Treatment of Depression With Mindfulness, Acceptance and Commitment

NCT03692130 | Unknown

• 1 other identifier: SCHULZE02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized trial to proof the effects and efficacy of a new mindfulness and acceptance based group-treatment for depressive patients

Conditions

Psychotherapy; Depression

Keywords

Acceptance; Mindfulness; Commitment; Group-Psychotherapy

Outcome Measures

Primary Outcomes (1)

• Depression - Patient Health Questionnaire-9

  Measurement of changes of depressive Symptoms, so called PHQ-9. There will be a measure of the total score, range from 9 to 36, pathological in sense of depression will be any score above 15. There is only one measurement scale (PHQ-9) with nine items, no other measurements or different units in the PHQ-9.

  Measurement of PHQ-Data 3 months after inclusion of participant

Secondary Outcomes (3)

• Quality of Life - European Quality 5 Dimensions on 3 Levels

  Measurement of QoL 3 months after inclusion of participant

• Anxiety - Generalized Anxiety Disorder

  Measurement of Generalized Anxiety 3 months after inclusion of participant

• Acceptance and Commitment - Questionnaire of Mindfulness, Acceptance and Commitment (MAC-Q)

  Measurement of Mindfulness, Acceptance and Commitment 3 months after inclusion of participant

Study Arms (2)

New Treatment

ACTIVE COMPARATOR

The patients will be treated with psychological group treatment for 8 Sessions with focus on mindfulness, acceptance and commitment in a special adapted treatment process.This will be called "Mindfulness, Acceptance and Commitment-Therapy for depressive Patients".

Behavioral: Mindfulness, Acceptance and Commitment-Therapy

Known Treatment

SHAM COMPARATOR

The participants will be treated with a relaxation-treatment, long time established as "jacobson muscle relaxing technique".

Behavioral: Jacobson

Interventions

Mindfulness, Acceptance and Commitment-Therapy BEHAVIORAL

Psychotherapeutic intervention to treat depressive patients with special exercises and education to be mindful, to accept situations and behaviors and to commit with the situation or the possibility to change.

New Treatment

Jacobson BEHAVIORAL

Relaxation treatment in technique of Jacobson

Known Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Depressive Disorder

You may not qualify if:

• Somatic disorder
• psychotic disorder
• personality disorder

Sponsors & Collaborators

• Neuropsychiatrischen Zentrums Hamburg-Altona: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (1)

Neuropsychiatric Center of Hamburg

Hamburg, 22769, Germany

Location

MeSH Terms

Conditions

Depression

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Peter Tonn, MD

  Managing Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants don't know in which of the both arms they are, the outcome assessor don't know which participant of which study-arm he/she calculate
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: One group with new treatment, one group with known and defined treatment

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: October 2, 2018
• Study Start: March 18, 2019
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)