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A randomized controlled trial of Problem-solving versus Cognitive restructuring Of Medically Ill Seniors with depression (PROMISE-D trial)

A randomized controlled trial of the effect on depression of Problem-solving versus Cognitive restructuring Of Medically Ill Seniors with depression (PROMISE-D trial)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000854831
Acronym
PROMISE-D
Enrollment
177
Registered
2012-08-14
Start date
2012-10-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The proposed study is a randomized controlled trial of two evidence-based treatments for late-life depression for patients who also have at least one co-morbid health problem. Participants will be randomised to two active interventions (ie PST or CBT) or treatment as usual (TAU). Randomization will be stratified by diagnosis: major depressive episode or minor depression/dysthymia, using computer-generated random numbers. All assessments will be completed by a researcher that remains blind to the allocation throughout the study. Participants will be assessed, using a range of questionnaire measures and a diagnostic interview, at pre and post-treatment, 6, and 12 months follow-up.

Interventions

Problem-solving therapy: Participants are taught problem solving strategies for dealing with illness and other stress related problems. 10 x 1 hour weekly individual sessions Cognitive Therapy: Participants are introduced to the role of thoughts in emotions, learn to recognise and challenge unhelpful beliefs and construct behavioural experiments to test out their concerns. 10, 1 hour weekly individual sessions

Sponsors

Louise Sharpe
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

(1) diagnosis of major or minor depressive disorder or dysthymia; (2) if taking anti-depressant medication, a stable dose for > 8 weeks; (3) have not received electroconvulsive therapy within 6 mths (to exclude memory problems) and (4) sufficient English.

Exclusion criteria

(1) suicidal intent requiring immediate treatment; (2) alcohol or drug abuse or dependence; (3) a history of bipolar disorder or cyclothymia; (3) a psychotic illness; (4) cognitive deficits (< 24 on the Mini-Mental State Examination); or (5) have received psychotherapy within six months.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 25, 2026