Is Less More? Dosing and Sequencing Effect
ConditionDepression/Anxiety
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive restructuring
BehavioralCR drawn from classic CBT
Attention allocation
BehavioralAA drawn from contemporary CBTs
Treatment groups
180 Participants
are divided into 4 treatment groupsGroup A: Cognitive restructuring (CR)Experimental treatment 1 intervention
Group B: Attention allocation (AA)Experimental treatment 1 intervention
Group C: CR followed by AAExperimental treatment 2 interventions
Group D: AA followed by CRExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Change from pre (just prior to session 1) to post treatment (after session 6), app. 7 weeks in total.2
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).
Time frame
Change from pre (just prior to session 1) to post treatment (after session 6), app. 7 weeks in total.Secondary outcomes
1
Depressive symptoms
PHQ-9
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.2
Anxiety symptoms
BAI
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.3
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).
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.4
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).
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.Other outcomes
1
Depressive symptoms
PHQ-9, rated as noted above.
Time frame
Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.2
Anxiety symptoms
BAI, rated as noted above.
Time frame
Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.3
Decentering
EQ, rated as noted above.
Time frame
Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.4
Cognitive change
CC (5 items), rated as noted above but only five items are evaluated on a session-by-session basis.
Time frame
Session-by-session changes from pre-treatment (just prior to session 1) to post-treatment (just after 6 sessions), app. 7 weeks in total.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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