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Completed

NCT Number: NCT03735576

Cognitive Behavioural Therapy for the Treatment of Late Life Depression

This study addresses the unmet medical problem of insufficient treatment of late life depression (LLD). Compared with depression in early adulthood, treatment options of LLD are limited. This trial is the first confirmatory multicentre study to test the efficacy of an LLD-adapted cognitive behavioural therapy (CBT) program. It will test the hypothesis, that LLD-specific cognitive behavioural therapy (CBT) is superior to unspecific supportive intervention (SUI) with regard to reducing symptoms of depression over the course of 6 months. Secondary goals are to test the efficacy of LLD-CBT in comparison with SUI on patient reported outcome in major depressive disorders (PRO-MDD), anxiety, cognition, quality of life, overall health status, sleep and global clinical impression.

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Key information

Conditions

Late-Life Depression Depressive Disorder Depressive Disorder, Major Disease Attributes Major Depressive Disorder Major Depressive Disorder, Recurrent Major Depressive Episode Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Berlin, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • out-patient status
  • male or female, age ≥ 60 years
  • ability to provide informed consent and written informed consent signed
  • DSM-5 diagnosis of a Major Depressive Disorder/MDD (depressive episode at least moderate to severe)
  • score of at least 10 on the Geriatric Depression Scale (GDS)
  • score of at least 10 on the Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
  • score of at least 25 in the Mini-Mental-Status-Test (MMST)
  • no or stable (≥ 6 weeks) antidepressive pharmacological treatment at baseline (medication will be kept stable at least throughout the 8 weeks of treatment).
  • sufficient German language skills

Exclusion criteria

  • Bipolar depression
  • Schizophrenia or other psychotic disorders
  • Substance abuse or dependency
  • Dementia
  • Acute suicidality
  • Anxiety disorder as stand-alone diagnosis (e.g. generalized anxiety disorder, panic disorder, social phobia)
  • Obsessive-compulsive disorder (OCD) as stand-alone diagnosis
  • Participation in any another clinical trial parallel to this trial
  • Additional psychological/psychotherapeutic treatment throughout the 8-week treatment period
  • Regular use with scheduled daily dosing of benzodiazepines (not PRN) during 8-week treatment
  • Severe or instable medical condition, which clearly impacts on depression or on the ability to participate in the trial
  • Brain disease with severe functional impairment that impacts the ability to participate in the trial (e.g. aphasia, Parkinson's disease)

Treatment and study plan

Psychotherapy

Behavioral

15-session individually-delivered CBT specific for LLD in comparison with a supportive unspecific intervention (SUI) of the same quantity

Questionnaires

Diagnostic Test

There will be a total of four assessments (see primary & secondary endpoints). The first visit of the study will be a screening and baseline (T0) visit. After the baseline assessment, the subjects will be randomized to either of the two treatment arms. Within one week, the first of the successive bi-weekly 50-minute individual face-to-face treatment sessions will be performed by a study therapist. After 7 therapy sessions, the primary and secondary outcomes will be obtained in week 5 (T1) by the blinded rater. This will be followed by the treatment sessions 8 to 15 which will be carried out by the therapist. End-of-treatment primary and secondary outcomes will be obtained in week 10 (T2). The final follow-up assessment (T3) will be performed 6 months after randomization by the blinded rater.

Magnetic Resonance Imaging

Other

Underlying mechanisms are examined using neuroimaging. MRI data are acquired at four scanning sites and will be performed at baseline, end-of-treatment and follow-up to obtain a high-resolution structural T1-weighted image, a T2-weighted FLAIR image, a resting state fMRI, and diffusion tensor imaging (DTI) of the subjects' brain.

Blood analysis

Other

Blood sampling will be acquired in order to investigate the underlying mechanisms in LLD and the specific effects of psychotherapy. Blood samples are acquired at five sites at baseline (T0), T1, T2 and T3 for genetic and epigenetic analyses, measurement of Amyloid-β, Neurofilament light chain (NFL), Peripheral Blood Mononuclear Cells (PBMCs), Metabolomics, Proteomics and miRNA analyses.

