German Evaluation of the Effectiveness of the Psychological Intervention Managing Cancer and Living Meaningfully (CALM)

Not Applicable

Completed

• Conditions: Depression; Psychological Distress
• Interventions: Behavioral: Manualized CALM intervention; Behavioral: Non-manualized supportive intervention.

• Registration Number: NCT02051660
• Lead Sponsor: University of Leipzig

Brief Summary

Purpose of this randomized controlled trial is to test the efficacy of the individual psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) in a German sample of patients with advanced cancer. The interventions aim is to reduce depression and distress and support psychological well-being.

Detailed Description

Principal hypothesis: The manualized psychotherapeutic intervention (CALM) will result in a significantly greater reduction in depression and psychological distress compared to a non-manualized supportive psycho-oncological intervention. Secondary hypothesis: The manualized psychotherapeutic intervention (CALM) will further result in a significantly improve psychological well-being, quality of life and sense of meaning compared to a non-manualized supportive psycho-oncological intervention.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-31
• Primary Completion: 2017-06
• Study Completion: 2017-12
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

• ≥18 years of age
• Fluency in German
• No cognitive impairment indicated in the medical record or by the attending oncologist
• Confirmed diagnosis of solid tumors with UICC (Union Internationale Contre le Cancer) stages III/IV/ metastasized cancer (all with expected survival of 12-18 months)
• PHQ-9 depression score >=9 or Distress thermometer score >=5

Exclusion Criteria

• Major communication difficulties (including language barriers)
• Inability to commit to the required 3-6 psychotherapy sessions
• A score <20 on the Short Orientation-Memory-Concentration (SOMC) test, indicating cognitive impairment unless deemed suitable at recruiter's discretion
• A score <70 on the Karnofsky-Performance Status Scale, indicating high physical symptom burden impeding study participation
• Being in psychotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manualized CALM Intervention	Manualized CALM intervention	-
Non-manualized supportive intervention	Non-manualized supportive intervention.	-

Primary Outcome Measures

Name	Time	Method
Beck Depression-Inventory II (BDI-II)	6-months	A reliable and valid 21-item self-report instrument for evaluating the severity of depression.
Depression module of the Patient Health Questionnaire (PHQ-9)	6-months	A reliable and valid 9-item measure of depression.

Trial Locations

Locations (2)

Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig; 🇩🇪 Leipzig, Saxony, Germany

Department of Medical Psychology, University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany