About this trial
The goal of this clinical trial is to investigate the effect of allowing patients to choose between two internet-based cognitive behavioral treatments (ICBT) for generalized anxiety disorder (GAD). The goal is also to examine psychologists' ability to predict which of the two treatments the patient will benefit most from.
The main questions it aims to answer are:
* Do patients who are randomized to choose their treatment improve more in their GAD symptoms compared to patients who are randomly assigned to a treatment? * Does allowing patients to choose their treatment increase treatment adherence, compared to being randomly assigned to a treatment? * Does allowing patients to choose their treatment increase treatment satisfaction and credibility, compared to being randomly assigned to a treatment? * Does allowing patients to choose their treatment increase patients' sense of agency related to the treatment process, compared to being randomly assigned to a treatment? * Do patients who receive a treatment that matches the psychologist's prediction of which treatment would fit the patient best show better treatment outcomes (primarily reduction in GAD symptoms over time, but also secondary outcomes such as satisfaction), compared to patients who receive a treatment that does not match the psychologist's prediction?
Participants included in the trial will be randomized to one of two conditions: 1) read short descriptions of the two treatment programs and based on that choose the preferred treatment, 2) randomly being allocated to one of the two treatments. The two internet-based treatment programs which the patients can choose between or be randomly allocated to are: 1) Intolerance of uncertainty-based ICBT and 2) Metacognition-based ICBT. Both programs consist of 8 treatment modules and run for 10 weeks. Patients in both conditions receive continuous support by a psychologist through a built-in message function on the treatment platform. The patient will receive feedback from the psychologist on their assignments and exercises and the psychologist will respond to the participants' messages.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older.
Meet diagnostic criteria for GAD according to DSM-5, as assessed by a psychologist on a video-call.
Self-rated score ≥ 7 on GAD-7.
Can read and speak Swedish fluently.
Disqualifiers
Patients that are judged to be in greater need of another psychiatric treatment for another psychiatric diagnosis (for example severe depression) and/or is judged to have a high risk of suicide.
Current drug or alcohol abuse.
Current severe somatic health concern or social vulnerability if this is judged to be too great an obstacle for the patient to carry out the treatment.
Trial design
Parallel
Treatments tested in this trial
Metacognitive Internet delivered Cognitive Behavior Therapy
BehavioralSpecialist Guided Internet delivered Cognitive Behavior Therapy based on the metacognitive model of excessive worry
Intolerance of uncertainty based Internet delivered Cognitive Behavior Therapy
BehavioralSpecialist Guided Internet delivered Cognitive Behavior Therapy based on the Intolerance of uncertainty model of excessive worry
Treatment groups
Trial outcomes
Primary outcomes
Change in Generalized Anxiety Disorder - score (GAD-7)
Measures generalized anxiety symptoms. 7 items. Scores range from 0-21 with higher scores indicating more generalized anxiety
Secondary outcomes
Therapeutic Agency Inventory (adapted to the clinic)
Measures patients' sense of agency related to their treatment process. 15 items. Scores range from 0-75 with higher scores indicating a higher degree of agency.
Penn-State Worry Questionnaire (PSWQ)
Measures trait worry. 16 items. Scores range from 16-80 with higher scores indicating more worry.
Client satisfaction questionnaire (adapted to the clinic)
Measures satisfaction with treatment. 8 items. Scores range from 8-32 with higher scores indicating more satisfaction with the treatment.
Treatment Credibility Questionnaire (adapted to the clinic)
Measures treatment rationale credibility. 5 items. Scores range from 0-50 with higher scores indicating higher treatment credibility.
Sponsors and contacts
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