Depression in Old AgeNCT04015505
Can Life's Wisdom Help Counter Depression? Evaluating the CBT Timeline Approach for Older Adults With Depression
A study testing Cognitive Behavioural Therapy for older adults: wisdom enhancement 'timeline technique' in people with Depression in Old Age, run by University of East Anglia at 2 sites in United Kingdom.
Trial summary
This study aims to evaluate a specific psychological technique to help older adults with depression improve their mood and develop or utilise their 'wisdom' for managing their current difficulties. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression in Old Age
- What is being tested?
- Cognitive Behavioural Therapy for older adults: wisdom enhancement 'timeline technique'
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 27 Aug 2019to 21 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged over 60.
- Primary problem depression, as measured by the screening tool PHQ-9 cut off point of 5.
- Currently on a waiting list for psychological treatment or considered treatment resistant.
- Low risk for suicide or self-harm, as screened through recruiting clinicians, health records and clinical judgement of the researcher
- Absence of cognitive impairment or substance misuse
- Participants should be on a stable dose, at least 3 months without change, of antidepressant medication
- Able to speak and understand English
Who cannot join
- Must not already be receiving any active psychological treatment for depression, or changes to any antidepressant medication in the past three months. If participants are on antidepressant medication which has not been changed in the last three months they will be still be eligible - this will be considered a stable dose.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Cambridge and Peterborough NHS Foundation Trust
Cambridge
Norfolk and Suffolk NHS Foundation Trust
Norwich
About this study
Official title: Does the Timeline Approach With Older Adults Experiencing Depression Reduce Negative Affect, and Result in Increased Self-compassion and Wisdom for Managing Current Difficulties? A Single Case Experimental Design
This study aims to evaluate a specific psychological technique to help older adults with depression improve their mood and develop or utilise their 'wisdom' for managing their current difficulties. The United Kingdom (UK) population is ageing and effective psychological therapies for older adults need to be well evaluated and developed. This study aims to develop evidence for this technique, and links between gerontological theories of wisdom and clinical psychology.
The 'timeline' technique (Laidlaw, 2010, 2015) is recommended within Cognitive Behavioural Therapy (CBT) for older adults. CBT is the most evidenced based psychological treatment for a range of psychiatric disorders including depression. Outcome studies have found that older people are just as likely to respond to CBT as younger people.
Read more
This technique draws on theories of 'wisdom', where one's wisdom can develop from how they reflect on their life experiences. Depressed individuals may view their lives in overgeneralised negative ways, making this process harder. The timeline technique asks people to create a timeline of their lives. Through reflection and discussion of past events, they are helped to recognise personal resilience, develop self-compassion, and utilise their wisdom for managing current difficulties. This technique requires specific evaluation to determine its validity and effectiveness.
This study uses a single-case experimental research design to allow conclusions to be drawn from a small number of participants. Six individuals from primary and secondary care mental health waiting lists, as well as third sector providers, aged over 60 and experiencing depression or low mood, will be invited to take part in a short testing of this technique. Individuals will be asked to measure their mood and complete relevant questionnaires throughout their involvement in the study and will do this for up to 4 weeks on their own. They will then meet with a trainee clinical psychologist for five weekly sessions of a structured therapy using the timeline technique.
Read the detailed description
BACKGROUND
The United Kingdom (UK) population is getting older, with those over 65 predicted to reach 24% by 2037 (Office for National Statistics, 2017). With improved quality of life and advances in healthcare, there is increased pressure on services to cater for the wellbeing of older adults. UK government states that depression affects one in five older people living in the community (UK Government, 2017). Depression is therefore a significant mental health condition for older adults and for which effective treatments and approaches are required. As such, there is a growing need to tailor psychological therapies to the older adult population and for new techniques to be well evaluated.
'Cognitive behavioural therapy (CBT) for older adults' augments traditional evidence-based CBT for the older adult population with 'age-appropriate' techniques, developed from lifespan developmental models and gerontological theory to help enhance treatment outcomes for older adults (Knight \& Laidlaw, 2009; Laidlaw, 2010). One technique is the 'wisdom enhancement' timeline technique (Laidlaw, 2010, 2015; Laidlaw \& Kishita, 2015), which builds on a psychological model of wisdom applied to clinical psychology. The technique has roots in classical cognitive behavioural techniques but is distinctive in how it uses one's life narrative as a resource. The timeline technique can be regarded as an innovative and structured way of using peoples' life narratives and experiences in a cognitive-behavioural framework to evolve the psychological resource of wisdom and increase mood and coping in the present. It is time-limited and present problem focused. The timeline technique is recommended in Increased Access to Psychological Therapies Services (IAPT) guidelines for CBT for older adults, meaning that it will be routinely used in National Health Service (NHS) settings in England. The timeline technique is theorised to improve mood by increasing self-acceptance and wisdom. However, the technique has not been specifically tested in detail.
PURPOSE OF THE STUDY
This study will investigate in detail the 'wisdom enhancement' timeline technique for helping older adults with depression develop 'wisdom', self-compassion and improve mood. The study will use a single-case experimental design to evaluate the technique's effectiveness and mechanisms of change. It will provide a valuable examination of a specific recommended CBT technique, where there is a general need for more testing of individual components of therapy. The results from this investigation will help inform further developments of wisdom enhancement models in clinical psychology and efficacy of CBT for older adults.
RESEARCH AIM
The primary aim of this study is to evaluate the 'timeline technique' (Laidlaw, 2015) with older adults experiencing mild-moderate depression. This will be achieved by delivering a short psychological intervention to older adults using the timeline technique, based on appropriate guidelines. Principle research questions:
- Does the timeline intervention reduce negative affect?
- Does the timeline intervention increase self-compassion?
- Does the timeline intervention increase wisdom for managing current difficulties?
STUDY DESIGN
This study uses a single case experimental design (SCED) to measure the effects that the 'timeline' intervention has on mood, self-compassion and wisdom, as measured by structured self-report questionnaires and idiographic measures. Older adults experiencing depression/low mood will be recruited from NHS primary and secondary care or third sector psychological treatment waiting lists.
SCEDs have long been used in psychology intervention research and are a useful method for examining the effectiveness of an intervention on individuals with only a few participants (Morgan \& Morgan, 2001; Kazdin, 2011). Unlike randomised controlled trials, each participant acts as their own control by measuring their baseline state for a period of time before the intervention is introduced. Each participant will take part in three phases:
- Baseline phase: participants will complete weekly standardised measures of mood and daily idiographic measures of mood, self-compassion and wisdom.
- Intervention phase: participants will receive a 5 week psychological intervention, whilst continuing to complete the baseline measures. This will allow for any observable change in mood during the onset of the intervention to be determined.
- Participants will complete a single set of follow up measures 1 month after the intervention phase ends.
Participants will also complete standardised measures of mood, self-compassion and wisdom at pre-baseline, pre-intervention and post-intervention time points, to allow for further between phase testing. Measurement during the intervention phase and at follow up will account for effects of the intervention that accrue slowly over time and test if any effects are sustained.
The study adopts an across-participant multiple baseline component which means that each participant will be randomly assigned to one of three pre-determined baseline phases of differing lengths:
Group A: 2 weeks Group B: 3 weeks Group C: 4 weeks The multiple baseline design is the most frequent design used in psychology single case studies (Smith, 2012) and allows for greater control for determining when changes in the target variable are attributed to a specific study phase.
Participants will take part once they are recruited and it is convenient for them to take part, rather than needing to all start simultaneously. This is therefore considered a non-concurrent multiple baseline design and allows greater flexibility for both researchers and participants.
ADDITIONAL INFO
This study is taking place as part of the chief investigator's research training and qualification for a UK Doctorate in Clinical Psychology.
- Conditions
- Depression in Old Age
- Being tested
- Cognitive Behavioural Therapy for older adults: wisdom enhancement 'timeline technique'
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy for older adults: wisdom enhancement 'timeline technique'Behavioural
The intervention is comprised of five one-hour sessions of structured talking therapy, where participants create a timeline of their life with significant events included. Through dialogue with the therapist and structured worksheets, participants are encouraged to reflect on events in their life to recognise and develop qualities of resilience and self-compassion. They are then asked to use 'the wisdom of their years' to develop strategies to manage difficulties they are currently facing. Participants will also be asked to complete worksheets and try out new strategies between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive 5 sessions of a psychological (talking therapy) intervention based on the wisdom enhancement 'timeline technique' within cognitive behavioural therapy for older adults. Receives: Behavioral: Cognitive Behavioural Therapy for older adults: wisdom enhancement 'timeline technique' |
What is being measured
The primary outcome is the main question the study is designed to answer.
9-item Patient Health Questionnaire - assessing levels of change over time for each participant
9 item self-report measure for depression. (PHQ-9; Kroenke, Spitzer, \& Williams, 2001).
The PHQ-9 is a brief and widely used nine-item self-report tool for measuring depression. Total scores range from 0 to 27 with higher scores suggesting higher severity of depression. This measure will be used as a primary outcome measure to monitor changes in mood across the duration of the study and will be assessed each week. The PHQ-9 will also be used as a study screening tool with a score above 5 (indicating mild depression; Kroenke et al., 2001) set as the cut-off point.
Measured: Group A: Weekly throughout study completion, up to 7 weeks and once at 1 month follow-up: at week 11
9-item Patient Health Questionnaire - assessing levels of change over time for each participant
9 item self-report measure for depression. (PHQ-9; Kroenke, Spitzer, \& Williams, 2001).
The PHQ-9 is a brief and widely used nine-item self-report tool for measuring depression. Total scores range from 0 to 27 with higher scores suggesting higher severity of depression. This measure will be used as a primary outcome measure to monitor changes in mood across the duration of the study and will be assessed each week. The PHQ-9 will also be used as a study screening tool with a score above 5 (indicating mild depression; Kroenke et al., 2001) set as the cut-off point.
Measured: Group B: Weekly throughout study completion, up to 8 weeks and once at 1 month follow-up: at week 12
9-item Patient Health Questionnaire - assessing levels of change over time for each participant
9 item self-report measure for depression. (PHQ-9; Kroenke, Spitzer, \& Williams, 2001).
The PHQ-9 is a brief and widely used nine-item self-report tool for measuring depression. Total scores range from 0 to 27 with higher scores suggesting higher severity of depression. This measure will be used as a primary outcome measure to monitor changes in mood across the duration of the study and will be assessed each week. The PHQ-9 will also be used as a study screening tool with a score above 5 (indicating mild depression; Kroenke et al., 2001) set as the cut-off point.
Measured: Group C: Weekly throughout study completion, up to 9 weeks and once at 1 month follow-up: at week 13
10-item Geriatric Anxiety Scale - assessing levels of change over time for each participant
10 item self-report measure for anxiety in later life. (GAS-10; Mueller et al, 2015).
The GAS-10 is a brief 10 item scale is a shorty form scale adapted from the 30-item Geriatric Anxiety Scale (Segal, June, Payne, Coolidge, \& Yochim, 2010). It is a self-report questionnaire designed to measure severity of anxiety for older adults. Total scores range from 0 to 30, with higher total scores meaning higher levels of anxiety.
Measured: Group A: Weekly throughout study completion, up to 7 weeks and once at 1 month follow-up: at week 11
10-item Geriatric Anxiety Scale - assessing levels of change over time for each participant
10 item self-report measure for anxiety in later life. (GAS-10; Mueller et al, 2015).
The GAS-10 is a brief 10 item scale is a shorty form scale adapted from the 30-item Geriatric Anxiety Scale (Segal, June, Payne, Coolidge, \& Yochim, 2010). It is a self-report questionnaire designed to measure severity of anxiety for older adults. Total scores range from 0 to 30, with higher total scores meaning higher levels of anxiety.
Measured: Group B: Weekly throughout study completion, up to 8 weeks and once at 1 month follow-up: at week 12
10-item Geriatric Anxiety Scale - assessing levels of change over time for each participant
10 item self-report measure for anxiety in later life. (GAS-10; Mueller et al, 2015).
The GAS-10 is a brief 10 item scale is a shorty form scale adapted from the 30-item Geriatric Anxiety Scale (Segal, June, Payne, Coolidge, \& Yochim, 2010). It is a self-report questionnaire designed to measure severity of anxiety for older adults. Total scores range from 0 to 30, with higher total scores meaning higher levels of anxiety.
Measured: Group C: Weekly throughout study completion, up to 9 weeks and once at 1 month follow-up: at week 13
Idiographic visual analogue scale - assessing daily change over time for each participant
Self-reported idiographic visual analogue scale with specific questions developed in accordance with the study hypotheses:
- Today, I feel that my mood is good
- Today, I feel accepting of myself
- Today, I feel that I can use the wisdom of my life to help deal with current difficulties
Idiographic measures are often used as well as standardized measures in single case design. They allow for specific target constructs to be measured in a way that is repeatable and efficient. The visual analogue scale consists of a ten-centimeter line anchored at either end with maximal and minimal extremes of the dimension being measured. Participants put a mark on the line, with the mark closer to the right side indicating stronger agreement of that statement. A numerical measurement of the line gives a score for each statement based on length (between 0 and 10.)
Measured: Group A: Daily through study completion, for total of 43 days and once at 1 month following end of intervention period: at week 11
Idiographic visual analogue scale - assessing daily change over time for each participant
Self-reported idiographic visual analogue scale with specific questions developed in accordance with the study hypotheses:
- Today, I feel that my mood is good
- Today, I feel accepting of myself
- Today, I feel that I can use the wisdom of my life to help deal with current difficulties
Idiographic measures are often used as well as standardized measures in single case design. They allow for specific target constructs to be measured in a way that is repeatable and efficient. The visual analogue scale consists of a ten-centimeter line anchored at either end with maximal and minimal extremes of the dimension being measured. Participants put a mark on the line, with the mark closer to the right side indicating stronger agreement of that statement. A numerical measurement of the line gives a score for each statement based on length (between 0 and 10.)
Measured: Group B: Daily through study completion, for total of 50 days and once at 1 month following end of intervention period: at week 12
Idiographic visual analogue scale - assessing daily change over time for each participant
Self-reported idiographic visual analogue scale with specific questions developed in accordance with the study hypotheses:
- Today, I feel that my mood is good
- Today, I feel accepting of myself
- Today, I feel that I can use the wisdom of my life to help deal with current difficulties
Idiographic measures are often used as well as standardized measures in single case design. They allow for specific target constructs to be measured in a way that is repeatable and efficient. The visual analogue scale consists of a ten-centimeter line anchored at either end with maximal and minimal extremes of the dimension being measured. Participants put a mark on the line, with the mark closer to the right side indicating stronger agreement of that statement. A numerical measurement of the line gives a score for each statement based on length (between 0 and 10.)
Measured: Group C: Daily through study completion, for total of 57 days and once at 1 month following end of intervention period: at week 13
Self-compassion scale - assessing levels of change over time for each participant
26-item self-report measure of self-compassion (SCS; Neff, 2003)
26-item self-report measure of self-compassion measures overall self-compassion as well as six subscales, representing components of self-compassion: self-kindness versus self-judgment, sense of common humanity versus isolation, and mindfulness versus over-identification. Responses to each question are given on a 5-point Likert scale, from 'almost never' to 'almost always'. Subscale scores are computed by calculating the mean of subscale item responses, and therefore range from 0-5 with higher scores indicating higher levels of that construct. Total self-compassion score is calculated by reverse scoring the negative subscale items before calculating subscale means - self-judgment, isolation, and over-identification, then calculating a grand mean of all six subscale means. The total score ranges from 0-5 with higher scores indicating higher levels overall self-compassion.
Measured: Group A: At week 1, week 3, week 7, week 11.
Self-compassion scale - assessing levels of change over time for each participant
26-item self-report measure of self-compassion (SCS; Neff, 2003)
26-item self-report measure of self-compassion measures overall self-compassion as well as six subscales, representing components of self-compassion: self-kindness versus self-judgment, sense of common humanity versus isolation, and mindfulness versus over-identification. Responses to each question are given on a 5-point Likert scale, from 'almost never' to 'almost always'. Subscale scores are computed by calculating the mean of subscale item responses, and therefore range from 0-5 with higher scores indicating higher levels of that construct. Total self-compassion score is calculated by reverse scoring the negative subscale items before calculating subscale means - self-judgment, isolation, and over-identification, then calculating a grand mean of all six subscale means. The total score ranges from 0-5 with higher scores indicating higher levels overall self-compassion.
Measured: Group B: At week 1, week 4, week 8, week 12.
