Acceptance and commitment therapy for older people with treatment-resistant generalised anxiety disorder
| ISRCTN | ISRCTN85462326 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85462326 |
| IRAS number | 320523 |
| Secondary identifying numbers | CPMS 54812, IRAS 320523 |
- Submission date
- 09/12/2022
- Registration date
- 04/01/2023
- Last edited
- 15/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Generalised anxiety disorder (GAD), characterised by a tendency to worry, is the most common anxiety disorder in older people. Medication and talking therapy are usually offered as forms of treatment, but many do not find them helpful. Guidance on how to help older people manage GAD when it does not respond to such treatments is lacking. In a previous study (the FACTOID study), we developed and tailored a talking therapy intervention to the psychological, physical and cognitive needs of older people with treatment-resistant GAD (TR GAD). This was based on Acceptance and Commitment Therapy (ACT); a form of talking therapy that helps people learn how best to live with distressing thoughts, feelings and sensations, while still doing things that really matter to them. This showed that tailored ACT was acceptable to older people with TR-GAD and it may help improve anxiety, depression and coping. The aim of CONTACT-GAD is to find out whether tailored ACT is helpful for older people with TR-GAD and whether it represents value for money in a larger clinical trial.
Who can participate?
People aged 60 years and over with TR-GAD that has failed to respond to a previous drug and/or talking treatments or those with TR-GAD who did not want to start or continue these treatments previously and still have symptoms of GAD
What does the study involve?
Participants will be allocated at random to either have tailored ACT plus usual care (intervention group) or usual care alone (control group). We will test whether ACT plus usual care leads to a greater reduction in anxiety than usual care alone at 6 months. We will follow people up at 12 months to see if any effects are maintained. We will also look at ACT's value for money, quality of life, depression, adverse effects, satisfaction with ACT and usual care, adherence and behaviour change.
What are the possible benefits and risks of participating?
The main possible benefit is that participants may receive a new type of psychological therapy that has been shown to benefit people with other mood disorders such as depression. The main possible risk is that participants may experience distress when discussing their current situation in assessments and therapy sessions, or participants' mood may worsen after receiving ACT. Participants remain under the care of their clinical team during the study and will be monitored and referred for further support if necessary.
Where is the study run from?
University College London (UK)
When is the study starting and how long is it expected to run for?
August 2022 until July 2026
Who is funding the study?
1. National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme (UK)
2. National Health Medical Research Centre - National Institute for Health and Care Research (NHMRC-NIHR) Collaborative Research Grant Scheme (Australia)
Who is the main contact?
Prof. Rebecca Gould (r.gould@ucl.ac.uk) (UK)
Contact information
Principal Investigator
Division of Psychiatry
University College London
Wing B
6th floor Maple House
149 Tottenham Court Rd
London
W1T 7NF
United Kingdom
 ORCID ID |
0000-0001-9283-1626 |
|---|---|
| Phone | +44 (0)20 7679 9225 |
| r.gould@ucl.ac.uk |
Scientific
Clinical Trials Research Unit
ScHARR
The University of Sheffield
30 Regent Court
Sheffield
S1 4DA
United Kingdom
| ORCID ID |
0000-0003-3255-2849 |
|---|---|
| Phone | +44 (0)114 222 4397 |
| t.callaghan@sheffield.ac.uk |
Study information
| Study design | Randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice, Home, Hospital, Internet/virtual |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised CONtrolled trial of Tailored Acceptance and Commitment Therapy for older people with treatment-resistant generalised anxiety disorder (CONTACT-GAD) |
| Study acronym | CONTACT-GAD |
| Study objectives | Tailored acceptance and commitment therapy plus usual care will be more clinically and cost-effective at reducing anxiety in older people with treatment-resistant generalised anxiety disorder in comparison to usual care alone. |
| Ethics approval(s) | Approved 20/12/2022, West of Scotland REC 5 (West of Scotland Research Ethics Service, Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, Scotland; +44 (0)141 314 0213; WoSREC5@ggc.scot.nhs.uk), ref: none provided |
| Health condition(s) or problem(s) studied | Treatment-resistant generalised anxiety disorder (TR-GAD) |
| Intervention | 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). Participants will not be blinded to allocation. ACT plus usual care (intervention group): Participants will be offered up to 14, 1:1 ACT sessions, with each session lasting up to 1 hour, over 6 months, plus a booster session at approximately 3-months post-intervention. There will be a phased ending to the sessions, such that they will be approximately weekly for the first 12 sessions and then approximately fortnightly thereafter, as some older people with generalised anxiety disorder (GAD) can experience difficulties when therapy ends abruptly. Sessions will be delivered in person in the outpatient clinic, GP surgery or participant’s home, or via video call or telephone call (where videoconference facilities are not available), depending on participant preference, therapist availability and service restrictions. Therapists who will deliver ACT will be Band 7 or Band 8 clinical psychologists, counselling psychologists, psychotherapists or cognitive behavioural therapy (CBT) therapists who are based in primary or secondary care services, with ≥ 1 year experience of delivering psychotherapy interventions. Ideally, two or more therapists from each recruiting site will be identified, though this will vary across sites depending on therapist availability. All therapists will receive training in ACT and in the delivery of the intervention to older people with treatment-resistant (TR)-GAD. All therapists will attend a 4-day experiential ACT training workshop via video call, delivered by trained members of the research team with a minimum of