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

University of Leipzig

Status: Completed

Conditions: Depression; Psychological Distress

Treatments: Behavioral: Manualized CALM intervention; Behavioral: Non-manualized supportive intervention.

Study type: Interventional

Funder types: Other

Identifiers

NCT02051660

DKH-109967 (Other Grant/Funding Number)

DKH-110746

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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206 participants in 2 patient groups

Manualized CALM Intervention

Experimental group

Treatment:

Behavioral: Manualized CALM intervention

Non-manualized supportive intervention

Active Comparator group

Treatment:

Behavioral: Non-manualized supportive intervention.