Generalized Anxiety Disorder
Conditions
Brief summary
The feasibilty and preliminary comparative effectiveness of two methods of cognitive-behavioral therapy - metacognitive therapy and intolerance of uncertainty therapy - for primary care patients with generalized anxiety disorder is investigated in a pilot study using a randomized controlled design. Purpose of the study is to examine the feasibility of a full-scale randomized controlled trial. Research questions primarily concern recruitment, measurement, and adherence.
Interventions
BEHAVIORALMetacognitive therapy
Metacognitive therapy is a form av cognitive-behavioral therapy which aims to change cognitions about worry in patients with generalized anxiety disorder.
BEHAVIORALIntolerance of uncertainty therapy
Intolerance of uncertainty therapy is a form av cognitive-behavioral therapy which aims to reduce cognitive and behavioral avoidance of uncertain situations or cognitions which lead to worry in patients with generalized anxiety disorder.
Sponsors
Region Stockholm
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Primary diagnosis of generalized anxiety disorder * Age 18 years or above * Being able to understand and speak Swedish without interpreter support
Exclusion criteria
* Psychosis, bipolar disorder, severe depressive symptoms, risk of suicid, substance use disorder, intellectual disability * Simultaneous psychological treatment * If pharmacological treatment, it needs to be stable prior to and during treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Penn State Worry Questionnaire - Measure of Symptom Change | Change from baseline symptoms at 12 weeks | Penn State Worry Questionnaire, a self-reported symptom measure of worry. Scale ranges: 16-80 scores on a scale; higher values represent a worse outcome. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metacognitive Therapy Metacognitive therapy: Metacognitive therapy is a form av cognitive-behavioral therapy which aims to change cognitions about worry in patients with generalized anxiety disorder. | 31 |
| Intolerance of Uncertainty Therapy Intolerance of uncertainty therapy: Intolerance of uncertainty therapy is a form av cognitive-behavioral therapy which aims to reduce cognitive and behavioral avoidance of uncertain situations or cognitions which lead to worry in patients with generalized anxiety disorder. | 33 |
| Total | 64 |
Baseline characteristics
| Characteristic | Intolerance of Uncertainty Therapy | Total | Metacognitive Therapy |
|---|---|---|---|
| Age, Continuous | 37.1 years STANDARD_DEVIATION 11.6 | 36.4 years STANDARD_DEVIATION 11.1 | 35.7 years STANDARD_DEVIATION 10.8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Sweden | 33 participants | 64 participants | 31 participants |
| Sex: Female, Male Female | 27 Participants | 52 Participants | 25 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Penn State Worry Questionnaire - Measure of Symptom Change
Penn State Worry Questionnaire, a self-reported symptom measure of worry. Scale ranges: 16-80 scores on a scale; higher values represent a worse outcome.
Time frame: Change from baseline symptoms at 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metacognitive Therapy | Penn State Worry Questionnaire - Measure of Symptom Change | 42.1 score on a scale | Standard Deviation 7.5 |
| Intolerance of Uncertainty Therapy | Penn State Worry Questionnaire - Measure of Symptom Change | 55.8 score on a scale | Standard Deviation 7.5 |
p-value: <0.05Mixed Models Analysis