Treatment-resistant generalised anxiety disorder in older people Mental and Behavioural Disorders Anxiety
Conditions
Interventions
Phase 1:
Approximately 15 older people with generalised anxiety disorder (GAD) will be invited to participate in individual qualitative interviews lasting 1.5 hours in order to develop
Sponsors
UCLH/UCL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 65 years and over 2. Primary diagnosis of GAD, as determined by the Structured Clinical Interview for DSM-IV Axis I and Axis II Disorders, that has failed to respond to treatment (medication or psychotherapy) 3. Living in the community 4. Able to provide informed, written consent 5. Sufficient understanding of English to enable engagement in ACT and completion of patient-reported outcome measures 6. Added 31/08/2017: In Phase 2 only: Not previously participated in qualitative interviews in Phase 1 of the project
Exclusion criteria
Exclusion criteria: Currently inclusion criteria as of 31/08/2017: 1. Diagnosis of dementia 2. Standardised Mini-Mental State Examination score of <25 3. In Phase 2 only: Currently receiving ongoing psychotherapy or who are unwilling to refrain from engaging in other forms of psychotherapy during the receipt of ACT 4. Experiencing suicidal ideation with active intent for whom an inpatient admission would be more appropriate 5. Other medical or psychosocial factors that could compromise full study participation such as imminently life-limiting illness or severe sensory deficits (e.g. blindness) 6. Intellectual disabilities Previous exclusion criteria: 1. Diagnosis of dementia 2. Standardised Mini-Mental State Examination score of <25 3. Currently receiving ongoing psychotherapy or who are unwilling to refrain from engaging in other forms of psychotherapy during the receipt of ACT 4. Experiencing suicidal ideation with active intent for whom an inpatient admission would be more appropriate 5. Other medical or psychosocial factors that could compromise full study participation such as imminently life-limiting illness or severe sensory deficits (e.g. blindness)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptability: 1. Engagement rate is recorded as the number of eligible participants who consent to participate in the study and attend 60% or more of sessions by 20 weeks (session attendance records will be kept by therapists) 2. Satisfaction rate is recorded as the number of eligible participants who consent to participate in the study and give ‘satisfactory’ ratings of therapy using the Satisfaction with Therapy and Therapist Scale-Revised (Oei et al., 2008) at 20 weeks. There is no set definition of what constitutes “satisfactory” and so this will be defined as a total score of 21 or more on the Satisfaction with Therapy subscale. Feasibility: 1. Recruitment rate is recorded as the number of eligible participants who consent to participate in the study by 10 months 2. Retention rate is recorded as the number of eligible participants who consent to participate that remain in the study until follow up at 20 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptability: 1. Failure to recruit rate due to lack of acceptability is recorded as the number of eligible participants who refuse to consent to participate in the study by 10 months due to lack of acceptability of the intervention 2. Attrition rate due to lack of acceptability is recorded as the number of eligible participants who consent to participate in the study that drop out due to lack of acceptability of the intervention by 20 weeks 3. Treatment credibility/expectancy is measured using the Credibility/Expectancy Questionnaire at 1 week Feasibility: 1. Referral rate is recorded as the number of eligible referrals to the study overall and in each referral subgroup (self-referral, GPs, GP list searches, Improving Access to Psychological Therapies services, and Community Mental Health Teams) by 10 months 2. Failure to recruit rate for reasons other than lack of acceptability is recorded as the number of eligible participants who refuse to consent to participate in the study by 10 months for reasons other than dissatisfaction with therapy 3. Attrition rate for reasons other than lack of acceptability is recorded as the number of eligible participants who consent to participate in the study that drop out for reasons other than dissatisfaction with therapy by 20 weeks 4. Treatment integrity is measured using the ACT Treatment Integrity Coding Manual at 20 weeks 5. Treatment adherence is measured using the Adherence Checklist at 20 weeks Patient-reported outcome measures: 1. Anxiety is measured using the Geriatric Anxiety Inventory at baseline and 20 weeks. 2. Worry is measured using the Penn State Worry Questionnaire at baseline and 20 weeks. 3. Depression is measured using the Geriatric Depression Scale-15 at baseline and 20 weeks. 4. Healt | — |
Countries
England, United Kingdom
Outcome results
None listed