Primary outcomes

  1. Change of Geriatric Depression Scale (GDS) Score

    Time frame: 10 weeks

    The primary end point is the change in depression severity from baseline to week 10 measured by the 30-item Geriatric Depression Scale (GDS). It is a self-rating scale including 30 Items in a yes/no format and a total score range from 0 to 30. Higher values represent worse outcome.

Secondary outcomes

  1. Change of Geriatric Depression Scale (GDS) Score

    Time frame: 5 weeks

    A secondary outcome measure is the change in depression severity from baseline to week 5 measured by the 30-item Geriatric Depression Scale (GDS). It is a self-rating scale including 30 Items in a yes/no format and a total score range from 0 to 30. Higher values represent worse outcome.

  2. Change of Geriatric Depression Scale (GDS) Score

    Time frame: 6 months

    A secondary outcome measure is the change in depression severity from baseline to month 6 measured by the 30-item Geriatric Depression Scale (GDS). It is a self-rating scale including 30 Items in a yes/no format and a total score range from 0 to 30. Higher values represent worse outcome.

  3. Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)

    Time frame: 5 weeks

    A secondary outcome measure is the change in depression severity from baseline to week 5 measured by the 16-item Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C). It is a clinician-rated scale including 16 Items and a total score range from 0 to 27. Higher values represent worse outcome.

  4. Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)

    Time frame: 10 weeks

    A secondary outcome measure is the change in depression severity from baseline to week 10 measured by the 16-item Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C). It is a clinician-rated scale including 16 Items and a total score range from 0 to 27. Higher values represent worse outcome.

  5. Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)

    Time frame: 6 months

    A secondary outcome measure is the change in depression severity from baseline to month 6 measured by the 16-item Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C). It is a clinician-rated scale including 16 Items and a total score range from 0 to 27. Higher values represent worse outcome.

  6. Change of Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score

    Time frame: 10 weeks

    A secondary outcome measure is the change in depression severity from baseline to week 10 measured by the 35-item Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score. It is a self-rating scale including 35 Items on an11-point numeric rating scale. Higher values represent worse outcome.

  7. Change of Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score

    Time frame: 6 months

    A secondary outcome measure is the change in depression severity from baseline to month 6 measured by the 35-item Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score. It is a self-rating scale including 35 Items on an11-point numeric rating scale. Higher values represent worse outcome.

  8. Longitudinal Interval Follow-up Evaluation (LIFE)

    Time frame: 6 months

    A secondary outcome measure is the longitudinal evaluation of depressive symptoms by the Longitudinal Interval Follow-up Evaluation Interview (LIFE) at month 6.

  9. Change of Insomnia Severity Index (ISI) Score

    Time frame: 10 weeks

    A secondary outcome measure is the change in insomnia severity from baseline to week 10 measured by the 7-item Insomnia Severity Index (ISI). It is a self-rating scale including 7 Items rated on a scale from 0 to 4 from less to more severe. The total score ranges from 0 to 28. Higher values represent worse outcome.

  10. Change of Insomnia Severity Index (ISI) Score

    Time frame: 6 months

    A secondary outcome measure is the change in insomnia severity from baseline to month 6 measured by the 7-item Insomnia Severity Index (ISI). It is a self-rating scale including 7 Items rated on a scale from 0 to 4 from less to more severe. The total score ranges from 0 to 28. Higher values represent worse outcome.

  11. Change of Epworth Sleepiness Scale (ESS) Score

    Time frame: 10 weeks

    A secondary outcome measure is the change in sleepiness from baseline to week 10 measured by the 8-item Epworth Sleepiness Scale (ESS). It is a self-rating scale including 8 Items rated on a 4-point Likert scale. The total score ranges from 0 to 24. Higher values represent worse outcome.

  12. Change of Epworth Sleepiness Scale (ESS) Score

    Time frame: 6 months

    A secondary outcome measure is the change in sleepiness from baseline to month 6 measured by the 8-item Epworth Sleepiness Scale (ESS). It is a self-rating scale including 8 Items rated on a 4-point Likert scale. The total score ranges from 0 to 24. Higher values represent worse outcome.

