| Literature DB >> 34727088 |
Beáta Bőthe1,2, Christian Baumgartner3, Michael P Schaub3, Zsolt Demetrovics4,2, Gábor Orosz5.
Abstract
BACKGROUND AND AIMS: Despite problematic pornography use (PPU) being prevalent, no previous study has examined the effectiveness of evidence-based interventions for PPU, using rigorous methods. Using a two-armed randomized controlled trial study design, we examined the feasibility and initial effectiveness of a six-week online PPU intervention.Entities:
Keywords: cognitive-behavioral therapy; compulsive sexual behavior; feasibility; online intervention; problematic pornography use
Year: 2021 PMID: 34727088 PMCID: PMC8987418 DOI: 10.1556/2006.2021.00070
Source DB: PubMed Journal: J Behav Addict ISSN: 2062-5871 Impact factor: 6.756
Consort 2010 checklist of information to include when reporting a randomised trial*
| Section/Topic | Item No | Checklist item | Reported on page No |
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| 1a | Identification as a randomised trial in the title | 1 | |
| 1b | Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) | 1 | |
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| Background and objectives | 2a | Scientific background and explanation of rationale | 2 |
| 2b | Specific objectives or hypotheses | 2 | |
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| Trial design | 3a | Description of trial design (such as parallel, factorial) including allocation ratio | 3–5 |
| 3b | Important changes to methods after trial commencement (such as eligibility criteria), with reasons | NA | |
| Participants | 4a | Eligibility criteria for participants | 3 |
| 4b | Settings and locations where the data were collected | 3 | |
| Interventions | 5 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered | 3–5 |
| Outcomes | 6a | Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed | 5–6 |
| 6b | Any changes to trial outcomes after the trial commenced, with reasons | 2, 6 | |
| Sample size | 7a | How sample size was determined | 3 |
| 7b | When applicable, explanation of any interim analyses and stopping guidelines | NA | |
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| Sequence generation | 8a | Method used to generate the random allocation sequence | 3 |
| 8b | Type of randomisation; details of any restriction (such as blocking and block size) | 3 | |
| Allocation concealment mechanism | 9 | Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned | 3 |
| Implementation | 10 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | 3 |
| Blinding | 11a | If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how | 3 |
| 11b | If relevant, description of the similarity of interventions | NA | |
| Statistical methods | 12a | Statistical methods used to compare groups for primary and secondary outcomes | 6 |
| 12b | Methods for additional analyses, such as subgroup analyses and adjusted analyses | 6 | |
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| Participant flow (a diagram is strongly recommended) | 13a | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome | 3–6 |
| 13b | For each group, losses and exclusions after randomisation, together with reasons | 3 | |
| Recruitment | 14a | Dates defining the periods of recruitment and follow-up | 3 |
| 14b | Why the trial ended or was stopped | 3 | |
| Baseline data | 15 | A table showing baseline demographic and clinical characteristics for each group | 4–5 |
| Numbers analysed | 16 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | 8 |
| Outcomes and estimation | 17a | For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) | 7–8 |
| 17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | NA | |
| Ancillary analyses | 18 | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory | 7–11, 19–21 |
| Harms | 19 | All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) | NA |
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| Limitations | 20 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | 13 |
| Generalisability | 21 | Generalisability (external validity, applicability) of the trial findings | 11–13 |
| Interpretation | 22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | 11–13 |
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| Registration | 23 | Registration number and name of trial registry | 14 |
| Protocol | 24 | Where the full trial protocol can be accessed, if available | 3, 14 |
| Funding | 25 | Sources of funding and other support (such as supply of drugs), role of funders | 14 |
*We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org.
Fig. 1.Flowchart of Participants Based on the CONSORT Criteria
Note. CONSORT=Consolidated Standards of Reporting Trials.
