NCT01203293

Brief Summary

The purpose of this project is to implement culturally adapted Cognitive Behavioral Therapy (CBT) based interventions in general health settings that are delivered to reduce Generalized Anxiety Disorder (GAD) symptoms, increase levels of functioning, and improve health-related quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

August 28, 2014

Status Verified

August 1, 2014

Enrollment Period

3.4 years

First QC Date

June 11, 2010

Last Update Submit

August 26, 2014

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (3)

  • Penn State Worry Questionnaire

    Baseline

  • Penn State Worry Questionnaire

    Week 20

  • Penn State Worry Questionnaire

    Week 28.

Secondary Outcomes (6)

  • SF-36 Social Functioning Scale

    Baseline

  • SF-36 Social Functioning Scale

    Week 20

  • SF-36 Social Functioning Scale

    Week 28

  • Quality of Life Inventory

    Baseline

  • Quality of Life Inventory

    Week 20

  • +1 more secondary outcomes

Study Arms (2)

Cognitive Behavior Therapy

EXPERIMENTAL
Behavioral: Cognitive behavior based therapy

Treatment as usual

ACTIVE COMPARATOR
Behavioral: Treatment as usual

Interventions

Cognitive behavior based therapyBEHAVIORAL

15-20 individual psychotherapy sessions

Cognitive Behavior Therapy
Treatment as usualBEHAVIORAL

Treatment as usual is an active comparator group in which patients are provided referrals to specialty mental health care services or can use any primary or specialty care services available to them in usual care.

Treatment as usual

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of GAD
  • to 65 years
  • Spanish speaker
  • able to read and write
  • plan to continue receiving services in the health care setting during the next six months

You may not qualify if:

  • severe cognitive impairment, psychoses, history of bipolar disease, alcohol or drug abuse or dependence
  • clinically judged to have a high acute suicide risk
  • life-threatening medical condition
  • currently receiving psychotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Puerto Rico, Medical Sciences Campus

San Juan, 00936, Puerto Rico

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 11, 2010

First Posted

September 16, 2010

Study Start

September 1, 2009

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

August 28, 2014

Record last verified: 2014-08

Locations

PR(1)