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Controlling Anxiety in Late Life

Recruiting
Conditions
anxiety
anxiety symptoms
10002861
Registration Number
NL-OMON49745
Lead Sponsor
niversiteit Leiden
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
240
Inclusion Criteria

(a) presence of mild to moderate anxiety symptoms (a score between 4 and 15 on the GAD-7);
(b) age between 55 and 75 years;
(c) having internet-access;
(d) able to invest approximately 30 minutes per day up to three hours per week;
(e) able to communicate in Dutch.

Exclusion Criteria

(a) severe anxiety (GAD-7 > 15) and/or depressive symptomatology (PHQ-9 score > 20);
(b) at least two areas of role functioning with severe role impairment (SDS > 8);
(c) few anxiety (< 4 on the GAD-7) symptoms;
(d) receiving psychological or psychopharmacological treatment for emotional complaints within the last 3 months;
(e) lifetime diagnosis of bipolar disorder or schizophrenia;
(f) high suicide risk;
(g) dementia or other severe cognitive impairments;
(h) unstable severe medical condition;
(i) dependence on drugs or alcohol.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Severity of symptoms of anxiety will be investigated with the GAD-7 at T0 -<br /><br>T5.. The questionnaire consists of 7 items that are rated on a 4-point scale<br /><br>ranging from 0 *not at all* to 3 *nearly every day*, Scores of 5, 10, and 15<br /><br>are taken as the cut off points for mild, moderate, and severe anxiety. A<br /><br>change from one occasion to another of four points or more is considered real<br /><br>(i.e. statistically reliable). </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary outcomes at T0, T3, T6 and T12:<br /><br><br /><br>Depression symptom severity (PHQ-9)<br /><br>Presence of anxiety and depressive disorder (MINI-Plus)<br /><br>Functional impairment (SDS)<br /><br>Emotion regulation (CERQ)<br /><br>Experiential avoidance (AAQ-II)<br /><br>Positive Mental Health (MHC-SF)<br /><br>Quality of Life (EuroQol)<br /><br>Cost-effectiveness (TIC-P)<br /><br>Client Satisfaction (CSQ-8)<br /><br><br /><br>Weekly assessments during treatment period for mediation analysis:<br /><br>Level of anxiety/depression (PHQ-4)<br /><br>Cognitive emotion regulation (6 Likert-scales)<br /><br>Support counselor (SRS)</p><br>
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