Self-compassion scale - assessing levels of change over time for each participant
26-item self-report measure of self-compassion (SCS; Neff, 2003)
26-item self-report measure of self-compassion measures overall self-compassion as well as six subscales, representing components of self-compassion: self-kindness versus self-judgment, sense of common humanity versus isolation, and mindfulness versus over-identification. Responses to each question are given on a 5-point Likert scale, from 'almost never' to 'almost always'. Subscale scores are computed by calculating the mean of subscale item responses, and therefore range from 0-5 with higher scores indicating higher levels of that construct. Total self-compassion score is calculated by reverse scoring the negative subscale items before calculating subscale means - self-judgment, isolation, and over-identification, then calculating a grand mean of all six subscale means. The total score ranges from 0-5 with higher scores indicating higher levels overall self-compassion.
Measured: Group C: At week 1, week 5, week, 9, week 13
Self-Assessed Wisdom Scale (SAWS) - assessing levels of change over time for each participant
40-item self-report measure of wisdom (SAWS; Webster, 2007)
This 40-item self-report measure of wisdom uses a 6-point Likert scale to measure five subscales of wisdom: critical life experience, reminiscence and reflectiveness, openness, emotional regulation, and humor.
Each subsale total ranges from 0 to 40, with higher numbers indicating higher levels of that construct.
Adding total subscale scores together will generate a total SAWS wisdom score, with values ranging from 40 to 200, with a higher score indicating an overall higher level of wisdom.
Measured: Group A: At week 1, week 3, week 7, week 11.
Self-Assessed Wisdom Scale (SAWS) - assessing levels of change over time for each participant
40-item self-report measure of wisdom (SAWS; Webster, 2007)
This 40-item self-report measure of wisdom uses a 6-point Likert scale to measure five subscales of wisdom: critical life experience, reminiscence and reflectiveness, openness, emotional regulation, and humor.
Each subsale total ranges from 0 to 40, with higher numbers indicating higher levels of that construct.
Adding total subscale scores together will generate a total SAWS wisdom score, with values ranging from 40 to 200, with a higher score indicating an overall higher level of wisdom.
Measured: Group B: At week 1, week 4, week 8, week 12.
Self-Assessed Wisdom Scale (SAWS) - assessing levels of change over time for each participant
40-item self-report measure of wisdom (SAWS; Webster, 2007)
This 40-item self-report measure of wisdom uses a 6-point Likert scale to measure five subscales of wisdom: critical life experience, reminiscence and reflectiveness, openness, emotional regulation, and humor.
Each subsale total ranges from 0 to 40, with higher numbers indicating higher levels of that construct.
Adding total subscale scores together will generate a total SAWS wisdom score, with values ranging from 40 to 200, with a higher score indicating an overall higher level of wisdom.
Measured: Group C: At week 1, week 5, week, 9, week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start27 Aug 2019
- Primary completion21 Jan 2020
- Study completion21 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Depression in Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single case experimental design, with non-concurrent across-participants multiple baselines. All participants will receive the intervention, with a period of measured baseline stability acting as the control for each participant. Participants will not need to take part in the study simultaneously. Participants will be randomly allocated to one of three baseline conditions: Group A = 2 weeks baseline Group B = 3 weeks baseline Group C = 4 weeks baseline Following their baseline, each participant will complete a 5 week intervention period where they receive 5 sessions of the therapy. Throughout their baseline and intervention period, each participant will complete weekly measures of mood and a daily visual analogue scale. Each participant will also complete measures of self-compassion and wisdom at the start of baseline, end of baseline and end of intervention. Each participant will complete all measures again at one time point 1 month following the end of their intervention.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam JZ Kadri, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015505
- Sponsor's protocol ID
- 248358
- Status last verified
- Feb 2020
- First submitted
- 17 Jun 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kazdin, AE. Single-case research designs: Methods for clinical and applied settings. Oxford University Press, 2011.
Knight BG, Laidlaw, K. Translational theory: A wisdom-based model for psychological interventions to enhance well-being in later life. In V. L. Bengston, D. Gans, N. M. Pulney, & M. Silverstein (Eds.), Handbook of theories of aging (pp. 693-705). New York, NY, US: Springer Publishing Co. 2009.
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Laidlaw K. Are attitudes to ageing and wisdom enhancement legitimate targets for CBT for late life depression and anxiety?. Nordic Psychology 62: 27-42, 2010.
Laidlaw K. Enhancing cognitive behavior therapy with older people using gerontological theories as vehicles for change. Casebook of Clinical Geropsychology: International Perspectives on Practice, 17, 2010.
Laidlaw K, Kishita, N. Age-appropriate augmented cognitive behavior therapy to enhance treatment outcome for late-life depression and anxiety disorders. Geropsych 28: 57-66, 2015.
Laidlaw K. CBT for older people: An introduction. Sage, London, 2015.
Morgan DL, Morgan RK. Single-participant research design. Bringing science to managed care. Am Psychol. 2001 Feb;56(2):119-27.
PubMed 11279805Mueller AE, Segal DL, Gavett B, Marty MA, Yochim B, June A, Coolidge FL. Geriatric Anxiety Scale: item response theory analysis, differential item functioning, and creation of a ten-item short form (GAS-10). Int Psychogeriatr. 2015 Jul;27(7):1099-111. doi: 10.1017/S1041610214000210. Epub 2014 Feb 27.
PubMed 24576589Neff KD. The development and validation of a scale to measure self-compassion. Self and identity 2(3): 223-250, 2003.
Office for National Statistics (2017). Overview of the UK population: July 2017. Retrieved from https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/articles/overviewoftheukpopulation/july2017
Smith JD. Single-case experimental designs: a systematic review of published research and current standards. Psychol Methods. 2012 Dec;17(4):510-50. doi: 10.1037/a0029312. Epub 2012 Jul 30.
