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OpenTrials
Completed

NCT Number: NCT02599597

Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle

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

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vuxenpsykiatrimottagning allmänpsykiatri Fosievägen Malmö

Malmö, Skåne County, 21431, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapist-assisted ICBT

Behavioral

13 week long individualized prevention program containing, physical activation, sleep management, tailored cognitive behavioral therapy for individual problems.

Monthly screening with feedback

Behavioral

Participants are screened with a depression inventory each month and receives feedback from a therapist on the results

Primary outcomes

  1. Depressive relapse (change in diagnostic status, SCID-I)

    Time frame: Baseline - 12 months

    Monthly screening via Montgomery-Asberg Depression Rating Scale - Self rated & Structured Clinical Interview for DSM IV

  2. Change from baseline in depressive symptoms (MADRS-S)

    Time frame: Baseline - 6 months

    Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.

  3. Change from baseline in depressive symptoms (MADRS-S)

    Time frame: Baseline - 12 months

    Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.

  4. Change from baseline in depressive symptoms (MADRS-S)

    Time frame: 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 outcomes

  1. Change from baseline in health related quality of life (EQ-5D)

    Time frame: Baseline - 3 months

    Health related quality of life will be measured by an internet based version of the EQ-5D.

  2. Change from baseline in health related quality of life (EQ-5D)

    Time frame: Baseline - 6 months

    Health related quality of life will be measured by an internet based version of the EQ-5D.

  3. Change from baseline in health related quality of life (EQ-5D)

    Time frame: Baseline - 9 months

    Health related quality of life will be measured by an internet based version of the EQ-5D.

  4. Change from baseline in health related quality of life (EQ-5D)

    Time frame: Baseline - 12 months

    Health related quality of life will be measured by an internet based version of the EQ-5D.

  5. Change from baseline in Outcomes Questionnaire 45 (OQ-45)

    Time frame: 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.

  6. Change from baseline in Outcomes Questionnaire 45 (OQ-45)

    Time frame: 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.

  7. Change from baseline in Outcomes Questionnaire 45 (OQ-45)

    Time frame: 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.

  8. Change from baseline in Outcomes Questionnaire 45 (OQ-45)

    Time frame: 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.

  9. Change from baseline in the International Physical Activity Questionnaire (IPAQ)

    Time frame: Baseline - 3 months

    The International Physical Activity Questionnaire is a measure of physical activity

  10. Change from baseline in the International Physical Activity Questionnaire (IPAQ)

    Time frame: Baseline - 6 months

    The International Physical Activity Questionnaire is a measure of physical activity

  11. Change from baseline in the International Physical Activity Questionnaire (IPAQ)

    Time frame: Baseline - 9 months

    The International Physical Activity Questionnaire is a measure of physical activity

  12. Change from baseline in the International Physical Activity Questionnaire (IPAQ)

    Time frame: Baseline - 12 months

    The International Physical Activity Questionnaire is a measure of physical activity

  13. Morisky Medication Adherence Scale (MMAS-8)

    Time frame: Baseline - 3 months

    Self-reported measure of medication adherence

  14. Morisky Medication Adherence Scale (MMAS-8)

    Time frame: Baseline - 6 months

    Self-reported measure of medication adherence

  15. Morisky Medication Adherence Scale (MMAS-8)

    Time frame: Baseline - 9 months

    Self-reported measure of medication adherence

  16. Morisky Medication Adherence Scale (MMAS-8)

    Time frame: Baseline - 12 months

    Self-reported measure of medication adherence

  17. Insomnia Severity Index (ISI)

    Time frame: Baseline - 3 months

    Insomnia issues

  18. Insomnia Severity Index (ISI)

    Time frame: Baseline - 6 months

    Insomnia issues

  19. Insomnia Severity Index (ISI)

    Time frame: Baseline - 9 months

    Insomnia issues

  20. Insomnia Severity Index (ISI)

    Time frame: Baseline - 12 months

    Insomnia issues

  21. Alcohol Use Disorder Identification Test (AUDIT)

    Time frame: Baseline - 3 months

  22. Alcohol Use Disorder Identification Test (AUDIT)

    Time frame: Baseline - 6 months

  23. Alcohol Use Disorder Identification Test (AUDIT)

    Time frame: Baseline - 9 months

  24. Alcohol Use Disorder Identification Test (AUDIT)

    Time frame: Baseline - 12 months

  25. Time to depressive relapse

    Time frame: Baseline - 12 months

    Time to depressive relapse is recorded as secondary outcome variable

  26. Self reported treatment seeking

    Time frame: Baseline - 12 months

    Treatment seeking among participants is recorded as secondary outcome variable

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2015
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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