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Evaluation of an evidence-based, Internet-supported self-help program for people living with HIV suffering from mild to moderate depressive symptoms.

Evaluation of an evidence-based, Internet-supported self-help program for people living with HIV suffering from mild to moderate depressive symptoms. - Evaluation of an online intervention for people with hiv and depression.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41852
Enrollment
200
Registered
2014-09-16
Start date
2015-02-01
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blue sad

Interventions

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 eig

Sponsors

Universiteit Leiden
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Being HIV positive; * The presence of mild to moderate depressive symptoms (defined as PHQ-9; Kroenke et al., 2001 score >4 and

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)