PubMed 22845874Webster JD. Measuring the character strength of wisdom. Int J Aging Hum Dev. 2007;65(2):163-83. doi: 10.2190/AG.65.2.d.
PubMed 17957986UK Government (2017) Living Well in Older Years. Retrieved from: https://www.gov.uk/government/publications/better-mental-health-jsna-toolkit/7-living-well-in-older-years#fn:4
Elliott R. Hermeneutic single-case efficacy design. Psychother Res. 2002 Mar 1;12(1):1-21. doi: 10.1080/713869614.
PubMed 22471329
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Timeline Approach With Older Adults Experiencing Depression Reduce Negative Affect, and Result in Increased Self-compassion and Wisdom for Managing Current Difficulties? A Single Case Experimental Design
- ClinicalTrials.gov ID
- NCT04015505
- Acronym / sponsor ID
- 248358
- Conditions
- Depression in Old Age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate a specific psychological technique to help older adults with depression improve their mood and develop or utilise their 'wisdom' for managing their current difficulties. The United Kingdom (UK) population is ageing and effective psychological therapies for older adults need to be well evaluated and developed. This study aims to develop evidence for this technique, and links between gerontological theories of wisdom and clinical psychology.
The 'timeline' technique (Laidlaw, 2010, 2015) is recommended within Cognitive Behavioural Therapy (CBT) for older adults. CBT is the most evidenced based psychological treatment for a range of psychiatric disorders including depression. Outcome studies have found that older people are just as likely to respond to CBT as younger people.
This technique draws on theories of 'wisdom', where one's wisdom can develop from how they reflect on their life experiences. Depressed individuals may view their lives in overgeneralised negative ways, making this process harder. The timeline technique asks people to create a timeline of their lives. Through reflection and discussion of past events, they are helped to recognise personal resilience, develop self-compassion, and utilise their wisdom for managing current difficulties. This technique requires specific evaluation to determine its validity and effectiveness.
This study uses a single-case experimental research design to allow conclusions to be drawn from a small number of participants. Six individuals from primary and secondary care mental health waiting lists, as well as third sector providers, aged over 60 and experiencing depression or low mood, will be invited to take part in a short testing of this technique. Individuals will be asked to measure their mood and complete relevant questionnaires throughout their involvement in the study and will do this for up to 4 weeks on their own. They will then meet with a trainee clinical psychologist for five weekly sessions of a structured therapy using the timeline technique.
Detailed description
BACKGROUND
The United Kingdom (UK) population is getting older, with those over 65 predicted to reach 24% by 2037 (Office for National Statistics, 2017). With improved quality of life and advances in healthcare, there is increased pressure on services to cater for the wellbeing of older adults. UK government states that depression affects one in five older people living in the community (UK Government, 2017). Depression is therefore a significant mental health condition for older adults and for which effective treatments and approaches are required. As such, there is a growing need to tailor psychological therapies to the older adult population and for new techniques to be well evaluated.
'Cognitive behavioural therapy (CBT) for older adults' augments traditional evidence-based CBT for the older adult population with 'age-appropriate' techniques, developed from lifespan developmental models and gerontological theory to help enhance treatment outcomes for older adults (Knight \& Laidlaw, 2009; Laidlaw, 2010). One technique is the 'wisdom enhancement' timeline technique (Laidlaw, 2010, 2015; Laidlaw \& Kishita, 2015), which builds on a psychological model of wisdom applied to clinical psychology. The technique has roots in classical cognitive behavioural techniques but is distinctive in how it uses one's life narrative as a resource. The timeline technique can be regarded as an innovative and structured way of using peoples' life narratives and experiences in a cognitive-behavioural framework to evolve the psychological resource of wisdom and increase mood and coping in the present. It is time-limited and present problem focused. The timeline technique is recommended in Increased Access to Psychological Therapies Services (IAPT) guidelines for CBT for older adults, meaning that it will be routinely used in National Health Service (NHS) settings in England. The timeline technique is theorised to improve mood by increasing self-acceptance and wisdom. However, the technique has not been specifically tested in detail.
PURPOSE OF THE STUDY
This study will investigate in detail the 'wisdom enhancement' timeline technique for helping older adults with depression develop 'wisdom', self-compassion and improve mood. The study will use a single-case experimental design to evaluate the technique's effectiveness and mechanisms of change. It will provide a valuable examination of a specific recommended CBT technique, where there is a general need for more testing of individual components of therapy. The results from this investigation will help inform further developments of wisdom enhancement models in clinical psychology and efficacy of CBT for older adults.
RESEARCH AIM
The primary aim of this study is to evaluate the 'timeline technique' (Laidlaw, 2015) with older adults experiencing mild-moderate depression. This will be achieved by delivering a short psychological intervention to older adults using the timeline technique, based on appropriate guidelines. Principle research questions:
- Does the timeline intervention reduce negative affect?
- Does the timeline intervention increase self-compassion?
- Does the timeline intervention increase wisdom for managing current difficulties?
STUDY DESIGN
This study uses a single case experimental design (SCED) to measure the effects that the 'timeline' intervention has on mood, self-compassion and wisdom, as measured by structured self-report questionnaires and idiographic measures. Older adults experiencing depression/low mood will be recruited from NHS primary and secondary care or third sector psychological treatment waiting lists.
SCEDs have long been used in psychology intervention research and are a useful method for examining the effectiveness of an intervention on individuals with only a few participants (Morgan \& Morgan, 2001; Kazdin, 2011). Unlike randomised controlled trials, each participant acts as their own control by measuring their baseline state for a period of time before the intervention is introduced. Each participant will take part in three phases:
- Baseline phase: participants will complete weekly standardised measures of mood and daily idiographic measures of mood, self-compassion and wisdom.