Baseline sociodemographic, pornography use-related, and psychological characteristics of participants in the intervention and control groups
| Intervention group ( | Waitlist control group ( | Total ( | Statistical analysis | |
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| Woman | 5 (4.1) | 5 (3.5) | 10 (3.8) | |
| Man | 118 (95.9) | 136 (96.5) | 254 (96.2) | |
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| 33.3 (11.5) | 33.1 (9.9) | 33.2 (10.6) |
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| Primary school | 0 (0.0) | 2 (1.4) | 2 (0.8) | |
| Vocational school | 2 (1.6) | 2 (1.4) | 4 (1.5) | |
| High school | 26 (21.1) | 28 (19.9) | 54 (20.5) | |
| College or university | 95 (77.2) | 109 (77.3) | 127 (77.3) | |
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| United States | 43 (35.0) | 57 (40.4) | 100 (37.9) | |
| England | 19 (15.4) | 22 (15.6) | 41 (15.5) | |
| Canada | 12 (9.8) | 8 (5.7) | 20 (7.6) | |
| Hungary | 10 (8.1) | 8 (5.7) | 18 (6.8) | |
| India | 3 (2.4) | 7 (5.0) | 10 (3.8) | |
| Other (combineda) | 36 (29.2) | 39 (27.7) | 75 (28.4) | |
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| Single | 43 (35.0) | 68 (48.2) | 111 (42.0) | |
| In a relationship | 40 (32.5) | 30 (21.3) | 70 (26.5) | |
| Married | 37 (30.1) | 34 (24.1) | 71 (26.9) | |
| Engaged | 2 (1.6) | 6 (4.3) | 8 (3.0) | |
| Divorced | 0 (0.0) | 2 (1.4) | 2 (0.8) | |
| Other | 1 (0.8) | 1 (0.7) | 2 (0.8) | |
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| Heterosexual | 92 (74.8) | 102 (72.3) | 194 (73.5) | |
| Homosexual | 7 (5.7) | 6 (4.3) | 13 (4.9) | |
| Bisexual | 17 (13.8) | 30 (21.3) | 47 (17.8) | |
| Unsure | 7 (5.7) | 3 (2.1) | 10 (3.8) | |
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| 40 (32.5) | 48 (34.0) | 88 (33.3) |
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| 80.5 (16.6) | 81.1 (20.4) | 80.8 (18.7) |
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| >7 a week | 35 (28.5) | 44 (31.3) | 79 (29.9) | |
| 6–7 a week | 21 (17.1) | 20 (14.2) | 41 (15.5) | |
| 4–5 a week | 22 (17.9) | 25 (17.7) | 47 (17.8) | |
| 2–3 a week | 19 (15.4) | 24 (17.0) | 43 (16.3) | |
| weekly | 11 (8.9) | 16 (11.3) | 27 (10.2) | |
| Less frequently | 15 (12.4) | 12 (8.5) | 27 (10.2) | |
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| 50.9 (47.3) | 53.4 (52.2) | 52.2 (50.47) |
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| 3.0 (2.1) | 3.3 (2.2) | 3.2 (2.2) |
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| 4.6 (1.5) | 4.7 (1.4) | 4.7 (1.4) |
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| 46.7 (15.9) | 47.0 (15.6) | 46.9 (15.7) |
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| 52.2 (18.0) | 51.8 (18.9) | 52.0 (18.5) |
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| 13.0 (5.2) | 13.7 (5.1) | 13.4 (5.2) |
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| 2.1 (1.3) | 2.0 (1.2) | 2.0 (1.3) |
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| 18.9 (7.5) | 17.2 (7.6) | 18.0 (7.6) |
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| 12.0 (4.2) | 12.1 (4.5) | 12.0 (4.4) |
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| 2.6 (5.9) | 2.6 (4.4) | 2.6 (5.1) |
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| 18.3 (12.5) | 20.0 (11.5) | 19.2 (12.0) |
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| 15.0 (3.5) | 14.9 (4.3) | 14.9 (4.0) |
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| 17.3 (4.0) | 17.2 (4.6) | 17.2 (4.3) |
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| Never | 84 (68.3) | 94 (66.7) | 178 (67.4) | |
| Once or twice | 20 (16.3) | 14 (9.9) | 34 (12.9) | |
| Monthly | 4 (3.3) | 8 (5.7) | 12 (4.5) | |
| Weekly | 9 (7.3) | 7 (5.0) | 16 (6.1) | |
| Daily or almost daily | 6 (4.9) | 16 (12.8) | 24 (9.1) | |
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| Never | 104 (84.6) | 114 (80.9) | 218 (82.6) | |
| Once or twice | 2 (1.6) | 2 (1.4) | 4 (1.5) | |
| Monthly | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| Weekly | 1 (0.8) | 5 (3.5) | 6 (2.3) | |
| Daily or almost daily | 16 (13.0) | 20 (14.2) | 36 (13.6) |
Note. aLess than 5 participants in each unlisted country, bADHD: attention deficit hyperactivity disorder, cPrevious three months; the two most commonly used substances (i.e., cannabis and prescription stimulants) are included in table. M = mean, SD = standard deviation.