five years of experience in delivering ACT, as well as experience in training therapists to deliver ACT in clinical trials. Training will be conducted via video call in order to accommodate therapists being located in geographically diverse regions across the UK. Participants in this group will receive usual care in addition to ACT, with the exception of formal psychological therapies such as CBT since this may lead to conflicts in therapeutic approaches and goals. Usual care (control group): Participants in this group will receive usual care, as outlined in NICE clinical guideline 113 for GAD. Supervision of therapists delivering ACT: Therapists will be invited to attend group supervision and consultation via video call on a fortnightly basis, though sessions will be provided weekly to make them as accessible as possible. Group supervision and consultation will be provided by trained members of the research team with a minimum of five years of experience in delivering ACT, as well as experience in supervising ACT, including within a clinical trial. Anonymised supervision notes will be recorded in each session and made available to both supervisors and therapists, and supervisors will observe some of each other's sessions to ensure that a consistent approach is used with therapists. In addition to group supervision and consultation via video call, therapists will be able to receive support through a secure, supervisor-moderated online forum. Therapists will be able to discuss anonymised issues arising in intervention delivery with supervisors and other therapists. The flexibility of this approach means that therapists will have the opportunity to receive supervisor and peer support between fortnightly group supervision and consultation sessions. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 outcome measures | 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. 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. Adherence (i.e., session attendance for those in the ACT arm) |
| Overall study start date | 01/08/2022 |
| Completion date | 31/07/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 60 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 296; UK Sample Size: 296 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 24/05/2023 |
| Date of final enrolment | 31/01/2026 |
Locations
Countries of recruitment
- Australia
- England
- United Kingdom
- Wales
Study participating centres
Beverley Road
Willerby
Hull
HU10 6ED
United Kingdom
Pinewood PLACE
Dartford
DA2 7WG
United Kingdom
Atlas Way
Sheffield
S4 7QQ
United Kingdom
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom
Long Leys Road
Lincoln
LN1 1FS
United Kingdom
St Georges Hospital
Corporation Street
Stafford
ST16 3SR
United Kingdom
United Kingdom
Treharris Health Centre
Treharris
CF46 5HE
United Kingdom
Kingsway Hospital
Kingsway
Derby
DE22 3LZ
United Kingdom
Drayton High Road
Norwich
NR6 5BE
United Kingdom
West Park Hospital
Edward Pease Way
Darlington
DL2 2TS
United Kingdom
St Ann's Hospital
St Ann's Road
London
N15 3TH
United Kingdom
Charles Hastings Way
Worcester
WR5 1JR
United Kingdom
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
9 Alie Street
London
E1 8DE
United Kingdom
Magdala Avenue
London
N19 5NF
United Kingdom
Lodge Approach
Runwell
Wickford
SS11 7XX
United Kingdom
C E M E Centre
Marsh Way
Rainham
RM13 8GQ
United Kingdom
Randalls Road
Leatherhead
KT22 7AD
United Kingdom
Macquarie Park
Sydney
NSW 2113
Australia
Southall
London
UB2 4SD
United Kingdom
Sponsor information
Hospital/treatment centre
Noclor Research Support Service
JML House
8 Regis Road
London
NW5 3EG
England
United Kingdom
| Phone | +44 (0)207 850 8507 |
|---|---|
| sponsor.noclor@nhs.ne | |
| Website | http://www.candi.nhs.uk/ |
"ROR" |
https://ror.org/03ekq2173 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 31/07/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Findings will be disseminated to the academic and clinical community, service users and the broader public through: 1. Planned publication in a high-impact peer-reviewed journal 2. Blogs about key findings 3. National and international academic conferences 4. Local clinical conferences and meetings 5. Talks to local groups, Primary Care Research Network, MIND and other organisations 6. University media releases, Twitter feeds and the University website 7. Training and seminars delivered via ACT special interest groups and professional bodies 8. Participants will have the option to receive a summary of findings once the trial has concluded |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
15/07/2025: The date of final enrolment was changed from 31/07/2025 to 31/01/2026.
24/10/2024: Herefordshire and Worcestershire Health and Care NHS Trust, Greater Manchester Mental Health NHS Foundation Trust, East London NHS Foundation Trust, Whittington Health NHS Trust, Essex Partnership University NHS Foundation Trust, North East London NHS Foundation Trust, Surrey and Borders Partnership NHS Foundation Trust, Macquarie University, and West London NHS Trust were added as study participating centres.
30/01/2024: The following changes were made to the study record:
1. The target number of participants was changed from 218 to 296.
2. Australia and Wales were added to the countries of recruitment.
3. Sheffield Health and Social Care NHS Foundation Trust, Oxford Health NHS Foundation Trust, Lincolnshire Partnership NHS Foundation Trust Hq, Midlands Partnership University NHS Foundation Trust, Cardiff and Vale UHB, Cwm Taf Morgannwg UHB, Derbyshire Healthcare NHS Foundation Trust, Norfolk and Suffolk NHS Foundation Trust, Tees, Esk and Wear Valleys NHS Foundation Trust, and Barnet, Enfield and Haringey Mental Health NHS Trust were added to the study participating centres.
25/05/2023: The following changes have been made:
1. The recruitment start date was changed from 01/05/2023 to 24/05/2023.
2. The study participating centres were updated to remove West Park Hospital, Mind Havering, Barking and Dagenham, Guys Hospital, Bethlem Royal Hospital, Central and North West London NHS Foundation Trust and add Oxleas NHS Foundation Trust.
05/05/2023: The following changes have been made:
1. The secondary outcome measures have been changed.
2. The participant inclusion criteria have been changed.
14/02/2023: The study setting has been changed from ‘Other’.
09/12/2022: Trial's existence confirmed by the NIHR.
