Controlling anxiety in late life (CALL)
The primary aim of the proposed RCT is to evaluate whether LF-TLP in blended form as an indicated prevention for anxiety complaints is more (cost-) effective than TAU according to the NHG guideline Anxiety. We hypothesize that in comparison to TAU, LF-TLP will result in a significantly greater reduction of anxiety symptoms and associated outcomes on the short and long term in a cost-effective way .
Exploratively, we want to examine to what extent certain baseline characteristics are predictive of outcome (effect modification) and to what extent changes in emotion regulation and the quality of the relationship with POH-GGZ mediate the effect of LF-TLP (mediation)
- 2017 - 2020
- Philip Spinhoven
Trimbos Institute, Leiden University Medical Center, Universiteit Twente
1. STUDY DESIGN
A pragmatic parallel-groups cluster randomized single-blind trial. POH-GGZ will be randomized to LF-TLP or TAU. Participants in the intervention condition will receive access to Living to the full – Third Life Phase (LF-TLP), an internet self-help therapy with a limited amount of face-to-face contacts with the POH-GGZ (blended care). Patients in the TAU condition will be invited for an appointment with their GP/POH-GGZ and be treated according to the NHG guideline for anxiety complaints. Participants will receive no financial compensation for participation in the trial.
There will be four main measurements via an on online-survey program and interviews conducted by telephone: before the start of the intervention (T1), directly following the intervention (T2: 3 months after baseline), and again six and twelve months after baseline (T3 and T4). Process measurements of emotion regulation (VAS-scales) and anxiety/depression (PHQ-4) will be collected on a weekly basis during treatment with LF-TLP.
2. STUDY POPULATION
To include a sufficient number of participants different recruitment strategies will be used. Firstly, eligible persons attending their general practitioner will be informed about the possibility to participate in the study. However, because most older adults with anxiety complaints do not ask for professional help, this recruitment strategy has to be complemented by a large-scale internet-based screening in enlisted older persons. Based on computerized lists GPs will send a personal invitation letter to people aged 55-75 with the request to complete a screening questionnaire via the internet.
(a) presence of mild to moderate anxiety symptoms, operationalized as 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.
(a) persons with 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.
3. TREATMENT OF SUBJECTS
Acceptance and Commitment Therapy (ACT) is more effective than treatment as usual or placebo and is as effective in treating anxiety and depression as established psychological interventions. The web-based intervention Living to the full is based on the ACT self-help intervention ‘Living to the full’. The program consists of nine lessons to be completed in 12 weeks. The modules are based on six core processes to promote cognitive flexibility: acceptance, cognitive defusion, contact with the present moment, self as context, values, and committed action. Each module uses experiential exercises and metaphors, text messages, tailored stories for motivation, and an option to personalize the homepage. Furthermore participants are instructed to practice daily mindfulness exercises of 10-15 minutes provided on audio and downloadable within the web-based intervention. After completing a session, participants have to write an e-mail to their POH-GGZ, reflecting on their process and having the opportunity to ask questions. In addition, participants will have four face-to-face sessions with their POH-GGZ to evaluate their progress using the intervention, discuss problems and asking for support and advice.
TAU will be provided as optimized care as usual. Patients will be contacted to make an appointment with their GP/POH-GGZ, which is expected to follow the NHG guideline for anxiety complaints (i.e. psycho-education and if indicated short-term therapy). A manual for older adults with anxiety complaints will be developed comprising psycho-educative texts and exercises based on problem-solving therapy and cognitive behavioural therapy (such as relaxation therapy or exposure exercises).
The primary outcome measure is level of anxiety symptoms (GAD-7). Secondary outcome measures are level of depressive symptoms (PHQ-9), and presence of anxiety and depressive disorder (MINI-Plus), functional impairments (SDS), positive mental health (MHC-SF), experiential avoidance (AAQ-II), cognitive emotion regulation (CERQ), 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).
Cluster randomization will be applied to allocate the 36 POH-GGZ to the intervention group or the TAU group by an independent statistician. Informed consent of eligible patients (120 in each study arm) will be obtained and patients will be kept blind to the group assignment until completing the baseline measurements. Diagnostic interviewers will be kept blind to group assignment of participants.