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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive restructuring (CR) | Experimental | 6 sessions of CR drawn from classic Cognitive Behavioral Therapy (CBT) |
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| Attention allocation (AA) | Experimental | 6 sessions of AA building on contemporary CBTs |
|
| CR followed by AA | Experimental | 3 sessions of CR followed by 3 sessions of AA |
|
| AA followed by CR | Experimental | 3 sessions of AA followed by 3 sessions of CR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive restructuring | Behavioral | CR drawn from classic CBT |
|
| 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. |
| 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 |
| 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 |
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mia S O'Toole, PhD, MSc | Contact | +4587165289 | mia@psy.au.dk | |
| Emma Elkjær, PhD, MSc | Contact | emep@psy.au.dk |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000088686 | Cognitive Restructuring |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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.
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Participants will be unaware both of the planned component comparisons and of the study hypotheses.
| Attention allocation | Behavioral | AA drawn from contemporary CBTs |
|
| 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). |
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]. |