An interventional study of Psychological therapy in Psychological Distress, Anxiety and Depression, sponsored by University of Lincoln. Completed at 1 site in United Kingdom. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-01.
Sponsored by University of Lincoln · Not applicable, Interventional, and Treatment
Title: Acceptance and Commitment Therapy for older adults experiencing psychological distress: A hermeneutic single case efficacy design (HSCED) series.
Anxiety and depression in older age is associated with increased level of disability and lower quality of life (OAs). Unfortunately, pharmacological treatments are disproportionality relied upon to manage the mental health of OAs. Despite cognitive behaviour therapy (CBT) being the recommended psychotherapy, there is evidence that CBT is less effective for OAs than younger populations.
An alternative treatment, Acceptance and Commitment Therapy (ACT), has been shown to be effective in reducing distress for OAs experiencing physical health difficulties. Several case studies have also indicated that ACT can be effective for OAs with psychological difficulties. ACT aims to change how a person interacts with their thoughts/feelings; to reduce avoidance; and to promote value-focused living.
The study aims to use an adjudicated HSCED to answer the following questions:
i) Is ACT an effective intervention for older adult clients experiencing psychological distress.
ii) Do meaningful changes occur for client-participants over the course of ACT intervention?
iii) What specific factors (ACT-specific, non-specific, extra-therapeutic) contribute to observed changes?
iv) Are observed changes broadly attributable to the ACT intervention?
v) What adaptations may facilitate change when using ACT with older adult clients.
For the study, up to four participants will be recruited from an OA community mental health team, each receiving up to 12 individual sessions of ACT. Participants will be required to complete a number of questionnaires throughout the study, including before/after sessions. Post-treatment, there will be a semi-structured 1:1 interview to explore any changes participants experienced, before a six-week follow-up is employed to check stability of change.
This study aims to investigate whether Acceptance and Commitment Therapy (ACT) is an effective psychotherapeutic intervention for older adults experiencing psychological distress; what processes contribute towards psychological change; and what adaptations may be required to optimise ACT for older adults. There is currently an over-reliance on pharmacological treatments to manage older adult mental health (Andreescu \& Reynolds, 2011), and a lack of inclusion of older adult in efficacy studies of psychological treatments (Gatz, 2006). Cognitive behaviour therapy (CBT) is the most evidence-based psychological treatment for mental health conditions. It emphasises the link between thoughts and feelings, and uses cognitive restructuring to facilitate improvement in psychological symptoms. However, of the studies that have included older adults, there is evidence that CBT has a lower effect size in older adults than with working age adults (Kishita \& Laidlaw, 2017). There are a number of possible reasons for this, including a lack of age specific adaptations, the over focus on diagnosis specific treatment protocols in CBT, and the increasing physical and psychological co-morbidity associated ageing.
ACT is a trans-diagnostic approach which aims to promote better living by supporting clients through six key processes (e.g. mindfulness, values). ACT does not aim to reduce distress, rather its goal is to promote better living or a better quality of life despite distress (Hayes, Strosahl \& Wilson, 1999). ACT has been shown to have equal or superior efficacy to CBT with a number of psychological and physical health conditions (A-Tjak et al., 2015; Ruiz, 2012). We propose that ACT would be especially suitable for older adult clients due to the high rate of co-morbidity older adults experience and the reduced ability to change aspects of these.
However, there is a lack of understanding about the processes by which ACT works (Öst, 2014). Randomised controlled trails (RCTs) are the standard research methodology to investigate psychotherapy efficacy. Due to the stringent criteria required for RCT analyses, there is a limit to how transferrable the findings of an RCT can be to clinical populations (i.e. heterogenous groups). As such, a hermeneutic single case efficacy design (HSCED) is an ideal methodology to employ to identify what contributes towards change for each client. HSCED benefits from high ecological validity, whilst actively focusing on non-specific factors (components common to all psychotherapies, e.g., therapeutic alliance) and extra-therapeutic factors (components that are not related to the therapy, usually participant factors) to delineate change processes.
The research proposal has been developed as part of a Doctoral Thesis in Clinical Psychology. This involved various research presentations panels and submission of an initial research protocol. These are designed to guide the decision-making process and gain feedback from the course research team. As part of the doctoral program, each trainee is allocated a Primary and Secondary Research Supervisor (both Clinical Psychologists), who aided in shaping the practicalities of this research proposal. Each project also recruits a Field Supervisor who supports with expertise in the project area. Participants will be recruited from the service the Field Supervisor is employed at, thereby creating a direct level of clinical supervision that is paramount to psychotherapy.