Baseline sociodemographic, pornography use-related, and psychological characteristics of participants in the intervention group who did not complete any modules, completed only one module, and completed more than one module
| Did not complete any moules ( | Completed only one module ( | Completed more than one module ( |
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| Woman | 4 (9.8) | 0 (0) | 1 (2.2) |
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| Man | 37 (90.2) | 37 (100.0) | 44 (97.8) | |
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| 35.4 (11.7) | 28.4 (8.8) | 35.4 (12.2) |
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| Primary school | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| Vocational school | 1 (2.4) | 1 (2.7) | 0 (0.0) | |
| High school | 12 (29.3) | 7 (18.9) | 7 (15.6) | |
| College or university | 28 (68.3) | 29 (78.4) | 38 (84.4) | |
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| United States | 13 (31.7) | 13 (35.1) | 17 (37.8) | |
| England | 6 (14.6) | 5 (13.5) | 8 (17.8) | |
| Canada | 5 (12.2) | 2 (5.4) | 5 (11.1) | |
| Hungary | 5 (12.2) | 3 (8.1) | 2 (4.4) | |
| India | 0 (0.0) | 3 (8.1) | 0 (0.0) | |
| Other (combineda) | 12 (29.3) | 11 (29.7) | 13 (28.9) | |
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| Single | 15 (36.6) | 17 (45.9) | 11 (24.4) | |
| In a relationship | 12 (29.3) | 16 (43.2) | 12 (26.7) | |
| Married | 13 (31.7) | 4 (10.8) | 20 (44.4) | |
| Engaged | 1 (2.4) | 0 (0.0) | 1 (2.2) | |
| Other | 0 (0.0) | 0 (0.0) | 1 (0.0) | |
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| Heterosexual | 31 (75.6) | 27 (73.0) | 34 (75.6) | |
| Homosexual | 1 (2.4) | 4 (10.8) | 2 (4.4) | |
| Bisexual | 6 (14.6) | 3 (8.1) | 8 (17.8) | |
| Unsure | 3 (7.3) | 3 (8.1) | 1 (2.2) | |
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| 13 (31.7) | 12 (32.4) | 15 (33.3) |
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| 76.5 (19.8) | 82.5 (13.7) | 82.4 (15.4) |
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| >7 a week | 14 (34.1) | 9 (24.3) | 12 (26.7) | |
| 6–7 a week | 7 (17.1) | 7 (18.9) | 7 (15.6) | |
| 4–5 a week | 8 (19.5) | 7 (18.9) | 7 (15.6) | |
| 2–3 a week | 5 (12.2) | 6 (16.2) | 8 (17.8) | |
| weekly | 2 (4.9) | 3 (8.1) | 6 (13.3) | |
| Less frequently | 5 (12.2) | 5 (13.5) | 5 (11.1) | |
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| 46.9 (44.1) | 47.4 (35.9) | 57.7 (57.8) |
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| 2.7 (1.9) | 3.2 (2.2) | 3.2 (2.2) |
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| 4.5 (1.7) | 4.7 (1.5) | 4.7 (1.2) |
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| 42.9 (16.2) | 50.5 (14.7) | 46.9 (16.1) |
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| 54.1 (20.1) | 49.1 (14.5) | 53.1 (18.8) |
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| 13.5 (5.1) | 12.5 (5.5) | 13.0 (5.1) |
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| 2.3 (1.4) | 1.9 (1.4) | 2.1 (1.2) |
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| 18.5 (7.6) | 17.2 (7.0) | 20.7 (7.5) |
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| 11.2 (4.3) | 12.7 (3.7) | 12.0 (4.5) |
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| 3.5 (7.6) | 2.8 (6.3) | 1.6 (3.1) |
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| 15.9 (11.7) | 22.1 (13.3) | 17.5 (12.1) |
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| 14.6 (3.6) | 14.9 (3.8) | 15.5 (3.2) |
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| 17.5 (3.9) | 17.2 (4.5) | 17.1 (3.8) |
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| Never | 23 (56.1) | 26 (70.3) | 35 (77.8) |
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| Once or twice | 8 (19.5) | 5 (16.2) | 6 (13.3) | |
| Monthly | 2 (4.9) | 2 (5.4) | 0 (0) | |
| Weekly | 3 (7.3) | 3 (8.1) | 3 (6.7) | |
| Daily or almost daily | 5 (12.2) | 0 (0.0) | 1 (2.2) | |
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| Never | 35 (85.4) | 30 (81.1) | 39 (86.7) |
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| Once or twice | 0 (0.0) | 0 (0.0) | 2 (4.4) | |
| Monthly | 0 (0.0 | 0 (0.0) | 0 (0.0) | |
| Weekly | 1 (2.4) | 0 (0.0) | 0 (0.0) | |
| Daily or almost daily | 5 (12.2) | 7 (18.9) | 4 (8.9) | |
Note. aLess than 5 participants in each unlisted country, bADHD: attention deficit hyperactivity disorder, cPrevious three months; the two most commonly used substances (i.e., cannabis and prescription stimulants) are included in table. M = mean, SD = standard deviation, NA = not applicable.
