|- candidate number||10171|
|- NTR Number||NTR2993|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-jul-2011|
|- Secondary IDs||2011/2 METC VUmc|
|- Public Title||Effectiveness of Happy@Work: A guided self-help internet-based intervention for employees with depressive symptoms.|
|- Scientific Title||(Cost-)Effectiveness of a guided self-help internet-based intervention for employees with depressive symptoms: A randomized controlled trial.|
|- hypothesis||The self-help intervention Happy@Work will reduce symptoms of depression.|
The self-help intervention Happy@Work will be cost effective.
|- Healt Condition(s) or Problem(s) studied||Depression, Burnout , Absenteeism, Presenteeism|
|- Inclusion criteria||1. 18 years or older;|
2. Depressive symptoms (> 16 CES-D).
|- Exclusion criteria||1. Labor dispute;|
2. No internet access and email.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2011|
|- planned closingdate||1-sep-2013|
|- Target number of participants||200|
|- Interventions||Happy@Work: |
An internet self-help intervention with guidance. The intervention is based on Problem Solving Therapy and Cognitive Behavioral Therapy. The intervention consists of 6 sessions and takes 6 weeks in total. Every session has a specific theme. During the course the respondents indicate what they think is important in their lives, they make a list of their "problems and worries" and they categorize their problems into three groups:
1. Unimportant (not related to what they think is important in their lives);
2. Important and solvable. These problems are solved by a systematic problem-solving approach consisting of 6 steps;
3. Important but unsolvable, for example having lost someone by death, having a chronic general medical disease. For these problems participants make a plan how to live with these problems.
One of the sessions specifically focuses on problems at work which are in relation to the depressive symptoms of the participant. Another session specifically concentrates on how to change dysfunctional attitudes into more positive thoughts.
The participants are supported by a trained coach (a social worker), who gives feedback to the homework assignments of the participant via the website.
The control group is a care as usual group. The care as usual group does not receive any special treatment during this trial. Participants in this group are only advised to seek help for their problems, such as advising their occupational physician or a psychologist.
|- Primary outcome||Depressive symptoms (CES-D).|
|- Secondary outcome||Absenteeism, presenteeism, health care use, anxiety symptoms, burnout symptoms, quality of life, social support and locus of control.|
|- Timepoints||Baseline and at 8 weeks, 6 months and 12 months after baseline. |
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. A.S. Geraedts|
|- CONTACT for SCIENTIFIC QUERIES||Drs. A.S. Geraedts|
|- Sponsor/Initiator ||VU University Medical Center, Department of Clinical Psychology|
(Source(s) of Monetary or Material Support)
|- Brief summary||Unipolar depressive disorders are highly prevalent, have high incidence, and have considerable impact on quality of life in patients and their relatives. Moreover, depressive disorders are linked with increased mortality rates, high levels of service use and huge economic costs.|
Prevention of depression is in the interests of businesses because the pay about 75% of the total economic costs of depression. These costs exist of absenteeism from work and loss of work productivity (presenteeism). We therefore developed a guided-self help internet-based intervention for employees with depressive symptoms.
|- Main changes (audit trail)|
|- RECORD||19-jul-2011 - 30-aug-2011|