Evaluation of a booklet self-help intervention for people living with HIV and depressive symptoms

A booklet self-help intervention to reduce depressive symptoms among people living with HIV in Botswana: A randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON19871

Enrollment

200

Registered

2018-08-10

Start date

2018-09-10

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

Depression, HIV infection

Interventions

Intervention: "Living a positive life with HIV": The booklet self-help intervention employs CBT and stress management techniques and is based on self-regulation and stress-coping theories. The content

Eligibility

Inclusion criteria

Inclusion criteria: -Being HIV positive -Presenting with mild to moderate depressive symptoms (that is; a score greater than 4 and less than 20 on the Patient Health Questionnaire-9 (PHQ-9) -Aged 18 years and older -Having sufficient knowledge of the Setswana or the English language -Having a telephone -Availability for the eight weeks following enrollment into the study to work on the intervention.

Exclusion criteria

Exclusion criteria: -Having (almost) no symptoms of depression (a score of 4 or less on the PHQ-9) -Presenting with severe cognitive impairments, such as forgetfulness -Being in the first six months post HIV-diagnosis -Suicidality as determined by a score of ˃1 on the suicide item of the PHQ-9.

Design outcomes

Primary

Measure	Time frame
Depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) and the Center for Epidemiologic Studies Depression Scale (CES-D). Timepoints: Pretest, End of intervention at 8 weeks and follow-up 3 months later.	—

Secondary

Measure	Time frame
Physical tension (physical tension questionnaire); activation (Behavioral Activation for Depression Scale (BADS)); cognitive coping (Cognitive Emotion Regulation Questionnaire-short (CERQ-short)); behavioral coping (Behavioral Emotion Regulation Questionnaire (BERQ)); symptoms of anxiety (Generalized Anxiety Disorder 7 (GAD-7)); negative life events (Life Events Scale); self-efficacy; goal reengagement; social support;alcohol and substance abuse; motivation to start the intervention; drop-out and reasons for dropout; and user satisfaction. At baseline demographic variables will be measured as potential moderators of treatment outcome (e.g. gender and age) as well as clinical and psychological characteristics (such age depressive symptoms severity, physical health). The following mediator variables will be assessed in the study: physical tension (one-item), activation (one-item), coping (four subscales from the CERQ-short: rumination, catastrophizing, positive refocusing and refocus on planning), self-efficacy (one-item) and goal reengagement (six-items). the dependent variable (depressive symptoms) will be measured using the PHQ-4. Mediator variables will be measured at three points during the intervention/waiting period, at pretest and posttest.	—

Measure

Time frame

Physical tension (physical tension questionnaire); activation (Behavioral Activation for Depression Scale (BADS)); cognitive coping (Cognitive Emotion Regulation Questionnaire-short (CERQ-short)); behavioral coping (Behavioral Emotion Regulation Questionnaire (BERQ)); symptoms of anxiety (Generalized Anxiety Disorder 7 (GAD-7)); negative life events (Life Events Scale); self-efficacy; goal reengagement; social support;alcohol and substance abuse; motivation to start the intervention; drop-out and reasons for dropout; and user satisfaction. At baseline demographic variables will be measured as potential moderators of treatment outcome (e.g. gender and age) as well as clinical and psychological characteristics (such age depressive symptoms severity, physical health). The following mediator variables will be assessed in the study: physical tension (one-item), activation (one-item), coping (four subscales from the CERQ-short: rumination, catastrophizing, positive refocusing and refocus on planning), self-efficacy (one-item) and goal reengagement (six-items). the dependent variable (depressive symptoms) will be measured using the PHQ-4. Mediator variables will be measured at three points during the intervention/waiting period, at pretest and posttest.

—

Contacts

Public ContactBoitumelo Vavani-Tembo

vavanib@UB.AC.BW+267 72 192 773

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)