- Intervention phase: participants will receive a 5 week psychological intervention, whilst continuing to complete the baseline measures. This will allow for any observable change in mood during the onset of the intervention to be determined.
- Participants will complete a single set of follow up measures 1 month after the intervention phase ends.
Participants will also complete standardised measures of mood, self-compassion and wisdom at pre-baseline, pre-intervention and post-intervention time points, to allow for further between phase testing. Measurement during the intervention phase and at follow up will account for effects of the intervention that accrue slowly over time and test if any effects are sustained.
The study adopts an across-participant multiple baseline component which means that each participant will be randomly assigned to one of three pre-determined baseline phases of differing lengths:
Group A: 2 weeks Group B: 3 weeks Group C: 4 weeks The multiple baseline design is the most frequent design used in psychology single case studies (Smith, 2012) and allows for greater control for determining when changes in the target variable are attributed to a specific study phase.
Participants will take part once they are recruited and it is convenient for them to take part, rather than needing to all start simultaneously. This is therefore considered a non-concurrent multiple baseline design and allows greater flexibility for both researchers and participants.
ADDITIONAL INFO
This study is taking place as part of the chief investigator's research training and qualification for a UK Doctorate in Clinical Psychology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single case experimental design, with non-concurrent across-participants multiple baselines. All participants will receive the intervention, with a period of measured baseline stability acting as the control for each participant. Participants will not need to take part in the study simultaneously. Participants will be randomly allocated to one of three baseline conditions: Group A = 2 weeks baseline Group B = 3 weeks baseline Group C = 4 weeks baseline Following their baseline, each participant will complete a 5 week intervention period where they receive 5 sessions of the therapy. Throughout their baseline and intervention period, each participant will complete weekly measures of mood and a daily visual analogue scale. Each participant will also complete measures of self-compassion and wisdom at the start of baseline, end of baseline and end of intervention. Each participant will complete all measures again at one time point 1 month following the end of their intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Cognitive Behavioural Therapy for older adults: wisdom enhancement 'timeline technique'Participants will receive 5 sessions of a psychological (talking therapy) intervention based on the wisdom enhancement 'timeline technique' within cognitive behavioural therapy for older adults. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged over 60.
- Primary problem depression, as measured by the screening tool PHQ-9 cut off point of 5.
- Currently on a waiting list for psychological treatment or considered treatment resistant.
- Low risk for suicide or self-harm, as screened through recruiting clinicians, health records and clinical judgement of the researcher
- Absence of cognitive impairment or substance misuse
Key exclusion criteria (1 listed)
- Must not already be receiving any active psychological treatment for depression, or changes to any antidepressant medication in the past three months. If participants are on antidepressant medication which has not been changed in the last three months they will be still be eligible - this will be considered a stable dose.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural Therapy for older adults: wisdom enhancement 'timeline technique'The intervention is comprised of five one-hour sessions of structured talking therapy, where participants create a timeline of their life with significant events included. Through dialogue with the therapist and structured worksheets, participants are encouraged to reflect on events in their life to recognise and develop qualities of resilience and self-compassion. They are then asked to use 'the wisdom of their years' to develop strategies to manage difficulties they are currently facing. Participants will also be asked to complete worksheets and try out new strategies between sessions. | Behavioural | Intervention |
Primary outcome
9-item Patient Health Questionnaire - assessing levels of change over time for each participant
Time frame: Group A: Weekly throughout study completion, up to 7 weeks and once at 1 month follow-up: at week 11
9 item self-report measure for depression. (PHQ-9; Kroenke, Spitzer, \& Williams, 2001). The PHQ-9 is a brief and widely used nine-item self-report tool for measuring depression. Total scores range from 0 to 27 with higher scores suggesting higher severity of depression. This measure will be used as a primary outcome measure to monitor changes in mood across the duration of the study and will be assessed each week. The PHQ-9 will also be used as a study screening tool with a score above 5 (indicating mild depression; Kroenke et al., 2001) set as the cut-off point.
9-item Patient Health Questionnaire - assessing levels of change over time for each participant
Time frame: Group B: Weekly throughout study completion, up to 8 weeks and once at 1 month follow-up: at week 12
9 item self-report measure for depression. (PHQ-9; Kroenke, Spitzer, \& Williams, 2001). The PHQ-9 is a brief and widely used nine-item self-report tool for measuring depression. Total scores range from 0 to 27 with higher scores suggesting higher severity of depression. This measure will be used as a primary outcome measure to monitor changes in mood across the duration of the study and will be assessed each week. The PHQ-9 will also be used as a study screening tool with a score above 5 (indicating mild depression; Kroenke et al., 2001) set as the cut-off point.
9-item Patient Health Questionnaire - assessing levels of change over time for each participant
Time frame: Group C: Weekly throughout study completion, up to 9 weeks and once at 1 month follow-up: at week 13
9 item self-report measure for depression. (PHQ-9; Kroenke, Spitzer, \& Williams, 2001). The PHQ-9 is a brief and widely used nine-item self-report tool for measuring depression. Total scores range from 0 to 27 with higher scores suggesting higher severity of depression. This measure will be used as a primary outcome measure to monitor changes in mood across the duration of the study and will be assessed each week. The PHQ-9 will also be used as a study screening tool with a score above 5 (indicating mild depression; Kroenke et al., 2001) set as the cut-off point.