  13. Change of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)Score

    Time frame: 10 weeks

    A secondary outcome measure is the change in REM sleep behavior from baseline to week 10 measured by the 10-item REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ). It is a self-rating scale including 10 Items in a yes/no format. The total score ranges from 0 to 13. Higher values represent worse outcome.

  14. Change of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)Score

    Time frame: 6 months

    A secondary outcome measure is the change in REM sleep behavior from baseline to month 6 measured by the 10-item REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ). It is a self-rating scale including 10 Items in a yes/no format. The total score ranges from 0 to 13. Higher values represent worse outcome.

  15. Change of Geriatric Anxiety Inventory (GAI) Score

    Time frame: 10 weeks

    A secondary outcome measure is the change in anxiety symptoms from baseline to week 10 measured by the 20-item Geriatric Anxiety Inventory (GAI). It is a self-rating scale including 20 Items in a agree/disagree format and a total score range from 0 to 20. The cut-off score of 9 classifies the presence of clinically significant anxiety. Higher values represent worse outcome.

  16. Change of Geriatric Anxiety Inventory (GAI) Score

    Time frame: 6 months

    A secondary outcome measure is the change in anxiety symptoms from baseline to month 6 measured by the 20-item Geriatric Anxiety Inventory (GAI). It is a self-rating scale including 20 Items in a agree/disagree format and a total score range from 0 to 20. The cut-off score of 9 classifies the presence of clinically significant anxiety. Higher values represent worse outcome.

  17. Change in Quality of Life (WHOQOL)

    Time frame: 10 weeks

    A secondary outcome measure is the change in quality of life from baseline to week 10 measured by the 24-item WHOQOL-OLD and 26-item WHOQOL-BREF.

  18. Change in Quality of Life (WHOQOL)

    Time frame: 6 months

    A secondary outcome measure is the change in quality of life from baseline to month 6 measured by the 24-item WHOQOL-OLD and 26-item WHOQOL-BREF.

  19. Change in Short Form Health Survey (SF-36)

    Time frame: 10 weeks

    A secondary outcome measure is the change in overall health status from baseline to week 10 measured by the 36-item Short Form Health Survey (SF-36).

  20. Change in Short Form Health Survey (SF-36)

    Time frame: 6 months

    A secondary outcome measure is the change in overall health status from baseline to month 6 measured by the 36-item Short Form Health Survey (SF-36).

  21. Change in Subjective Cognitive Functioning

    Time frame: 6 months

    A secondary outcome measure is the change in subjective cognitive functioning from baseline to month 6 measured by the semi-structured Subjective Cognitive Decline interview.

  22. Change in cognitive function (CERAD-Plus)

    Time frame: 6 months

    A secondary outcome measure is the change in cognitive function from baseline to month 6 measured by the Consortium to Establish a Registry for Alzheimer's Disease (CERAD-Plus) neuropsychological test battery.

  23. Change in executive function (NAB maze test)

    Time frame: 6 months

    A secondary outcome measure is the change in executive function from baseline to month 6 measured by the Neuropsychological Assessment Battery (NAB) maze subtest.

  24. Childhood Trauma Questionnaire (CTQ)

    Time frame: baseline

    Assessment of the severity of five categories of childhood trauma(emotional/physical/sexual abuse and emotional/physical neglect) at baseline

  25. Big Five-Inventory 10 Item Short Version (BFI-10)

    Time frame: baseline

    10-item scale measuring the personality traits Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness to assess the influence of personality traits on treatment outcome at baseline. The items are rated on a five-step scale from 1 "disagree strongly" to 5 "agree strongly". The scale consists of 2 BFI items for each Big Five Dimension.

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

Cognitive Behavioural Therapy for the Treatment of Late Life Depression - a Multicentre, Randomized, Observer- Blinded, Controlled Trial (CBTlate)

Acronym: CBTlate

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Nov 8, 2018
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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