Condition category
Mental and Behavioural Disorders
Date applied
23/01/2017
Date assigned
23/01/2017
Last edited
31/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Generalised anxiety disorder (GAD), characterised by a tendency to worry, is the most common anxiety disorder in older people. It is associated with distress, difficulty in coping, poor quality of life and increased disability. Medication and talking therapy are usually offered to older people experiencing GAD, but for many this treatment is unsuccessful. Guidance as to how best manage this treatment-resistant GAD in older people is lacking. Acceptance and Commitment Therapy (ACT) is a type of taking therapy helps people to learn different ways of coping with distressing thoughts and feelings, and how to take part in more activities that are meaningful to them. It is helpful for reducing distress in other conditions including anxiety, depression, life-limiting illness and long-term pain. The aim of this study is to find out how acceptable and feasible it is to develop and deliver a new treatment program based on ACT to older adults with GAD.

Who can participate?
Older adults aged 65 years and over who have been diagnosed with GAD that has not responded to treatment (either medication and/or conventional talking therapy).

What does the study involve?
In the first part of the study, around 15 older people with GAD take part in an hour and a half long interview about their experiences of treatment. Information collected from these interviews is then discussed with healthcare professionals in order to create a treatment programme using ACT techniques. The participants are then interviewed again for their views on the programme.
In the second part of the study, around 40 older people with GAD receive around 16 face-to-face sessions of ACT over 20 weeks plus usual care. These sessions are delivered within the GP surgery, outpatient clinic or participant's home by therapists attached to talking therapy and specialist mental health services. All therapists will receive training in ACT, as well as regular supervision. The sessions involve working with therapists to learn new skills to help better manage their GAD. At the start of the study and then again after 20 weeks, participants are asked to complete a number of questionnaires to assess levels of anxiety, worry, depression and quality of life, and to see how satisfied they are with the therapy they have received.

What are the possible benefits and risks of participating?
The main possible benefits include that participants will be given access to a novel form of talking therapy that is not yet available in the NHS for this condition. They will also be given a more in­depth screening assessment than they might otherwise receive as part of their routine NHS care. The main possible risks include that participants may experience a deterioration in anxiety and/or depression symptoms during the intervention (as it may not be beneficial for them) or distress during the interviews (e.g. when discussing their current difficulties). Participants will remain under the care of their GP or mental health professional during the study, and will be monitored and referred for further support if necessary.

Where is the study run from?
The first part of the study is taking place in multiple sites in:
1. Camden and Islington NHS Foundation Trust (lead trust) (UK)
2. South London and Maudsley NHS Foundation Trust (UK)
3. Oxford Health NHS Foundation Trust (UK)
4. Barnet Enfield and Haringey Mental Health Trust (UK)
5. Thames Valley CRN (UK)
6. North East London NHS Foundation Trust (UK)

The second part of the study is taking place in multiple sites in:
1. Camden and Islington NHS Foundation Trust (lead trust) (UK)
2. South London and Maudsley NHS Foundation Trust (UK)
3. Oxford Health NHS Foundation Trust (UK)
4. Barnet Enfield and Haringey Mental Health Trust (UK)
5. Whittington Health NHS Trust (UK)


When is the study starting and how long is it expected to run for?
May 2017 to April 2019

Who is funding the study?
National Institute for Health Research, Health Technology Assessment Programme (UK)

Who is the main contact?
Dr Rebecca Gould
r.gould@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rebecca Gould

ORCID ID

Contact details

Division of Psychiatry
University College London
Wing A
6th floor Maple House
149 Tottenham Court Rd
London
W1T 7NF
United Kingdom
+44 20 7679 9225
r.gould@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3

Study information

Scientific title

A Feasibility study of Acceptance and Commitment Therapy for Older people with treatment-resIstant generalised anxiety Disorder

Acronym

FACTOID

Study hypothesis

The aim of this study is to investigate the feasibility of conducting a study to examine the clinical and cost effectiveness of Acceptance and Commitment Therapy (ACT) for older people with treatment-resistant generalised anxiety disorder.

Ethics approval

1. London – Camberwell St Giles, 09/05/2017, ref: 17/LO/0704
2. HRA, 12/05/2017

Study design

Uncontrolled non-randomised feasibility study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Treatment-resistant generalised anxiety disorder in older people

Intervention

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 and adapt the intervention for this population. These interviews will explore positive/negative experiences of previous psychotherapy, facilitators/barriers to engagement in therapy, and the perceived suitability and relevance of an intervention based on Acceptance and Commitment Therapy (ACT) for treatment-resistant GAD in older people. Data from these interviews, together with discussions with experts in the field, will inform development of an intervention for this population. This will be based on the acceptance model of generalised anxiety disorder and existing ACT approaches. Once the intervention has been developed, the same set of participants from the initial interviews will be invited to participate in further individual qualitative interviews lasting 1.5 hours. These interviews will explore the acceptability and perceived value of the different components of the intervention, the practicalities of the intervention, and ways of optimising engagement. Modifications will be made to the intervention based on feedback from these interviews.

