Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04015505
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
University of East Anglia

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.


Condition or disease Intervention/treatment Phase
Depression in Old Age Behavioral: Cognitive Behavioural Therapy for older adults: wisdom enhancement 'timeline technique' Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 27, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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'
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 Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.


  6. 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.


  7. 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.)


  8. 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.)


  9. 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.)


  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.


  11. 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.


  12. 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.


  13. 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.


  14. 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.


  15. 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.



Other Outcome Measures:
  1. Change interview questionnaire (non standardised brief qualitative questionnaire) [ Time Frame: Group A: At week 7 / End of intervention period ]

    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:

    1. What has changed for you over the course of the study?
    2. Why do you think these changes occurred?
    3. 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.


  2. Change interview questionnaire (non standardised brief qualitative questionnaire) [ Time Frame: Group B: At week 8 / End of intervention period ]

    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:

    1. What has changed for you over the course of the study?
    2. Why do you think these changes occurred?
    3. 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.


  3. Change interview questionnaire (non standardised brief qualitative questionnaire) [ Time Frame: Group C: At week 9 / End of intervention period ]

    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:

    1. What has changed for you over the course of the study?
    2. Why do you think these changes occurred?
    3. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04015505


Contacts
Layout table for location contacts
Contact: Adam JZ Kadri (+44) 07938 622501 a.kadri@uea.ac.uk
Contact: Adrian Leddy, ClinpsyD (+44) 01603 456161 a.leddy@uea.ac.uk

Locations
Layout table for location information
United Kingdom
Cambridge and Peterborough NHS Foundation Trust Recruiting
Cambridge, United Kingdom
Contact: Adam Kadri       a.kadri@uea.ac.uk   
Norfolk and Suffolk NHS Foundation Trust Recruiting
Norwich, United Kingdom
Contact: Adam Kadri       a.kadri@uea.ac.uk   
Sponsors and Collaborators
University of East Anglia
Investigators
Layout table for investigator information
Principal Investigator: Adam JZ Kadri University of East Anglia

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.
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.
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.
Neff 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
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

Layout table for additonal information
Responsible Party: University of East Anglia
ClinicalTrials.gov Identifier: NCT04015505     History of Changes
Other Study ID Numbers: 248358
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders