Clinical Trials Logo

Clinical Trial Summary

Persons with affective disorder have a considerably increased risk of cardiovascular disease. To a considerable extent, this is due to an unhealthy life style. At present, no adequate lifestyle interventions are available for these patients. In the present pilot intervention study we study the acceptability and feasibility of a newly developed lifestyle intervention that is specifically tailored to the needs of patients with affective disorders treated in mental health care or general practice.

Clinical Trial Description

Rationale: Patients with bipolar disorder and severe depressions have a 10-year shorter life expectancy, on average, than the population as a whole. Also patients with less severe depression are still at a substantially increased risk of cardiovascular events. This may be attributed primarily to somatic complications resulting from a largely sedentary existence and an unhealthy lifestyle related to their disorder and/or the side effects of psychopharmacological treatment. Generally speaking, multimodal lifestyle interventions are about as effective as medication in reducing cardiovascular risks. Very little research has been conducted into the effect of lifestyle interventions among outpatients in mental health care or patients with mental health problems in general practice. This study seeks to examine the extent to which a personalised lifestyle approach can promote the physical health and quality of life of outpatients and general practice patients with affective disorders. Objective: The objective of this study is to develop a personalised state-of-the art lifestyle intervention that is both feasible and acceptable to outpatients with bipolar and severe recurrent depressive disorder and to patients with depression in general practice Study design: An explorative pilot study (n = 38) with baseline measurement and different follow-up measurements during and after the intervention. Study population: Patients (18-65 years old) with bipolar disorder or severe recurrent depression who are being treated at GGZ Drenthe (N=30) and patients with depression in primary care (N=8). Intervention (if applicable): A personalised multimodal lifestyle intervention consisting of several modules comprising both individual and group sessions. The support network is involved during the individual sessions. Main study parameters/endpoints: Feasibility and acceptability of the lifestyle intervention. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05767073
Study type Interventional
Source University Medical Center Groningen
Contact Huibert Burger, MD PhD
Phone +31(0)50 361 6722
Status Recruiting
Phase N/A
Start date September 1, 2020
Completion date June 1, 2023

See also
  Status Clinical Trial Phase
Completed NCT04469322 - Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression N/A
Recruiting NCT02919280 - Dallas 2K: A Natural History Study of Depression
Completed NCT00060489 - Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar Depression Phase 3
Completed NCT04121091 - Pramipexole to Target "Anhedonic Depression" Phase 2
Recruiting NCT04057378 - Optimal Electrical Stimulus During Electroconvulsive Therapy Phase 4
Completed NCT03287037 - The Effects of tDCS on Depressive Symptoms,Neurocognitive Function and HRV in Unipolar Depression and Bipolar Depression N/A
Completed NCT00483548 - Adjunctive Ziprasidone in the Treatment of Bipolar I Depression Phase 3
Not yet recruiting NCT05568823 - Biomarkers of ANTidepressant RESponse and Development Risk of Bipolar Disorder N/A
Completed NCT00191399 - Bipolar Depression Study: Bipolar Depression Assessment Study on Treatment Response Phase 4
Recruiting NCT05436613 - Transcranial Direct Current Stimulation Therapy for Bipolar Depression N/A
Recruiting NCT03538275 - Medibio Depression Monitoring Study
Recruiting NCT04846010 - Recovering Damaged Cells for Sequelae Caused by COVID-19, SARS-CoV-2 Phase 1/Phase 2
Withdrawn NCT02625779 - Combined Cytidine and Creatine-containing Drug in the Treatment of the Bipolar Depression Phase 2
Recruiting NCT02778256 - Study of the Effectiveness of Vestibular Stimulation Treatment in the Depressive Phase of Bipolar Disorder N/A
Active, not recruiting NCT04643210 - Management of my Bipolarity Intervention in Bipolar Disorder Patients N/A
Completed NCT01396447 - Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression Phase 2
Enrolling by invitation NCT02827045 - Study of a Vestibular Biomarker of Phase in Bipolar Disorder
Completed NCT01898429 - Deep Brain Stimulation (DBS) for Treatment-Resistant Depression (TRD) N/A
Completed NCT01303601 - Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression Phase 4
Active, not recruiting NCT00590265 - Light-Therapy in the Treatment of the Acute Phase of the Bipolar Type II Depression N/A