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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metacognitive therapy | Experimental |
| |
| Intolerance of uncertainty therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metacognitive therapy | Behavioral | Metacognitive therapy is a form av cognitive-behavioral therapy which aims to change cognitions about worry in patients with generalized anxiety disorder. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline symptoms at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Bohman, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liljeholmen Primary Health Care Center | Stockholm | 11794 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37315099 | Derived | Af Winklerfelt Hammarberg S, Toth-Pal E, Jansson-Frojmark M, Lundgren T, Westman J, Bohman B. Intolerance-of-uncertainty therapy versus metacognitive therapy for generalized anxiety disorder in primary health care: A randomized controlled pilot trial. PLoS One. 2023 Jun 14;18(6):e0287171. doi: 10.1371/journal.pone.0287171. eCollection 2023. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Intolerance of Uncertainty Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline symptoms at 12 weeks |
|
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All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Benjamin Bohman | Karolinska Institutet | 701713443 | +46 | benjamin.bohman@ki.se |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 4, 2024 | Jan 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Intolerance of uncertainty therapy | Behavioral | 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. |
|
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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