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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02051660

Enrollment

206

Registered

2014-01-31

Start date

2013-03-31

Completion date

2017-12-31

Last updated

2019-05-24

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

Conditions

Depression, Psychological Distress

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.

Interventions

BEHAVIORALManualized CALM intervention

Managing Cancer and Living Meaning Cancer (CALM) is a short-term individual psychotherapy for patients with advanced disease.

BEHAVIORALNon-manualized supportive intervention.

Supportive psycho-oncological intervention.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026