Clinical trial NCT04015505: Can Life's Wisdom Help Counter Depression? Evaluating the CBT Timeline Approach for Older Adults With Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression in Old Age
Lead sponsor: University of East Anglia
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 7
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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:

1. Does the timeline intervention reduce negative affect?
2. Does the timeline intervention increase self-compassion?
3. 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:

1. Baseline phase: participants will complete weekly standardised measures of mood and daily idiographic measures of mood, self-compassion and wisdom.
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 9-item Patient Health Questionnaire - assessing levels of change over time for each participant
timeFrame: Group A: Weekly throughout study completion, up to 7 weeks and once at 1 month follow-up: at week 11
measure: 9-item Patient Health Questionnaire - assessing levels of change over time for each participant
timeFrame: Group B: Weekly throughout study completion, up to 8 weeks and once at 1 month follow-up: at week 12
measure: 9-item Patient Health Questionnaire - assessing levels of change over time for each participant
timeFrame: Group C: Weekly throughout study completion, up to 9 weeks and once at 1 month follow-up: at week 13
measure: 10-item Geriatric Anxiety Scale - assessing levels of change over time for each participant
timeFrame: Group A: Weekly throughout study completion, up to 7 weeks and once at 1 month follow-up: at week 11
measure: 10-item Geriatric Anxiety Scale - assessing levels of change over time for each participant
timeFrame: Group B: Weekly throughout study completion, up to 8 weeks and once at 1 month follow-up: at week 12
measure: 10-item Geriatric Anxiety Scale - assessing levels of change over time for each participant
timeFrame: Group C: Weekly throughout study completion, up to 9 weeks and once at 1 month follow-up: at week 13
measure: Idiographic visual analogue scale - assessing daily change over time for each participant
timeFrame: Group A: Daily through study completion, for total of 43 days and once at 1 month following end of intervention period: at week 11
measure: Idiographic visual analogue scale - assessing daily change over time for each participant
timeFrame: Group B: Daily through study completion, for total of 50 days and once at 1 month following end of intervention period: at week 12
measure: Idiographic visual analogue scale - assessing daily change over time for each participant
timeFrame: Group C: Daily through study completion, for total of 57 days and once at 1 month following end of intervention period: at week 13
measure: Self-compassion scale - assessing levels of change over time for each participant
timeFrame: Group A: At week 1, week 3, week 7, week 11.
measure: Self-compassion scale - assessing levels of change over time for each participant
timeFrame: Group B: At week 1, week 4, week 8, week 12.
measure: Self-compassion scale - assessing levels of change over time for each participant
timeFrame: Group C: At week 1, week 5, week, 9, week 13
measure: Self-Assessed Wisdom Scale (SAWS) - assessing levels of change over time for each participant
timeFrame: Group A: At week 1, week 3, week 7, week 11.
measure: Self-Assessed Wisdom Scale (SAWS) - assessing levels of change over time for each participant
timeFrame: Group B: At week 1, week 4, week 8, week 12.
measure: Self-Assessed Wisdom Scale (SAWS) - assessing levels of change over time for each participant
timeFrame: Group C: At week 1, week 5, week, 9, week 13
Secondary outcomes:
Other outcomes:
measure: Change interview questionnaire (non standardised brief qualitative questionnaire)
timeFrame: Group A: At week 7 / End of intervention period
measure: Change interview questionnaire (non standardised brief qualitative questionnaire)
timeFrame: Group B: At week 8 / End of intervention period
measure: Change interview questionnaire (non standardised brief qualitative questionnaire)
timeFrame: Group C: At week 9 / End of intervention period
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge and Peterborough NHS Foundation Trust
city: Norwich
country: United Kingdom
facility: Norfolk and Suffolk NHS Foundation Trust
Study officials:
affiliation: University of East Anglia
name: Adam JZ Kadri
role: PRINCIPAL_INVESTIGATOR
References:
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