Recovery-by-eHealth

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression
• Intervention / Treatment: Behavioral: Recovery-group

Detailed Description

Background: During the last seven years, our research group has collected considerable experience with conducting and contributing studies aiming to prevent relapse of depression and readmissions using a complex intervention with electronic self-monitoring in combination with feedback from health investigators. In our first study ("SAFE-I: Electronic self-monitoring with clinical feedback in depression, a feasibility study"), we used a self-monitoring system to investigate the connection between sleep and depression after discharge from a psychiatric inpatient ward to the Intensive Affective Outpatient Clinic (IAOC) in combination with weekly feedback from investigators by telephone. Patients evaluated the electronic system with a high usability score, and there was a high data entry rate. Patients gradually delayed their sleep after discharge from the psychiatric inpatient ward, and this delay of sleep was found to be related to a worsening of depression. Subsequently, we designed a Randomized Controlled Trial (RCT) ("SAFE II: Can electronic self-monitoring with closed loop feedback focusing on regulation of the sleep-wake cycle reduce relapse of depression after discharge from a psychiatric ward") that included patients before discharge from a psychiatric inpatient ward and in the early faces of their stay at IAOC, and followed them for four weeks. Patients were randomized to one group using electronic self-monitoring with feedback from health investigators focusing on self-reported data, and another group that in addition to the electronic self-monitoring was guided to attain signals to the circadian clock to stabilize the, sleep-wake cycle (diet, daylight exposure, sleep, and behavioral motivation towards social function and physical activity). In all, 103 patients were included in the trial (last patient visit 22-12-2020). From the qualitative data in this study, we found that patients expressed a feeling of support and safety by participating in the study. They especially felt that the electronic self-monitoring with continuous feedback from investigators provided them with an important reflection on their activity and mental health. The depression severity decreased significantly in both groups, comparable to what was found in the SAFE-I study. Readmission rates were low in both groups (7.8 %). However, the study lacked an independent evaluation of the implementation of the health interventions, i.e. process evaluation. Users were not involved in the study's design. The SAFE-studies found that feedback from investigators is deemed critical for a positive outcome, a finding supported by reviews of studies using electronic self-monitoring in combination with feedback from investigators for patients with depression. This proposed trial comprise further development based on experiences from these studies.

Objective: Recovery-by-eHealth 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.

Design: A randomized controlled trial. Participants will be 1:1 randomized into either an recovery-group or a control-group.

Intervention: Participants allocated to the recovery-group will make daily self-monitoring about their physical, mental and social health in an app for one week in total each month. At the end of these weekly periods a health investigator will phone the patients to provide feedback. Additional calls are allowed when needed. Patients allocated to the control-group will follow their usual treatment at their general practitioner and/or private practice psychiatrist.

The project will be an intersectoral collaboration between 1) Mental Health Centre Copenhagen Rigshospitalet, Intensive Affective Outpatient Clinic 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.

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

Primary outcome:

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

Secondary outcomes:

• Number of relapses of depression blindly assessed by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
• Depressive symptoms self-assessed by the Hamilton Depression Rating 6-item Scale (Ham-D6)
• Well-being self-assessed by the WHO-5 scale
• Recovery support self-assessed by the INSPIRE scale

Explorative outcomes:

• Adherence to medication according to Medicine Adherence Rating Scale (MARS)
• Rate of hospital re-admissions
• Perceived stress according to Cohen's Perceived Stress Scale (PSS)
• The Perseverative Thinking Questionnaire (PTQ) to assess repetitive negative thinking and anxiety
• Rate of biochemistry: C-Reactive Protein (CRP; mg/dL), total-cholesterol (mg/dL), Low-Density Lipoprotein cholesterol (LDL; mg/dL), Low-Density Lipoprotein cholesterol (HDL; mg/dL), triglyceride (mg/dL), thyrotropin (TSH; mIU/L), vitamin-D (nmol/L) and HbA1c, oxidative stress, and hair cortisol
• Rate of Body Mass Index (BMI)
• Rate of blood pressure
• Rate of psychiatric readmissions in a five-year follow-up period after ending the study
• Rate of connection to the labor market in a five-year follow-up period after ending the study

Qualitative data will be used to support the quantitative outcomes.

Trial size: 130 participants.

Time schedule: The trial has been submitted for regulatory approvals November 2020, the first participant will be included August 2021, the expected last follow-up of the last participant will be August 2024. Data will be analyzed and published from August 2023 till August 2024, and we expect to submit the first manuscript December 2023.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Sofie Aggestrup, MSc, PhD student; Phone Number: +45 40149422; Email: anne.sofie.aggestrup@regionh.dk
• Study Contact Backup: Name: Klaus Martiny, Professor; Phone Number: +45 38647102; Email: klaus.martiny@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Recovery-group; The recovery group consists of: Physical, mental and social health education, advice and feedback from a health investigator.; Daily self-monitoring about their mood and health in an app, Monsenso.; 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 Names: Intervention-group
NO_INTERVENTION: Control-group; The control group consists of usual treatment at their General Practitioner and / or Private Practicing Psychiatrist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery support self-assessed by the INSPIRE scale	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.	12 months
Depressive symptoms self-assessed by the Hamilton Depression Rating 6-item Scale (Ham-D6)	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).	12 months
Wellbeing self-assessed by the WHO-5 scale	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.	12 months
Number of relapses of depression blindly-assessed by the Mini International Neuropsychiatric Interview	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).	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to medication according to Medicine Adherence Rating Scale (MARS)	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).	12 months
Rate of hospital re-admissions	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).	12 months
Perceived stress self-assessed by the Perceived Stress Scale (PSS)	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).	12 months
Repetitive negative thinking and anxiety self-assessed by the Perseverative Thinking Questionnaire (PTQ)	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).	12 months
Blood level	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).	12 months
Weight (kg)	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).	12 months
Height (meter)	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).	12 months
Blood pressure	Difference between the two groups in return to blood pressure (mm Hg) from baseline until 12 months after baseline (explorative outcome).	12 months
Blood level	Difference between the two groups in return to Thyrotropin (TSH; mIU/L) from baseline until 12 months after baseline (explorative outcome).	12 months
Blood level	Difference between the two groups in return to Vitamin D (nmol/L) from baseline until 12 months after baseline (explorative outcome).	12 months
Blood level	Difference between the two groups in return to Hemoglobin A1c (HbA1c; mmol/mol) from baseline until 12 months after baseline (explorative outcome).	12 months

Collaborators and Investigators

• Sponsor: Mental Health Centre Copenhagen
• Collaborators: Frederiksberg University Hospital; Research Unit Of General Practice, Copenhagen; Psychiatric Center Ballerup

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2021
• Primary Completion (ANTICIPATED): August 1, 2024
• Study Completion (ANTICIPATED): August 1, 2024

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (ACTUAL): December 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Depression; Recovery; Prevention; Randomized Controlled Trial; Mental health; Mixed methods; Physical health; Intersectoral collaboration
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: H-20076894

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No