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Recovery-by-eHealth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04675684
Recruitment Status : Not yet recruiting
First Posted : December 19, 2020
Last Update Posted : March 18, 2021
Sponsor:
Collaborators:
Research Unit Of General Practice, Copenhagen
Frederiksberg University Hospital
Psychiatric Center Ballerup
Information provided by (Responsible Party):
Anne Sofie Aggestrup, Mental Health Centre Copenhagen

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Recovery-group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be 1:1 randomized into either a recovery group (experimental) or a control group (no intervention).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Recovery-by-eHealth: A Complex Intervention Aiding Recovery in Patients With Depression Discharged From a Psychiatric Outpatient Clinic - a 12 Months Randomized Controlled Clinical Trial
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Recovery-group

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
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.
Other Name: Intervention-group

No Intervention: Control-group
The control group consists of usual treatment at their General Practitioner and / or Private Practicing Psychiatrist.



Primary Outcome Measures :
  1. Personal recovery self-assessed by the Brief INSPIRE-O scale [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Recovery support self-assessed by the INSPIRE scale [ Time Frame: 12 months ]
    Difference between the two groups in return to recovery support from a clinician/worker from baseline until 12 months after baseline measured with Brief INSPIRE's 5-item self-rated measure of recovery support from a clinician/worker.

  2. Depressive symptoms self-assessed by the Hamilton Depression Rating 6-item Scale (Ham-D6) [ Time Frame: 12 months ]
    Difference between the two groups in return to symptoms of depression from baseline until 12 months after baseline measured with Hamilton Depression Rating Scale consisting of 6 items. Total scores from zero (no depression) to 22 (most severe depression).

  3. Wellbeing self-assessed by the WHO-5 scale [ Time Frame: 12 months ]
    Difference between the two groups in return to wellbeing from baseline until 12 months after baseline measured with WHO-5's wellbeing self-assessed scale consisting of 5 items.

  4. Number of relapses of depression blindly-assessed by the Mini International Neuropsychiatric Interview [ Time Frame: 12 months ]
    Difference between the two groups in return to number of relapses of depression from baseline until 12 months after baseline measured with a short, structured clinical diagnostic interview based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).


Other Outcome Measures:
  1. Adherence to medication according to Medicine Adherence Rating Scale (MARS) [ Time Frame: 12 months ]
    Difference between the two groups in return to medication adherence from baseline until 12 months after baseline from patients interviews and patient records (explorative outcome).

  2. Rate of hospital re-admissions [ Time Frame: 12 months ]
    Difference between the two groups in return to rate of hospital re-admissions during the project period from patient interviews and patient records (explorative outcome).

  3. Perceived stress self-assessed by the Perceived Stress Scale (PSS) [ Time Frame: 12 months ]
    Difference between the two groups in return to perceived stress according to Cohen's Perceived Stress Scale (PSS) from baseline and until 12 months after baseline (explorative outcome).

  4. Repetitive negative thinking and anxiety self-assessed by the Perseverative Thinking Questionnaire (PTQ) [ Time Frame: 12 months ]
    Difference between the two groups in return to repetitive negative thinking and anxiety according to the Perseverative Thinking Questionnaire (PTQ) from baseline and until 12 months after baseline (explorative outcome).

  5. Blood level [ Time Frame: 12 months ]
    Difference between the two groups in return to the following blood levels: C-Reactive Protein (CRP), total-cholesterol, Low-Density Lipoprotein (LDL), Low-Density Lipoprotein (HDL), and triglyceride (mg/dL) from baseline until 12 months after baseline from patient records (explorative outcome).

  6. Weight (kg) [ Time Frame: 12 months ]
    Difference between the two groups in return to weight (kg) from baseline until 12 months after baseline. The participants weight (kg) and height (meter) will be combined to calculate their Body Mass Index (kg/m^2) (explorative outcome).

  7. Height (meter) [ Time Frame: 12 months ]
    Difference between the two groups in return to height (meter) from baseline until 12 months after baseline. The participants weight (kg) and height (meter) will be combined to calculate their Body Mass Index (kg/m^2) (explorative outcome).

  8. Blood pressure [ Time Frame: 12 months ]
    Difference between the two groups in return to blood pressure (mm Hg) from baseline until 12 months after baseline (explorative outcome).

  9. Blood level [ Time Frame: 12 months ]
    Difference between the two groups in return to Thyrotropin (TSH; mIU/L) from baseline until 12 months after baseline (explorative outcome).

  10. Blood level [ Time Frame: 12 months ]
    Difference between the two groups in return to Vitamin D (nmol/L) from baseline until 12 months after baseline (explorative outcome).

  11. Blood level [ Time Frame: 12 months ]
    Difference between the two groups in return to Hemoglobin A1c (HbA1c; mmol/mol) from baseline until 12 months after baseline (explorative outcome).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Psychotic depression at inclusion
  • Dementia or other organic brain disorders
  • Alcohol substance abuse that is expected to interfere with the study procedures
  • INSPIRE-O score > 65 at inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04675684


Contacts
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Contact: Anne Sofie Aggestrup, MSc, PhD student +45 40149422 anne.sofie.aggestrup@regionh.dk
Contact: Klaus Martiny, Professor +45 38647102 klaus.martiny@regionh.dk

Sponsors and Collaborators
Mental Health Centre Copenhagen
Research Unit Of General Practice, Copenhagen
Frederiksberg University Hospital
Psychiatric Center Ballerup
Additional Information:
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Responsible Party: Anne Sofie Aggestrup, MSc, PhD student, Mental Health Centre Copenhagen
ClinicalTrials.gov Identifier: NCT04675684    
Other Study ID Numbers: H-20076894
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anne Sofie Aggestrup, Mental Health Centre Copenhagen:
Recovery
Depression
Prevention
Physical health
Mental health
Randomized Controlled Trial
Mixed methods
Intersectoral collaboration
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders