Defeating Fear with Exposure therapy delivered by mental health nurses in primary care for Anxiety Disorders in older adults - a cluster-randomized controlled trial

Defeating Fear with Exposure therapy delivered by mental health nurses in primary care for Anxiety Disorders in older adults - a cluster-randomized controlled trial - Exposure therapy for late-life anxiety (DeFEAD65+)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57146

Enrollment

170

Registered

2024-09-24

Start date

2025-02-12

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

phobia worry fear, anxiety, worry

Interventions

One group will receive ET and the other group will receive UC for their anxiety symptoms in primary care. Patients assigned to ET will receive 8 (30-minute) sessions within 12 weeks and homework ass

Eligibility

Age

65 Years to 99 Years

Inclusion criteria

Inclusion criteria: Participants need to meet the criteria for a primary DSM-5 anxiety disorder,  namely Generalized Anxiety Disorder, Agoraphobia, Social Anxiety Disorder,   Panic Disorder or Anxiety Disorder Not Otherwise Specified (NOS).

Exclusion criteria

Exclusion criteria: Exclusion criteria include somatic and/or another psychiatric morbidity that could interfere with treatment, severe suicidality, chronic and interfering substance or alcohol abuse, having received previous psychotherapy focusing on the anxiety disorder in the past year.

Design outcomes

Primary

Measure	Time frame
Anxiety severity as assessed with the Geriatric Anxiety Inventory (GAI), societal costs with the Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P) and quality of life using the EuroQol 5 Dimension 5 Level version (EQ-5D-5L) during the 12-week treatment period and 1-year follow-up.	—

Secondary

Measure	Time frame
Outcome: Agorafobie (Mobility Inventory; MI), Social Anxiety (Liebowitz Social Anxiety Scale for adults; LSAS), Generalized Anxiety Disorder (Generalized Anxiety Disorder-7 questionnaire; GAD-7), Worry (Penn State Worry Questionnaire; PSWQ), Depression (Quick Inventory of Depressive Symptomatology - self report; QIDS-SR), Quality of Life (Recovering Quality of Life - Utility Index; ReQoL-UI), Somatic Symptom Severity (Patient Health Questionnaire - 15; PHQ-15), Limitations (WHO Disability Assessment Schedule; WHODAS), Well-being (visual analogue scale). Process ET-specific: Therapeutic alliance (Session Rating Scale; SRS), Therapeutic alliance (Working Alliance Inventory; WAI), Expectancy (Expectancy and credibility list), Change of threat expectancy, Safety behavior (Safety Behaviours Scale; SBS), Experiential Avoidance (Brief Experiential Avoidance Questionnaire; BEAQ), Cognitive-Behavioural Avoidance (Cognitive-Behavioural Avoidance Scale; CBAS), Self-efficacy (General Self-Efficacy Scale; GSE), Metacognitions (Metacognitions Questionnaire-30; MCQ-30). Process general: Ageism (Expectations Regarding Aging; ERA-12), Life Events (Life Events Checklists for DSM-5; LEC-5), Cognitive functioning (Stroop & Self-Reference Encoding Task; SRET & Digit Symbol Substitution Test; DSST), Cognitive functioning (Montreal Cognitive Assessment; MoCa).	—

Measure

Time frame

Outcome: Agorafobie (Mobility Inventory; MI), Social Anxiety (Liebowitz Social Anxiety Scale for adults; LSAS), Generalized Anxiety Disorder (Generalized Anxiety Disorder-7 questionnaire; GAD-7), Worry (Penn State Worry Questionnaire; PSWQ), Depression (Quick Inventory of Depressive Symptomatology - self report; QIDS-SR), Quality of Life (Recovering Quality of Life - Utility Index; ReQoL-UI), Somatic Symptom Severity (Patient Health Questionnaire - 15; PHQ-15), Limitations (WHO Disability Assessment Schedule; WHODAS), Well-being (visual analogue scale). Process ET-specific: Therapeutic alliance (Session Rating Scale; SRS), Therapeutic alliance (Working Alliance Inventory; WAI), Expectancy (Expectancy and credibility list), Change of threat expectancy, Safety behavior (Safety Behaviours Scale; SBS), Experiential Avoidance (Brief Experiential Avoidance Questionnaire; BEAQ), Cognitive-Behavioural Avoidance (Cognitive-Behavioural Avoidance Scale; CBAS), Self-efficacy (General Self-Efficacy Scale; GSE), Metacognitions (Metacognitions Questionnaire-30; MCQ-30). Process general: Ageism (Expectations Regarding Aging; ERA-12), Life Events (Life Events Checklists for DSM-5; LEC-5), Cognitive functioning (Stroop & Self-Reference Encoding Task; SRET & Digit Symbol Substitution Test; DSST), Cognitive functioning (Montreal Cognitive Assessment; MoCa).

—

Countries

Netherlands

Contacts

Public ContactG.J. Hendriks

Pro Persona

g.hendriks@propersona.nl0610038897

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 9, 2026