Integrative-Interpersonal Dynamic Therapy for Post Stroke Depression: INID-PILOT

Phase 1

• Conditions: Depression according to DSM-5; I61; I63; F32; Intracerebral haemorrhage; Cerebral infarction; Depressive episode

• Registration Number: DRKS00030378
• Lead Sponsor: Klinisches Institut für Psychosomatische Medizin und Psychotherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1) Occurrence of ischemic stroke (ICD-Code: I.63) and intracerebral hemorrhage (I.61) in patients admitted to the two participating Stroke Units Düsseldorf and Heidelberg.
2) Sufficient verbal comprehension at baseline (T0) as defined by sum of = 6 points of the shortened Aphasie-Schnell-Test (AST)3) Sufficient German language comprehension for questionnaire completion and participation in psychotherapy.
4) Depression (i.e., a PHQ-9 score = 11) after discharge from inpatient rehabilitation (T1)

Exclusion Criteria

1) patients with transitory ischemic attack (TIA: ICD-Code G.45)
2) Patients with severe intracerebral hemorrhage, requiring neurosurgical treatment shortly after stroke.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is 1) RCT recruitment feasibility and 2) intervention acceptability defined as:<br><br>1) recruitment rate (i.e., consent to randomization) of >=20% of eligible patients at T1 (i.e., self-reported PHQ >= 11 at the screening after discharge from inpatient rehabilitation <br>2) Treatment completion (i.e., participation in >=66% of all therapy sessions) of >=70% in the intervention group

Secondary Outcome Measures

Name	Time	Method
As secondary outcomes, changes in depression (PHQ-9/HAMD-D) and anxiety (GAD-7) across all follow-ups (T1 and T2) will tested using uni- and multivariate ANOVA with repeated measurements.