Results of the complete case analysis concerning pornography use-related variables
| Variables | 6-week follow-up | ||
| B (95% CI) |
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| Problematic pornography use | −19.33 (−28.75, −9.91) | −1.12 (−1.67, −0.58) | <0.001 |
| Pornography craving | −10.45 (−18.91, −1.99) | −0.71 (−1.28, −0.13) | 0.02 |
| Moral incongruence concerning pornography use | 0.61 (−0.17, 1.40) | 0.47 (−0.14, 1.09) | 0.12 |
| Self-perceived pornography addiction | −1.04 (−1.83, −0.24) | −0.66 (−1.16, −0.15) | 0.01 |
| Pornography avoidance self-efficacy | 17.89 (7.22, 28.56) | 0.95 (0.39, 1.53) | 0.001 |
| Pornography use frequency last 7 days | −2.88 (−4.11, −1.65) | −1.44 (−2.06, −0.83) | <0.001 |
| Time spent with pornography use per session in minutes | −7.75 (−32.16, 16.66) | −0.16 (−0.66, 0.34) | 0.53 |
Note. 95% CI = 95% confidence interval.
Comparison of the control and intervention groups concerning pornography use-related variables based on the complete case analysis
| Waitlist control group ( | Intervention group ( | ||||
| Variables | Baseline | 6-week follow-up | Baseline | 6-week follow-up | Cohen's |
| Problematic pornography use | 79.63 (20.30) | 80.06 (20.77) | 85.31 (19.43) | 64.00 (14.81) | 1.32 (0.68, 1.92) |
| Pornography craving | 46.58 (16.64) | 47.40 (15.80) | 38.69 (11.86) | 31.64 (12.19) | 0.40 (−0.20, 0.98) |
| Moral incongruence concerning pornography use | 3.29 (2.20) | 3.18 (2.18) | 2.85 (2.03) | 3.63 (1.96) | −0.51 (−1.09, 0.10) |
| Self-perceived pornography addiction | 4.67 (1.47) | 4.90 (1.31) | 4.92 (0.86) | 4.00 (1.34) | 0.85 (0.24, 1.44) |
| Pornography avoidance self-efficacy | 52.54 (19.77) | 51.63 (20.75) | 56.32 (17.90) | 73.08 (17.55) | −0.87 (−1.46, −0.25) |
| Pornography use frequency in the last 7 days | 4.94 (2.44) | 5.12 (2.35) | 5.36 (2.17) | 2.44 (1.69) | 1.65 (0.99, 2.26) |
| Time spent with pornography use per session in minutes | 56.81 (62.21) | 54.16 (53.48) | 37.85 (40.49) | 36.54 (34.00) | −0.02 (−0.61, 0.56) |
Note. aCohen's d reflects the difference between the intervention and control groups based on the change scores (i.e., from baseline to 6-week follow-up). 95% CI = 95% confidence interval. M = mean, SD = standard deviation.
Fig. 2.Completion of modules in the intervention group
Participants feedback on the usefulness, length, overall rating of the modules
| Modulesa,b | Usefulness | Understandability | Length | Appearance | Likelihood of quitting the module before finishing the module | Likelihood of quitting the program after finishing the module | Overall rating |
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| 74.58 (22.82) | 86.92 (17.72) | 28.75 (30.61) | 81.33 (22.52) | 25.50 (26.05) | 16.25 (22.61) | 78.17 (20.94) |
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| 78.15 (24.58) | 84.07 (19.48) | 22.78 (26.16) | 78.89 (22.88) | 23.89 (28.38) | 11.48 (17.20) | 77.59 (27.40) |
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| 78.82 (18.38) | 87.94 (14.73) | 33.82 (29.13) | 85.59 (14.81) | 26.76 (27.93) | 16.47 (24.73) | 73.82 (30.55) |
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| 82.27 (20.45) | 82.73 (20.04) | 15.00 (24.83) | 85.00 (18.20) | 13.18 (19.85) | 9.09 (16.01) | 78.18 (28.89) |
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| 77.22 (31.59) | 81.11 (22.72) | 15.56 (22.29) | 81.11 (22.72) | 11.67 (24.55) | 3.33 (5.90) | 79.44 (26.89) |
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| 82.67 (18.70) | 94.00 (9.86) | 8.00 (17.40) | 88.67 (14.57) | 6.00 (18.05) | 6.67 (20.59) | 82.00 (27.83) |
Note. aThe Modules column of the table has been published in the study protocol paper (Bőthe, Baumgartner, et al., 2020). bAs only 5 participants completed the Booster module (module 7), and it took place four weeks after finishing the intervention, we did not include it in the present analysis. The number of participants who provided feedback for each module is presented in parentheses after each module's title. As participants in the waitlist control condition were provided the opportunity to participate in the intervention three months after completing the baseline survey, their responses, and active participants' responses are also included in this table for comprehensiveness, resulting in larger subsample sizes than number of participants completing each module in the intervention group in Fig. 2. cThe range of response options for all questions was between 0% and 100%. Higher scores indicate more positive attitudes in the case of usefulness, understandability, appearance, and overall rating. In the case of length and quitting questions, higher scores indicate more negative attitudes. As 0 was the default value for all questions, we removed those participants' data from this analysis who had a 0 answer for all questions. M = mean, SD = standard deviation.
Modules in the intervention and summary of participants' qualitative feedback
| Modulesa,b | Contenta | Components mentioned as most usefulc | Components mentioned as least usefulc |
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General overview Introduction to fictional companions Reflections on personal pornography use (e.g., advantages and disadvantages, reasons for change, reviewing useful resources for a change) |
Reflecting on past success Identification of pros and cons of pornography use Identification of reasons to quit pornography use Looking at the antecedents and consequences of pornography use all at one time on the page Companions and reading about their experiences Interactive parts Diary, identifying resources that already have |
Identification of pros and cons of pornography use Identification of resources Age (i.e., only relatively young companions) and credibility of companions High number of questions and typing tasks Too much reading and text Too generic examples Some components seem redundant More explanation is needed for some tasks No human interaction Listing habits the participant has already changed |
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Identification of the internal and external risk situations that can lead to pornography use Learning how to deal with these risk situations |
Mindfulness Listing the feelings followed by porn use Examples of companions Identification and reflection on triggers The break-down of how to tackle risk situations Giving advice to a companion |
Giving advice to a companion Giving advice to future self Explaining mindfulness in own words, “too academical” examples (e.g., linked blogs), and already knowing about mindfulness Age (i.e., only relatively young companions) of companions Not mentioning "masturbation addiction" Some figures were too small on phones |
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Learning how to change personal pornography using habits Learning how to integrate joyful activities into everyday life |
Identifying things to do instead of pornography use (fun activities) Bringing up earlier responses from the participant about the reasons for quitting pornography use The realization that good habits can become lasting habits given time Knowledge that willpower can be changed |
List of sports and free time activities |
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Identification of personal triggers for cravings Learning strategies to reduce craving |
Learning about how cravings work (e.g., visualizations) Learning about how to deal with cravings |
Bringing up earlier responses from the participant Giving advice for future participants |
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Getting to know automatic negative thoughts and the most frequent common thinking errors Learning about the relations between one's thoughts, emotions, and pornography use Learning strategies to challenge automatic negative thoughts and develop balanced thoughts |
Learning about automatic negative thoughts Explanations and examples Learning about how to deal with automatic negative thoughts |
Keeping a thought diary (pdf) on a shared computer might be problematic |
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Reviewing the main contents of the previous modules Identification of one's toughest moments in the program and how he/she overcame them Planning strategies to prevent relapses to previous pornography use habits |
Reviewing previous content and opportunity to go back to earlier modules Best strategies part Prevention plan |
NA |
Note. aThe Modules and Content columns of the table have been published in the study protocol paper (Bőthe, Baumgartner, et al., 2020). bAs only 5 participants completed the Booster module (module 7), and it took place four weeks after finishing the intervention, we did not include it in the present analysis. cAs the number of participants gradually decreased, the number of and variety of mentioned topics in the feedback also decreased. The number of participants who provided qualitative feedback for each module is presented in parentheses after each module's title. As participants in the waitlist control condition were provided the opportunity to participate in the intervention three months after completing the baseline survey, their responses, and active participants' responses are also included in this table for comprehensiveness, resulting in larger subsample sizes than number of participants completing each module in the intervention group in Fig. 2.