Participants will be informed about the study through a member of their healthcare team. The service will ensure potential participants have the capacity to consent to treatment and will provide them with an overview of the study. Potential participants will be made aware of informed consent; that they do not have to take part and that declining to take part will in no way affect their treatment from the service. If a participant declines to take part at this stage, they will be offered treatment as usual from the service. If they consent to take part, the researcher will contact them the following week to answer any additional questions. This will allow them sufficient time to consider whether they would like to take part or not.
This research aims to use a sample that is representative of older adults presenting with psychological distress. See Inclusion/Exclusion sections for further explanation of these criteria.
This study aims to reflect usual clinical practice where possible; therefore, the burden to participants will be of a similar level to treatment as usual. That is, they will be expected to attend the older adults service for regular one-to-one psychotherapy and to discuss their mental health difficulties, contributing factors and what is maintaining their difficulties. Thus, as with any psychological therapy, there is a potential risk that talking about distressing experiences will cause an increase in frequency or intensity of pre-existing mental health conditions. These risks will be monitored through the study by the Trainee Clinical Psychologist (who is both researcher and therapist) through discussion with the participant, use of outcome measures and importantly by utilising weekly clinical supervision with the Clinical Psychologist at the service. This allows a space for any concerns to be raised and for the service to have clinical oversight of the participants.
The aspects of the study which are additional to usual practice are as follows: participants will be required to complete more questionnaires; and participants will be required to come in for an interview after the block of therapy has ended. Every effort has been made to reduce the burden these place upon participants. For instance, shorter questionnaires have been used where possible. Participants will also be asked about any adaptations required to complete questionnaires (e.g. larger font, someone completing questionnaires with them). Participants will be reimbursed for the aspects of the study which are additional to usual practice.
There are several potential benefits to participants taking part in this research, as suggested by the ACT literature. These include decreased psychological distress, increased psychological flexibility and improved quality of life.
To ensure confidentiality, Participant Study Numbers (PSN) will be assigned to each participant to correspond with treatment data. PSNs will be listed in the Trial Recruitment Log along with participant's name, date of birth and NHS number. All other documents related to the participant will use the PSN only. All researchers will endeavour to protect the rights of the participants to privacy and will adhere to the Data Protection Act, 2018. Only the minimum required information for the purposes of the study will be collected. Participant information will be held securely, in a locked room, or locked cupboard or cabinet. Access to the information will be limited to the study staff and investigators. Computer held data including the study database will be held securely and password protected. All data will be stored on a secure dedicated web server. Access will be restricted by user identifiers and passwords (encrypted using a one-way encryption method). Information about the study in the participant's medical records / hospital notes will be treated confidentially in the same way as all other confidential medical information.
As the main researcher is also the therapist, potential conflict of interests will be managed by: using weekly clinical supervision; fortnightly ACT supervision; a 20% random sampling of the audio recorded sessions to ensure adherence to ACT techniques; and using an independent researcher to carry out the Change Interview. Another benefit of using a HSCED series, is that an independent panel adjudicates on the final outcome as to where change was attributed for each client, reducing the researcher-therapist bias.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 3 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →University of Lincoln is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will receive psychological therapy. There will be no placebos or waiting list controlled participants to compare findings to.
Other: Psychological therapy
Acceptance and Commitment Therapy (ACT) is a trans-diagnostic approach which aims to promote better living by supporting clients through six key processes (e.g. mindfulness, values). ACT does not aim to reduce distress, rather its goal is to promote better living or a better quality of life despite distress (Hayes, Strosahl \& Wilson, 1999). ACT has been shown to have equal or superior efficacy to CBT with a number of psychological and physical health conditions (A-Tjak et al., 2015; Ruiz, 2012).
Also known as: Acceptance and Commitment Therapy
Change in Quality of Life Assessed Using the Older People's Quality of Life Questionnaire (OPQOL-brief).
Brief measure of quality of life (QoL) in older age.
Time frame: up to 20 weeks
Client's Level of Cognitive Functioning Assessed Using the Montreal Cognitive Assessment (MoCA).
A brief cognitive screening questionnaire which will be administered by the usual care team at the start of the study.
Time frame: up to 5 weeks
Symptoms of Anxiety and Depression Assessed With the Hospital Anxiety and Depression Scale (HADS).
