Trial Outcomes & Findings for A Comparison Between Cognitive, Behavioral, and Cognitive-Behavioral Therapy for Generalized Anxiety Disorder (NCT NCT00635999)

Results Overview

Percentage of participants meeting high end state functioning (e.g., within 1 standard deviation of mean of nonanxious samples on Hamilton Anxiety Rating Scales, Spielberger's State-Trait Anxiety Inventory, Penn State Worry Questionnaire, and Reactions to Relaxation and Arousal Questionnaire)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

76 participants

Primary outcome timeframe

10-14 days after last therapy session and months 6, 12, and 24 following last therapy session

Results posted on

2018-01-25

Participant Flow

Principal diagnosis of GAD, no panic disorder, Clinician's Severity Rating (CSR) for GAD of 4 or more, absence of concurrent therapy, no history of having received CBT methods in prior therapy, no medical contributions to the anxiety, no antidepressant medication, and absence of severe MDD, substance abuse, psychosis, and organic brain syndrome.

Participant milestones

Participant milestones
Measure	Self-control Desensitization Participants will receive treatment with applied relaxation and self-control desensitization.	Cognitive Therapy Participants will receive treatment with cognitive therapy.	Combined Cognitive Behavioral Therapy Participants will receive treatment with a combination of applied relaxation, self-control desensitization, and cognitive behavioral therapy.
Overall Study STARTED	27	25	24
Overall Study COMPLETED	23	23	23
Overall Study NOT COMPLETED	4	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Self-control Desensitization Participants will receive treatment with applied relaxation and self-control desensitization.	Cognitive Therapy Participants will receive treatment with cognitive therapy.	Combined Cognitive Behavioral Therapy Participants will receive treatment with a combination of applied relaxation, self-control desensitization, and cognitive behavioral therapy.
Overall Study Withdrawal by Subject	4	2	1

Baseline Characteristics

A Comparison Between Cognitive, Behavioral, and Cognitive-Behavioral Therapy for Generalized Anxiety Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Self-control Desensitization n=27 Participants Participants will receive treatment with applied relaxation and self-control desensitization.	Cognitive Therapy n=25 Participants Participants will receive treatment with cognitive therapy.	Combined Cognitive Behavioral Therapy n=24 Participants Participants will receive treatment with a combination of applied relaxation, self-control desensitization, and cognitive behavioral therapy.	Total n=76 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	25 Participants n=7 Participants	24 Participants n=5 Participants	76 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	38.02 years STANDARD_DEVIATION 10.36 • n=5 Participants	38.42 years STANDARD_DEVIATION 11.10 • n=7 Participants	35.64 years STANDARD_DEVIATION 13.92 • n=5 Participants	37.36 years STANDARD_DEVIATION 11.78 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	17 Participants n=7 Participants	16 Participants n=5 Participants	52 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	24 Participants n=4 Participants
Region of Enrollment United States	27 participants n=5 Participants	25 participants n=7 Participants	24 participants n=5 Participants	76 participants n=4 Participants

PRIMARY outcome

Timeframe: 10-14 days after last therapy session and months 6, 12, and 24 following last therapy session

Population: People who completed treatment

Percentage of participants meeting high end state functioning (e.g., within 1 standard deviation of mean of nonanxious samples on Hamilton Anxiety Rating Scales, Spielberger's State-Trait Anxiety Inventory, Penn State Worry Questionnaire, and Reactions to Relaxation and Arousal Questionnaire)

Outcome measures

Outcome measures
Measure	Self-control Desensitization n=23 Participants Participants will receive treatment with applied relaxation and self-control desensitization.	Cognitive Therapy n=23 Participants Participants will receive treatment with cognitive therapy.	Combined Cognitive Behavioral Therapy n=23 Participants Participants will receive treatment with a combination of applied relaxation, self-control desensitization, and cognitive behavioral therapy.
High End State Function 10-14 days after last therapy session	56.52 % people meeting high endstate status	43.48 % people meeting high endstate status	56.52 % people meeting high endstate status
High End State Function 6 month follow-up	47.62 % people meeting high endstate status	68.18 % people meeting high endstate status	56.52 % people meeting high endstate status
High End State Function 12 month follow-up	28.57 % people meeting high endstate status	47.62 % people meeting high endstate status	43.48 % people meeting high endstate status
High End State Function 24 month follow-up	47.62 % people meeting high endstate status	52.38 % people meeting high endstate status	38.10 % people meeting high endstate status

SECONDARY outcome

Timeframe: 10-14 days after last therapy session and months 6, 12, and 24 following last therapy session

Population: People who completed treatment

Cohen's d within-group effect sizes comparing pre-therapy assessment to assessment at 10-14 days after last therapy session, at 6-month follow-up, at 12-month follow-up, and at 24-month follow-up. Findings reported in table are Cohen's d effect sizes averaged over Hamilton Anxiety Scale (scores ranging from 0-56, higher scores mean more anxiety), the Assessor Severity Scale (scores ranging from 0-8, higher scores mean more severity), and the State-Trait Anxiety Inventory-Trait version (scores ranging from 20-80, higher scores mean more state anxiety). The within-group effective sizes are the posttherapy \[or follow-up\] mean minus pretherapy mean divided by the pretherapy standard deviation.

Outcome measures

Outcome measures
Measure	Self-control Desensitization n=23 Participants Participants will receive treatment with applied relaxation and self-control desensitization.	Cognitive Therapy n=23 Participants Participants will receive treatment with cognitive therapy.	Combined Cognitive Behavioral Therapy n=23 Participants Participants will receive treatment with a combination of applied relaxation, self-control desensitization, and cognitive behavioral therapy.
Within-group Change Represented as Cohen's d Effect Sizes 10-14 days after last therapy session	2.38 Cohen's d within group effect size	2.95 Cohen's d within group effect size	2.8 Cohen's d within group effect size
Within-group Change Represented as Cohen's d Effect Sizes 6 month follow-up	2.35 Cohen's d within group effect size	2.81 Cohen's d within group effect size	2.86 Cohen's d within group effect size
Within-group Change Represented as Cohen's d Effect Sizes 12 month year follow-up	2.43 Cohen's d within group effect size	2.48 Cohen's d within group effect size	2.45 Cohen's d within group effect size
Within-group Change Represented as Cohen's d Effect Sizes 24 month follow-up	2.34 Cohen's d within group effect size	2.67 Cohen's d within group effect size	2.31 Cohen's d within group effect size

Adverse Events

Self-control Desensitization

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cognitive Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Combined Cognitive Behavioral 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

Michelle G. Newman

Penn State University

Phone: 814-863-1148

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place