The primary aim of the proposed RCT is to evaluate whether younger and older adults with mild to moderately severe anxiety symptoms gain similar treatment benefits from an online-based psychological treatment (Acceptance and Commitment Therapy: ACT…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Anxiety symptom severity will be measured by self-report (GAD-7) and presence
of anxiety disorder by diagnostic interview (MINI-Plus).
Secondary outcome
Secondary outcome measures are level of depressive symptoms (PHQ-9), presence
of depressive disorder (MINI-Plus), functional impairments (SDS), positive
mental health (MHC-SF), experiential avoidance (AAQ-II), trait cognitive
emotion regulation (CERQ), executive functioning (ATQ), quality of life
(EQ-5D), costs associated with psychiatric illness (TIC-P), and client
satisfaction (CSQ-8).
Potential baseline predictor and moderator variables will be measured at T0.
The following variables will be tested as predictors or moderators of treatment
response and/or compliance: demographic variables (age, gender, nationality,
marital status, living conditions, education, work status, children),
recruitment source, internet usage, self-esteem (four items), mastery (four
items), affective social support (two items) and confident/problem solving
social support (four items), and comorbid diseases.
Mediator variables and their corresponding dependent variable will be measured
weekly during the online-intervention. Mediator variables include: anxiety and
depression (PHQ-4), cognitive emotion regulation (single item-scales) and
perceived support from the counselor (SRS).
Background summary
Anxiety disorder is among the most ubiquitous and debilitating mental health
problems in older adults. Only about 10% of older adults with anxiety disorders
are receiving appropriate treatment. Meta-analyses on the treatment of
late-life anxiety suggest that late-life anxiety disorder can be effectively
treated with both cognitive-behavioral therapy and selective serotonergic
reuptake inhibitors. There is a dearth of studies examining whether the
treatment response of older adults is comparable to that of younger adults.
Online self-help courses with a limited amount of coaching are promising low
threshold and cost-effective interventions in anxiety disorders.
Study objective
The primary aim of the proposed RCT is to evaluate whether younger and older
adults with mild to moderately severe anxiety symptoms gain similar treatment
benefits from an online-based psychological treatment (Acceptance and
Commitment Therapy: ACT) compared to a Waiting List Control Condition (WLC).
The secondary objective is to examine predictors, moderators and mediators of
intervention responses. The third objective is to examine the
cost-effectiveness of ACT.
Study design
A parallel-groups pragmatic randomized single-blind trial. Participants will be
randomized to ACT or WLC using stratified (on age and anxiety disorder)
permuted block randomization. There will be four main measurements via an on
online-survey program and interviews conducted by telephone: one before the
start of the intervention (T1), one directly following the intervention after 3
months (T2), and the third one 6 and the fourth one 12 months after baseline.
Process measurements of emotion regulation, perceived support and
anxiety/depression will be collected on a weekly basis during treatment.
Intervention
The online-intervention consists of nine weekly online modules, divided in
three parts, which have to be completed in 12 weeks. Furthermore participants
are instructed to practice daily mindfulness exercises of 10-15 minutes. Weekly
E-mail support will be provided by junior psychologists, supervised by a
formally registered clinical psychologist.
Study burden and risks
There are no anticipated risks for taking part in this study. The burden is
kept to a minimum: a screening questionnaire (+/- 5 minutes) and four other
assessments (30 to 60 min. each), being the T1, T2, T3, and T4 with
questionnaires and interviews (not at T3).
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
Inclusion criteria
(a) presence of mild to moderate anxiety symptoms
(b) age between 18 and 75 years;
Exclusion criteria
(a) severe anxiety or depression symptomatology
(b) severe role impairments on various life domains
(c) other severe psychiatric disorders
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50505.058.14 |