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Can Life's Wisdom Help Counter Depression? Evaluating the CBT Timeline Approach for Older Adults With Depression

Primary Purpose

Depression in Old Age

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy for older adults: wisdom enhancement 'timeline technique'
Sponsored by
University of East Anglia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression in Old Age

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cambridge and Peterborough NHS Foundation Trust
  • Norfolk and Suffolk NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.)
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.)
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.)
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 17, 2019
Last Updated
February 3, 2020
Sponsor
University of East Anglia
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1. Study Identification

Unique Protocol Identification Number
NCT04015505
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 27, 2019 (Actual)
Primary Completion Date
January 21, 2020 (Actual)
Study Completion Date
January 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of East Anglia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression in Old Age

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy for older adults: wisdom enhancement 'timeline technique'
Intervention Description
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.
Primary Outcome Measure Information:
Title
9-item Patient Health Questionnaire - assessing levels of change over time for each participant
Description
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.
Time Frame
Group A: Weekly throughout study completion, up to 7 weeks and once at 1 month follow-up: at week 11
Title
9-item Patient Health Questionnaire - assessing levels of change over time for each participant
Description
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.
Time Frame
Group B: Weekly throughout study completion, up to 8 weeks and once at 1 month follow-up: at week 12
Title
9-item Patient Health Questionnaire - assessing levels of change over time for each participant
Description
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.
Time Frame
Group C: Weekly throughout study completion, up to 9 weeks and once at 1 month follow-up: at week 13
Title
10-item Geriatric Anxiety Scale - assessing levels of change over time for each participant
Description
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.
Time Frame
Group A: Weekly throughout study completion, up to 7 weeks and once at 1 month follow-up: at week 11
Title
10-item Geriatric Anxiety Scale - assessing levels of change over time for each participant
Description
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.
Time Frame
Group B: Weekly throughout study completion, up to 8 weeks and once at 1 month follow-up: at week 12
Title
10-item Geriatric Anxiety Scale - assessing levels of change over time for each participant
Description
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.
Time Frame
Group C: Weekly throughout study completion, up to 9 weeks and once at 1 month follow-up: at week 13
Title
Idiographic visual analogue scale - assessing daily change over time for each participant
Description
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.)
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
Title
Idiographic visual analogue scale - assessing daily change over time for each participant
Description
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.)
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
Title
Idiographic visual analogue scale - assessing daily change over time for each participant
Description
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.)
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
Title
Self-compassion scale - assessing levels of change over time for each participant
Description
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.
Time Frame
Group A: At week 1, week 3, week 7, week 11.
Title
Self-compassion scale - assessing levels of change over time for each participant
Description
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.
Time Frame
Group B: At week 1, week 4, week 8, week 12.
Title
Self-compassion scale - assessing levels of change over time for each participant
Description
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.
Time Frame
Group C: At week 1, week 5, week, 9, week 13
Title
Self-Assessed Wisdom Scale (SAWS) - assessing levels of change over time for each participant
Description
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.
Time Frame
Group A: At week 1, week 3, week 7, week 11.
Title
Self-Assessed Wisdom Scale (SAWS) - assessing levels of change over time for each participant
Description
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.
Time Frame
Group B: At week 1, week 4, week 8, week 12.
Title
Self-Assessed Wisdom Scale (SAWS) - assessing levels of change over time for each participant
Description
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.
Time Frame
Group C: At week 1, week 5, week, 9, week 13
Other Pre-specified Outcome Measures:
Title
Change interview questionnaire (non standardised brief qualitative questionnaire)
Description
The 'Change interview questionnaire' is a three question qualitative questionnaire that has been created by the research team to be used specifically for this study. It is therefore not a standardised measure or scale. The questionnaire comprises of three qualitative questions based on the key information elicited in the semi-structured 'Change Interview' (Elliot, 2002), adapted to the format of a written questionnaire. This questionnaire asks the following three questions: What has changed for you over the course of the study? Why do you think these changes occurred? What has been helpful? Participants are asked to write qualitative answers to each question using the free space provided after each question. The answers to these questions will not be included in any formal analysis but will provide additional information in helping to evaluate the validity of any intervention effects for each case.
Time Frame
Group A: At week 7 / End of intervention period
Title
Change interview questionnaire (non standardised brief qualitative questionnaire)
Description
The 'Change interview questionnaire' is a three question qualitative questionnaire that has been created by the research team to be used specifically for this study. It is therefore not a standardised measure or scale. The questionnaire comprises of three qualitative questions based on the key information elicited in the semi-structured 'Change Interview' (Elliot, 2002), adapted to the format of a written questionnaire. This questionnaire asks the following three questions: What has changed for you over the course of the study? Why do you think these changes occurred? What has been helpful? Participants are asked to write qualitative answers to each question using the free space provided after each question. The answers to these questions will not be included in any formal analysis but will provide additional information in helping to evaluate the validity of any intervention effects for each case.
Time Frame
Group B: At week 8 / End of intervention period
Title
Change interview questionnaire (non standardised brief qualitative questionnaire)
Description
The 'Change interview questionnaire' is a three question qualitative questionnaire that has been created by the research team to be used specifically for this study. It is therefore not a standardised measure or scale. The questionnaire comprises of three qualitative questions based on the key information elicited in the semi-structured 'Change Interview' (Elliot, 2002), adapted to the format of a written questionnaire. This questionnaire asks the following three questions: What has changed for you over the course of the study? Why do you think these changes occurred? What has been helpful? Participants are asked to write qualitative answers to each question using the free space provided after each question. The answers to these questions will not be included in any formal analysis but will provide additional information in helping to evaluate the validity of any intervention effects for each case.
Time Frame
Group C: At week 9 / End of intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam JZ Kadri
Organizational Affiliation
University of East Anglia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge and Peterborough NHS Foundation Trust
City
Cambridge
Country
United Kingdom
Facility Name
Norfolk and Suffolk NHS Foundation Trust
City
Norwich
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Kazdin, AE. Single-case research designs: Methods for clinical and applied settings. Oxford University Press, 2011.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
11556941
Citation
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.
Results Reference
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Citation
Laidlaw K. Are attitudes to ageing and wisdom enhancement legitimate targets for CBT for late life depression and anxiety?. Nordic Psychology 62: 27-42, 2010.
Results Reference
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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.
Results Reference
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Citation
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.
Results Reference
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Citation
Laidlaw K. CBT for older people: An introduction. Sage, London, 2015.
Results Reference
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PubMed Identifier
11279805
Citation
Morgan DL, Morgan RK. Single-participant research design. Bringing science to managed care. Am Psychol. 2001 Feb;56(2):119-27.
Results Reference
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PubMed Identifier
24576589
Citation
Mueller 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.
Results Reference
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Citation
Neff KD. The development and validation of a scale to measure self-compassion. Self and identity 2(3): 223-250, 2003.
Results Reference
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Citation
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
Results Reference
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PubMed Identifier
22845874
Citation
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.
Results Reference
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PubMed Identifier
17957986
Citation
Webster JD. Measuring the character strength of wisdom. Int J Aging Hum Dev. 2007;65(2):163-83. doi: 10.2190/AG.65.2.d.
Results Reference
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Citation
UK 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
Results Reference
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PubMed Identifier
22471329
Citation
Elliott R. Hermeneutic single-case efficacy design. Psychother Res. 2002 Mar 1;12(1):1-21. doi: 10.1080/713869614.
Results Reference
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Can Life's Wisdom Help Counter Depression? Evaluating the CBT Timeline Approach for Older Adults With Depression

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