (i.e., a positive outcome).	Measure obtained two times; at session 2 [app. week 2 of the intervention] and session 4 [app. week 4 of the intervention].

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: CBT; Dosing; MOST; Combinatory effects; Optimizing; Sequencing effects
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 4282-00031B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No