A brief measure of anxiety and depression that is less prone to conflation of physical health symptoms onto symptoms of psychological distress.
Time frame: up to 20 weeks
Change in/Progress on Client's Goals Assessed Using the Simplified Personal Questionnaire (PQ).
This consists of up to ten problem statements the client outlines at start of therapy and rates on a 7-point Likert scale for how much they have been bothered by the problem in the past week. They will then re-rate this before each therapy session and again at six-week follow-up.
Time frame: up to 20 weeks
Change in Client's Weekly Level of Quality of Life Assessed Using the Outcome Rating Scale (ORS).
A brief measure of patient rated outcomes in therapy session.
Time frame: up to 20 weeks
Change in Therapeutic Alliance Assessed With the Session Rating Scale (SRS).
A brief measure of patient rated therapeutic alliance.
Time frame: up to 20 weeks
Client's (Qualitative) Views on Individual Therapy Sessions Assessed With the Helpful Aspects of Therapy Form (HAT).
A qualitative measure of patient rated therapeutic alliance.
Time frame: up to 20 weeks
Change in Psychological Flexibility Assessed Using the CompACT
An ACT process measure.
Time frame: up to 20 weeks
Client's Attribution of Change and View on Therapy Assessed With the Change Interview
A semi-structured interview to determine the participant's view on any change achieved during therapy. Delivered by a researcher other than the therapist.
Time frame: up to 20 weeks
Adherence to ACT Related Processes Assessed With the ACT Fidelity Measure (ACT-FM).
A fidelity measure to ensure that sessions meet the requirements of ACT.
Time frame: up to 20 weeks
| Milestone | Psychological Therapy |
|---|---|
| Started | 3 |
| Completed | 3 |
| Not completed | 0 |
Brief measure of quality of life (QoL) in older age.
| score on a scale | Psychological Therapy |
|---|---|
| Change in Quality of Life Assessed Using the Older People's Quality of Life Questionnaire (OPQOL-brief). | 43.33 ± 8.39 |
A brief cognitive screening questionnaire which will be administered by the usual care team at the start of the study.
Results for this outcome have not been posted.
A brief measure of anxiety and depression that is less prone to conflation of physical health symptoms onto symptoms of psychological distress.
Results for this outcome have not been posted.
This consists of up to ten problem statements the client outlines at start of therapy and rates on a 7-point Likert scale for how much they have been bothered by the problem in the past week. They will then re-rate this before each therapy session and again at six-week follow-up.
Results for this outcome have not been posted.
A brief measure of patient rated outcomes in therapy session.
Results for this outcome have not been posted.
A brief measure of patient rated therapeutic alliance.
Results for this outcome have not been posted.
A qualitative measure of patient rated therapeutic alliance.
Results for this outcome have not been posted.
An ACT process measure.
Results for this outcome have not been posted.
A semi-structured interview to determine the participant's view on any change achieved during therapy. Delivered by a researcher other than the therapist.
Results for this outcome have not been posted.
A fidelity measure to ensure that sessions meet the requirements of ACT.
Results for this outcome have not been posted.
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Psychological Therapy | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | Psychological Therapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 3 |
| Age, Continuous(years) | Psychological Therapy |
|---|---|
| Mean | 72.67 ± 5.86 |
| Sex: Female, Male(Participants) | Psychological Therapy |
|---|---|
| Female | 2 |
| Male | 1 |
| Race/Ethnicity, Customized(Participants) | Psychological Therapy |
|---|---|
| White British | 3 |
| Older People's Quality of Life questionnaire, brief version (OPQOL-brief)(units on a scale) | Psychological Therapy |
|---|---|
| Mean | 43.67 ± 7.57 |
| Hospital Anxiety and Depression Scale - Anxiety Subscale(HADS-A)(units on a scale) | Psychological Therapy |
|---|---|
| Mean | 13.67 ± 6.66 |
| Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)(units on a scale) | Psychological Therapy |
|---|---|
| Mean | 9.67 ± 3.06 |
| Comprehensive Assessment of Acceptance and Commitment Therapy processes, short-form,(CompACT-8)(units on a scale) | Psychological Therapy |
|---|---|
| Mean | 20 ± 1.73 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Results will be written up in a peer-reviewed journal and as part of a Doctoral Thesis. Individual participant data will be anonymised. Should a request be made for individualised data, this would have to be approved by the various ethical and research boards involved.
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