10-item Geriatric Anxiety Scale - assessing levels of change over time for each participant
Time frame: Group A: Weekly throughout study completion, up to 7 weeks and once at 1 month follow-up: at week 11
10 item self-report measure for anxiety in later life. (GAS-10; Mueller et al, 2015). The GAS-10 is a brief 10 item scale is a shorty form scale adapted from the 30-item Geriatric Anxiety Scale (Segal, June, Payne, Coolidge, \& Yochim, 2010). It is a self-report questionnaire designed to measure severity of anxiety for older adults. Total scores range from 0 to 30, with higher total scores meaning higher levels of anxiety.
10-item Geriatric Anxiety Scale - assessing levels of change over time for each participant
Time frame: Group B: Weekly throughout study completion, up to 8 weeks and once at 1 month follow-up: at week 12
10 item self-report measure for anxiety in later life. (GAS-10; Mueller et al, 2015). The GAS-10 is a brief 10 item scale is a shorty form scale adapted from the 30-item Geriatric Anxiety Scale (Segal, June, Payne, Coolidge, \& Yochim, 2010). It is a self-report questionnaire designed to measure severity of anxiety for older adults. Total scores range from 0 to 30, with higher total scores meaning higher levels of anxiety.
10-item Geriatric Anxiety Scale - assessing levels of change over time for each participant
Time frame: Group C: Weekly throughout study completion, up to 9 weeks and once at 1 month follow-up: at week 13
10 item self-report measure for anxiety in later life. (GAS-10; Mueller et al, 2015). The GAS-10 is a brief 10 item scale is a shorty form scale adapted from the 30-item Geriatric Anxiety Scale (Segal, June, Payne, Coolidge, \& Yochim, 2010). It is a self-report questionnaire designed to measure severity of anxiety for older adults. Total scores range from 0 to 30, with higher total scores meaning higher levels of anxiety.
Idiographic visual analogue scale - assessing daily change over time for each participant
Time frame: Group A: Daily through study completion, for total of 43 days and once at 1 month following end of intervention period: at week 11
Self-reported idiographic visual analogue scale with specific questions developed in accordance with the study hypotheses: 1. Today, I feel that my mood is good 2. Today, I feel accepting of myself 3. Today, I feel that I can use the wisdom of my life to help deal with current difficulties Idiographic measures are often used as well as standardized measures in single case design. They allow for specific target constructs to be measured in a way that is repeatable and efficient. The visual analogue scale consists of a ten-centimeter line anchored at either end with maximal and minimal extremes of the dimension being measured. Participants put a mark on the line, with the mark closer to the right side indicating stronger agreement of that statement. A numerical measurement of the line gives a score for each statement based on length (between 0 and 10.)
Idiographic visual analogue scale - assessing daily change over time for each participant
Time frame: Group B: Daily through study completion, for total of 50 days and once at 1 month following end of intervention period: at week 12
Self-reported idiographic visual analogue scale with specific questions developed in accordance with the study hypotheses: 1. Today, I feel that my mood is good 2. Today, I feel accepting of myself 3. Today, I feel that I can use the wisdom of my life to help deal with current difficulties Idiographic measures are often used as well as standardized measures in single case design. They allow for specific target constructs to be measured in a way that is repeatable and efficient. The visual analogue scale consists of a ten-centimeter line anchored at either end with maximal and minimal extremes of the dimension being measured. Participants put a mark on the line, with the mark closer to the right side indicating stronger agreement of that statement. A numerical measurement of the line gives a score for each statement based on length (between 0 and 10.)
Idiographic visual analogue scale - assessing daily change over time for each participant
Time frame: Group C: Daily through study completion, for total of 57 days and once at 1 month following end of intervention period: at week 13
Self-reported idiographic visual analogue scale with specific questions developed in accordance with the study hypotheses: 1. Today, I feel that my mood is good 2. Today, I feel accepting of myself 3. Today, I feel that I can use the wisdom of my life to help deal with current difficulties Idiographic measures are often used as well as standardized measures in single case design. They allow for specific target constructs to be measured in a way that is repeatable and efficient. The visual analogue scale consists of a ten-centimeter line anchored at either end with maximal and minimal extremes of the dimension being measured. Participants put a mark on the line, with the mark closer to the right side indicating stronger agreement of that statement. A numerical measurement of the line gives a score for each statement based on length (between 0 and 10.)
Self-compassion scale - assessing levels of change over time for each participant
Time frame: Group A: At week 1, week 3, week 7, week 11.
26-item self-report measure of self-compassion (SCS; Neff, 2003) 26-item self-report measure of self-compassion measures overall self-compassion as well as six subscales, representing components of self-compassion: self-kindness versus self-judgment, sense of common humanity versus isolation, and mindfulness versus over-identification. Responses to each question are given on a 5-point Likert scale, from 'almost never' to 'almost always'. Subscale scores are computed by calculating the mean of subscale item responses, and therefore range from 0-5 with higher scores indicating higher levels of that construct. Total self-compassion score is calculated by reverse scoring the negative subscale items before calculating subscale means - self-judgment, isolation, and over-identification, then calculating a grand mean of all six subscale means. The total score ranges from 0-5 with higher scores indicating higher levels overall self-compassion.
Self-compassion scale - assessing levels of change over time for each participant
Time frame: Group B: At week 1, week 4, week 8, week 12.
26-item self-report measure of self-compassion (SCS; Neff, 2003) 26-item self-report measure of self-compassion measures overall self-compassion as well as six subscales, representing components of self-compassion: self-kindness versus self-judgment, sense of common humanity versus isolation, and mindfulness versus over-identification. Responses to each question are given on a 5-point Likert scale, from 'almost never' to 'almost always'. Subscale scores are computed by calculating the mean of subscale item responses, and therefore range from 0-5 with higher scores indicating higher levels of that construct. Total self-compassion score is calculated by reverse scoring the negative subscale items before calculating subscale means - self-judgment, isolation, and over-identification, then calculating a grand mean of all six subscale means. The total score ranges from 0-5 with higher scores indicating higher levels overall self-compassion.
