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Evaluation of an online self-help intervention for people with HIV and depressive symptoms

Effectiveness of an internet-based self-help intervention for people with HIV and depressive symptoms: A search for mediators and moderators

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26719
Enrollment
200
Registered
2015-09-11
Start date
2015-02-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

HIV, aids, depression depressie, somberheid

Interventions

Intervention: "Living positive with HIV": Online self-help program to decrease depressive symptoms. The intervention includes telephone coaching once a week. The program lasts 6-10 weeks, 1-2 hours a

Sponsors

Leiden University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Being HIV positive. - The presence of mild to moderate depressive symptoms (defined as PHQ-9 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

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 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
Depressive symptoms: Patient Health Questionnaire 9 (PHQ-9) and the Center of Epidemiologic Studies Depression Scale (CES-D). Timepoint: pretest, end of intervention/waiting period and 3 and 6 months later.

Secondary

MeasureTime frame
Secondary outcomes are: physical tension; activation (Behavioral Activation for Depression Scale [BADS]); cognitive reappraisal (Emotion Regulation Questionnaire [ERQ]); cognitive coping (Cognitive Emotion Regulation Questionnaire [CERQ]); depressive thoughts (Crandell Cognitions Inventory [CCI]); behavioral coping (Behavioral Emotion Regulation Questionnaire [BERQ]); coping self-efficacy; goal adjustment (Goal Disengagement and Reengagement Scale); personal growth; symptoms of anxiety (Generalized Anxiety Disorder 7 [GAD-7]); negative life events (Life Events Scale); motivation to start with the intervention; compliance; dropout and reasons for dropout; medical data; and user satisfaction. Secondary outcomes will be measures at the pretest and at the 3 posttests. As potential moderators of treatment outcome demographic variables (such as gender and age), clinical and psychological characteristics (such as severity of depressive symptoms at baseline) will be tested. Mediator variables and the dependent variable will be measured three times during the intervention/waiting period, at the pretest and the first posttest. The following mediator variables will be assessed in the study: activation (2 items of the BADS), physical tension (2 items), cognitive reappraisal (2 items of the ERQ), cognitive coping (12 items of the CERQ), goal adjustment (2 items of the Goal disengagement and Reengagement Scale), symptoms of anxiety (PHQ-4), and self-efficacy (2 items). The dependent variable in the mediational analysis is depressive symptoms (PHQ-4).

Contacts

Public ContactSanne van Luenen

Leiden University, Faculty of Social Sciences, Clinical Psychology

s.van.luenen@fsw.leidenuniv.nl071-5277957

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)