NCT04675684

Brief Summary

This study investigates whether a complex intervention can aid recovery and prevent relapse in depression and readmissions in patients who have previously been treated for depression at a psychiatric outpatient clinic.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable depression

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

3 years

First QC Date

December 3, 2020

Last Update Submit

March 16, 2021

Conditions

Depression

Keywords

RecoveryDepressionPreventionPhysical healthMental healthRandomized Controlled TrialMixed methodsIntersectoral collaboration

Outcome Measures

Primary Outcomes (1)

  • Personal recovery self-assessed by the Brief INSPIRE-O scale

    Difference between the two groups in return to personal recovery from baseline until 12 months after baseline measured whit Brief INSPIRE-O's 5-item self-rated measure of personal recovery.

    12 months

Secondary Outcomes (4)

  • Recovery support self-assessed by the INSPIRE scale

    12 months

  • Depressive symptoms self-assessed by the Hamilton Depression Rating 6-item Scale (Ham-D6)

    12 months

  • Wellbeing self-assessed by the WHO-5 scale

    12 months

  • Number of relapses of depression blindly-assessed by the Mini International Neuropsychiatric Interview

    12 months

Other Outcomes (11)

  • Adherence to medication according to Medicine Adherence Rating Scale (MARS)

    12 months

  • Rate of hospital re-admissions

    12 months

  • Perceived stress self-assessed by the Perceived Stress Scale (PSS)

    12 months

  • +8 more other outcomes

Study Arms (2)

Recovery-group

EXPERIMENTAL

The recovery group consists of: 1. Physical, mental and social health education, advice and feedback from a health investigator. 2. Daily self-monitoring about their mood and health in an app, Monsenso. 3. Intersectoral collaboration between 1) Mental Health Centre Copenhagen Rigshospitalet, IAOC 2) Centre for Research and Education in General Practice, University of Copenhagen 2) Centre for Social Medicine at Frederiksberg Hospital, 3) Competence Centre for Rehabilitation and Recovery, Mental Health Centre Ballerup, and 5) Private Practicing Psychiatrists.

Behavioral: Recovery-group

Control-group

NO INTERVENTION

The control group consists of usual treatment at their General Practitioner and / or Private Practicing Psychiatrist.

Interventions

Recovery-groupBEHAVIORAL

The complex intervention are instructions in ruminations-therapy and mindfulness, advice in healthy diets, physical - and social activities and sleep hygiene, and support in smoking cessation, alcohol counseling and medication adherence.

Also known as: Intervention-group
Recovery-group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Treated for depression at the IAOC for minimum 6 months and with a planned continued treatment in primary health care

You may not qualify if:

  • Dementia or other organic brain disorders
  • Alcohol substance abuse that is expected to interfere with the study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

DepressionPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Central Study Contacts

Anne Sofie Aggestrup, MSc, PhD student

CONTACT

+45 40149422anne.sofie.aggestrup@regionh.dk

Klaus Martiny, Professor

CONTACT

+45 38647102klaus.martiny@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be 1:1 randomized into either a recovery group (experimental) or a control group (no intervention).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PhD student

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 19, 2020

Study Start

August 1, 2021

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

March 18, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share