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

NCT04015505 | Completed

• 1 other identifier: 248358
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression in Old Age

Outcome Measures

Primary Outcomes (15)

• 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.

  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.

  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.

  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.

  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.

  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.

  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: 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.)

  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: 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.)

  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: 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.)

  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.

  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.

  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.

  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.

  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.

  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.

  Group C: At week 1, week 5, week, 9, week 13

Other Outcomes (3)

• Change interview questionnaire (non standardised brief qualitative questionnaire)

  Group A: At week 7 / End of intervention period

• Change interview questionnaire (non standardised brief qualitative questionnaire)

  Group B: At week 8 / End of intervention period

• Change interview questionnaire (non standardised brief qualitative questionnaire)

  Group C: At week 9 / End of intervention period

Study Arms (1)

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.

Behavioral: Cognitive Behavioural Therapy for older adults: wisdom enhancement 'timeline technique'

Interventions

Cognitive Behavioural Therapy for older adults: wisdom enhancement 'timeline technique' BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of East Anglia: lead

Study Sites (2)

Cambridge and Peterborough NHS Foundation Trust

Cambridge, United Kingdom

Location

Norfolk and Suffolk NHS Foundation Trust

Norwich, United Kingdom

Location

Related Publications (15)

• Kazdin, AE. Single-case research designs: Methods for clinical and applied settings. Oxford University Press, 2011.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Laidlaw K. CBT for older people: An introduction. Sage, London, 2015.

  BACKGROUND

• Morgan DL, Morgan RK. Single-participant research design. Bringing science to managed care. Am Psychol. 2001 Feb;56(2):119-27.

  PMID: 11279805 BACKGROUND

• 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.

  PMID: 24576589 BACKGROUND

• Neff KD. The development and validation of a scale to measure self-compassion. Self and identity 2(3): 223-250, 2003.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 22845874 BACKGROUND

• 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.

  PMID: 17957986 BACKGROUND

• 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

  BACKGROUND

• Elliott R. Hermeneutic single-case efficacy design. Psychother Res. 2002 Mar 1;12(1):1-21. doi: 10.1080/713869614.

  PMID: 22471329 BACKGROUND

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Adam JZ Kadri

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: July 11, 2019
• Study Start: August 27, 2019
• Primary Completion: January 21, 2020
• Study Completion: January 21, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)