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

Not Applicable

• Conditions: Depressive Illness in the context of one or more medical illnesses; Mental Health - Depression

• Registration Number: ACTRN12612000854831
• Lead Sponsor: ouise Sharpe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 177

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis of depression (PRIME-MD)[Pre-treatment<br>Mid-treatment at 5 weeks<br>Post-treatment<br>6 month follow-up<br>12 month follow-up];Severity of depression (Hamilton Depression Rating Scale)[Pre-treatment<br>Post-treatment<br>6 month follow-up<br>12 month follow-up];Depressive symptoms (Geriatric Depression Scale)[Pre-treatment<br>Post-treatment<br>6 month follow-up<br>12 month follow-up]

Secondary Outcome Measures

Name	Time	Method
Quality of life (SF-36)[Pre-treatment<br>Post-treatment<br>6 month follow-up<br>12 month follow-up];Anxiety (Beck Anxiety Inventory)[Pre-treatment<br>Post-treatment<br>6 month follow-up<br>12 month follow-up];Health Care Utilization[At two year follow-up]