Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle

Study Overview
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Brief Summary
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Depression treatments including physical activity and sleep management has been shown to relieve depressive symptoms among participants suffering depressive episodes. This study evaluates the potential of these methods as prevention of depressive relapse or recurrence

Official Title
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Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Therapist-assisted iCBT
* Behavioral: Monthly screening with feedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A history of at least one episode of Major Depression. If medicating - Taking a stable (since one month) and therapeutic dosage of antidepressant medication Being able to read and write Swedish Having access to the internet Exclusion Criteria: Fulfilling the criteria for Major depression Bipolar disorder Psychosis Substance abuse Suicidality Currently in psychotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapist-assisted iCBT<br>Internet-delivered cognitive behavioral therapy (iCBT), containing physical activity and sleep management for preventing depressive relapse. Monthly depression screening with therapist feedback. | Behavioral: Therapist-assisted iCBT<br>* 13 week long individualized prevention program containing, physical activation, sleep management, tailored cognitive behavioral therapy for individual problems.<br>Behavioral: Monthly screening with feedback<br>* Participants are screened with a depression inventory each month and receives feedback from a therapist on the results<br>|
| Active Comparator: Monthly screening with feedback<br>Monthly depression screening with therapist feedback. | Behavioral: Monthly screening with feedback<br>* Participants are screened with a depression inventory each month and receives feedback from a therapist on the results<br>|
| No Intervention: Control<br>No intervention, follow-up along with all participants at 6 and 12-months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive relapse (change in diagnostic status, SCID-I) | Monthly screening via Montgomery-Asberg Depression Rating Scale - Self rated & Structured Clinical Interview for DSM IV | Baseline - 12 months | 
| Change from baseline in depressive symptoms (MADRS-S) | Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated. | Baseline - 6 months | 
| Change from baseline in depressive symptoms (MADRS-S) | Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated. | Baseline - 12 months | 
| Change from baseline in depressive symptoms (MADRS-S) | Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated. | Monthly, 0-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in health related quality of life (EQ-5D) | Health related quality of life will be measured by an internet based version of the EQ-5D. | Baseline - 3 months | 
| Change from baseline in health related quality of life (EQ-5D) | Health related quality of life will be measured by an internet based version of the EQ-5D. | Baseline - 6 months | 
| Change from baseline in health related quality of life (EQ-5D) | Health related quality of life will be measured by an internet based version of the EQ-5D. | Baseline - 9 months | 
| Change from baseline in health related quality of life (EQ-5D) | Health related quality of life will be measured by an internet based version of the EQ-5D. | Baseline - 12 months | 
| Change from baseline in Outcomes Questionnaire 45 (OQ-45) | The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role. It enables the clinician to assess functional level and change over time. | Baseline - 3 months | 
| Change from baseline in Outcomes Questionnaire 45 (OQ-45) | The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role. It enables the clinician to assess functional level and change over time. | Baseline - 6 months | 
| Change from baseline in Outcomes Questionnaire 45 (OQ-45) | The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role. It enables the clinician to assess functional level and change over time. | Baseline - 9 months | 
| Change from baseline in Outcomes Questionnaire 45 (OQ-45) | The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role. It enables the clinician to assess functional level and change over time. | Baseline - 12 months | 
| Change from baseline in the International Physical Activity Questionnaire (IPAQ) | The International Physical Activity Questionnaire is a measure of physical activity | Baseline - 3 months | 
| Change from baseline in the International Physical Activity Questionnaire (IPAQ) | The International Physical Activity Questionnaire is a measure of physical activity | Baseline - 6 months | 
| Change from baseline in the International Physical Activity Questionnaire (IPAQ) | The International Physical Activity Questionnaire is a measure of physical activity | Baseline - 9 months | 
| Change from baseline in the International Physical Activity Questionnaire (IPAQ) | The International Physical Activity Questionnaire is a measure of physical activity | Baseline - 12 months | 
| Morisky Medication Adherence Scale (MMAS-8) | Self-reported measure of medication adherence | Baseline - 3 months | 
| Morisky Medication Adherence Scale (MMAS-8) | Self-reported measure of medication adherence | Baseline - 6 months | 
| Morisky Medication Adherence Scale (MMAS-8) | Self-reported measure of medication adherence | Baseline - 9 months | 
| Morisky Medication Adherence Scale (MMAS-8) | Self-reported measure of medication adherence | Baseline - 12 months | 
| Insomnia Severity Index (ISI) | Insomnia issues | Baseline - 3 months | 
| Insomnia Severity Index (ISI) | Insomnia issues | Baseline - 6 months | 
| Insomnia Severity Index (ISI) | Insomnia issues | Baseline - 9 months | 
| Insomnia Severity Index (ISI) | Insomnia issues | Baseline - 12 months | 
| Alcohol Use Disorder Identification Test (AUDIT) |  | Baseline - 3 months | 
| Alcohol Use Disorder Identification Test (AUDIT) |  | Baseline - 6 months | 
| Alcohol Use Disorder Identification Test (AUDIT) |  | Baseline - 9 months | 
| Alcohol Use Disorder Identification Test (AUDIT) |  | Baseline - 12 months | 
| Time to depressive relapse | Time to depressive relapse is recorded as secondary outcome variable | Baseline - 12 months | 
| Self reported treatment seeking | Treatment seeking among participants is recorded as secondary outcome variable | Baseline - 12 months |