NCT02403557

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable anxiety

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

February 1, 2012

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 2, 2016

Status Verified

March 1, 2016

Enrollment Period

3.8 years

First QC Date

March 26, 2015

Last Update Submit

March 1, 2016

Conditions

AnxietyDepression

Outcome Measures

Primary Outcomes (1)

  • Beck Anxiety Inventory (BAI)

    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 Outcomes (7)

  • Patient Health Questionnaire (PHQ)

    Two weeks pre treatment, two weeks post treatment and 12 months post treatment

  • The Generalized Anxiety Disorder 7-item Scale (GAD-7)

    Two weeks pre treatment, two weeks post treatment and 12 months post treatment

  • Quality of Life Inventory (QOLI)

    Two weeks pre treatment, two weeks post treatment and 12 months post treatment

  • Montgomery Åsberg Depression Rating Scale - Self Rated (MADRS-S)

    Two weeks pre treatment, two weeks post treatment and 12 months post treatment

  • Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)

    Two weeks pre treatment, two weeks post treatment and 12 months post treatment

  • +2 more secondary outcomes

Study Arms (2)

Tailored Internet-delivered CBT

EXPERIMENTAL

Tailored Internet-delivered CBT during 8 weeks.

Behavioral: Tailored Internet-delivered CBT

Waitlist

ACTIVE COMPARATOR

Weekly check-up.

Behavioral: Waitlist

Interventions

WaitlistBEHAVIORAL

Weekly check up.

Waitlist
Tailored Internet-delivered CBTBEHAVIORAL

Tailored Internet-delivered CBT during 8 weeks.

Tailored Internet-delivered CBT

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have anxiety symptoms

You may not qualify if:

  • Suicidal ideation
  • Alcohol addiction
  • Other major primary psychiatric disorder
  • Ongoing psychological treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 26, 2015

First Posted

March 31, 2015

Study Start

February 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 2, 2016

Record last verified: 2016-03