- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02403557
Internet-delivered Cognitive Behaviour Therapy for Older Adults With Anxiety
March 1, 2016 updated by: Gerhard Andersson, Linkoeping University
Individually-tailored Internet-delivered Cognitive Behaviour Therapy Treatment for Older Adults With Anxiety and Depression: a Randomized Controlled Trial
The purpose of this study is to determine whether tailored internet-administrated cognitive behaviour therapy (ICBT) is a feasible approach in the treatment of anxiety symptoms and comorbid depressive symptoms in older adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have anxiety symptoms
Exclusion Criteria:
- Suicidal ideation
- Alcohol addiction
- Other major primary psychiatric disorder
- Ongoing psychological treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tailored Internet-delivered CBT
Tailored Internet-delivered CBT during 8 weeks.
|
Tailored Internet-delivered CBT during 8 weeks.
|
Active Comparator: Waitlist
Weekly check-up.
|
Weekly check up.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Anxiety Inventory (BAI)
Time Frame: Two weeks pre treatment, two weeks post treatment and 12 months post treatment
|
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
|
Two weeks pre treatment, two weeks post treatment and 12 months post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire (PHQ)
Time Frame: Two weeks pre treatment, two weeks post treatment and 12 months post treatment
|
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
|
Two weeks pre treatment, two weeks post treatment and 12 months post treatment
|
The Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time Frame: Two weeks pre treatment, two weeks post treatment and 12 months post treatment
|
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
|
Two weeks pre treatment, two weeks post treatment and 12 months post treatment
|
Quality of Life Inventory (QOLI)
Time Frame: Two weeks pre treatment, two weeks post treatment and 12 months post treatment
|
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
|
Two weeks pre treatment, two weeks post treatment and 12 months post treatment
|
Montgomery Åsberg Depression Rating Scale - Self Rated (MADRS-S)
Time Frame: Two weeks pre treatment, two weeks post treatment and 12 months post treatment
|
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
|
Two weeks pre treatment, two weeks post treatment and 12 months post treatment
|
Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)
Time Frame: Two weeks pre treatment, two weeks post treatment and 12 months post treatment
|
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
|
Two weeks pre treatment, two weeks post treatment and 12 months post treatment
|
Cognitive Failures Questionnaire (CFQ)
Time Frame: Two weeks pre treatment, two weeks post treatment and 12 months post treatment
|
Two weeks pre treatment, two weeks post treatment and 12 months post treatment
|
|
Wisconsin Card Sorting Test-64 (WCST-64)
Time Frame: Two weeks pre treatment, two weeks post treatment and 12 months post treatment
|
Two weeks pre treatment, two weeks post treatment and 12 months post treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
March 26, 2015
First Submitted That Met QC Criteria
March 26, 2015
First Posted (Estimate)
March 31, 2015
Study Record Updates
Last Update Posted (Estimate)
March 2, 2016
Last Update Submitted That Met QC Criteria
March 1, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GA-Forte-Older-Adults-Anx
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Lawson Health Research InstituteTerminated
Clinical Trials on Tailored Internet-delivered CBT
-
Linkoeping UniversityCompletedDepression | Anxiety DisordersSweden
-
Karolinska InstitutetCompletedDyspepsia | Abdominal Pain | Functional Gastrointestinal DisordersSweden
-
Karolinska InstitutetCompletedInternet-delivered CBT for Children With Functional Gastrointestinal Disorders - an Open Pilot StudyFunctional Gastrointestinal DisordersSweden
-
Linkoeping UniversityKarolinska Institutet; Uppsala University; Umeå University; Stockholm UniversityUnknownBrain Plasticity and Cellular Aging After Internet-delivered CBT for Social Anxiety Disorder (UMEII)Anxiety Disorders | Social Anxiety DisorderSweden
-
Linkoeping UniversityCompletedBulimia | Eating Disorders
-
Linkoeping UniversityCompletedDepression | AnxietySweden
-
University of NebraskaNational Institute of Nursing Research (NINR)CompletedPre-HypertensionUnited States
-
Hadassah Medical OrganizationBar-Ilan University, IsraelUnknown
-
Karolinska InstitutetRegion StockholmRecruitingPost Traumatic Stress DisorderSweden
-
Seattle Children's HospitalUniversity of VirginiaActive, not recruitingMigraine Disorders | Insomnia | Headache DisordersUnited States