Phase 2:
Approximately 40 older people with treatment-resistant GAD will receive 16 1-hour face-to-face sessions of ACT over 20 weeks in addition to usual care. The intervention will involve helping participants to increase psychological flexibility through learning new skills, metaphors, experiential exercises and home practice tasks. These will aim to:
1. Reduce avoidance of difficult or uncomfortable experiences where such behaviour might be a barrier to life enriching activity
2. Reduce the amount of time people are "stuck in their head" ruminating about the past or worrying about the future
3. Reduce the degree to which people are caught up in negative or unhelpful thoughts about themselves, their situation or their identity and roles
4. Identify what really matters to them in their lives
5. Commit to doing personally meaningful activities that support what they value.
Sessions will be delivered within the GP surgery, outpatient clinic or participant's home by therapists attached to talking therapy and specialist mental health services. All therapists will receive training in ACT, as well as regular supervision. After 20 weeks, all participants will be followed up to assess how acceptable and feasible the intervention was. In addition, a sample of 15 participants and all therapists will also be invited to complete individual interviews lasting 1.5 hours to further assess acceptability and feasibility. These interviews will explore the perceived benefits and limitations of the intervention, together with any recommendations for revising it.

After 20 weeks, all participants will be followed up by an independent outcome assessor and the acceptability and feasibility of the intervention will be assessed.

Intervention type

Other

Phase

Drug names

Primary outcome measures

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 outcome measures

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. Health-related quality of life is measured using the EQ-5D-5L at baseline and 20 weeks.
5. Service utilization is measured using a short modified version of the Client Service Receipt Inventory at baseline and 20 weeks.
6. Psychological flexibility is measured using the Acceptance and Action Questionnaire-II at baseline and 20 weeks.

Overall trial start date

01/05/2017

Overall trial end date

30/04/2019

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

40

Participant 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)

Recruitment start date

23/06/2017

Recruitment end date

28/02/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Services for Ageing and Mental Health
Camden Community Mental Health Team The Peckwater Centre 1st floor 6 Peckwater Street
London
NW5 2TX
United Kingdom

Trial participating centre

Islington Services for Ageing and Mental Health
Community Mental Health Team Units 8-10 Blenheim Court 62 Brewery Road
London
N7 9NY
United Kingdom

Trial participating centre

Community Mental Health Team for Older Adults (Southwark)
Marina House 63-65 Denmark Hill Camberwell
London
SE5 8RS
United Kingdom

Trial participating centre

Community Mental Health Team for Older Adults (Lambeth)
First Floor Reay House Lambeth Hospital 109 Landor Road
London
SW9 9NT
United Kingdom

Trial participating centre

Community Mental Health Team for Older Adults (Lewisham)
91 Granville Park Lewisham
London
SE13 7DW
United Kingdom

Trial participating centre

Community Mental Health Team for Older Adults (Croydon North)
Heavers Resource Centre 122 Selhurst Road
London
SE25 6LL
United Kingdom

Trial participating centre

Community Mental Health Team for Older Adults (Croydon South)
Purley Resource Centre 50 Pampisford Road
Purley
CR8 2NE
United Kingdom

Trial participating centre

Southwark Improving Access to Psychological Therapies
Maudsley Psychology Centre Maudsley Hospital Denmark Hill
London
SE5 8AZ
United Kingdom

Trial participating centre

Croydon Improving Access to Psychological Therapies
Wickham Park House Bethlem Royal Hospital Monks Orchard Road
Beckenham
BR3 3BX
United Kingdom

Trial participating centre

Lambeth Talking Therapies Service (IAPT)
Adamson Centre South Wing St Thomas’ Hospital Westminster Bridge Road
London
SE1 7EH
United Kingdom

Trial participating centre

Improving Access to Psychological Therapies Lewisham
Primary Care Psychological Therapies Service PO Box 61678
London
SE12 2AN
United Kingdom

Trial participating centre

Community Mental Health Team (Older Adult) - Central Oxfordshire
Manzil Resource Centre Manzil Way
Oxford
OX4 1XE
United Kingdom

