LIVES: Personalized Lifestyle Intervention for Patients With Depression

NCT05767073 | Recruiting

• 1 other identifier: 11178
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cardiovascular Risk; Depression, Unipolar; Depression, Bipolar

Keywords

depression; lifestyle; mental health care; general practice

Outcome Measures

Primary Outcomes (9)

• Reach of LIVE

  Reach of our intervention as defined by the absolute number, proportion, and representativeness of individuals who are willing to participate in LIVE

  27 months (September 2020 through November 2022)

• Adherence to LIVE

  Adherence to the LIVE lifestyle intervention as defined by the number of sessions attended by the participant out of the total of 18 sessions

  18 weeks

• Drop out from LIVE

  Drop-out from the LIVE intervention as defined by the proportion of participants who decide to prematurely stop taking part in the LIVE intervention

  18 weeks

• Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis

  Feasibility and acceptability of the LIVE intervention will be assessed using qualitative interviews Participants will be interrogated on how they experienced themes during the different modules of the intervention. A topic-list will be used by the interviewer to check whether all relevant themes on feasibility and acceptability have been discussed

  Up to week 3

• Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis

  Feasibility and acceptability of the LIVE intervention will be assessed using qualitative interviews Participants will be interrogated on how they experienced themes during the different modules of the intervention. A topic-list will be used by the interviewer to check whether all relevant themes on feasibility and acceptability have been discussed

  Up to week 6

• Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis

  Feasibility and acceptability of the LIVE intervention will be assessed using qualitative interviews Participants will be interrogated on how they experienced themes during the different modules of the intervention. A topic-list will be used by the interviewer to check whether all relevant themes on feasibility and acceptability have been discussed

  Up to week 9

• Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis

  Feasibility and acceptability of the LIVE intervention will be assessed using qualitative interviews Participants will be interrogated on how they experienced themes during the different modules of the intervention. A topic-list will be used by the interviewer to check whether all relevant themes on feasibility and acceptability have been discussed

  Up to week 12

• Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis

  Feasibility and acceptability of the LIVE intervention will be assessed using qualitative interviews Participants will be interrogated on how they experienced themes during the different modules of the intervention. A topic-list will be used by the interviewer to check whether all relevant themes on feasibility and acceptability have been discussed

  Up to week 15

• Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis

  Feasibility and acceptability of the LIVE intervention will be assessed using qualitative interviews Participants will be interrogated on how they experienced themes during the different modules of the intervention. A topic-list will be used by the interviewer to check whether all relevant themes on feasibility and acceptability have been discussed

  Up to week 18

Secondary Outcomes (18)

• Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis

  Up to week 3

• Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis

  Up to week 6

• Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis

  Up to week 9

• Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis

  Up to week 12

• Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis

  Up to week 15

Study Arms (1)

Intervention

EXPERIMENTAL

Lifestyle intervention

Behavioral: Lifestyle InterVEntion (LIVE)

Interventions

Lifestyle InterVEntion (LIVE) BEHAVIORAL

The lifestyle intervention Coaching on Lifestyle (CooL) (van Rinsum 2018)),formed the basis of LIVE and was adapted to specific dysfunctional elements in depressed patients regarding motivation and self-management. The focus is on reducing depressive symptoms, enhancing the quality of life and possibly achieving weight loss. The lifestyle intervention lasts six months, with 13 weekly 1.5 to 2 hour group sessions and five 45 to 60 -minute individual sessions with at least one person from the patient's support network of friends or family (preferably sharing the same household). All sessions end with individual homework exercises, and each session starts with a 10 to 15-minute positive psychology intervention (PPI) and 5 to 15 minutes of physical activity. These sessions are followed by two booster sessions after about two and six months. Groups consist of 4-8 people.

Intervention

Eligibility Criteria

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

You may qualify if:

• For patients in mental health care only:
• Outpatients
• Diagnosed during intake, the primary diagnosis being chronic bipolar disorder (type I or 2) or a chronic or recurrent severe depression in the narrower sense of the word
• Receiving psychopharmacological treatment
• Have had a physical and lifestyle Routine Outcome Monitoring measurement showing that three or more metabolic parameters were outside the normal range
• For patients in general practice (GP) only:
• Diagnosis of depressive symptoms or depressive disorder in the past year as registered in the general practice electronic health record and coded according to the International Classification of Primary Care (ICPC) as P03 and P76, respectively,
• At least mild depressive symptom level according to the Beck Depression Inventory-II (BDI) (score ≥14)
• Body mass index ≥ 25 kg/m2 or increased waist circumference (\>88cm (women) of \>102cm (men)).
• For both patient groups:
• \- 18 years or older and capable to participate in the intervention according to the treating physician Availability of one or two people close to the patient (friends or family, preferably sharing the same household), i.e. to act as the buddy of the patient.

You may not qualify if:

• For GP patients only: current treatment in mental health care (GGZ in Dutch)
• For GP patients only: severe somatic / neurological disease at the discretion of the GP
• Currently participating in another lifestyle intervention
• Insufficient proficiency in Dutch
• Unability to read and write

Sponsors & Collaborators

• University Medical Center Groningen: lead
• GGZ Drenthe Mental Health Institution: collaborator

Study Sites (2)

GGZ Drenthe

Assen, Drenthe, 9404 LA, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, 9700 AD, Netherlands

RECRUITING

Related Publications (2)

• Ormel J, Von Korff M, Burger H, Scott K, Demyttenaere K, Huang YQ, Posada-Villa J, Pierre Lepine J, Angermeyer MC, Levinson D, de Girolamo G, Kawakami N, Karam E, Medina-Mora ME, Gureje O, Williams D, Haro JM, Bromet EJ, Alonso J, Kessler R. Mental disorders among persons with heart disease - results from World Mental Health surveys. Gen Hosp Psychiatry. 2007 Jul-Aug;29(4):325-34. doi: 10.1016/j.genhosppsych.2007.03.009.

  PMID: 17591509 BACKGROUND

• Knol MJ, Heerdink ER, Egberts AC, Geerlings MI, Gorter KJ, Numans ME, Grobbee DE, Klungel OH, Burger H. Depressive symptoms in subjects with diagnosed and undiagnosed type 2 diabetes. Psychosom Med. 2007 May;69(4):300-5. doi: 10.1097/PSY.0b013e31805f48b9. Epub 2007 Apr 30.

  PMID: 17470664 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder; Bipolar Disorder; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Behavioral Symptoms; Behavior

Study Officials

• Danielle Cath, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

• Marjolein Berger, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huibert Burger, MD PhD

CONTACT

+31(0)50 361 6722; h.burger@umcg.nl

Edith Liemburg, PhD

CONTACT

+31 6 10589718; e.j.liemburg@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Un controlled cohort study

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: March 14, 2023
• Study Start: September 1, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)