Treatment-resistant generalised anxiety disorder (TR-GAD) Mental and Behavioural Disorders
Conditions
Interventions
Treatment allocation:
Participants will be randomly allocated 1:1 to either the intervention group (Acceptance and Commitment Therapy [ACT] plus usual care) or the control group (usual care alone). Pa
Sponsors
Camden and Islington NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
60 Years to 100 Years
Inclusion criteria
Inclusion criteria: For older people with a treatment-resistant generalised anxiety disorder (TR-GAD): 1. People aged 60 years and over 2. Diagnosis of GAD using the Mini-International Neuropsychiatric Interview 3. GAD that is ‘treatment resistant’, defined as GAD that has failed to respond adequately to pharmacotherapy and/or psychotherapy treatment, as described in step 3 of the UK's stepped care model for GAD. GAD that has failed to respond adequately will be defined as continued symptoms of GAD that are still causing difficulties. Those who have been offered pharmacotherapy and/or psychotherapy treatment and did not want to start it or continue it and are still symptomatic will also be included in this definition. When determining whether GAD has failed to respond adequately to treatment, if a person has remitted and then relapsed in relation to GAD then any treatment received prior to remission will not be considered when deciding whether they meet the criteria for TR-GAD 4. Living in the community (i.e. those living in domestic residences or assisted living facilities, but not care homes) The Mini-International Neuropsychiatric Interview has been modified for the purpose of this trial, with questions surrounding suicidality removed. The expression of suicidal ideation with active suicidal behaviours/plans and active intent is instead assessed via the Geriatric Suicide Ideation Scale, as detailed in the principal exclusion criteria. For study therapists completing the qualitative satisfaction questionnaire: 1. Aged 18 years and over 2. Therapists involved in intervention delivery within the CONTACT-GAD trial
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 05/05/2023: For older people with TR-GAD: 1. Judged to lack the capacity to provide fully informed written consent to participate in the trial 2. A diagnosis of dementia or intellectual disability using standard diagnostic guidelines, or clinically judged to have moderate or severe cognitive impairment (e.g. due to probable dementia, traumatic brain injury, stroke, etc) 3. A diagnosis of an imminently life-limiting illness where they would not be expected to survive for the duration of the study 4. Expressing suicidal ideation with active suicidal behaviours/plans and active intent, as assessed using the Columbia-Suicide Severity Rating Scale Screener, for whom an inpatient admission would be more appropriate 5. Currently receiving a course of formal psychological therapy delivered by a formally trained psychologist or psychotherapist (e.g. cognitive behavioural therapy, psychodynamic psychotherapy, systemic therapy, counselling, etc), or those who are unwilling to refrain from engaging in such formal psychological therapy should they be randomly allocated to the ACT arm 6. Self-report having received ACT in the FACTOID feasibility study 7. Having already been randomised in the CONTACT-GAD trial or living with another person who has already been randomised in the CONTACT-GAD trial 8. Taking part in clinical trials of other interventions for GAD Previous participant exclusion criteria: For older people with TR-GAD: 1. Judged to lack the capacity to provide fully informed written consent to participate in the trial 2. A diagnosis of dementia or intellectual disability using standard diagnostic guidelines, or clinically judged to have moderate or severe cognitive impairment (e.g. due to probable dementia, traumatic brain injury, stroke, etc) 3. A diagnosis of an imminently life-limiting illness where they would not be expected to survive for the duration of the study 4. Expressing suicidal ideation with active suicidal behaviours/plans and active intent, as assessed using the Geriatric Suicide Ideation Scale, for whom an inpatient admission would be more appropriate 5. Currently receiving a course of formal psychological therapy delivered by a formally trained psychologist or psychotherapist (e.g. cognitive behavioural therapy, psychodynamic psychotherapy, systemic therapy, counselling, etc), or those who are unwilling to refrain from engaging in such formal psychological therapy should they be randomly allocated to the ACT arm 6. Self-report having received ACT in the FACTOID feasibility study 7. Having already been randomised in the CONTACT-GAD trial or living with another person who has already been randomised in the CONTACT-GAD trial 8. Taking part in clinical trials of other interventions for GAD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Generalised anxiety disorder measured using the Generalised Anxiety Disorder Assessment (GAD-7) at baseline (0 months), 6-months post-randomisation (the primary endpoint), and 12 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/05/2023: All secondary outcome measures are measured at baseline (0 months), 6-months post-randomisation, and 12 months post-randomisation, with three exceptions. The Client Satisfaction Questionnaire-8 will only be collected at the 6-month follow-up. Adverse events will be collected at 6- and 12-month follow-ups. Data on session attendance for those in the ACT arm will be collected after each session. Secondary outcome measures are as follows: 1. Quality of life measured using the McGill Quality of Life Questionnaire-Revised 2. Depression measured using the Geriatric Depression Scale-15 3. Psychological flexibility measured using the Comprehensive Assessment of ACT processes (CompACT) 4. Health and social care resource use measured using a modified version of the Client Service Receipt Inventory 5. Health-related quality of life measured using the EQ-5D-5L plus EQ-Visual Analogue Scale 6. Capability-adjusted life years measured using the ICECAP-O 7. Adverse events 8. Satisfaction with ACT and/or usual care measured using the Client Satisfaction Questionnaire-8 9. Personally meaningful behaviour change measured using the Goal-Based Outcomes tool 10. Cognitive and leisure activities measured using the Cognitive & Leisure Activity Scale 11. Adherence (i.e., session attendance for those in the ACT arm) Previous secondary outcome measures: All secondary outcome measures are measured at baseline (0 months), 6-months post-randomisation, and 12 months post-randomisation, with three exceptions. The Client Satisfaction Questionnaire-8 will only be collected at the 6-month follow-up. Adverse events will be collected at 6- and 12-month follow-ups. Data on session attendance for those in the ACT arm will be collected after each session. Secondary outcome measures are as follows: 1. Quality of life measured using the McGill Quality of Life Questionnaire-Revised 2. Depression measured using the Geriatric Depression Scale-15 3. Psycholo | — |
Countries
Australia, England, United Kingdom, Wales
Outcome results
None listed