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

Depression Clinical Trial

Official title:

German Randomized Controlled Trial of the Psychotherapeutic Intervention for Advanced Cancer Patients: Managing Cancer and Living Meaningfully (CALM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02051660
• Other study ID #: DKH-110746
• Secondary ID: DKH-109967
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: December 2017

Study information

• Verified date: May 2019
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Psychological Distress

Intervention

Behavioral:
• Manualized CALM intervention
Managing Cancer and Living Meaning Cancer (CALM) is a short-term individual psychotherapy for patients with advanced disease.
• Non-manualized supportive intervention.
Supportive psycho-oncological intervention.

Locations

Country	Name	City	State
Germany	Department of Medical Psychology, University Medical Center Hamburg-Eppendorf	Hamburg
Germany	Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig	Leipzig	Saxony

Sponsors (4)

Lead Sponsor	Collaborator
University of Leipzig	German Cancer Aid, University Health Network, Toronto, University of Hamburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression module of the Patient Health Questionnaire (PHQ-9)	A reliable and valid 9-item measure of depression.	6-months
Primary	Beck Depression-Inventory II (BDI-II)	A reliable and valid 21-item self-report instrument for evaluating the severity of depression.	6-months