Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Therapist-assisted iCBT 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
13 week long individualized prevention program containing, physical activation, sleep management, tailored cognitive behavioral therapy for individual problems.
Behavioral: Monthly screening with feedback
Participants are screened with a depression inventory each month and receives feedback from a therapist on the results
|
| Active Comparator: Monthly screening with feedback Monthly depression screening with therapist feedback. |
Behavioral: Monthly screening with feedback
Participants are screened with a depression inventory each month and receives feedback from a therapist on the results
|
| No Intervention: Control No intervention, follow-up along with all participants at 6 and 12-months. |
Outcome Measures
Primary Outcome Measures
- Depressive relapse (change in diagnostic status, SCID-I) [Baseline - 12 months]
Monthly screening via Montgomery-Asberg Depression Rating Scale - Self rated & Structured Clinical Interview for DSM IV
- Change from baseline in depressive symptoms (MADRS-S) [Baseline - 6 months]
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
- Change from baseline in depressive symptoms (MADRS-S) [Baseline - 12 months]
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
- Change from baseline in depressive symptoms (MADRS-S) [Monthly, 0-12 months]
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
Secondary Outcome Measures
- Change from baseline in health related quality of life (EQ-5D) [Baseline - 3 months]
Health related quality of life will be measured by an internet based version of the EQ-5D.
- Change from baseline in health related quality of life (EQ-5D) [Baseline - 6 months]
Health related quality of life will be measured by an internet based version of the EQ-5D.
- Change from baseline in health related quality of life (EQ-5D) [Baseline - 9 months]
Health related quality of life will be measured by an internet based version of the EQ-5D.
- Change from baseline in health related quality of life (EQ-5D) [Baseline - 12 months]
Health related quality of life will be measured by an internet based version of the EQ-5D.
- Change from baseline in Outcomes Questionnaire 45 (OQ-45) [Baseline - 3 months]
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.
- Change from baseline in Outcomes Questionnaire 45 (OQ-45) [Baseline - 6 months]
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.
- Change from baseline in Outcomes Questionnaire 45 (OQ-45) [Baseline - 9 months]
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.
- Change from baseline in Outcomes Questionnaire 45 (OQ-45) [Baseline - 12 months]
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.
- Change from baseline in the International Physical Activity Questionnaire (IPAQ) [Baseline - 3 months]
The International Physical Activity Questionnaire is a measure of physical activity
- Change from baseline in the International Physical Activity Questionnaire (IPAQ) [Baseline - 6 months]
The International Physical Activity Questionnaire is a measure of physical activity
- Change from baseline in the International Physical Activity Questionnaire (IPAQ) [Baseline - 9 months]
The International Physical Activity Questionnaire is a measure of physical activity
- Change from baseline in the International Physical Activity Questionnaire (IPAQ) [Baseline - 12 months]
The International Physical Activity Questionnaire is a measure of physical activity
- Morisky Medication Adherence Scale (MMAS-8) [Baseline - 3 months]
Self-reported measure of medication adherence
- Morisky Medication Adherence Scale (MMAS-8) [Baseline - 6 months]
Self-reported measure of medication adherence
- Morisky Medication Adherence Scale (MMAS-8) [Baseline - 9 months]
Self-reported measure of medication adherence
- Morisky Medication Adherence Scale (MMAS-8) [Baseline - 12 months]
Self-reported measure of medication adherence
- Insomnia Severity Index (ISI) [Baseline - 3 months]
Insomnia issues
- Insomnia Severity Index (ISI) [Baseline - 6 months]
Insomnia issues
- Insomnia Severity Index (ISI) [Baseline - 9 months]
Insomnia issues
- Insomnia Severity Index (ISI) [Baseline - 12 months]
Insomnia issues
- 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 [Baseline - 12 months]
Time to depressive relapse is recorded as secondary outcome variable
- Self reported treatment seeking [Baseline - 12 months]
Treatment seeking among participants is recorded as secondary outcome variable
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vuxenpsykiatrimottagning allmänpsykiatri Fosievägen Malmö | Malmö | Skåne | Sweden | 21431 |
Sponsors and Collaborators
- Lund University
Investigators
- Principal Investigator: Lars-Gunnar Lundh, Professor, Lund University, Departement of psychology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- rel-prev