The primary objective of this study is to compare the effectiveness and cost-effectiveness of behavioural activation (BA) and treatment as usual (TAU) for late-life depression in primary care in the Netherlands. The main hypothesis is that compared…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Depression severity as assessed with the Quick Inventory of Depressive
Symptomatology (Q-IDS) and Patient Health Questionnaire 9 (PHQ-9) and quality
of life as assessed with the EuroQuol-5D (EQ-5D) during the 8-week treatment
period and follow-up.
Secondary outcome
A secondary goal of the study is to explore several process measures,
moderators and predictors of treatment outcome.
1. Psychopathology will be measured using the Brief symptom inventory-18
(BSI-18; [54, 55]).
2. To assess the behavioural limitations that patient experience in daily life,
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS, short
version) will be used [57].
3. To test baseline cognitive functioning the Montréal Cognitive Assessment
scale (MoCA) can be used.
4. To measure active behaviour in both BA and TAU conditions the behavioural
activation for depression scale (BADS) can be used. The BADS is a 25-item
self-report instrument measuring behavioural activation [61].
5. The expected influence of BA on physical activity of depressed participants
can be objectively registered with an accelerometer (DYnaPort MoveMonitor).
6. To test the extent of depressive brooding, the Dutch translation of the
brooding subscale of the RRS will be used [69, 70] T
7. The De Jong Gierveld short scales for emotional and social loneliness, a
6-item self-report measure can be used to test loneliness[74].
8. To measure therapeutic alliance, the Session Rating Scale (SRS) is the
instrument of choice. It consists of 4 visual scales and aims to measure the
self reported therapeutic alliance by the patient [75].
9. With the Digit Symbol substitution test (DSST) the degeneration or
improvement of psychomotor performance will be measured[76]. To measure whether
behavioural activation is effective regardless of the level of executive
functioning, the Stroop-task will be used at baseline, at the end of treatment
and in follow up measures[78].
10. Positive expectations about the treatment are related to better treatment
outcome for people with Major depressive disorder [79]. To asses this, the
credibility & expectancy questionnaire can be used.
54. Derogatis, L.R., Brief symptom inventory 18. Minneapolis, MN: NCS Pearson,
2000.
55. De Beurs, E., Brief Symptom Inventory (BSI) en BSI 18. Handleiding 2011,
2011.
57. Üstün, T.B., Measuring health and disability: manual for WHO disability
assessment schedule WHODAS 2.0. 2010: World Health Organization.
61. Kanter, J.W., et al., The Behavioral Activation for Depression Scale
(BADS): Psychometric Properties and Factor Structure. Journal of
Psychopathology and Behavioral Assessment, 2006. 29(3): p. 191-202.
69. Nolen-Hoeksema, S., Responses to depression and their effects on the
duration of depressive episodes. Journal of abnormal psychology, 1991. 100(4):
p. 569.
70. Raes, F. and D. Hermans, The revised version of the Dutch ruminative
response scale. Unpublished instrument, 2007. 8.
74. Gierveld, J.D.J. and T. Van Tilburg, The De Jong Gierveld short scales for
emotional and social loneliness: tested on data from 7 countries in the UN
generations and gender surveys. European journal of ageing, 2010. 7(2): p.
121-130.
75. Duncan, B.L., et al., The Session Rating Scale: Preliminary psychometric
properties of a *working* alliance measure. Journal of brief Therapy, 2003.
3(1): p. 3-12.
76. Wechsler, D. and W.A.I. Scale, Revised. Psychological Corp., San Antonio,
TX, 1981.
78. Stroop, J.R., Studies of interference in serial verbal reactions. Journal
of experimental psychology, 1935. 18(6): p. 643.
79. Rutherford, B.R., T.D. Wager, and S.P. Roose, Expectancy and the treatment
of depression: a review of experimental methodology and effects on patient
outcome. Current psychiatry reviews, 2010. 6(1): p. 1.
Background summary
With 12-25% prevalence, clinically significant depression is common in later
life [1, 2]. However, the efficacy of current pharmacological and psychological
treatments is limited [3]. A behavioural approach to depression is demonstrably
attractive to many older adults but such care is still largely unavailable.
