Is Less More? Dosing and Sequencing Effect

University of Aarhus

Status: Not yet enrolling

Conditions: Depression/Anxiety

Treatments: Behavioral: Attention allocation; Behavioral: Cognitive restructuring

Study type: Interventional

Funder types: Other

Identifiers

NCT06920888

4282-00031B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 4 patient groups

Cognitive restructuring (CR)

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive restructuring

Attention allocation (AA)

Experimental group

Description:

6 sessions of AA building on contemporary CBTs

Treatment:

Behavioral: Attention allocation

CR followed by AA

Experimental group

Description:

3 sessions of CR followed by 3 sessions of AA

Treatment:

Behavioral: Attention allocation

Behavioral: Cognitive restructuring

AA followed by CR

Experimental group

Description:

3 sessions of AA followed by 3 sessions of CR

Treatment:

Behavioral: Attention allocation

Behavioral: Cognitive restructuring