Trial Outcomes & Findings for Cognitive-behavioral Therapy for Generalized Anxiety Disorder in Primary Care (NCT NCT03621371)

NCT ID: NCT03621371

Last Updated: 2025-01-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 64 participants
• Primary outcome timeframe: Change from baseline symptoms at 12 weeks
• Results posted on: 2025-01-30

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	31	33
Overall Study COMPLETED	25	32
Overall Study NOT COMPLETED	6	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Metacognitive Therapy n=31 Participants Metacognitive therapy: Metacognitive therapy is a form av cognitive-behavioral therapy which aims to change cognitions about worry in patients with generalized anxiety disorder.	Intolerance of Uncertainty Therapy n=33 Participants 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.	Total n=64 Participants Total of all reporting groups
Age, Continuous	35.7 years STANDARD_DEVIATION 10.8 • n=31 Participants	37.1 years STANDARD_DEVIATION 11.6 • n=33 Participants	36.4 years STANDARD_DEVIATION 11.1 • n=64 Participants
Sex: Female, Male Female	25 Participants n=31 Participants	27 Participants n=33 Participants	52 Participants n=64 Participants
Sex: Female, Male Male	6 Participants n=31 Participants	6 Participants n=33 Participants	12 Participants n=64 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Sweden	31 participants n=31 Participants	33 participants n=33 Participants	64 participants n=64 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Metacognitive Therapy n=31 Participants Metacognitive therapy: Metacognitive therapy is a form av cognitive-behavioral therapy which aims to change cognitions about worry in patients with generalized anxiety disorder.	Intolerance of Uncertainty Therapy n=33 Participants 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.
Penn State Worry Questionnaire - Measure of Symptom Change	42.1 score on a scale Standard Deviation 7.5	55.8 score on a scale Standard Deviation 7.5

Adverse Events

Metacognitive Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intolerance of Uncertainty Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Benjamin Bohman

Karolinska Institutet

Phone: 701713443

Email: benjamin.bohman@ki.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place