Behavioural programmes for late-life depression have recently received renewed
attention with findings suggesting that Behavioural Activation (BA) may be
effective[4]. BA protocols are less complex, more trainable, and more easily
implemented than other psychological therapies, making them very suitable for
delivery by less highly trained staff. The recent introduction of the mental
health nurse (MHN) in PCCs has created major opportunities for the delivery of
dedicated programmes, improving the accessibility of and optimising
psychological treatments for late-life depression in primary care. BA may thus
help meet the needs of older patients while improving treatment outcome and
lowering costs [5, 6].
This study will compare the effectiveness and cost-effectiveness of
behavioural activation (BA), delivered by a MHN and treatment as usual (TAU)
for late-life depression in primary care .
BA is expected to be more effective and cost-effective than TAU.
1. Luppa, M., et al., Age- and gender-specific prevalence of depression in
latest-life--systematic review and meta-analysis. J Affect Disord, 2012.
136(3): p. 212-21.
2. Riedel-Heller, S.G., A. Busse, and M.C. Angermeyer, The state of mental
health in old-age across the 'old' European Union-- a systematic review. Acta
Psychiatr Scand, 2006. 113(5): p. 388-401.
3. Licht-Strunk, E., et al., Outcome of depression in later life in primary
care: longitudinal cohort study with three years' follow-up. BMJ, 2009. 338: p.
a3079.
4. Riebe, G., et al., Activity scheduling as a core component of effective care
management for late-life depression. Int J Geriatr Psychiatry, 2012. 27(12): p.
1298-304.
5. Houtjes, W., et al., Unmet needs of outpatients with late-life depression; a
comparison of patient, staff and carer perceptions. J Affect Disord, 2011.
134(1-3): p. 242-8.
6. Luppa, M., et al., Health service utilization and costs of depressive
symptoms in late life - a systematic review. Curr Pharm Des, 2012. 18(36): p.
5936-57.
Study objective
The primary objective of this study is to compare the effectiveness and
cost-effectiveness of behavioural activation (BA) and treatment as usual (TAU)
for late-life depression in primary care in the Netherlands. The main
hypothesis is that compared to TAU, BA will be more effective and less costly.
A secondary goal is to explore several potential mechanisms of change, as well
as predictors and moderators of treatment outcome of BA for late-life
depression.
Study design
The design of this study is a multicentre trial with two parallel treatment
groups: a) behavioural activation (BA, n=100), and b) treatment as usual (TAU,
n=100). 10 primary care centres (PCC) will participate, with 9 mental health
nurses .
The primary care centres, will be randomized over the two treatment conditions.
Some MHNS work for two different PCC*s. Therefore an extra randomisation rule
is: A PCC with the same MHN as another PCC, will be in the same treatment
condition as the other one. Hereby we can assure that an MHN can only be
assigned to one of the two conditions, preventing the possible transfer of
knowledge between the two treatment conditions. In half of the PCC*s the MHN*s
will be trained to give BA-treatment while the other half will treat patients
as usual. Patients in the BA-condition will receive 8 weekly 30-minute sessions
of BA. Patients in TAU will get the treatment option that their own GP
suggests.
Several outcome- and process-measurements are administered at pre-treatment,
every two to four weeks during the 8 week treatment period, post-treatment,
and every three months during the 52-week follow-up.
Intervention
The intervention will consist of 8 weekly 30-minute BA sessions delivered by a
trained mental health nurse (MHN) of the primary care practice.
Study burden and risks
Though the burden includes a time investment of the patient, no risks are
associated with participation in the study. By offering participants BA, a
new, promising treatment for depression, participants will benefit immediately
as we expect a positive influence on their depressive symptoms.
Tarweweg 2
Nijmegen 6534 AM
NL
Tarweweg 2
Nijmegen 6534 AM
NL
Listed location countries
Age
Inclusion criteria
The main inclusion criterion is a PHQ-9 score >9.
Exclusion criteria
Patients will be excluded from the trial in the case of
I) severe mental illness, including bipolar disorder, obsessive-compulsive disorder, (history of) psychosis, severe drug- or alcohol dependence.
II) high risk of suicide.
III) drug and/or alcohol abuse or dependence,
IV) prior psychotherapy received in the previous year.
V) current treatment by a mental health specialist.
VI) moderate to severe cognitive impairment (MoCA <18).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL54470.091.16 |
| OMON | NL-OMON20783 |