Self-compassion scale - assessing levels of change over time for each participant
Time frame: Group C: At week 1, week 5, week, 9, week 13
26-item self-report measure of self-compassion (SCS; Neff, 2003) 26-item self-report measure of self-compassion measures overall self-compassion as well as six subscales, representing components of self-compassion: self-kindness versus self-judgment, sense of common humanity versus isolation, and mindfulness versus over-identification. Responses to each question are given on a 5-point Likert scale, from 'almost never' to 'almost always'. Subscale scores are computed by calculating the mean of subscale item responses, and therefore range from 0-5 with higher scores indicating higher levels of that construct. Total self-compassion score is calculated by reverse scoring the negative subscale items before calculating subscale means - self-judgment, isolation, and over-identification, then calculating a grand mean of all six subscale means. The total score ranges from 0-5 with higher scores indicating higher levels overall self-compassion.
Self-Assessed Wisdom Scale (SAWS) - assessing levels of change over time for each participant
Time frame: Group A: At week 1, week 3, week 7, week 11.
40-item self-report measure of wisdom (SAWS; Webster, 2007) This 40-item self-report measure of wisdom uses a 6-point Likert scale to measure five subscales of wisdom: critical life experience, reminiscence and reflectiveness, openness, emotional regulation, and humor. Each subsale total ranges from 0 to 40, with higher numbers indicating higher levels of that construct. Adding total subscale scores together will generate a total SAWS wisdom score, with values ranging from 40 to 200, with a higher score indicating an overall higher level of wisdom.
Self-Assessed Wisdom Scale (SAWS) - assessing levels of change over time for each participant
Time frame: Group B: At week 1, week 4, week 8, week 12.
40-item self-report measure of wisdom (SAWS; Webster, 2007) This 40-item self-report measure of wisdom uses a 6-point Likert scale to measure five subscales of wisdom: critical life experience, reminiscence and reflectiveness, openness, emotional regulation, and humor. Each subsale total ranges from 0 to 40, with higher numbers indicating higher levels of that construct. Adding total subscale scores together will generate a total SAWS wisdom score, with values ranging from 40 to 200, with a higher score indicating an overall higher level of wisdom.
Self-Assessed Wisdom Scale (SAWS) - assessing levels of change over time for each participant
Time frame: Group C: At week 1, week 5, week, 9, week 13
40-item self-report measure of wisdom (SAWS; Webster, 2007) This 40-item self-report measure of wisdom uses a 6-point Likert scale to measure five subscales of wisdom: critical life experience, reminiscence and reflectiveness, openness, emotional regulation, and humor. Each subsale total ranges from 0 to 40, with higher numbers indicating higher levels of that construct. Adding total subscale scores together will generate a total SAWS wisdom score, with values ranging from 40 to 200, with a higher score indicating an overall higher level of wisdom.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- BackgroundKazdin, AE. Single-case research designs: Methods for clinical and applied settings. Oxford University Press, 2011.
- BackgroundKnight BG, Laidlaw, K. Translational theory: A wisdom-based model for psychological interventions to enhance well-being in later life. In V. L. Bengston, D. Gans, N. M. Pulney, & M. Silverstein (Eds.), Handbook of theories of aging (pp. 693-705). New York, NY, US: Springer Publishing Co. 2009.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- BackgroundLaidlaw K. Are attitudes to ageing and wisdom enhancement legitimate targets for CBT for late life depression and anxiety?. Nordic Psychology 62: 27-42, 2010.
- BackgroundLaidlaw K. Enhancing cognitive behavior therapy with older people using gerontological theories as vehicles for change. Casebook of Clinical Geropsychology: International Perspectives on Practice, 17, 2010.
- BackgroundLaidlaw K, Kishita, N. Age-appropriate augmented cognitive behavior therapy to enhance treatment outcome for late-life depression and anxiety disorders. Geropsych 28: 57-66, 2015.
- BackgroundLaidlaw K. CBT for older people: An introduction. Sage, London, 2015.
- Background: PubMed 11279805Morgan DL, Morgan RK. Single-participant research design. Bringing science to managed care. Am Psychol. 2001 Feb;56(2):119-27.
- Background: PubMed 24576589Mueller AE, Segal DL, Gavett B, Marty MA, Yochim B, June A, Coolidge FL. Geriatric Anxiety Scale: item response theory analysis, differential item functioning, and creation of a ten-item short form (GAS-10). Int Psychogeriatr. 2015 Jul;27(7):1099-111. doi: 10.1017/S1041610214000210. Epub 2014 Feb 27.
- BackgroundNeff KD. The development and validation of a scale to measure self-compassion. Self and identity 2(3): 223-250, 2003.
- BackgroundOffice for National Statistics (2017). Overview of the UK population: July 2017. Retrieved from https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/articles/overviewoftheukpopulation/july2017
- Background: PubMed 22845874Smith JD. Single-case experimental designs: a systematic review of published research and current standards. Psychol Methods. 2012 Dec;17(4):510-50. doi: 10.1037/a0029312. Epub 2012 Jul 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam JZ Kadri principal investigator
University of East Anglia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy for older adults: wisdom enhancement 'timeline technique' in people with Depression in Old Age, run by University of East Anglia at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
9-item Patient Health Questionnaire - assessing levels of change over time for each participant (time frame: Group A: Weekly throughout study completion, up to 7 weeks and once at 1 month follow-up: at week 11). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04015505, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.