The main objective of this study is to investigate the effectiveness of the self-help program compared to a waiting-list control group in reducing depressive symptoms. Secondary objectives include the investigation of moderators and mediators of…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: We will examine the change in depressive
symptoms from baseline to the posttests in both groups as measured by the
Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001) and
the Center of Epidemiologic Studies Depression Scale (CES-D; Radloff, 1977).
Secondary outcome
Secundary outcomes are: physical tension; activation (Behavioral Activation for
Depression Scale [BADS]; Kanter, Mulick, Busch, Berlin, & Martell, 2007);
cognitive reappraisal (Emotion Regulation Questionnaire [ERQ]; Gross & John,
2003); cognitive coping (Cognitive Emotion Regulation Questionnaire [CERQ];
Garnefski, Kraaij, & Spinhoven, 2001); depressive thoughts (Crandell Cognitions
Inventory [CCI]; Crandell & Chambless, 1986); behavioral coping (Behavioral
Emotion Regulation Questionnaire [BERQ]; Kraaij & Garnefski, 2012);
self-efficacy; goal adjustment (Goal Disengagement and Reengagement Scale,
Wrosch, Scheier, Miller, Schulz, & Carver, 2003); personal growth; symptoms of
anxiety (Generalized Anxiety Disorder 7 [GAD-7]; Spitzer, Kroenke, Williams, &
Löwe, 2006); negative life events (Life Events Scale, Garnefski & Kraaij,
2001); motivation to start with the intervention; compliance; dropout and
reasons for dropout; medical data; and user satisfaction. Cost-effectiveness
will be evaluated by using the PHQ-9 (scores will be transformed to Short Form
(36) Health Survey (SF-36; Ware & Sherbourne, 1992) quality of life scores) and
the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness
(TiC-P; Bouwmans et al., 2013).
With regard to all secondary outcomes, we will study the pre- versus
post-treatment changes.
The following variables will be tested as potential moderators of treatment
outcome: demographic variables (gender, age, educational level), severity of
depressive symptoms at baseline (PHQ-9 and CES-D), previous episodes of
depression, time since HIV diagnosis, use of medication, cognitive coping
(CERQ), and motivation to start with the intervention.
Mediator variables and the dependent variable will be measured every two weeks
during the intervention, at de pretest and at the three posttests. The
following mediator variables will be assessed in the study: activation (BADS),
physical tension, cognitive reappraisal (ERQ), cognitive coping (CERQ),
depressive thoughts (CCI), goal adjustment (Goal disengagement and Reengagement
Scale), and self-efficacy. The dependent variable is depressive symptoms
(PHQ-9).
Background summary
Many people living with HIV (PLH) suffer from depressive symptoms. In previous
research, it was found that self-help (in booklet format) cognitive behavioural
therapy (CBT) is effective in treating depression in PLH. We are currently
developing an online self-help program (based on the booklet) for PLH and
depressive symptoms. In this study we will investigate the effectiveness of the
self-help program. We expect that the program is effective in reducing
depressive symptoms in PLH.
Study objective
The main objective of this study is to investigate the effectiveness of the
self-help program compared to a waiting-list control group in reducing
depressive symptoms. Secondary objectives include the investigation of
moderators and mediators of treatment outcome and the investigation of the
cost-effectiveness of the intervention.
Study design
The study is a randomized controlled trial with a pretest and three posttests.
Intervention
The self-help program consists of four components: activation, relaxation,
changing irrational cognitions and goal attainment. The intervention group will
follow the self-help program for six to eight weeks, 1-2 hours a week. They
will receive weekly motivational support from a coach by telephone. The
waiting-list control group will receive minimal support from a coach, through
weekly telephone calls. They can follow the program after the second posttest
(after 5 months).
Study burden and risks
Participants in the intervention group will (probably) benefit from working on
the self-help program, their depressive symptoms will decrease. Participants in
the control group receive minimal support during the first 5 months, some
participants will improve during this time. Other participants may worsen in
these first months; their depressive symptoms may increase. Therefore, a coach
will monitor their well-being (also the participants in the intervention group)
and will follow a protocol with guidelines that describe what to do in which
situations. Furthermore, participants have to complete multiple questionnaires
during the study, every two weeks. This takes time for participants (10-30
minutes per assessment). When the outcome of the study is that the self-help
program is effective in decreasing depressive symptoms in PLH, we will
implement the self-help program for PLH.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
Inclusion criteria
* Being HIV positive;
* The presence of mild to moderate depressive symptoms (defined as PHQ-9; Kroenke et al., 2001 score >4 and < 20);
* Age 18 and older;
* Sufficient knowledge of the Dutch or English language;
* Access to the Internet;
* Having an e-mail address;
* Available for the next 8 weeks to work on the intervention.
Exclusion criteria
* Being in the first half year post HIV-diagnosis;
* Having severe cognitive impairments (e.g. forgetfulness);
* The presence of severe depressive symptoms (defined as PHQ-9; Kroenke et al., 2001, score of 20 or higher);
* Prominent suicide ideation (indicated by a score >1 on the suicide item of the PHQ-9);
* The absence of depressive symptoms (indicated by a PHQ-9 score of 4 or lower).
* Treatment by a psychologist or psychiatrist at the moment;
* Use of antidepressants for less than 3 months or change of type or dose of antidepressants in the past 3 months.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL48373.058.14 |