Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle

NCT ID: NCT02599597

Last Updated: 2020-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Therapist-assisted iCBT

Intervention Type BEHAVIORAL

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

Monthly screening with feedback

Intervention Type BEHAVIORAL

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

Monthly screening with feedback

Monthly depression screening with therapist feedback.

Group Type ACTIVE_COMPARATOR

Monthly screening with feedback

Intervention Type BEHAVIORAL

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

Control

No intervention, follow-up along with all participants at 6 and 12-months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Therapist-assisted iCBT

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

Intervention Type BEHAVIORAL

Monthly screening with feedback

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lund University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Olof Johansson

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lars-Gunnar Lundh, Professor

Role: PRINCIPAL_INVESTIGATOR

Lund University, Departement of psychology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vuxenpsykiatrimottagning allmänpsykiatri Fosievägen Malmö

Malmo, Skåne County, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

rel-prev

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CBT+ for Depression
NCT06001346 COMPLETED NA