Trial participating centre

Community Mental Health Team (Older Adult) - South Oxfordshire
Abingdon Hospital Marcham Road
Abingdon
OX14 1AG
United Kingdom

Trial participating centre

Community Mental Health Team (Older Adult) - North Oxfordshire
The Elms Centre Oxford Road
Banbury
OX16 9AL
United Kingdom

Trial participating centre

Warneford Hospital
Warneford Lane Headington
Oxford
OX3 7JX
United Kingdom

Trial participating centre

The Whiteleaf Centre
Bierton Road
Aylesbury
HP20 1EG
United Kingdom

Trial participating centre

TalkingSpace Plus
Oxbridge Court Osney Mead
Oxford
OX2 0ES
United Kingdom

Trial participating centre

Healthy Minds Bucks
Floor 2 Prospect House Crendon Street
High Wycombe
HP13 6LA
United Kingdom

Trial participating centre

Enfield Older People Community Mental Health Team
Cumbria Villa Chase Farm Hospital The Ridgeway
Enfield
EN2 8JL
United Kingdom

Trial participating centre

Haringey Mental Health Services for Older People
Community Mental Health Team Victoria Unit St Ann’s Hospital St Ann’s Road
London
N15 3TH
United Kingdom

Trial participating centre

Springwell Centre
Barnet Hospital Mental Health Services Wellhouse Lane
Herts
EN5 3DJ
United Kingdom

Trial participating centre

Camden iCope (IAPT) Psychological Therapies & Wellbeing Service
3rd floor South Wing St Pancras Hospital 4 St Pancras Way
London
NW1 0PE
United Kingdom

Trial participating centre

Islington iCope (IAPT) Psychological Therapies & Wellbeing Service
Finsbury Health Centre 17 Pine St
London
EC1R 0LP
United Kingdom

Trial participating centre

Older People Community Services
Refuge House 9-10 River Front
Enfield
EN1 3SZ
United Kingdom

Trial participating centre

IAPT, St Ann's General Hospital (Beh-Mht services)
St Ann's Road
London
N15 3TH
United Kingdom

Trial participating centre

Older Adults Mental Health Team
Broad St Health Centre Morland Road
Dagenham
RM10 9HU
United Kingdom

Trial participating centre

Havering Older Adults Mental Health Team
Yew Tree Resource Centre 20 Yew Tree Gardens
Romford
RM7 9AA
United Kingdom

Trial participating centre

Older Adults Mental Health Team
Red Oak Lodge 17 Thorne Close Langthorne Road
Leytonstone
E11 4HU
United Kingdom

Trial participating centre

IAPT
Goodmayes Hospital Barley Lane Goodmayes Essex
Ilford
IG3 8XJ

Sponsor information

Organisation

UCLH/UCL

Sponsor details

Joint Research Office
1st floor Maple House
149 Tottenham Court Rd
London
W1T 7NF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned dissemination to the mental health and primary care academic and clinical community, service users and the broader public through:
1. Peer-reviewed, international academic journals such as the Journal of the American Geriatrics Society, the International Journal of Geriatric Psychiatry, and the Journal of Consulting and Clinical Psychology. Findings will be reported in accordance with reporting guidelines for quantitative cohort studies (STROBE) and qualitative research (COREQ), as well as guidelines relevant to non-pharmacological treatment interventions (e.g. CONSORT for non-pharmacological treatment interventions).
2. National and international academic conferences (e.g. British Association for Behavioural & Cognitive Psychotherapies, World Congress of Behavioural and Cognitive Therapies)
3. Local clinical conferences and meetings
4. Talks to local Service User groups, Primary Care Research Network, MIND and other organisations following guidance from our Project Service User Advisory Group, and including an interested service user from this group
5. University media releases, twitter feeds and the University website

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/04/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

31/08/2017: Protocol number has been updated from 1 to 3. Ethics approval information has been added. Overall trial start date has been updated from 01/01/2017 to 01/05/2017. Inclusion and exclusion criteria have been added. Recruitment dates have been updated from 01/11/2017-31/08/2017 to 23/06/2017-28/02/2019. The following trial participating sites have been added: Mental Health Services for older people in Barnet, Springwell Centre, Camden iCope (IAPT) Psychological Therapies & Wellbeing Service, Islington iCope (IAPT) Psychological Therapies & Wellbeing Service, Older People Community Services, Refuge House, IAPT, St Ann's General Hospital (Beh-Mht services), Havering Older Adults Mental Health Team, IAPT, Goodmayes Hospital. Plain English summary has been updated