AnxietyNCT02403557
Internet-delivered Cognitive Behaviour Therapy for Older Adults With Anxiety
A study testing Waitlist and Tailored Internet-delivered CBT in people with Anxiety and Depression, run by Linkoeping University.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Waitlist and Tailored Internet-delivered CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have anxiety symptoms
Who cannot join
- Suicidal ideation
- Alcohol addiction
- Other major primary psychiatric disorder
- Ongoing psychological treatment
About this study
Official title: 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.
- Conditions
- Anxiety, Depression
- Being tested
- Waitlist, Tailored Internet-delivered CBT
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaitlistBehavioural
Weekly check up.
Tailored Internet-delivered CBTBehavioural
Tailored Internet-delivered CBT during 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Internet-delivered CBT | Experimental | Tailored Internet-delivered CBT during 8 weeks. Receives: Behavioral: Tailored Internet-delivered CBT |
| Waitlist | Active comparator | Weekly check-up. Receives: Behavioral: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Inventory (BAI)
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Measured: Two weeks pre treatment, two weeks post treatment and 12 months post treatment
Secondary outcomes (7)
Patient Health Questionnaire (PHQ)
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Measured: Two weeks pre treatment, two weeks post treatment and 12 months post treatment
The Generalized Anxiety Disorder 7-item Scale (GAD-7)
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Measured: Two weeks pre treatment, two weeks post treatment and 12 months post treatment
Quality of Life Inventory (QOLI)
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Measured: Two weeks pre treatment, two weeks post treatment and 12 months post treatment
Montgomery Åsberg Depression Rating Scale - Self Rated (MADRS-S)
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Measured: Two weeks pre treatment, two weeks post treatment and 12 months post treatment
Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Measured: Two weeks pre treatment, two weeks post treatment and 12 months post treatment
Cognitive Failures Questionnaire (CFQ)
Measured: Two weeks pre treatment, two weeks post treatment and 12 months post treatment
Wisconsin Card Sorting Test-64 (WCST-64)
Measured: Two weeks pre treatment, two weeks post treatment and 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startFeb 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403557
- Sponsor's protocol ID
- GA-Forte-Older-Adults-Anx
- Status last verified
- Mar 2016
- First submitted
- 26 Mar 2015
- Last updated
- 2 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individually-tailored Internet-delivered Cognitive Behaviour Therapy Treatment for Older Adults With Anxiety and Depression: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02403557
- Acronym / sponsor ID
- GA-Forte-Older-Adults-Anx
- Conditions
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Feb 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored Internet-delivered CBT | Experimental | Behavioral: Tailored Internet-delivered CBTTailored Internet-delivered CBT during 8 weeks. |
| Waitlist | Active comparator | Behavioral: WaitlistWeekly check-up. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have anxiety symptoms
Key exclusion criteria (4 listed)
- Suicidal ideation
- Alcohol addiction
- Other major primary psychiatric disorder
- Ongoing psychological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WaitlistWeekly check up. | Behavioural | Waitlist |
| Tailored Internet-delivered CBTTailored Internet-delivered CBT during 8 weeks. | Behavioural | Tailored Internet-delivered CBT |
Primary outcome
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.
7 secondary outcomes
Patient Health Questionnaire (PHQ)
Time frame: 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
Quality of Life Inventory (QOLI)
Time frame: 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
Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)
Time frame: 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
Wisconsin Card Sorting Test-64 (WCST-64)
Time frame: Two weeks pre treatment, two weeks post treatment and 12 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Waitlist and Tailored Internet-delivered CBT in people with Anxiety and Depression, run by Linkoeping University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Anxiety Inventory (BAI) (time frame: Two weeks pre treatment, two weeks post treatment and 12 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016.